• 21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A
    • 78% of patients had tumor shrinkage at first scan
    • Median duration of response was 10.3 months as of data cutoff
    • Margetuximab plus retifanlimab was well tolerated with Grade 3 treatment-related adverse events (TRAEs) in 19% of patients; no Grade 4 TRAEs or treatment-related deaths
    • Findings suggest this chemotherapy-free combination, if validated and approved, may be a potential option for first-line HER2+ patients

    ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal…

    • 21 of 40 patients (53%) achieved confirmed responses by independent review, exceeding prespecified futility boundary for trial; enrollment proceeding to Part 2 of Cohort A
    • 78% of patients had tumor shrinkage at first scan
    • Median duration of response was 10.3 months as of data cutoff
    • Margetuximab plus retifanlimab was well tolerated with Grade 3 treatment-related adverse events (TRAEs) in 19% of patients; no Grade 4 TRAEs or treatment-related deaths
    • Findings suggest this chemotherapy-free combination, if validated and approved, may be a potential option for first-line HER2+ patients

    ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced results from Cohort A Part 1 of the Phase 2/3 MAHOGANY clinical trial of margetuximab. MARGENZA® (margetuximab-cmkb) is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ gastric cancer (GC) or gastroesophageal junction (GEJ) cancer in combination with a checkpoint inhibitor, with or without chemotherapy. The dataset is available in a poster titled "Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A" (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

    The efficacy data and safety cutoff dates were July 19, 2021 and August 3, 2021, respectively. In Cohort A Parts 1 and 2, the efficacy and safety of combining margetuximab and retifanlimab (investigational anti-PD-1 monoclonal antibody licensed to Incyte by MacroGenics) is planned to be evaluated in approximately 100 patients whose tumors are HER2+ at the 3+ level by immunohistochemical (IHC) staining, PD-L1+ (combined positive score ≥1%) and non-microsatellite instability-high (non-MSI-H). A pre-specified interim analysis assessing efficacy and safety was conducted on the first 40 non-MSI-H patients enrolled in Part 1. These data support advancement to Part 2 with plans to enroll approximately 60 additional response-evaluable non-MSI-H patients.

    A total of 43 HER2 3+ and PD-L1+ patients were enrolled in Cohort A Part 1 and received margetuximab 15 mg/kg plus retifanlimab 375 mg/kg administered intravenously every three weeks. Twenty-five patients (58%) had gastric cancer and 18 patients (42%) had gastroesophageal junction cancer; 36 patients (84%) had metastatic disease at study entry.

    MAHOGANY Cohort A Interim Analysis

    Anti-tumor activity was observed in patients treated with margetuximab plus retifanlimab in MAHOGANY Cohort A after the first scan. Tumor shrinkage was observed in 32 of 41 patients (78%) with at least one post-baseline target lesion measurement. Twenty-one of 40 response-evaluable patients achieved an objective response (53%, 95% confidence interval (CI): 36%-69%), including four confirmed complete responses and 17 confirmed partial responses. The number of confirmed responders by independent assessment exceeded the prespecified futility boundary for the trial, and enrollment is proceeding to Cohort A Part 2.

    Disease control was achieved in 29 of 40 patients (73%, CI: 56%-85%) and the median duration of response was 10.3 months (range: 2.1 – 14.5 months, CI: 4.6 months – not evaluable (NE)). Median progression-free survival (PFS) was 6.4 months by independent assessment (CI: 6.0 months – NE); median overall survival (OS) was not yet reached. At both 12 and 18 months, OS was 85% (CI: 63%-95%).

    Antitumor activity was comparable to historical data from the experimental arm of the Trastuzumab for Gastric Cancer (ToGA) study (trastuzumab + chemotherapy; n=294; objective response rate (ORR) of 47%; median duration of response (DOR) of 6.9 months)1 and initial data from the control arm (placebo + trastuzumab + chemotherapy) of the KEYNOTE‐811 study (ORR of 52%; median DOR of 9.5 months).2

    The safety analysis of all 43 patients treated with margetuximab plus retifanlimab suggests the combination was well tolerated in the study population. The most common TRAEs were fatigue (21% Grade 1-2, 0% Grade ≥3), infusion-related reaction (19% Grade 1-2, 0% Grade ≥3), rash (19% Grade 1-2, 0% Grade ≥3), diarrhea (16% Grade 1-2, 2% Grade 3), and pruritus (16% Grade 1-2, 0% Grade ≥3). A total of nine Grade 3 TRAEs were reported in eight patients (19%); no Grade 4 TRAEs were observed. Eight serious TRAEs were reported in seven patients. Infusion-related reactions considered as adverse events (AEs) of special interest occurred in six patients.

    Treatment-emergent AEs of Grade 3 occurred in 18 of 43 patients (42%) of patients. Three of 43 patients (7%) discontinued therapy due to immune-related AEs: renal dysfunction (Grade 3), hepatitis (Grade 3), and diabetic ketoacidosis (Grade 1); no AEs led to death.

    Safety data from MAHOGANY compare favorably to the experimental arm of ToGA in which overall Grade 3-4 AEs were 68% and the treatment-related mortality was 3%.1 Initial results from KEYNOTE-811 data presented at the 2021 ASCO Annual Meeting indicated that AEs of Grade 3-5 occurred in 57.1% of patients in the experimental arm (pembrolizumab + trastuzumab + chemotherapy) and in 57.4% of patients in the control arm, AEs leading to death occurred in 3.2% vs 4.6%, and AEs leading to discontinuation of any study drug occurred in 24.4% vs 25.9% of patients, respectively. Despite limitations of cross-study comparisons, regimens containing chemotherapy may have clinically relevant safety differences compared to the chemotherapy-free regimen in MAHOGANY Cohort A.

    "We are excited to share our results from the interim analysis of Part 1 of the MAHOGANY Cohort A study at ESMO," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "This study is designed to support potential registration of margetuximab in combination with other agents for patients with gastric or gastroesophageal junction cancer as part of our strategy to advance margetuximab in HER2+ cancer. The findings suggest the combination of margetuximab and retifanlimab may potentially provide a chemotherapy-free option as a first-line treatment for patients whose tumors are positive for both HER2 and PD-L1. We are pleased these data support the protocol's prespecified advancement into Part 2 of MAHOGANY Cohort A. We plan to discuss these results and future development of the combination in an upcoming scheduled meeting with the FDA."

    ESMO Presentation

    MacroGenics' Cohort A Part 1 MAHOGANY Study poster presentation is available for on-demand viewing on the ESMO website and on the "Events & Presentations" page on MacroGenics' website at http://ir.macrogenics.com/events.cfm.

    The MAHOGANY Study Design

    MAHOGANY (NCT04082364) is a Phase 2/3 clinical trial in two cohorts designed to evaluate margetuximab in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2+ GEJ/GC.

    Cohort A is designed as a single arm study to test margetuximab plus retifanlimab (previously known as MGA012 and INCMGA00012), an investigational anti-PD-1 monoclonal antibody, in patients with HER2+ and PD-L1+ tumors. The primary outcome measure for efficacy is ORR per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

    Cohort B is designed as a randomized trial to test margetuximab plus a checkpoint inhibitor in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2+ tumors irrespective of PD-L1 expression. Patients randomized to one of two experimental arms containing a checkpoint inhibitor will receive either retifanlimab or tebotelimab (previously known as MGD013), an investigational DART® molecule targeting PD-1 and LAG-3. The primary outcome measure for efficacy is OS.

    The Phase 2/3 clinical trial is being conducted at clinical sites globally, in collaboration with Zai Lab, the company's regional partner in Greater China. For additional information about the MAHOGANY study, please visit https://clinicaltrials.gov/ct2/show/NCT04082364.

    About Gastric and Gastroesophageal Junction Cancer

    Cancer of the stomach (gastric cancer, GC), or the gastroesophageal junction (GEJ) where the esophagus joins the stomach, is collectively known as gastroesophageal adenocarcinoma and is the fifth most common tumor type worldwide. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2+.

    About Margetuximab

    MARGENZA® (margetuximab-cmkb) is approved in HER2+ metastatic breast cancer and is being investigated as a potential first-line treatment for patients with HER2+ GC or GEJ cancer in combination with a checkpoint inhibitor, with or without chemotherapy. Margetuximab is an Fc-engineered monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors.  Through MacroGenics' Fc Optimization technology, margetuximab has been engineered to enhance the engagement of the immune system.

    Margetuximab is also being evaluated in combination with tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in various HER2+ tumors (NCT03219268). MacroGenics is partnered with Zai Lab for the development and commercialization of margetuximab in Greater China. For more information, please visit www.clinicaltrials.gov.

    About Retifanlimab

    Retifanlimab is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics. Retifanlimab was licensed to Incyte Corporation in 2017 under an exclusive global collaboration and license agreement. MacroGenics retains the right to develop its pipeline molecules with retifanlimab. Incyte is pursuing development of retifanlimab monotherapy in four potentially registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma, anal cancer and non-small cell lung cancer. Incyte and MacroGenics are each conducting multiple studies of retifanlimab in combination with other agents.

    About Tebotelimab

    Tebotelimab is an investigational, first-in-class bispecific DART molecule designed to provide co-blockade of PD-1 and LAG-3 for the potential treatment of a range of solid tumors and hematological malignancies.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, including enrollment in clinical trials, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "potential, " "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.






    1 Bang YJ, et al., Lancet. 2010; 376 (9742): 687-697.

    2 Janjigian YY, et al., J Clin Oncol. 2021; 39 (suppl 15): 4013.





    CONTACTS:
    Chris James, M.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172,  info@macrogenics.com
    View Full Article Hide Full Article
    • Metastatic castration-resistant prostate cancer (mCRPC): 21 of 39 patients (54%) achieved ≥ 50% prostate-specific antigen (PSA) reduction; 10 of 16 (63%) RECIST-evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved partial responses (two confirmed and two unconfirmed)
    • Non-small cell lung cancer (NSCLC): 13 of 16 (81%) evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved unconfirmed partial responses
    • Manageable safety profile overall, with low rate (7%) of discontinuation due to treatment-related adverse events (TRAEs)

    ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics…

    • Metastatic castration-resistant prostate cancer (mCRPC): 21 of 39 patients (54%) achieved ≥ 50% prostate-specific antigen (PSA) reduction; 10 of 16 (63%) RECIST-evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved partial responses (two confirmed and two unconfirmed)
    • Non-small cell lung cancer (NSCLC): 13 of 16 (81%) evaluable patients had anti-tumor activity; 4 of 16 (25%) achieved unconfirmed partial responses
    • Manageable safety profile overall, with low rate (7%) of discontinuation due to treatment-related adverse events (TRAEs)

    ROCKVILLE, MD, Sept. 16, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from dose expansion cohorts of the Company's ongoing Phase 1 clinical trial of MGC018. This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA-alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset is being presented in a poster titled "MGC018, an Anti-B7-H3 Antibody-Drug Conjugate (ADC), in Patients with Advanced Solid Tumors: Preliminary Results of Phase 1 Cohort Expansion" (Poster #620P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

    Cohort Expansion Results Update

    As of the August 16, 2021 data cut-off, a total of 86 patients with advanced solid tumors were enrolled in the cohort expansion of MGC018 at the recommended Phase 2 dose (RP2D) of 3.0 mg/kg, administered intravenously every three weeks. The enrollment includes 40 patients with mCRPC, 21 patients with NSCLC, 16 patients with triple negative breast cancer (TNBC) and nine patients with melanoma. In addition, enrollment of patients with squamous cell carcinoma of the head and neck (SCCHN) was recently initiated. The safety analysis both in the poster and below includes all enrolled patients, whereas the efficacy analysis was limited to mCRPC and NSCLC patients, as enrollment continues in the other tumor cohorts.

    In the cohort expansion, tumor response by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) was evaluated every nine weeks for all patients and PSA was assessed every three weeks in mCRPC.

    Preliminary Anti-tumor Results for mCRPC Cohort Expansion

    As of the August 16, 2021 data cut-off, all 40 patients in the mCRPC cohort expansion had been enrolled. Patients had previously received a median of three prior therapies for advanced disease, with all 40 patients having received both chemotherapy and next-generation hormonal therapy. The median B7-H3 H-score for all mCRPC patients was 223.

    A total of 39 mCRPC patients were evaluable for PSA response. Reductions in PSA levels of ≥ 50% were observed in 21 of 39 patients (54%). Twenty-four of the 39 patients (62%) remained on treatment as of the data cut-off.

    Of the 40 patients in the mCRPC cohort, 16 of the 23 patients with measurable disease were evaluable for tumor response by RECIST as of the data cut-off. Ten of these 16 patients (63%) had reductions in their target lesion sums from baseline. Four patients (25%) demonstrated a partial response (PR), consisting of two confirmed and two unconfirmed PRs. Treatment was ongoing in six of 16 patients with evaluable tumor response as of the data cut-off.

    Preliminary Anti-tumor Results for NSCLC Cohort Expansion

    As of the August 16, 2021 data cut-off, the NSCLC cohort expansion had been fully enrolled with 21 patients. Patients had previously received a median of two prior therapies for advanced disease, with 15 (71%) having previously received anti-PD-1/PD-L1 therapy. The median B7-H3 H-score for these patients was 139.

    A total of 16 NSCLC patients were evaluable for tumor response by RECIST. Thirteen of 16 (81%) patients had reductions in their target lesion sums from baseline. Four of these 16 patients (25%) experienced unconfirmed partial responses. Another one of these 16 patients experienced a 30% reduction in target lesions; however, the patient's non-target lesions were not evaluated due to an obstruction of the bronchus and overall response was not evaluable. Treatment was ongoing in seven of 16 patients as of the data cut-off.

    Preliminary Safety Results

    The safety analysis includes all 86 patients enrolled in the cohort expansion as of the August 16, 2021 data cut-off. The median number of doses received by mCRPC patients was 3.5 (range: 1-8); those with NSCLC received 3.0 (range: 1-7). Adverse events for the dose expansion cohorts of 3 mg/kg were generally consistent with those previously reported at ASCO 2021. TRAEs included hematologic and skin toxicities that have been clinically manageable to date. In the cohort expansion study overall, at least one TRAE of any grade was experienced by 78 of 86 patients (91%), with 43 of 86 patients (50%) experiencing a Grade ≥3 TRAE.  There were two Grade 5 fatal events: one from an unknown cause and one due to SARS-CoV-2.

    The most common TRAEs were fatigue (37% all grades; 1% Grade ≥3), neutropenia (34% all grades; 22% Grade ≥3), palmar plantar erythrodysesthesia syndrome (31% all grades; 4% Grade ≥3), pleural effusion (23% all grades; 1% Grade ≥3), nausea (22% all grades; 1% Grade ≥3), asthenia (20% all grades; 5% Grade ≥3) and thrombocytopenia (14% all grades; 7% Grade ≥3). The overall results have demonstrated a manageable safety profile with a low rate of treatment discontinuation due to TRAEs: only six of 86 (7%) patients had discontinued therapy in the cohort expansion as of the data cut-off date due to TRAEs.

    "We are highly encouraged by the growing data from our ongoing Phase 1 study of MGC018," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Consistent with previously presented data, we observed PSA reductions of 50% or greater in 54% of patients with metastatic castration-resistant prostate cancer. And now, we are particularly pleased to see partial responses emerge – both confirmed and unconfirmed – in mCRPC and NSCLC patients, with encouraging anti-tumor activity observed in the majority of patients for both tumor types. Also, we are very pleased with the evolving safety profile of MGC018, which showed neutropenia as the only Grade 3 or higher TRAE that exceeded a rate of 10% in this trial. Finally, further optimization of patient management has resulted in a low rate of MGC018 discontinuation due to TRAEs as of the data cutoff. Enrollment is ongoing in the TNBC, SCCHN, and melanoma cohorts and we look forward to providing further updates on patients in these cohorts, as well as patients in the mCRPC and NSCLC cohorts, at subsequent scientific conferences."

    ESMO Presentation

    MacroGenics' MGC018 poster presentation is available for on-demand viewing on the ESMO website and on the "Events & Presentations" page on MacroGenics' website at http://ir.macrogenics.com/events.cfm.

    About MGC018

    MGC018 is an ADC comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. B7-H3 is a molecule highly expressed on many solid tumors and associated with a poor clinical outcome. MGC018 is being evaluated in a Phase 1 study (NCT03729596). MacroGenics retains worldwide rights to MGC018.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, including enrollment in clinical trials, commercial prospects of or product revenues from MARGENZA®, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "potential," "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.





    CONTACTS:
    Chris James, M.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172,  info@macrogenics.com
    View Full Article Hide Full Article
  1. ROCKVILLE, MD, Sept. 12, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced poster presentations relating to multiple investigational product candidates at the European Society for Medical Oncology (ESMO) Virtual Conference, taking place September 16-21, 2021.

    Posters will be available on September 16, 2021. Details are as follows:

    620P - MGC018, an Anti-B7-H3 Antibody-Drug Conjugate (ADC), in Patients with Advanced Solid Tumors: Preliminary Results of Phase 1 Cohort Expansion
    Preliminary clinical results from the Phase 1 cohort expansion study of MGC018 in patients…

    ROCKVILLE, MD, Sept. 12, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced poster presentations relating to multiple investigational product candidates at the European Society for Medical Oncology (ESMO) Virtual Conference, taking place September 16-21, 2021.

    Posters will be available on September 16, 2021. Details are as follows:

    620P - MGC018, an Anti-B7-H3 Antibody-Drug Conjugate (ADC), in Patients with Advanced Solid Tumors: Preliminary Results of Phase 1 Cohort Expansion

    Preliminary clinical results from the Phase 1 cohort expansion study of MGC018 in patients with metastatic castration-resistant prostate cancer and non-small cell lung cancer will be presented in this poster. The abstract submitted to ESMO included data as of May 3, 2021, while the final poster will include updated results as of August 16, 2021.

    Presentation Topic: Genitourinary tumours, prostate

    1379P - Margetuximab with Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A

    Results from Cohort A Part 1 of the Phase 2/3 MAHOGANY clinical trial of margetuximab in combination with retifanlimab in treatment-naïve patients with locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) who are positive for both HER2 and PD-L1 will be presented in this poster. The efficacy data and safety cutoff dates for this poster were July 19, 2021 and August 3, 2021, respectively.

    Presentation Topic: Oesophagogastric cancer

    627P - Phase 2 Neoadjuvant Trial of the Anti-B7-H3 Antibody, Enoblituzumab, in Men with Localized Prostate Cancer: Safety, Efficacy, and Immune Correlates

    Results of a Phase 2 neoadjuvant trial of enoblituzumab in men with localized prostate cancer will be presented in this poster by Johns Hopkins University School of Medicine.

    Presentation Topic: Genitourinary tumours, prostate

    926TiP - Phase 2 Trial of Enoblituzumab Plus Retifanlimab or Tebotelimab in First-Line Treatment of Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

    A trial-in-progress poster regarding the Phase 2 study of enoblituzumab, an Fc‐engineered, anti‐B7‐H3 monoclonal antibody, will be presented.

    Presentation Topic: Head and neck cancer, excluding thyroid

    The abstracts referenced above were submitted to ESMO in May 2021 and are available on the ESMO website. The posters will be available for on-demand viewing on the ESMO website and on the "Events & Presentations" page in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm on or around September 16, 2021.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA®, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.



    CONTACTS:
    Chris James, M.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172,  info@macrogenics.com
    View Full Article Hide Full Article
    • Final overall survival (OS) analysis did not demonstrate a statistically significant advantage for MARGENZA over trastuzumab
    • OS was greater with MARGENZA plus chemotherapy in exploratory subgroups of patients carrying a CD16A 158F allele compared to trastuzumab plus chemotherapy arm, while the OS for trastuzumab plus chemotherapy was greater than MARGENZA plus chemotherapy for the small exploratory subgroup of patients homozygous for the CD16A 158V allele
    • The safety profile remains similar to what has been reported previously

    ROCKVILLE, MD, Sept. 07, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment…

    • Final overall survival (OS) analysis did not demonstrate a statistically significant advantage for MARGENZA over trastuzumab
    • OS was greater with MARGENZA plus chemotherapy in exploratory subgroups of patients carrying a CD16A 158F allele compared to trastuzumab plus chemotherapy arm, while the OS for trastuzumab plus chemotherapy was greater than MARGENZA plus chemotherapy for the small exploratory subgroup of patients homozygous for the CD16A 158V allele
    • The safety profile remains similar to what has been reported previously

    ROCKVILLE, MD, Sept. 07, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the final overall survival (OS) results of the SOPHIA Phase 3 study in adult patients with metastatic HER2-positive breast cancer. In 2020, MARGENZA (margetuximab-cmkb) was approved by the U.S. Food and Drug Administration (FDA) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The basis for this full approval was the progression-free survival (PFS) results in the SOPHIA study, which compared MARGENZA plus chemotherapy to trastuzumab plus chemotherapy in patients with metastatic HER2-positive breast cancer.

    The final OS analysis of the SOPHIA study was performed after 385 OS events occurred in the intent-to-treat (ITT) population. As per the study protocol, OS was defined as the number of days from randomization to the date of death (from any cause). The final OS analysis for the ITT population did not demonstrate a statistically significant advantage for MARGENZA plus chemotherapy compared to that of patients who received trastuzumab plus chemotherapy (hazard ratio [HR]=0.95; 95% Confidence Interval [CI]: 0.77-1.17; P=0.62). In this overall ITT population, the median survival was 21.6 months in patients treated with MARGENZA plus chemotherapy (N=266) compared to 21.9 months in patients treated with trastuzumab plus chemotherapy (N=270).

    A pre-specified, non-alpha-allocated exploratory analysis evaluated the effect of CD16A allelic variation on MARGENZA activity. Among the patients in the trial carrying a CD16A 158F allele, representing approximately 82% of study patients (437 of 536 patients), the median OS was prolonged by 2.5 months in the MARGENZA arm compared to the trastuzumab arm (23.3 months versus 20.8 months; HR=0.86; 95% CI: 0.69-1.08; nominal P=0.19). The numerical OS advantage was observed in the subgroup of CD16A patients who were homozygous for the F-allele at position 158 (i.e., "F/F" patients) in favor of MARGENZA plus chemotherapy (HR=0.72; 95% CI: 0.52-1.00; nominal P=0.05). In this subgroup, the median OS was 23.6 months in patients treated with MARGENZA plus chemotherapy (102 of 266 patients) compared to 19.2 months in patients treated with trastuzumab plus chemotherapy (90 of 270 patients).

    In the subgroup of CD16A F/V patients, the median OS was 21.3 months in patients treated with MARGENZA plus chemotherapy (119 of 266 patients) compared to 22.0 months in patients treated with trastuzumab plus chemotherapy (126 of 270 patients) (HR=0.96; 95% CI: 0.71-1.30; nominal P=0.78).

    In a small subgroup of CD16A V/V patients, OS was greater for trastuzumab plus chemotherapy than MARGENZA plus chemotherapy (HR=1.77; 95% CI: 1.01-3.12; nominal P=0.04). In this subgroup, the median survival was 22.0 months in patients treated with MARGENZA plus chemotherapy (37 of 266 patients) compared to 31.1 months in patients treated with trastuzumab plus chemotherapy (32 of 270 patients).

    The safety profile at the time of the final OS analysis of SOPHIA was similar to what was previously reported and consistent with the product's existing FDA-approved label. Adverse reactions occurring in greater than 20% of patients with MARGENZA in combination with chemotherapy were consistent with the existing product label. The MARGENZA U.S. Prescribing Information has a BOXED WARNING for left ventricular dysfunction and embryo-fetal toxicity. In addition, MARGENZA can cause infusion related reactions (IRRs). As stated in the U.S. Prescribing Information, IRRs occurred in 13% of patients treated with MARGENZA, with the majority reported as Grade 2 or less. Grade 3 IRRs occurred in 1.5% of patients. See below for Important Safety Information.

    "While the OS results in the SOPHIA ITT population are disappointing, the greater OS observed in the CD16A subgroup of patients with the lowest binding allelic variant of CD16 to the Fc region of IgG1 — namely, the F/F allele representing about 40% of all individuals (35.8% in this study) — is consistent with enhancements observed in MARGENZA's engineered Fc region," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Therefore, further studies are warranted to determine the impact of MARGENZA on HER2-positive breast cancer patients with different CD16A allelic variants, including the ongoing investigator-sponsored neoadjuvant study examining the effects of MARGENZA versus trastuzumab in patients expressing F-allelic variants of CD16A. We continue to believe MARGENZA may be the right choice for certain patients," added Dr. Koenig.

    The data will be submitted to the FDA and presented at a future scientific meeting.

    IMPORTANT SAFETY INFORMATION

    WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

    Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.

    Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

    WARNINGS & PRECAUTIONS:

    Left Ventricular Dysfunction

    • Left ventricular cardiac dysfunction can occur with MARGENZA.
    • In SOPHIA, left ventricular dysfunction occurred in 1.9% of patients treated with MARGENZA.
    • MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
    • Withhold MARGENZA for ≥16% absolute decrease in LVEF from pretreatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
    • Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
    • Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
    • Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.

    Embryo-Fetal Toxicity

    • Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
    • Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
    • Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
    • Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.

    Infusion-Related Reactions (IRRs)

    • MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
    • In SOPHIA, IRRs were reported by 13% of patients on MARGENZA plus chemotherapy. Most of the IRRs occur during Cycle 1. Grade 3 IRRs were reported in 1.5% of MARGENZA-treated patients.
    • Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
    • In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
    • Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.

    MOST COMMON ADVERSE REACTIONS:

    The most common adverse drug reactions (>10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia (57%), nausea (33%), diarrhea (25%), vomiting (21%), constipation (19%), headache (19%), pyrexia (19%), alopecia (18%), abdominal pain (17%), peripheral neuropathy (16%), arthralgia/myalgia (14%), cough (14%), decreased appetite (14%), dyspnea (13%), infusion-related reactions (13%), palmar-plantar erythrodysesthesia (13%), and extremity pain (11%).

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

    INDICATION

    MARGENZA is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

    Please see full Prescribing Information, including Boxed Warning.

    About the SOPHIA Study

    The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating MARGENZA plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer, who have previously been treated with anti-HER2-targeted therapies. All study patients had previously received trastuzumab, all but one patient had previously received pertuzumab, and 91% had previously received ado-trastuzumab emtansine, or T-DM1.

    The study enrolled 536 patients who were randomized 1:1 to receive either MARGENZA (n=266) given intravenously at 15 mg/kg every three weeks or trastuzumab (n=270) given intravenously at 6 mg/kg (or 8 mg/kg for loading dose) every three weeks in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine) given at the standard dose. Intent-to-treat PFS analysis occurred after 265 PFS events.

    The primary endpoints of the study were sequentially-assessed PFS, determined by blinded, centrally-reviewed radiological review, followed by OS. Additional key secondary endpoints are PFS by investigator assessment and ORR. Tertiary endpoints include ORR by investigator assessment and safety. PFS and ORR were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    About HER2-positive Breast Cancer

    Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Monoclonal antibodies targeting HER2 have greatly improved outcomes; however, a significant number of patients progress to later lines of therapy. Effective treatments for metastatic HER2-positive breast cancer continue to remain an unmet need.

    About MARGENZA

    MARGENZA (margetuximab-cmkb) is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Similar to trastuzumab, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC). However, through MacroGenics' Fc Optimization technology, margetuximab-cmkb has been engineered to enhance the engagement of the immune system. In vitro, the modified Fc region of margetuximab-cmkb increases binding to the activating Fc receptor FCGR3A (CD16A) and decreases binding to inhibitor Fc receptor FCGR2B (CD32B).  These changes lead to greater in vitro ADCC and NK cell activation.  The clinical significance of in vitro data is unknown.

    MARGENZA is also being evaluated in combination with checkpoint blockade in the Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer (NCT04082364), and in combination with tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in various HER2+ tumors (NCT03219268). In addition, MARGENZA is being evaluated in an investigator-sponsored, Phase 2 neoadjuvant study in patients with stage 2-3 HER2-positive breast cancer (NCT04425018). For more information, please visit www.clinicaltrials.gov.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.



    CONTACTS:
    Chris James, M.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172,  info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  2. ROCKVILLE, MD, Sept. 02, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in September:

    • Citi's 16th Annual BioPharma Virtual Conference.  MacroGenics' President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a panel discussion, Novel Antibodies and Protein Therapies in Oncology, on Thursday, September 9, 2021, at 1:25 pm ET.  Management will also participate in one-on-one meetings.
    • H.C. Wainwright 23rd Annual Global Investment Conference.  MacroGenics management…

    ROCKVILLE, MD, Sept. 02, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in September:

    • Citi's 16th Annual BioPharma Virtual Conference.  MacroGenics' President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a panel discussion, Novel Antibodies and Protein Therapies in Oncology, on Thursday, September 9, 2021, at 1:25 pm ET.  Management will also participate in one-on-one meetings.
    • H.C. Wainwright 23rd Annual Global Investment Conference.  MacroGenics management is scheduled to participate in a fireside chat, which will be available for on-demand viewing from September 13-15, 2021.  In addition, management will participate in one-on-one meetings.
    • 2021 Cantor Virtual Global Healthcare Conference.  MacroGenics management is scheduled to participate in a fireside chat on Thursday, September 30, 2021, at 12:40 pm ET, and will also participate in one-on-one meetings.

    Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm.  The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.



    CONTACTS:
    Chris James, M.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172,  info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  3. ROCKVILLE, Aug. 05, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following conferences in August:

    • BTIG Virtual Biotechnology Conference 2021.  MacroGenics' management is scheduled to participate in a fireside chat on Tuesday, August 10, 2021, at 9:30 am ET live via webcast to conference attendees (not available for replay).  Management will also participate in one-on-one meetings.
    • 12th Annual Wedbush PacGrow Healthcare Conference.  MacroGenics' President & Chief Executive Officer, Scott Koenig, M.D., Ph.D…

    ROCKVILLE, Aug. 05, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following conferences in August:

    • BTIG Virtual Biotechnology Conference 2021.  MacroGenics' management is scheduled to participate in a fireside chat on Tuesday, August 10, 2021, at 9:30 am ET live via webcast to conference attendees (not available for replay).  Management will also participate in one-on-one meetings.
    • 12th Annual Wedbush PacGrow Healthcare Conference.  MacroGenics' President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a panel discussion, ADCs – Take Me to Your Tumor, on Wednesday, August 11, 2021, at 2:20 pm ET.  Management will also participate in one-on-one meetings.

    A webcast of the August 11, 2021 panel discussion may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company maintains archived replays of webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###



    CONTACTS:
    Chris James, M.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172,  info@macrogenics.com
    

    Primary Logo

    View Full Article Hide Full Article
    • Upcoming MGC018 and margetuximab MAHOGANY clinical data presentations at European Society for Medical Oncology (ESMO) Meeting
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., July 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021.

    "In June, we presented encouraging data from a Phase 1 study of MGC018 at ASCO. We look forward to providing further updates on this compound and margetuximab in gastric cancer at ESMO in September. Beyond these…

    • Upcoming MGC018 and margetuximab MAHOGANY clinical data presentations at European Society for Medical Oncology (ESMO) Meeting
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., July 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended June 30, 2021.

    "In June, we presented encouraging data from a Phase 1 study of MGC018 at ASCO. We look forward to providing further updates on this compound and margetuximab in gastric cancer at ESMO in September. Beyond these two programs, we continue to progress our growing pipeline of investigational therapeutics for the potential treatment of cancer as well as to execute on the recent launch and commercialization of MARGENZA® with our partner, EVERSANA," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Also in June, we announced our broad strategic collaboration with Zai Lab to develop and commercialize preclinical bispecific antibodies in oncology. We're very pleased to have entered this second collaboration with Zai Lab."

    Key Updates on Proprietary Programs

    Recent progress and anticipated events in 2021 related to MacroGenics' approved product, MARGENZA, and its investigational product candidates in clinical development are highlighted below.

    • Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.
      • MARGENZA (margetuximab-cmkb) commercial launch. In March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Based on the accrued overall survival (OS) events in the SOPHIA metastatic breast cancer Phase 3 study, the Company expects to complete and share top-line results from the final analysis of OS data, based on 385 OS events by the end of the third quarter of 2021.
      • Phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer.  All 40 patients have been enrolled in the first part of Module A of the MAHOGANY study, which is evaluating margetuximab in combination with retifanlimab, an anti-PD-1 molecule the Company licensed to Incyte Corporation in 2017. The Company plans to report interim safety and efficacy data on these patients at ESMO in September 2021.
    • Flotetuzumab is a bispecific CD123 × CD3 DART® molecule being evaluated in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in late 2021.
    • MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. In June 2021, MacroGenics presented updated clinical data at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating anti-tumor activity in patients with melanoma and metastatic castration-resistant prostate cancer (mCRPC). Preliminary results in the mCRPC cohort expansion showed 11 of 22 patients (50%) had a PSA reduction of 50% or greater, with anti-tumor activity observed in four of seven patients with measurable disease who had their first 9-week imaging results available, including one unconfirmed partial response. Anti-tumor activity was also reported in all three melanoma patients who received 4 mg/kg in dose escalation, with one patient achieving a confirmed partial response. MGC018 trial cohorts are ongoing for mCRPC, melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN) and triple negative breast cancer (TNBC). MacroGenics will provide an update of clinical data at ESMO in September.
    • Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 mAb. MacroGenics continues to recruit its Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative. The Company has recently activated clinical trial sites in Europe to advance enrollment of the study.
    • Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. MacroGenics is evaluating the molecule in patients as both monotherapy as well as in combination with other agents. The Company's partner in Greater China, Zai Lab, is evaluating tebotelimab as monotherapy in patients with hepatocellular carcinoma and melanoma as well as in combination with niraparib in a variety of advanced or metastatic solid tumors. MacroGenics expects to provide an update on the next stage of development for tebotelimab later this year.
    • MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting a Phase 1 dose expansion study in cohorts of patients with microsatellite stable colorectal cancer (MSS CRC), checkpoint-naïve NSCLC, mCRPC and melanoma.
    • IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in patients with select cancers and have indicated they anticipate disclosing initial data in early 2022.
    • MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development. The molecule incorporates a CD3 component designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, along with an Fc domain to permit intermittent dosing through a longer half-life. The Company expects to submit an Investigational New Drug (IND) application to the FDA in the fourth quarter of 2021.

    Second Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2021 were $297.3 million, compared to $272.5 million as of December 31, 2020. This does not include $55 million in consideration (consisting of a $25 million upfront payment and a $30 million equity investment) received from Zai Lab in July 2021, which related to the execution of the collaboration agreement that was announced on June 16, 2021.

       
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $30.8 million for the quarter ended June 30, 2021, including $3.2 million net sales of MARGENZA, compared to total revenue of $20.3 million for the quarter ended June 30, 2020. This increase was primarily due to the recognition of $14.4 million of revenue from Zai Lab related to the recent June 2021 collaboration announcement and recognition of a $5 million milestone from Incyte Corporation.



    • R&D Expenses: Research and development expenses were $55.8 million for the quarter ended June 30, 2021, compared to $57.4 million for the quarter ended June 30, 2020.



    • SG&A Expenses: Selling, general and administrative expenses were $15.2 million for the quarter ended June 30, 2021, compared to $10.2 million for the quarter ended June 30, 2020. This increase was primarily related to MARGENZA launch costs.
    • Net Loss: Net loss was $39.9 million for the quarter ended June 30, 2021, compared to net loss of $46.9 million for the quarter ended June 30, 2020.

       
    • Shares Outstanding: Shares outstanding as of June 30, 2021 were 60,133,447, which excluded 958,467 shares issued to Zai Lab in July as part of the recently announced collaboration.

       
    • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of June 30, 2021, plus consideration received from Zai Lab in July 2021, as well as anticipated and potential collaboration payments, should enable it to fund its operations through 2023, assuming the Company's programs and collaborations advance as currently contemplated.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended June 30, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 7983402.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    MACROGENICS, INC.

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

     June 30, 2021 December 31, 2020
     (unaudited)  
    Cash, cash equivalents and marketable securities$297,316  $272,531 
    Total assets425,911  378,743 
    Deferred revenue30,041  11,382 
    Total stockholders' equity319,045  295,884 

    MACROGENICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Amounts in thousands, except share and per share data)

     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Revenues:       
    Revenue from collaborative and other agreements$27,168   $15,636   $42,352   $28,603  
    Product revenue, net3,203      4,090     
    Revenue from government agreements386   4,621   1,196   5,336  
    Total revenues30,757   20,257   47,638   33,939  
    Costs and expenses:       
    Cost of product sales22      39     
    Research and development55,780   57,351   108,901   106,245  
    Selling, general and administrative15,234   10,216   30,270   20,449  
    Total costs and expenses71,036   67,567   139,210   126,694  
    Loss from operations(40,279)  (47,310)  (91,572)  (92,755) 
    Other income344   425   365   1,146  
    Net loss(39,935)  (46,885)  (91,207)  (91,609) 
    Other comprehensive income:       
    Unrealized gain on investments(10)  (55)  8   1  
    Comprehensive loss$(39,945)  $(46,940)  $(91,199)  $(91,608) 
            
    Basic and diluted net loss per common share$(0.66)  $(0.94)  $(1.56)  $(1.85) 
    Basic and diluted weighted average common shares outstanding60,068,315   50,018,462   58,643,496   49,515,562  

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    CONTACTS:

    Chris James, M.D., Vice President, Investor Relations & Corporate Communications

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172

    info@macrogenics.com



    Primary Logo

    View Full Article Hide Full Article
  4. ROCKVILLE, MD, July 22, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the second quarter 2021 after the market closes on Thursday, July 29, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, July 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 7983402.

    The listen-only webcast of the…

    ROCKVILLE, MD, July 22, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the second quarter 2021 after the market closes on Thursday, July 29, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, July 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 7983402.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. 



    CONTACTS: 
    Christopher James, M.D., Vice President, Investor Relations and Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com
    

    Primary Logo

    View Full Article Hide Full Article
    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules
    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    ROCKVILLE, MD, SHANGHAI and SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, and Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, announced today…

    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules
    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    ROCKVILLE, MD, SHANGHAI and SAN FRANCISCO, June 16, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, and Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, announced today that the companies have entered into an exclusive collaboration and license agreement involving up to four immuno-oncology molecules.

    The first collaboration program covers a lead research molecule that incorporates MacroGenics' DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The next-generation CD3 component of the DART bispecific molecule has been designed to minimize cytokine-release syndrome while maintaining anti-tumor cytolytic activity. The second collaboration program will cover a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea and MacroGenics receives commercial rights in all other territories. For the lead molecule, Zai Lab receives an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share.

    Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules. For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.

    "We are very pleased to be expanding our existing relationship with Zai Lab, which already includes regional rights in Greater China for two clinical-stage programs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Zai has a strong track record of rapidly progressing the development of innovative product candidates in China. This new partnership enables us to jointly discover, develop and deliver potentially best-in-class therapeutics to address patients' unmet medical needs."

    "MacroGenics has been a great partner and one of the leading companies in the immuno-oncology field," said Samantha Du, Ph.D., Founder, Chairperson, Chief Executive Officer of Zai Lab.  "We are pleased to expand our strategic collaboration, which leverages both companies' unique research capabilities and gives Zai Lab access to MacroGenics' proprietary technologies to expand our innovative oncology portfolio on a global basis."

    Under the terms of the agreement, MacroGenics receives initial consideration from Zai Lab of $55 million, including an upfront payment of $25 million and an equity investment of $30 million in MacroGenics' common stock at $31.30 per share. In addition, MacroGenics is eligible to receive up to $1.4 billion in potential development, regulatory and commercial milestone payments for the four programs. If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Lab's territories.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, DART and TRIDENT are trademarks or registered trademarks of MacroGenics, Inc.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB, HKEX: 9688))) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. Our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of potentially innovative, marketed products and product candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to positively impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    MacroGenics Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Zai Lab Forward-Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects and plans for developing and commercializing the preclinical bispecific antibody-based molecules and other statements containing words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would" and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab's ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab's ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab's results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions and (6) the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab's views as of any date subsequent to the date of this press release.

    ###



    For more information, please contact:
    
    MacroGenics Contacts
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172
    info@macrogenics.com
    
    Zai Lab Contacts
    Billy Cho, CFO
    +86 137 6151 2501 
    billy.cho@zailaboratory.com
    
    Media: Ryo Imai / Robert Flamm, Ph.D.
    Burns McClellan, on behalf of Zai Lab
    212-213-0006 ext. 315 / 364
    rimai@burnsmc.com / rflamm@burnsmc.com
    
    Investors: Mike Zanoni
    Endurance Advisors, on behalf of Zai Lab
    610-442-8570
    mzanoni@enduranceadvisors.com

    Primary Logo

    View Full Article Hide Full Article
    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules
    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    SHANGHAI, SAN FRANCISCO and ROCKVILLE, MD, June 16, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, and MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, announced today…

    • Zai Lab granted combination of regional Asian and global rights for up to four CD3- or CD47-based bispecific molecules

    • MacroGenics provides rights to Zai Lab for its DART® and TRIDENT® multi-specific platforms and a lead research program targeting solid tumors
    • Zai Lab provides rights to MacroGenics for certain intellectual property related to CD47 for select tumor targets

    SHANGHAI, SAN FRANCISCO and ROCKVILLE, MD, June 16, 2021 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ:ZLAB, HKEX: 9688))), an innovative commercial-stage biopharmaceutical company, and MacroGenics (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal-antibody-based therapeutics for the treatment of cancer, announced today that the companies have entered into an exclusive collaboration and license agreement involving up to four immuno-oncology molecules.

    The first collaboration program covers a lead research molecule that incorporates MacroGenics' DART platform and binds CD3 and an undisclosed target that is expressed in multiple solid tumors. The next-generation CD3 component of the DART bispecific molecule has been designed to minimize cytokine-release syndrome while maintaining anti-tumor cytolytic activity. The second collaboration program will cover a target to be designated by MacroGenics. For both molecules, Zai receives commercial rights in Greater China, Japan, and Korea and MacroGenics receives commercial rights in all other territories. For the lead molecule, Zai Lab receives an option upon reaching a predefined clinical milestone to convert the regional arrangement into a global 50/50 profit share.

    Zai Lab also obtains exclusive, global licenses from MacroGenics to develop, manufacture and commercialize two additional molecules. For the four programs, each company will contribute intellectual property to generate either CD3- or CD47-based bispecific antibodies.

    "We are very pleased to be expanding our existing relationship with Zai Lab, which already includes regional rights in Greater China for two clinical-stage programs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Zai has a strong track record of rapidly progressing the development of innovative product candidates in China. This new partnership enables us to jointly discover, develop and deliver potentially best-in-class therapeutics to address patients' unmet medical needs."

    "MacroGenics has been a great partner and one of the leading companies in the immuno-oncology field," said Samantha Du, Ph.D., Founder, Chairperson, Chief Executive Officer of Zai Lab. "We are pleased to expand our strategic collaboration, which leverages both companies' unique research capabilities and gives Zai Lab access to MacroGenics' proprietary technologies to expand our innovative oncology portfolio on a global basis."

    Under the terms of the agreement, MacroGenics receives initial consideration from Zai Lab of $55 million, including an upfront payment of $25 million and an equity investment of $30 million in MacroGenics' common stock at $31.30 per share. In addition, MacroGenics is eligible to receive up to $1.4 billion in potential development, regulatory and commercial milestone payments for the four programs. If products from the collaboration are commercialized, MacroGenics would also receive royalties on annual net sales in Zai Lab's territories.

    About Zai Lab

    Zai Lab (NASDAQ:ZLAB, HKEX: 9688))) is an innovative commercial-stage biopharmaceutical company focused on bringing transformative medicines for cancer and infectious and autoimmune diseases to patients in China and around the world. We aim to address significant unmet medical needs in large, fast-growing segments of the pharmaceutical market. Our experienced team has secured partnerships with leading global biopharmaceutical companies to generate a broad pipeline of potentially innovative, marketed products and product candidates. We have also built an in-house team with strong drug discovery and translational research capabilities and are establishing a pipeline of proprietary drug candidates with global rights. Our vision is to become a leading global biopharmaceutical company, discovering, developing, manufacturing and commercializing our portfolio in order to positively impact human health worldwide.

    For additional information about the company, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, DART and TRIDENT are trademarks or registered trademarks of MacroGenics, Inc.

    Zai Lab Forward-Looking Statements

    This press release contains statements about future expectations, plans and prospects for Zai Lab, including, without limitation, statements regarding the prospects and plans for developing and commercializing the preclinical bispecific antibody-based molecules and other statements containing words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would" and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact nor are they guarantees or assurances of future performance. Forward-looking statements are based on Zai Lab's expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) Zai Lab's ability to successfully commercialize and generate revenue from its approved products; (2) Zai Lab's ability to finance its operations and business initiatives and obtain funding for such activities, (3) Zai Lab's results of clinical and pre-clinical development of its product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of Zai Lab's product candidates, (5) the effects of the novel coronavirus (COVID-19) pandemic on our business and general economic, regulatory and political conditions and (6) the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. Zai Lab anticipates that subsequent events and developments will cause Zai Lab's expectations and assumptions to change and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing Zai Lab's views as of any date subsequent to the date of this press release.

    MacroGenics Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    For more information, please contact:

    Zai Lab Contacts

    Billy Cho, CFO

    +86 137 6151 2501

    billy.cho@zailaboratory.com

    Media: Ryo Imai / Robert Flamm, Ph.D.

    Burns McClellan, on behalf of Zai Lab

    212-213-0006 ext. 315 / 364

    rimai@burnsmc.com / rflamm@burnsmc.com

    Investors: Mike Zanoni

    Endurance Advisors, on behalf of Zai Lab

    610-442-8570

    mzanoni@enduranceadvisors.com

    MacroGenics Contacts

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172

    info@macrogenics.com

    Zai Lab Limited



    Primary Logo

    View Full Article Hide Full Article
    • Dose escalation: anti-tumor activity observed in melanoma (including one confirmed partial response) and in mCRPC patients
    • Cohort expansion in mCRPC: 11/22 (50%) patients have ≥ 50% PSA reduction; anti-tumor activity observed in four of seven patients evaluated (including one unconfirmed partial response)
    • Conference call and webcast with external guest presenters on Friday, June 4, 2021 at 4:30 P.M. ET

    ROCKVILLE, MD, May 19, 2021 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from the Company's ongoing Phase 1 clinical…

    • Dose escalation: anti-tumor activity observed in melanoma (including one confirmed partial response) and in mCRPC patients
    • Cohort expansion in mCRPC: 11/22 (50%) patients have ≥ 50% PSA reduction; anti-tumor activity observed in four of seven patients evaluated (including one unconfirmed partial response)
    • Conference call and webcast with external guest presenters on Friday, June 4, 2021 at 4:30 P.M. ET

    ROCKVILLE, MD, May 19, 2021 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary safety and anti-tumor activity data from the Company's ongoing Phase 1 clinical trial of MGC018. This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset will be presented in a poster titled "Phase 1 Dose Escalation Study of MGC018, an anti-B7-H3 Antibody-Drug Conjugate (ADC), In Patients with Advanced Solid Tumors" (Abstract #2631) at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 4-8, 2021.

    Dose Escalation Results Update

    The ASCO abstract included data as of January 21, 2021; updated data as of a May 3, 2021 cut-off are included below and will be presented at ASCO.

    A total of 29 patients with advanced solid tumors were enrolled in five dose escalation cohorts with MGC018 at 0.5 to 4.0 mg/kg, administered intravenously every three weeks. This included six patients at the 4.0 mg/kg cohort enrolled subsequent to the 2020 ASCO poster presentation. A recommended Phase 2 dose (RP2D) was defined as 3.0 mg/kg every three weeks.

    mCRPC. Preliminary evidence of anti-tumor activity by MGC018 has been observed, most notably in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Reductions in prostate-specific antigen (PSA) levels of ≥ 50% were observed in five of nine mCRPC patients treated in dose escalation, including one with substantial regression of bone disease. Of the nine patients with mCRPC, eight were evaluated for tumor response, all of whom demonstrated a best response of stable disease. Two of these eight patients had measurable disease; both had reductions in target lesions, including a 29% reduction in one patient. The nine mCRPC patients treated in dose escalation received a median of four therapies prior to MGC018, including taxane chemotherapy (eight patients) and next generation hormonal agents (all patients had previously received abiraterone, enzalutamide or both). All nine mCRPC patients in dose escalation are off therapy.  Of the five patients who had ≥ 50% PSA reduction, one withdrew consent (without disease progression) at 4 months, one had new bone lesions at 6 months, one initiated subsequent therapy at 6 months, and two had no progression at 7 months.

    Melanoma. During dose escalation, three melanoma patients were administered MGC018 at 4.0 mg/kg (the highest dose administered). All had previously received three different checkpoint inhibitor agents. The best responses in target lesion sum reductions for these patients after being treated with MGC018 were 24%, 28% and 36% (confirmed partial response), with this last patient remaining on MGC018 therapy for more than 6 months as of the data cut-off. Based on these data, MacroGenics recently initiated a melanoma expansion cohort (N=approximately 20).

    Safety. Adverse events for the dose escalation cohorts of 0.5 mg/kg to 4.0 mg/kg as of the May 3, 2021 data cut-off were generally consistent with those previously reported at ASCO 2020. MGC018-related toxicities included hematologic and skin toxicities that have been clinically manageable. In dose escalation overall, at least one treatment-related adverse event was experienced by 27 of 29 patients (93%). At 4.0 mg/kg, one patient developed a dose-limiting toxicity manifested by Grade 3 fatigue that lasted for more than 72 hours and as previously reported, a Grade 4 neutropenia occurred in a patient in the 2.0 mg/kg cohort.

    Preliminary Results for mCRPC Cohort Expansion

    As of the May 3, 2021 data cut-off, 28 of the 40 patients in the mCRPC cohort expansion had been enrolled, with disease classification available for 20 of these patients: seven had bone only, nine had mixed soft tissue and bone, and four had soft tissue only. Of the 28 mCRPC patients in cohort expansion, 22 had received at least one dose of MGC018 and had a post-baseline PSA. Eleven of these 22 patients (50%) had a PSA reduction of 50% or greater. All but three of these 22 patients were still on therapy as of the data cut-off. Of 13 patients who had measurable disease, six were not yet evaluable and seven had their first 9-week imaging, of which four had reductions in target lesion sums of 13%, 21%, 27% and 35% (unconfirmed partial response). Twelve of these 13 patients were still ongoing on MGC018.

    "We continue to be very encouraged by evolving data from our ongoing Phase 1 study of MGC018. To date, we have observed preliminary signals of anti-tumor effects, including PSA reductions of 50% or more in 16 of 31 (52%) patients with late-stage castration-resistant prostate cancer across dose escalation and dose expansion," said Scott Koenig, M.D., Ph.D., President and CEO. "We are very pleased to report decreases in target lesion sums, including an unconfirmed partial response, in mCRPC patients with measurable disease. Finally, we are encouraged to see anti-tumor activity, including a confirmed partial response, in post-checkpoint melanoma patients who have received MGC018. We look forward to sharing the full data at ASCO and providing further updates on our ongoing dose expansion cohorts, including patients with mCRPC, non-small cell lung cancer, triple negative breast cancer, melanoma and squamous cell carcinoma of the head and neck, at subsequent scientific conferences."

    Conference Call

    MacroGenics' management will host a conference call and webcast with external guest presenters to discuss the preliminary MGC018 results on Friday, June 4, 2021 at 4:30 P.M. ET. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 1583522. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days.

    ASCO Presentation

    The abstract for MacroGenics' MGC018 poster presentation was submitted to ASCO in February 2021 and is available on the ASCO website at https://conferences.asco.org/am/abstracts. The poster will be available for on-demand viewing on the ASCO website and on the Events & Presentations page on MacroGenics' website at http://ir.macrogenics.com/events.cfm on or around June 4, 2021.

    About MGC018

    MGC018 is an ADC comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. B7-H3 is a molecule highly expressed on many solid tumors and associated with a poor clinical outcome. MGC018 is being evaluated in a Phase 1 study (NCT03729596). MacroGenics retains worldwide rights to MGC018.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    CONTACTS:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  5. ROCKVILLE, MD, May 19, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in Cowen's 2nd Annual Virtual Oncology Innovation Summit. MacroGenics' management will participate in a fireside chat with the analyst on Thursday, May 20, 2021, at 9:20 am ET.

    A webcast of the fireside chat may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company maintains archived replays of webcasts on its website for 30 days after each conference…

    ROCKVILLE, MD, May 19, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in Cowen's 2nd Annual Virtual Oncology Innovation Summit. MacroGenics' management will participate in a fireside chat with the analyst on Thursday, May 20, 2021, at 9:20 am ET.

    A webcast of the fireside chat may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company maintains archived replays of webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###



    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • MARGENZA™ launched in mid-March
    • Upcoming poster presentation of MGC018 initial Phase 1 clinical data at ASCO
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., April 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended March 31, 2021.

    "With the recent launch and commercialization of MARGENZA, we are delivering on our vision to provide potentially life-changing therapeutics to patients with cancer. We are well positioned to advance this mission as the growing…

    • MARGENZA™ launched in mid-March
    • Upcoming poster presentation of MGC018 initial Phase 1 clinical data at ASCO
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., April 29, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the quarter ended March 31, 2021.

    "With the recent launch and commercialization of MARGENZA, we are delivering on our vision to provide potentially life-changing therapeutics to patients with cancer. We are well positioned to advance this mission as the growing body of data emerges from our deep pipeline of clinical and pre-clinical product candidates," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, "and we look forward to sharing additional data with you as the year progresses."

    Key Updates on Proprietary Programs

    Recent progress and anticipated events in 2021 related to MacroGenics' approved and investigational product candidates in clinical development are highlighted below.

    • Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.



      • MARGENZA (margetuximab-cmkb) commercial launch. In mid-March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Also during the quarter, results from the SOPHIA metastatic breast cancer Phase 3 study of MARGENZA were published in the Journal of the American Medical Association (JAMA) Oncology. Finally, based on the current accrual rate of overall survival (OS) events in the ongoing SOPHIA trial that supported approval by the FDA, the Company now anticipates completing the final analysis of OS data, based on accrual of the 385th OS event, by the end of the third quarter.

      • Phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer. The MAHOGANY clinical program contains two modules designed to evaluate margetuximab as an investigational agent in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GC/GEJ. All 40 patients have been enrolled in the first part of Module A, which is evaluating margetuximab in combination with retifanlimab (an anti-PD-1 therapy). The Company expects to report safety and efficacy data in the third quarter of 2021. Enrollment in Module B, which is evaluating margetuximab plus MacroGenics' checkpoint inhibitor molecules in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2-positive tumors irrespective of PD-L1 expression, is currently ongoing in coordination with MacroGenics' regional partner in Greater China, Zai Lab.
    • Flotetuzumab is a bispecific CD123 × CD3 DART® molecule being evaluated in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in late 2021 and completing full enrollment of this study in 2022.
    • MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. In April 2021, MacroGenics presented pre-clinical data at the American Association for Cancer Research (AACR) Annual Meeting demonstrating that at clinically relevant dose levels, MGC018 potentiated antitumor activity in vivo in mouse patient-derived xenograft (PDX) models of squamous cell carcinoma of the head and neck (SCCHN). MacroGenics recently expanded its Phase 1 clinical study to include SCCHN and melanoma; the Company continues to enroll patients with metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). MacroGenics will provide a clinical data update via poster presentation at the upcoming American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, June 4-8, 2021.
    • Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 mAb. During the first quarter, MacroGenics initiated a Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative.
    • Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. Tebotelimab is being evaluated in a Phase 1 dose expansion study as monotherapy in several tumor types. MacroGenics expects to provide updates on the next-stage of development for tebotelimab later this year.
    • MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting Phase 1 dose expansion cohorts at the recommended Phase 2 dose in patients with microsatellite stable colorectal cancer (MSS CRC) and checkpoint-naïve NSCLC and recently added cohorts of patients with mCRPC and melanoma.
    • IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Pre-clinical data recently presented at the AACR Annual Meeting showed that IMGC936 had activity against multiple solid tumor types in in vivo mouse PDX models. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in patients with select cancers and have indicated they anticipate disclosing initial data by early 2022.
    • MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development. The molecule incorporates a CD3 component designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, along with an Fc domain to permit intermittent dosing through a longer half-life. The Company anticipates submitting an Investigational New Drug (IND) application to the FDA by the end of 2021.

    First Quarter 2021 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2021, were $343.2 million, compared to $272.5 million as of December 31, 2020. During the quarter ended March 31, 2021, $98.2 million in net proceeds were received from the sale of 3,622,186 shares of the Company's common stock pursuant to its at-the-market (ATM) offering.
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $16.9 million for the quarter ended March 31, 2021, including $0.9 million net sales of MARGENZA, which was launched in mid-March, compared to $13.7 million for the quarter ended March 31, 2020. This increase was primarily due to the recognition of a $10 million milestone from Incyte, partially offset by a decrease of approximately $5.8 million recognized under a clinical supply agreement with Incyte.
    • R&D Expenses: Research and development expenses were $53.1 million for the quarter ended March 31, 2021, compared to $48.9 million for the quarter ended March 31, 2020. This increase was primarily due to higher expenses related to flotetuzumab, MGC018, MGD019 and preclinical projects, partially offset by a decrease in development and manufacturing costs for retifanlimab.
    • SG&A Expenses: Selling, general and administrative expenses were $15.0 million for the quarter ended March 31, 2021, compared to $10.2 million for the quarter ended March 31, 2020. This increase was primarily due to MARGENZA pre-launch and launch costs.
    • Net Loss: Net loss was $51.3 million for the quarter ended March 31, 2021, compared to net loss of $44.7 million for the quarter ended March 31, 2020.
    • Shares Outstanding: Shares outstanding as of March 31, 2021 were 60,011,206.
    • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of March 31, 2021, as well as anticipated and potential collaboration payments, should enable it to fund its operations through 2023, assuming the Company's programs and collaborations advance as currently contemplated.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 p.m. (ET) to discuss financial results for the quarter ended March 31, 2021 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 5257004.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.



    MACROGENICS, INC.

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

     March 31, 2021 December 31, 2020
     (unaudited)  
    Cash, cash equivalents and marketable securities$343,177  $272,531 
    Total assets435,445  378,743 
    Deferred revenue10,780  11,382 
    Total stockholders' equity350,531  295,884 
          
          

    MACROGENICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited)

    (Amounts in thousands, except share and per share data)

     Three Months Ended March 31,
     2021 2020
    Revenues:   
    Revenue from collaborative and other agreements$15,184  $12,967 
    Product revenue, net887   
    Revenue from government agreements810  715 
    Total revenues16,881  13,682 
    Costs and expenses:   
    Cost of product sales17   
    Research and development53,121  48,894 
    Selling, general and administrative15,036  10,233 
    Total costs and expenses68,174  59,127 
    Loss from operations(51,293) (45,445)
    Other income21  721 
    Net loss(51,272) (44,724)
    Other comprehensive income:   
    Unrealized gain on investments18  56 
    Comprehensive loss$(51,254) $(44,668)
        
    Basic and diluted net loss per common share$(0.90) $(0.91)
    Basic and diluted weighted average common shares outstanding57,202,846  49,012,663 

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    CONTACTS:

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172

    info@macrogenics.com

     



    Primary Logo

    View Full Article Hide Full Article
  6. ROCKVILLE, MD, April 19, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the first quarter of 2021 after the market closes on Thursday, April 29, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, April 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 5257004.

    The listen-only webcast…

    ROCKVILLE, MD, April 19, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the first quarter of 2021 after the market closes on Thursday, April 29, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, April 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 5257004.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. 

    ###



    CONTACT: 
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  7. LUND, Sweden, April 15, 2021 /PRNewswire/ -- Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that it has entered into a joint research collaboration with MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The research collaboration will lead to the expansion of Alligator's proprietary patient specific immunotherapy Neo-X-Prime™ by incorporating MacroGenics' proprietary DART® and TRIDENT® multi-specific platforms against two undisclosed targets.

    Under the joint research collaboration agreement, which covers activities from candidate drug generation up until IND-enabling studies, each company will be…

    LUND, Sweden, April 15, 2021 /PRNewswire/ -- Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that it has entered into a joint research collaboration with MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The research collaboration will lead to the expansion of Alligator's proprietary patient specific immunotherapy Neo-X-Prime™ by incorporating MacroGenics' proprietary DART® and TRIDENT® multi-specific platforms against two undisclosed targets.

    Under the joint research collaboration agreement, which covers activities from candidate drug generation up until IND-enabling studies, each company will be responsible for its own costs. The parties may continue further development of the resulting bispecific molecule under a separate co-development collaboration and licensing agreement.

    "We are truly excited to start this collaboration with MacroGenics, validating the Neo-X-Prime drug concept. The aim is to create a drug candidate that takes advantage of a unique mechanism of a patient's own immune system to fight cancer. We look forward to working collaboratively to expand the Neo-X-Prime concept with MacroGenics' antibodies, their proven DART technology, and extensive capabilities," says Malin Carlsson, interim CEO of Alligator Bioscience.

    The Chairman of Alligator Bioscience, Peter Benson stated "MacroGenics is widely viewed as a leader in the antibody field as evidenced by their extensive pipeline of antibody-based molecules in clinical testing that are based on various platform technologies. Furthermore, MacroGenics' capabilities are an excellent fit with Alligator's strategy to develop next generation tumor specific immunotherapies to improve the lives of cancer patients."

    Neo-X-Prime is a drug concept for more personalized immunotherapy, launched by Alligator in 2020. The concept builds on bispecific antibodies that physically link circulating tumor material to the immune system, to allow neoantigen-specific T cell priming with potential for superior anti-tumor efficacy.

    MacroGenics' DART and TRIDENT multi-specific platforms enable the creation of potential medicines comprised of a single molecule designed to simultaneously bind to two or more targets, each with antibody-like specificity, with the goal of creating a more significant biological effect.

    For further information, please contact:

    Malin Carlsson, interim CEO

    E-mail: mcn@alligatorbioscience.com

    Phone: +46 46 540 82 00

    The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on April 15, 2021.

    About Alligator Bioscience

    Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator's pipeline includes the two key assets ATOR-1017 and mitazalimab. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc. In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. Alligator's shares are listed on Nasdaq Stockholm (ATORX). The Company is headquartered in Lund, Sweden. For more information, please visit www.alligatorbioscience.com.

    This information was brought to you by Cision http://news.cision.com

    https://news.cision.com/alligator-bioscience/r/alligator-bioscience-and-macrogenics-enter-into-a-research-collaboration-to-develop-a-novel-immunoth,c3325649

    The following files are available for download:

    https://mb.cision.com/Main/12681/3325649/1401649.pdf

    Alligator and MacroGenics Enter into a Research Collaboration

     

    Cision View original content:http://www.prnewswire.com/news-releases/alligator-bioscience-and-macrogenics-enter-into-a-research-collaboration-to-develop-a-novel-immunotherapy-301269490.html

    SOURCE Alligator Bioscience

    View Full Article Hide Full Article
  8. ROCKVILLE, MD, April 10, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 10-15, 2021.

    "This year's AACR presentations highlight three antibody-based technologies upon which multiple molecules are being developed at MacroGenics," said Ezio Bonvini, M.D., Senior Vice President and Chief Scientific Officer of MacroGenics. "We are presenting pre-clinical data on MGC018, our clinical-stage, investigational antibody-drug conjugate (ADC) targeting B7-H3. At clinically…

    ROCKVILLE, MD, April 10, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 10-15, 2021.

    "This year's AACR presentations highlight three antibody-based technologies upon which multiple molecules are being developed at MacroGenics," said Ezio Bonvini, M.D., Senior Vice President and Chief Scientific Officer of MacroGenics. "We are presenting pre-clinical data on MGC018, our clinical-stage, investigational antibody-drug conjugate (ADC) targeting B7-H3. At clinically relevant dose levels, MGC018 demonstrated potent antitumor activity in vivo in mouse patient-derived xenograft (PDX) models of squamous cell carcinoma of the head and neck (SCCHN). MGC018 is currently being investigated in a Phase 1 dose expansion study in advanced solid tumor cancers, including metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC)."

    "A second poster demonstrates that margetuximab, our Fc-engineered anti-HER2 mAb developed using our Fc Optimization platform, can upregulate checkpoint molecules on Natural Killer (NK) cells, CD8 T cells and tumor cells, potentially sensitizing them to immune checkpoint blockade. Consistent with this observation, PD-1 and LAG-3 blockade by tebotelimab, our investigational bispecific PD-1 × LAG-3 DART® molecule, enhances margetuximab-mediated NK cell cytolytic activity in vitro," added Dr. Bonvini. "Finally, our third poster highlights pre-clinical data on IMGC936, an investigational ADAM9-directed ADC being developed in collaboration with ImmunoGen Inc. ADAM9 is highly expressed in a large number of solid tumors and our presentation shows that IMGC936 has activity against multiple solid tumor types in in vivo mouse PDX models. IMGC936 is currently being studied in a Phase 1 clinical trial evaluating safety and pharmacokinetics in cancer patients. Together, these results illustrate the drug development potential of all three technologies MacroGenics is deploying to identify and advance promising anti-cancer drug candidates."



    Presentation details are as follows:

    April 10, 2021, 8:30 AM - 11:59 PM

    1555 - Enhanced HER2-dependent immune activation by margetuximab, an investigational Fc-engineered anti-HER2 mAb, supports combination with checkpoint blockade

    Session PO.IM02.02 - Combination Immunotherapies

    April 10, 2021, 8:30 AM - 11:59 PM

    950 - Targeting B7-H3 in squamous cell carcinoma of the head and neck: Preclinical proof-of-concept with the investigational anti-B7-H3 antibody-drug conjugate, MGC018

    Session PO.ET07.01 - Biological Therapeutic Agents

    April 10, 2021, 8:30 AM - 11:59 PM

    1841 - IMGC936, an investigational ADAM9-targeting antibody drug conjugate, is active against patient-derived ADAM9-expressing xenograft models

    Session PO.IM02.10 - Therapeutic Antibodies, Including Engineered Antibodies

    Posters of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contact:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  9. ROCKVILLE, MD, Feb. 26, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in March:

    • Cowen 41st Annual Health Care Conference. MacroGenics' management will participate in the Breast Cancer Panel on Tuesday, March 2, 2021 at 2:10 pm ET live via webcast to conference attendees (not available for replay). Management will also participate in one-on-one meetings.
    • H.C. Wainwright & Co. Global Life Sciences Conference.  MacroGenics' management is scheduled to participate in one-on-one meetings…

    ROCKVILLE, MD, Feb. 26, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in March:

    • Cowen 41st Annual Health Care Conference. MacroGenics' management will participate in the Breast Cancer Panel on Tuesday, March 2, 2021 at 2:10 pm ET live via webcast to conference attendees (not available for replay). Management will also participate in one-on-one meetings.
    • H.C. Wainwright & Co. Global Life Sciences Conference.  MacroGenics' management is scheduled to participate in one-on-one meetings on Tuesday, March 9, 2021.  In addition, a corporate overview provided by MacroGenics' management will be available for on-demand viewing March 9-10, 2021.
    • Barclays Global Healthcare Conference. MacroGenics' management is scheduled to participate in one-on-one meetings and provide a corporate overview on Thursday, March 11, 2021 at 3:45 pm ET.

    Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###



    CONTACT:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • MARGENZA™ approved in December 2020; commercial launch expected March 2021
    • July 2021 PDUFA target action dates for partnered products retifanlimab and teplizumab
    • Multiple clinical updates across portfolio anticipated in 2021
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., Feb. 25, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2020.

    "Following the approval in late 2020 of our first drug with the U.S. Food and Drug Administration (FDA), 2021 has the…

    • MARGENZA™ approved in December 2020; commercial launch expected March 2021
    • July 2021 PDUFA target action dates for partnered products retifanlimab and teplizumab
    • Multiple clinical updates across portfolio anticipated in 2021
    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., Feb. 25, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2020.

    "Following the approval in late 2020 of our first drug with the U.S. Food and Drug Administration (FDA), 2021 has the potential to be another transformative year for MacroGenics. We expect to launch MARGENZA in the coming weeks and will continue to advance our deep pipeline of promising product candidates in multiple clinical trials," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are particularly excited about our ongoing, potentially registration-enabling studies, including flotetuzumab in acute myeloid leukemia (AML) and margetuximab in gastric cancer, as well as two Prescription Drug User Fee Act (PDUFA) target action dates in July related to retifanlimab and teplizumab. And finally, we look forward to providing clinical updates on multiple, ongoing dose expansion studies this year."

    Key Updates on Proprietary Programs

    Recent progress and anticipated events in 2021 related to MacroGenics' approved and investigational product candidates in clinical development, as well as an advanced preclinical program, are highlighted below.

    • Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.



      • MARGENZA (margetuximab-cmkb) approval and commercial launch. In December 2020, the FDA approved MARGENZA in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. The launch, which is being coordinated with MacroGenics' commercial partner, EVERSANA, is expected in March.
      • Phase 2/3 MAHOGANY study in advanced gastric (GC) and gastroesophageal junction (GEJ) cancer. The MAHOGANY clinical program contains two modules designed to evaluate margetuximab as an investigational agent in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GC/GEJ. Initial safety and efficacy data from among the first 40 patients enrolled in Module A, which is evaluating margetuximab in combination with retifanlimab (an anti-PD-1 therapy), are expected in the first half of 2021. Enrollment in Module B, which is evaluating margetuximab plus MacroGenics' checkpoint inhibitor molecules in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2-positive tumors irrespective of PD-L1 expression, is currently ongoing in coordination with the Company's regional partner in Greater China, Zai Lab.
    • Flotetuzumab is a bispecific CD123 × CD3 DART® molecule being evaluated in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) AML. Six clinical and preclinical abstracts related to AML and flotetuzumab were presented at the American Society of Hematology (ASH) Annual Meeting & Exposition in December 2020. MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in the second half of 2021, and completing full enrollment of this study in 2022.
    • MGC018 is an antibody-drug conjugate that targets B7-H3. MacroGenics continues to enroll patients with metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) in the dose expansion portion of the Phase 1 clinical study. The Company expects to provide an update on this study in mid-2021.
    • Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 mAb. In the coming weeks, MacroGenics expects to initiate a Phase 2 study of enoblituzumab in a chemo-free regimen in combination with retifanlimab in front-line patients with squamous cell carcinoma of the head and neck (SCCHN) who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative.
    • Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. Tebotelimab is being evaluated in a Phase 1 dose expansion study as monotherapy in several tumor types. An oral presentation of tebotelimab Phase 1 data in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) was made at ASH in December 2020. In addition, data from the combination study of tebotelimab and margetuximab in patients with advanced HER2+ neoplasms were presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2020. MacroGenics' regional partner in Greater China, Zai Lab, is also evaluating tebotelimab in Phase 1 combination studies with niraparib and brivanib for the study of advanced gastric cancer and hepatocellular carcinoma, respectively, as well as a monotherapy study in patients with melanoma. MacroGenics expects to provide clinical updates on tebotelimab in 2021, including future development plans.
    • MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is enrolling Phase 1 dose expansion cohorts, initially in patients with microsatellite stable colorectal cancer (MSS CRC) and checkpoint-naïve NSCLC at the recommended Phase 2 dose. The Company expects to provide a clinical update on this study in mid-2021.
    • IMGC936 is an antibody-drug conjugate that targets ADAM9, a cell surface protein over-expressed in several solid tumor types. IMGC936 is being advanced under a co-development agreement with ImmunoGen, Inc. Under the 50/50 collaboration, ImmunoGen is leading clinical development and the Phase 1 dose escalation study is currently enrolling patients with select advanced solid tumors.
    • MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development. The molecule incorporates a CD3 component designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, along with an Fc domain to permit intermittent dosing through a longer half-life. The Company anticipates submitting an Investigational New Drug (IND) application to the FDA by the end of 2021.

    Key Partnered Programs Update

    Recent progress and disclosed priorities for MacroGenics' partnerered investigational molecules are highlighted below.

    • Retifanlimab is an anti-PD-1 mAb that has been exclusively licensed to Incyte Corporation. To date, MacroGenics has earned $65 million in milestones related to retifanlimab, triggered by advancement of the molecule through various clinical and regulatory activities. In January 2021, Incyte announced that the FDA had accepted for Priority Review its Biologics License Application (BLA) for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal. The PDUFA target action date for retifanlimab is July 25, 2021. MacroGenics is eligible to receive up to a total of $685 million in potential remaining development, regulatory and commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the drug.
    • Teplizumab is a mAb being developed by Provention Bio, Inc. for the treatment of type 1 diabetes. In January 2021, Provention announced the FDA filing of a BLA and Priority Review for this molecule, with a PDUFA target action date of July 2, 2021. In 2018, MacroGenics sold its interest in teplizumab to Provention and is eligible to receive up to $170 million upon the achievement of certain regulatory approval milestones, including $60 million upon approval of a BLA in the U.S., additional milestone payments totaling $225 million upon the achievement of certain sales milestones and single-digit royalties on net sales of the molecule.

    Corporate Updates

    • Janssen Collaboration. In December 2020, MacroGenics announced a research collaboration and global license agreement to develop a preclinical bispecific molecule with Janssen Biotech, Inc. The research collaboration will incorporate MacroGenics' proprietary DART platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology. Under the terms of the agreement, Janssen paid MacroGenics an upfront payment of $20 million and will be responsible for funding all expenses. MacroGenics will also be eligible to receive up to $312 million in potential milestone payments and tiered royalties on worldwide product sales.
    • Ms. Federica O'Brien Added to Board. MacroGenics recently announced the appointment of Federica "Freddi" O'Brien, a veteran executive with 25 years of financial and operational leadership in biopharmaceutical, medical device, and technology companies, to its Board of Directors.

    2020 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2020 were $272.5 million, compared to $215.8 million as of December 31, 2019.
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $104.9 million for the year ended December 31, 2020, compared to $64.2 million for the year ended December 31, 2019. This increase was primarily due to the recognition of milestones, partially offset by timing of revenue recognition under the Company's collaborative agreements.
    • R&D Expenses: Research and development expenses were $193.2 million for the year ended December 31, 2020, compared to $195.3 million for the year ended December 31, 2019.
    • G&A Expenses: General and administrative expenses were $42.7 million for the year ended December 31, 2020, compared to $46.1 million for the year ended December 31, 2019. This decrease was primarily due to a decrease in external costs, including consulting.
    • Net Loss: Net loss was $129.7 million for the year ended December 31, 2020, compared to net loss of $151.8 million for the year ended December 31, 2019.
    • Shares Outstanding: Shares outstanding as of December 31, 2020 were 56,244,771.
    • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of December 31, 2020, as well as anticipated and potential collaboration payments, should enable it to fund its operations into 2023, assuming the Company's programs and collaborations advance as currently contemplated.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the year ended December 31, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 6094343.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.



    MACROGENICS, INC.

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

     As of December 31,
     2020 2019
    Cash, cash equivalents and marketable securities$272,531  $215,756 
    Total assets378,743  312,501 
    Deferred revenue11,382  19,853 
    Total stockholders' equity295,884  230,628 



    MACROGENICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Amounts in thousands, except share and per share data)

     Year Ended December 31,
     2020 2019 2018
    Revenues:     
    Revenue from collaborative and other agreements$97,764  $62,024  $58,644 
    Revenue from government agreements7,119  2,164  1,477 
    Total revenues104,883  64,188  60,121 
          
    Costs and expenses:     
    Research and development193,201  195,309  190,827 
    General and administrative42,742  46,064  40,500 
    Total costs and expenses235,943  241,373  231,327 
          
    Loss from operations(131,060) (177,185) (171,206)
          
    Other income (expense)1,321  25,374  (247)
    Net loss(129,739) (151,811) (171,453)
          
    Other comprehensive loss:     
    Unrealized gain (loss) on investments(23) 19  58 
    Comprehensive loss$(129,762) $(151,792) $(171,395)
          
          
    Basic and diluted net loss per common share$(2.47) $(3.16) $(4.19)
    Basic and diluted weighted average number of common shares52,442,389  48,082,728  40,925,318 
          
          

    IMPORTANT SAFETY INFORMATION - MARGENZA

    BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

    • Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
    • Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

    WARNINGS & PRECAUTIONS:

    Left Ventricular Dysfunction

    • Left ventricular cardiac dysfunction can occur with MARGENZA.
    • MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
    • Withhold MARGENZA for ≥16% absolute decrease in LVEF from pre-treatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
    • Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
    • Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
    • Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.

    Embryo-Fetal Toxicity

    • Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER-2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
    • Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
    • Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
    • Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.

    Infusion-Related Reactions (IRRs)

    • MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
    • Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
    • In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
    • Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.

    MOST COMMON ADVERSE REACTIONS:

    The most common adverse drug reactions (≥10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

    Link to full Prescribing Information, including Boxed Warning.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    CONTACTS:

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172

    info@macrogenics.com 



    Primary Logo

    View Full Article Hide Full Article
  10. ROCKVILLE, MD, Feb. 18, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the fourth quarter and full year ended December 31, 2020 after the market closes on Thursday, February 25, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, February 25, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID…

    ROCKVILLE, MD, Feb. 18, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the fourth quarter and full year ended December 31, 2020 after the market closes on Thursday, February 25, 2021. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, February 25, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 6094343.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. 

    ###



    CONTACT:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  11. ROCKVILLE, MD, Feb. 11, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the appointment of Federica "Freddi" O'Brien, President of CFO'Brien Consulting, LLC, to its Board of Directors. 

    Federica O'Brien is a veteran executive with 25 years of financial and operational leadership in biopharmaceutical, medical device, and technology companies and currently serves on the Board of Directors of TELA Bio, Inc. where she also chairs the Audit Committee. Ms. O'Brien will be joining MacroGenics' Audit Committee.

    "We are delighted to welcome Ms. O'Brien to the Board. She is…

    ROCKVILLE, MD, Feb. 11, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the appointment of Federica "Freddi" O'Brien, President of CFO'Brien Consulting, LLC, to its Board of Directors. 

    Federica O'Brien is a veteran executive with 25 years of financial and operational leadership in biopharmaceutical, medical device, and technology companies and currently serves on the Board of Directors of TELA Bio, Inc. where she also chairs the Audit Committee. Ms. O'Brien will be joining MacroGenics' Audit Committee.

    "We are delighted to welcome Ms. O'Brien to the Board. She is a highly experienced financial and strategic leader in our industry and will prove invaluable to our team," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We will benefit from Freddi's deep expertise and guidance as we prepare for the launch of our first product and continue to advance our potential treatment options for patients with cancer." 

    Ms. O'Brien has held a variety of senior roles, including Chief Financial Officer, Chief Operating Officer, Controller and Director of Financial Reporting, at companies ranging from nonclinical through commercial stage. These companies have included Complexa Inc., Cerecor Inc., Cervilenz Inc., Cardiokine Inc., Barrier Therapeutics, Inc. and Infonautics, Inc.

    Before specializing in life sciences and technology, Ms. O'Brien spent over a decade in professional service accounting firms, most recently at Coopers & Lybrand (PricewaterhouseCoopers), where she was focused on high growth companies in multiple industries. Ms. O'Brien received her Bachelor of Arts degree in Accounting from Rutgers University and is a Certified Public Accountant-Inactive, retired after thirty-eight years.  

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. 

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to," "believe," "anticipate," "plan," "expect," "intend," "estimate," "project," "may," "will," "should," "would," "could," "can," the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. 

    ### 



    Contacts: 
    Jim Karrels, Senior Vice President, CFO 
    MacroGenics, Inc. 
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  12. ROCKVILLE, MD, Feb. 11, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that a $10 million milestone has been achieved related to development progress of retifanlimab outside the U.S., under its exclusive global collaboration and license agreement with Incyte. Retifanlimab is an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012).

    As previously announced in January 2021, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review Incyte's Biologics License Application (BLA) for retifanlimab as…

    ROCKVILLE, MD, Feb. 11, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that a $10 million milestone has been achieved related to development progress of retifanlimab outside the U.S., under its exclusive global collaboration and license agreement with Incyte. Retifanlimab is an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012).

    As previously announced in January 2021, the U.S. Food and Drug Administration (FDA) has accepted for Priority Review Incyte's Biologics License Application (BLA) for retifanlimab as a potential treatment for adult patients with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021. In addition, Incyte has stated it is pursuing development of retifanlimab as monotherapy in potentially registration-enabling studies in patients with MSI-high endometrial cancer and Merkel cell carcinoma.

    In 2020, Incyte initiated two Phase 3 studies of retifanlimab in combination with chemo-radiation or chemotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) and in patients with metastatic SCAC, known as POD1UM-304 and POD1UM-303, respectively. Incyte is also pursuing development of retifanlimab in combination with multiple product candidates from its pipeline.

    MacroGenics is currently evaluating retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 monoclonal antibody (mAb), in a potentially registration-enabling study of patients with HER2-positive gastric cancer. The Company also plans to initiate a study of retifanlimab in combination with enoblituzumab, an investigational Fc-engineered, anti-B7-H3 mAb, in patients with squamous cell carcinoma of the head and neck (SCCHN).

    Under the collaboration agreement with Incyte, MacroGenics has received $65 million in milestones to date and is eligible to receive up to a total of $355 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  13. ROCKVILLE, MD, Feb. 08, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in February:

    • Guggenheim Healthcare Talks 2021 Oncology Day. MacroGenics' management is scheduled to participate in a fireside chat on Thursday, February 11, 2021 at 11:30 AM ET. The conference will be held in a virtual meeting format.
    • SVB Leerink 10th Annual Global Healthcare Conference. MacroGenics' management is scheduled to participate in a fireside chat on Wednesday, February 24, 2021 at 12:00 PM ET. The conference…

    ROCKVILLE, MD, Feb. 08, 2021 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in February:

    • Guggenheim Healthcare Talks 2021 Oncology Day. MacroGenics' management is scheduled to participate in a fireside chat on Thursday, February 11, 2021 at 11:30 AM ET. The conference will be held in a virtual meeting format.
    • SVB Leerink 10th Annual Global Healthcare Conference. MacroGenics' management is scheduled to participate in a fireside chat on Wednesday, February 24, 2021 at 12:00 PM ET. The conference will be held in a virtual meeting format.

    Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###



    CONTACT:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • Primary endpoint of Phase 3 study met with MARGENZA (margetuximab-cmkb) showing a 24% Progression Free Survival (PFS) relative risk reduction compared to Herceptin® (trastuzumab), both with chemotherapy
    • In the U.S., MARGENZA is approved, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease

    ROCKVILLE, MD, Jan. 25, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of results from the SOPHIA trial…

    • Primary endpoint of Phase 3 study met with MARGENZA (margetuximab-cmkb) showing a 24% Progression Free Survival (PFS) relative risk reduction compared to Herceptin® (trastuzumab), both with chemotherapy
    • In the U.S., MARGENZA is approved, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease

    ROCKVILLE, MD, Jan. 25, 2021 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of results from the SOPHIA trial of MARGENZA™ (margetuximab-cmkb) in the Journal of the American Medical Association (JAMA) Oncology. SOPHIA is a pivotal Phase 3 clinical trial of 536 adult patients with metastatic HER2-positive breast cancer previously treated with two or more anti-HER2 regimens and from one to three lines of therapy for metastatic disease.  In the study, MARGENZA demonstrated a statistically significant 24% reduction in the risk of disease progression or death compared to Herceptin, each in combination with chemotherapy (Hazard Ratio [HR] = 0.76; 95% CI, 0.59-0.98; p=0.03; median PFS 5.8 vs. 4.9 months).

    "MARGENZA is the first HER2-targeted therapy to reduce the risk of disease progression in metastatic breast cancer patients over trastuzumab in a head-to-head comparison involving a heavily pretreated patient population," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "These data represent years of research and clinical development at MacroGenics leading to the forthcoming commercialization of this innovative antibody-based therapeutic for the treatment of metastatic HER2-positive breast cancer."

    In addition to the statistically significant improvement in primary endpoint of PFS by centrally blinded review, investigator-assessed PFS (based on 337 events) was also greater with MARGENZA compared to trastuzumab with a 30% PFS relative risk reduction compared to trastuzumab (HR=0.70; 95% CI, 0.56-0.87; P=0.001; median investigator-assessed PFS 5.6 vs 4.2 months).  Among 524 response-evaluable patients, the objective response rates for MARGENZA plus chemotherapy and trastuzumab plus chemotherapy were 22% and 16%, respectively (P=0.06) and the clinical benefit rates were 37% for MARGENZA and 25% for trastuzumab, (P=0.003).

    At the prespecified interim Overall Survival (OS) analysis, based on 270 events, median OS was 21.6 months with MARGENZA and 19.8 months with trastuzumab (HR=0.89; 95% CI, 0.69-1.13; P=0.33). The stopping threshold was not reached. The final OS analysis will occur after 385 events, and it is expected in the second half of 2021.

    Adverse reactions occurring in greater than twenty percent of patients with MARGENZA in combination with chemotherapy were fatigue/asthenia (57%), nausea (33%), diarrhea (25%), and vomiting (21%). The MARGENZA U.S. Prescribing Information has a BOXED WARNING for left ventricular dysfunction and embryo-fetal toxicity. In addition, MARGENZA can cause infusion related reactions (IRRs). IRRs occurred in 13% of patients treated with MARGENZA, with the majority reported as Grade 2 or less. Grade 3 IRRs occurred in 1.5% of patients. See below for Important Safety Information.

    "Up to one-fifth of all breast cancers are HER2-positive, and identifying new treatment options for patients in the metastatic setting represents a serious unmet medical need," said SOPHIA principal investigator Hope S. Rugo, M.D., Professor of Medicine and Director of Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. "These results show that MARGENZA provides improvement, for this patient population, beyond what we can achieve with trastuzumab, which is good news for patients with advanced disease."

    MacroGenics anticipates that MARGENZA will be available to patients in the U.S. in March of 2021.

    About the SOPHIA Study

    The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating MARGENZA plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer, who have previously been treated with anti-HER2-targeted therapies. All study patients had previously received trastuzumab, all but one patient had previously received pertuzumab, and 91% had previously received ado-trastuzumab emtansine, or T-DM1.

    The study enrolled 536 patients who were randomized 1:1 to receive either MARGENZA (n=266) given intravenously at 15 mg/kg every three weeks or trastuzumab (n=270) given intravenously at 6 mg/kg (or 8 mg/kg for loading dose) every three weeks in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine) given at the standard dose. Intent-to-treat PFS analysis occurred after 265 PFS events.

    The primary endpoints of the study were sequentially-assessed PFS, determined by blinded, centrally-reviewed radiological review, followed by OS. Additional key secondary endpoints are PFS by investigator assessment and ORR. Tertiary endpoints include ORR by investigator assessment and safety. PFS and ORR were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    About HER2-positive Breast Cancer

    Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Monoclonal antibodies targeting HER2 have greatly improved outcomes; however, a significant number of patients progress to later lines of therapy. Effective treatments for metastatic HER2-positive breast cancer continue to remain an unmet need.

    About MARGENZA

    MARGENZA (margetuximab-cmkb) is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Similar to trastuzumab, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytoxicity (ADCC). However, through MacroGenics' Fc Optimization technology, margetuximab-cmkb has been engineered to enhance the engagement of the immune system. In vitro, the modified Fc region of margetuximab-cmkb increases binding to the activitating Fc receptor FCGR3A (CD16A) and decreases binding to inhibitor Fc receptor FCGR2B (CD32B).  These changes lead to greater in vitro ADCC and NK cell activation.  The clinical significance of in vitro data is unknown. 

    Margetuximab-cmkb is also being evaluated in combination with checkpoint blockade in the Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer (NCT04082364), and in combination with tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in various HER2+ tumors (NCT03219268). For more information, please visit www.clinicaltrials.gov.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

    • Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
    • Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

    WARNINGS & PRECAUTIONS:

    Left Ventricular Dysfunction

    • Left ventricular cardiac dysfunction can occur with MARGENZA.
    • MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
    • Withhold MARGENZA for ≥16% absolute decrease in LVEF from pre-treatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
    • Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
    • Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
    • Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.

    Embryo-Fetal Toxicity

    • Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
    • Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
    • Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
    • Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.

    Infusion-Related Reactions (IRRs)

    • MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
    • Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
    • In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
    • Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.

    MOST COMMON ADVERSE REACTIONS:

    The most common adverse drug reactions (≥10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

    Link to full Prescribing Information, including Boxed Warning.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, MARGENZA and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to," "believe," "anticipate," "plan," "expect," "intend," "estimate," "project," "may," "will," "should," "would," "could," "can," the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    +1-301-251-5172
    info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  14. ROCKVILLE, MD, Jan. 11, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in January:

    • H.C. Wainwright & Co. BioConnect 2021 Conference. A corporate overview provided by MacroGenics' management will be available for on-demand viewing from January 11 - 14, 2021. In addition, MacroGenics' President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a panel discussion on Precision Medicine hosted by Scott Gottlieb, M.D., Former Commissioner of the U.S. Food and Drug…

    ROCKVILLE, MD, Jan. 11, 2021 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in January:

    • H.C. Wainwright & Co. BioConnect 2021 Conference. A corporate overview provided by MacroGenics' management will be available for on-demand viewing from January 11 - 14, 2021. In addition, MacroGenics' President & Chief Executive Officer, Scott Koenig, M.D., Ph.D., will participate in a panel discussion on Precision Medicine hosted by Scott Gottlieb, M.D., Former Commissioner of the U.S. Food and Drug Administration. The panel will cover the importance of biomarkers and cytogenetic profiling in drug discovery, development and commercialization and will take place on Wednesday, January 13, 2021, at noon ET.
    • 39th Annual J.P. Morgan Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview on January 14, 2021 at 10:00 AM ET.

    Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###



    CONTACT:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  15. ROCKVILLE, MD, Dec. 22, 2020 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript on MGD019, an investigational PD-1 × CTLA-4 bispecific DART molecule, in Cell Reports Medicine.  MacroGenics' DART platform allows for the creation of bispecific antibody-based molecules with the ability to bind to two distinct targets in contrast to a single target as supported by traditional monoclonal antibodies. 

    The publication, Development and Preliminary Clinical Activity of PD-1-Guided CTLA-4 Blocking Bispecific DART Molecule, highlights key findings from…

    ROCKVILLE, MD, Dec. 22, 2020 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript on MGD019, an investigational PD-1 × CTLA-4 bispecific DART molecule, in Cell Reports Medicine.  MacroGenics' DART platform allows for the creation of bispecific antibody-based molecules with the ability to bind to two distinct targets in contrast to a single target as supported by traditional monoclonal antibodies. 

    The publication, Development and Preliminary Clinical Activity of PD-1-Guided CTLA-4 Blocking Bispecific DART Molecule, highlights key findings from the ongoing Phase 1 trial of MGD019 first-in-human study of patients with advanced solid tumors (NCT03761017) as well as data from mechanistic studies. Findings in mechanistic studies demonstrated that cells co-expressing PD-1 and CTLA-4 are abundant in the tumor microenvironment (TME) compared to normal tissues, supporting PD-1 and CTLA-4 co-blockade in treating solid tumor cancers. This observation suggests that targeting dual PD-1/CTLA-4-expressing cells may also provide an opportunity for increased selectivity of checkpoint blockade in the TME, while relatively reducing effects in normal tissues.

    In vitro studies demonstrated that MGD019 may provide complete blockade of PD-1 together with tunable inhibition of CTLA-4, with greatly enhanced blockade of CTLA-4 activity on dual-antigen expressing cells, a potential advantage over PD-1 or CTLA-4 blockade with individual monoclonal antibodies. In addition, MGD019 was well tolerated in non-human primates following repeated intravenous (IV) administrations (four weekly doses) of MGD019 at dose levels of 10, 40 and 100 mg/kg, well exceeding the highest non-severely toxic dose reported for the combination of nivolumab and ipilimumab in this species.

    These mechanistic data formed the basis for the on-going, first-in-human study demonstrating clinical activity and correlated pharmacodynamics. At the cutoff date of April 1, 2020, 33 patients representing 21 different advanced solid tumor types were treated, including 13 patients (39.4%) who had previously received checkpoint inhibitor therapy.  Objective responses were reported in four patients (including one unconfirmed response) with tumor types typically unresponsive to conventional checkpoint inhibition.  MGD019 was generally well-tolerated up to the top predefined dose level of 10 mg/kg, with no dose limiting toxicities (DLTs) observed and a safety profile generally consistent with that of anti-PD-1 monotherapy.

    "Treatment with PD-1 and CTLA-4 inhibitors such as nivolumab and ipilimumab has been effective in several cancer indications; however, the combination is associated with significant toxicity," said Paul Moore, Ph.D., MacroGenics' Vice President of Cell Biology and Immunology and the senior author on the paper. "The pre-clinical and clinical results published today demonstrated that MGD019 can mediate complete blockade of PD-1 with tunable blockade of CTLA-4, which is enhanced on dual-expressing cells, a potential advantage over blockade by combining individual monoclonal antibodies to PD-1 and CTLA-4. The early clinical data from the Phase 1 trial of MGD019 appear to indicate an acceptable safety profile and support further clinical investigation of MGD019 in cancer treatment."

    About MGD019

    MGD019 is an investigational, bispecific DART molecule that was designed to enable blockade of two immune checkpoint molecules expressed on T cells, PD-1 and CTLA-4. Based upon the establishment of a recommended Phase 2 dose (RP2D) from a dose escalation study, MGD019 is initially being evaluated in a dose expansion study in microsatellite-stable colorectal cancer and non-small cell lung cancer. MacroGenics retains global rights to MGD019.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172
    info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  16. ROCKVILLE, MD, Dec. 18, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced today a research collaboration and global license agreement to develop a preclinical bispecific molecule with Janssen Biotech, Inc. The research collaboration will incorporate MacroGenics' proprietary DART® platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology.

    "We are excited to collaborate with Janssen, which we believe is a leader in the field of next generation antibody-based therapeutics, by bringing together our two companies' respective scientific…

    ROCKVILLE, MD, Dec. 18, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced today a research collaboration and global license agreement to develop a preclinical bispecific molecule with Janssen Biotech, Inc. The research collaboration will incorporate MacroGenics' proprietary DART® platform to enable simultaneous targeting of two undisclosed targets in a therapeutic area outside oncology.

    "We are excited to collaborate with Janssen, which we believe is a leader in the field of next generation antibody-based therapeutics, by bringing together our two companies' respective scientific talent and experience to leverage our DART platform to generate a compelling product candidate that addresses unmet patient needs," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics.

    Under the terms of the agreement, Janssen will pay MacroGenics an upfront payment of $20 million and will be responsible for funding all expenses. MacroGenics will also be eligible to receive up to $312 million in potential milestone payments and tiered royalties on worldwide product sales. Further details about the transaction are not disclosed.

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions, the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172
    info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • MARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin® (trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 clinical trial
    • MARGENZA is approved, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease
    • Product launch anticipated in March of 2021
    • Conference call scheduled for Thursday, December 17, 2020 at 8:00 a.m. ET

    ROCKVILLE, MD, Dec. 16, 2020 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal…

    • MARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin® (trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 clinical trial
    • MARGENZA is approved, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease
    • Product launch anticipated in March of 2021
    • Conference call scheduled for Thursday, December 17, 2020 at 8:00 a.m. ET

    ROCKVILLE, MD, Dec. 16, 2020 (GLOBE NEWSWIRE) --  MacroGenics, Inc. (NASDAQ:MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved MARGENZA, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. MARGENZA is the first product approved from MacroGenics' promising pipeline. The approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial.

    "The approval of MARGENZA is an exciting milestone for MacroGenics and, more importantly, it brings a new treatment option to metastatic breast cancer patients. We are grateful for the patients who participated in this study, as well as their families, and everyone who played a role in helping MacroGenics reach this milestone," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "As we prepare for our first commercial launch and look forward to being able to deliver MARGENZA to patients, we continue to focus on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer with eight product candidates currently in clinical development."  

    The approval for MARGENZA was based on data from SOPHIA, a randomized Phase 3 clinical trial. The study, which included 536 patients, showed a statistically significant 24% reduction in the risk of disease progression or death with MARGENZA plus chemotherapy compared with trastuzumab plus chemotherapy (hazard ratio [HR]=0.76; 95% CI, 0.59-0.98; P=0.033; median PFS 5.8 vs 4.9 months).  The objective response rate  for MARGENZA plus chemotherapy was 22% and for trastuzumab plus chemotherapy was 16%. The final Overall Survival (OS) analysis is expected in the second half of 2021.

    Adverse reactions occurring in greater than twenty percent of patients with MARGENZA in combination with chemotherapy were fatigue/asthenia (57%), nausea (33%), diarrhea (25%), and vomiting (21%). The MARGENZA U.S. Prescribing Information has a BOXED WARNING for left ventricular dysfunction and embryo-fetal toxicity.  In addition, MARGENZA can cause infusion related reactions (IRRs).  IRRs occurred in 13% of patients treated with MARGENZA, with the majority reported as Grade 2 or less. Grade 3 IRRs occurred in 1.5% of patients.  See below for Important Safety Information.

    "Early detection and treatment have had a positive impact on the survival of patients with breast cancer, but the prognosis for people diagnosed with metastatic breast cancer remains poor, and additional treatments are needed," said Hope S. Rugo, M.D., Professor of Medicine and Director of Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. "As the only HER2-targeted agent to have shown a PFS improvement versus trastuzumab in a head-to-head Phase 3 clinical trial, MARGENZA with chemotherapy represents the newest treatment option for patients who have progressed on available HER2-directed therapies."

    "Women with metastatic HER2-positive breast cancer are benefitting from ongoing scientific advances," said Christine Benjamin, LMSW, Chair, Metastatic Breast Cancer Alliance. "We are always excited to learn of additional treatment options that are available to healthcare professionals and those living with metastatic breast cancer."

    MacroGenics anticipates that MARGENZA will be available in March of 2021.

    Conference Call

    MacroGenics will host a conference call for analysts and investors on Thursday, December 17, 2020, at 8:00 a.m. ET. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 8657888.

    The listen-only webcast of the conference call, including presentation slides, can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at https://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.





    About the SOPHIA Study

    The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating MARGENZA plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer, who have previously been treated with anti-HER2-targeted therapies. All study patients had previously received trastuzumab, all but one patient had previously received pertuzumab, and 91% had previously received ado-trastuzumab emtansine, or T-DM1.

    The study enrolled 536 patients who were randomized 1:1 to receive either MARGENZA (n=266) given intravenously at 15 mg/kg every three weeks or trastuzumab (n=270) given intravenously at 6 mg/kg (or 8 mg/kg for loading dose) every three weeks in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine) given at the standard doses. Intent-to-treat PFS analysis occurred after 265 PFS events.

    The primary endpoints of the study are sequentially-assessed PFS, determined by blinded, centrally-reviewed radiological review, followed by OS. Additional key secondary endpoints are PFS by investigator assessment, ORR and Duration of Response. Tertiary endpoints include ORR by investigator assessment and safety. PFS and ORR were assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    About HER2-positive Breast Cancer

    Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Monoclonal antibodies targeting HER2 have greatly improved outcomes; however, a significant number of patients progress to later lines of therapy. Effective treatments for metastatic HER2-positive breast cancer continue to remain an unmet need.

    About MARGENZA

    MARGENZA (margetuximab-cmkb) is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Similar to trastuzumab, margetuximab-cmkb inhibits tumor cell proliferation, reduces shedding of the HER2 extracellular domain and mediates antibody-dependent cellular cytotoxicity (ADCC). However, through MacroGenics' Fc Optimization technology, margetuximab-cmkb has been engineered to enhance the engagement of the immune system. In vitro, the modified Fc region of margetuximab-cmkb increases binding to the activating Fc receptor FCGR3A (CD16A) and decreases binding to the inhibitory Fc receptor FCGR2B (CD32B).  These changes lead to greater in vitro ADCC and NK cell activation.  The clinical significance of in vitro data is unknown. 

    Margetuximab-cmkb is also being evaluated in combination with checkpoint blockade in the Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer (NCT04082364), and in combination with tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in various HER2-positive tumors (NCT03219268). MacroGenics is partnered with Zai Lab for the development and commercialization of margetuximab-cmkb in Greater China. For more information, please visit www.clinicaltrials.gov.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY

    • Left Ventricular Dysfunction: MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function.
    • Embryo-Fetal Toxicity: Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception.

    WARNINGS & PRECAUTIONS:

    Left Ventricular Dysfunction

    • Left ventricular cardiac dysfunction can occur with MARGENZA.
    • MARGENZA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of myocardial infarction or unstable angina within 6 months, or congestive heart failure NYHA class II-IV.
    • Withhold MARGENZA for ≥16% absolute decrease in LVEF from pre-treatment values or LVEF below institutional limits of normal (or 50% if no limits available) and ≥10% absolute decrease in LVEF from pretreatment values.
    • Permanently discontinue MARGENZA if LVEF decline persists greater than 8 weeks, or dosing is interrupted more than 3 times due to LVEF decline.
    • Evaluate cardiac function within 4 weeks prior to and every 3 months during and upon completion of treatment. Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan.
    • Monitor cardiac function every 4 weeks if MARGENZA is withheld for significant left ventricular cardiac dysfunction.

    Embryo-Fetal Toxicity

    • Based on findings in animals and mechanism of action, MARGENZA can cause fetal harm when administered to a pregnant woman. Post-marketing studies of other HER-2 directed antibodies during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
    • Verify pregnancy status of women of reproductive potential prior to initiation of MARGENZA.
    • Advise pregnant women and women of reproductive potential that exposure to MARGENZA during pregnancy or within 4 months prior to conception can result in fetal harm.
    • Advise women of reproductive potential to use effective contraception during treatment and for 4 months following the last dose of MARGENZA.

    Infusion-Related Reactions (IRRs)

    • MARGENZA can cause IRRs. Symptoms may include fever, chills, arthralgia, cough, dizziness, fatigue, nausea, vomiting, headache, diaphoresis, tachycardia, hypotension, pruritus, rash, urticaria, and dyspnea.
    • Monitor patients during and after MARGENZA infusion. Have medications and emergency equipment to treat IRRs available for immediate use.
    • In patients experiencing mild or moderate IRRs, decrease rate of infusion and consider premedications, including antihistamines, corticosteroids, and antipyretics. Monitor patients until symptoms completely resolve.
    • Interrupt MARGENZA infusion in patients experiencing dyspnea or clinically significant hypotension and intervene with supportive medical therapy as needed. Permanently discontinue MARGENZA in all patients with severe or life-threatening IRRs.

    MOST COMMON ADVERSE REACTIONS:

    The most common adverse drug reactions (≥10%) with MARGENZA in combination with chemotherapy are fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, infusion-related reactions, palmar-plantar erythrodysesthesia, and extremity pain.

    You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to MacroGenics at (844)-MED-MGNX (844-633-6469).

    Link to full Prescribing Information, including Boxed Warning

    About MacroGenics, Inc.

    MacroGenics is a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, commercial prospects of or product revenues from MARGENZA, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and other statements containing the words "subject to," "believe," "anticipate," "plan," "expect," "intend," "estimate," "project," "may," "will," "should," "would," "could," "can," the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that MARGENZA revenue, expenses and costs may not be as expected, risks relating to MARGENZA's market acceptance, competition, reimbursement and regulatory actions the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    +1-301-251-5172
    info@macrogenics.com
    
    Source: MacroGenics, Inc.
    
    Herceptin®  is a registered trademark of Genentech 

    Primary Logo

    View Full Article Hide Full Article
    • 53.8% ORR in relapsed/refractory DLBCL patients
    • Preliminary duration of response of up to 168 days observed, with six of seven ongoing responses as of cut-off date 

    ROCKVILLE, MD, Dec. 07, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced updated results from a dose expansion study of tebotelimab, an investigational, bispecific PD-1 × LAG-3 DART® molecule, in patients with diffuse large B-cell lymphoma (DLBCL). The data were presented at the 62nd Annual Meeting of the American Society of Hematology (ASH) taking place December 5-8, 2020.

    • 53.8% ORR in relapsed/refractory DLBCL patients
    • Preliminary duration of response of up to 168 days observed, with six of seven ongoing responses as of cut-off date 

    ROCKVILLE, MD, Dec. 07, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced updated results from a dose expansion study of tebotelimab, an investigational, bispecific PD-1 × LAG-3 DART® molecule, in patients with diffuse large B-cell lymphoma (DLBCL). The data were presented at the 62nd Annual Meeting of the American Society of Hematology (ASH) taking place December 5-8, 2020.

    LAG-3 has been shown to be highly expressed in DLBCL and has emerged as a therapeutic target of interest in this population, while PD-1-targeted therapy has yielded modest efficacy. There remains significant unmet need for patients with relapsed/refractory (R/R) DLBCL.

    In one of the tebotelimab monotherapy dose expansion cohorts, 20 DLBCL patients were enrolled, half of whom were CAR T cell therapy experienced. As of the October 23, 2020 data cut-off, there were 13 response-evaluable patients.

    A preliminary objective response rate (ORR) of 53.8% (7 of 13 patients) was observed, including responses in five of seven CAR T cell-naïve patients and in two of six CAR T cell experienced patients, the latter of whom both had complete responses. A preliminary duration of response of up to 168 days was observed, with six of seven ongoing responses as of the cut-off date. In the study, baseline LAG-3 expression appeared to associate with clinical response, with additional analyses ongoing.

    Tebotelimab was generally well-tolerated among heavily pre-treated R/R DLBCL patients, with manageable infusion-related reactions and no evidence of tumor lysis syndrome. The most common TRAE was pyrexia, which occurred in three (15%) patients. A single Grade 3 TRAE of anemia was observed.

    "Although early, the preliminary ORR observed in relapsed/refractory DLBCL patients treated with tebotelimab is promising," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Beyond our continued enrollment of patients in the combination study of tebotelimab in solid tumors, we look forward to presenting data from the full cohort of the 20 enrolled DLBCL patients, as well as potentially defining a future registration path for this DART molecule."

    About Diffuse Large B-Cell Lymphoma

    DLBCL is the most common histologic subtype of non-Hodgkin lymphoma (NHL) accounting for approximately 25 percent of NHL cases globally. According to published research, the incidence in the U.S. and England is approximately 7 cases per 100,000 persons per year, with a median age at presentation of 64 years. DLBCL represents a heterogeneous group of tumors consisting of large, transformed B cells with prominent nucleoli and basophilic cytoplasm, a diffuse growth pattern, and a high proliferation fraction. While DLBCL is curable in approximately half of cases with current therapy, particularly those who achieve a complete remission with first-line treatment, significant unmet medical need remains for patients with relapsed or refractory disease.

    About Tebotelimab

    Tebotelimab (previously known as MGD013) is an investigational, first-in-class bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. Tebotelimab has been engineered to concomitantly or independently bind to PD-1 and LAG-3 and disrupt these non-redundant inhibitory pathways to further restore exhausted T-cell function. Tebotelimab is being evaluated in a Phase 1 dose expansion study as monotherapy in several tumor types, including both solid tumors and hematological malignancies, and in combination with margetuximab, an investigational Fc-engineered monoclonal antibody targeting HER-2, in three cohorts of patients with advanced HER2-positive cancers (NCT03219268). Tebotelimab will also be evaluated in combination with margetuximab and chemotherapy as part of the ongoing Phase 2/3 MAHOGANY study in patients with HER2-positive gastric or gastroesophageal junction cancer (NCT04082364). MacroGenics' regional partner in Greater China, Zai Lab, participates in the MAHOGANY study and is also evaluating tebotelimab independently in Phase 1 combination studies with niraparib, a PARP inhibitor, and brivanib, a dual target tyrosine kinase inhibitor of the VEGF and FGF receptors, for the study of advanced gastric cancer and hepatocellular carcinoma, respectively.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172
    info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • 31.8% CR/CRh/CRi rate in primary induction failure and early relapsed AML patients
    • Median duration of response = 8.13 months

    ROCKVILLE, MD, Dec. 06, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced updated results from a single-arm, registrational study of flotetuzumab, an investigational, bispecific CD123 × CD3 DART® molecule, in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). The data were presented at the 62nd Annual Meeting of the American Society of Hematology (ASH) taking…

    • 31.8% CR/CRh/CRi rate in primary induction failure and early relapsed AML patients
    • Median duration of response = 8.13 months

    ROCKVILLE, MD, Dec. 06, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced updated results from a single-arm, registrational study of flotetuzumab, an investigational, bispecific CD123 × CD3 DART® molecule, in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). The data were presented at the 62nd Annual Meeting of the American Society of Hematology (ASH) taking place December 5-8, 2020.

    In the open label study of flotetuzumab, 44 AML patients had disease classified as either PIF or ER6. Of these patients, 72.7% (32 of 44) had adverse risk cytogenetics by ELN Risk Stratification (2017). Patients were treated with flotetuzumab at the recommended Phase 2 dose (RP2D) of 500 ng/kg/day by continuous infusion. Data were reported as of the cut-off date of November 10, 2020. The study is currently ongoing, with a total of up to 200 patients planned for enrollment for registrational purposes.

    The median time to achieve a response to flotetuzumab was one cycle (range of 1-3 cycles). Responses, including complete remission (CR), CRh (CR with partial hematological recovery) and CRi (CR with incomplete hematological improvement) per a modified International Working Group (IWG) Response Criteria for AML, are summarized in the table below.

     PIF/ER (n=44)PIF (n=27)ER6 (n=17)
    CR/CRh25.0% (11)33.3% (9)11.8% (2)
    CR/CRh/Cri31.8% (14)37.0% (10)23.5% (4)
    HSCT57.1% (8/14)70.0% (7/10)25.0% (1/4)
    Median Duration of Response8.13 mos.

    (n=14)
    15.2 mos.

    (n=10)
    2.4 mos.

    (n=4)

    As shown in the table, over 50% of responders (8 of 14) successfully received allogeneic hematopoietic stem cell transplantation (HSCT) as consolidation therapy with durable remission (median not reached). Also, among those PIF/ER6 patients who achieved remission (CR, CRh or CRi), the median duration of response was 8.13 months, with a median overall survival of 10.7 months. Within the PIF/ER6 population, five of ten patients with TP53MUT AML achieved CR/CRh/CRi responses, three of whom went on to receive HSCT. More detailed flotetuzumab clinical data in the TP53MUT AML population is available via a separate poster presentation at ASH (see "TP53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in Acute Myeloid Leukemia", Session 617).

    The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), which occurred in all patients. However, most CRS events observed were of short duration and mild to moderate (Grade 1 or 2) in severity, with only a single Grade 3 event reported.

    "For the approximately 50% of AML patients who fail primary induction therapy or relapse within six months of an initial response, there is no standard of care among the available treatment regimens. Historically, these patients have CR/CRh rates to subsequent interventions in the range of only 5-12% with a median overall survival of approximately 3.5 months. A remission rate of 32% with good duration and a manageable safety profile observed to date in the ongoing registrational study of flotetuzumab in this extremely challenging patient population is very encouraging," said Ibrahim Aldoss, M.D., Assistant Professor of Hematology/HCT at City of Hope Comprehensive Cancer Center.

    In addition to the above data provided in an oral presentation, five additional presentations related to flotetuzumab and AML have or will be presented at ASH.

    "We are very encouraged by the updated results from this study, and continue to enroll patients in this single arm, registrational trial," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Especially encouraging is the duration of response we've seen to date in this otherwise fragile population of patients for whom no approved therapies exist."

    About Acute Myeloid Leukemia

    AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure, or PIF) or experience disease recurrence after a short remission duration (<6 months; early relapsed, or ER6). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations.

    About Flotetuzumab

    Flotetuzumab (previously known as MGD006) is a clinical-stage bispecific, investigational DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML. MacroGenics retains global development and commercialization rights to flotetuzumab.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172
    info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • MacroGenics accesses EVERSANA's full suite of commercial services for which both parties share expenses
    • EVERSANA may earn revenue share payments over five years subject to predefined cap
    • MacroGenics' projected cash runway remains into 2023

    ROCKVILLE, MD and CHICAGO, IL, Nov. 30, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that it has partnered with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry, to commercialize margetuximab in the United States, if approved.

    Margetuximab is an investigational, monoclonal…

    • MacroGenics accesses EVERSANA's full suite of commercial services for which both parties share expenses
    • EVERSANA may earn revenue share payments over five years subject to predefined cap
    • MacroGenics' projected cash runway remains into 2023

    ROCKVILLE, MD and CHICAGO, IL, Nov. 30, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that it has partnered with EVERSANA, a pioneer of next-generation commercial services to the global life sciences industry, to commercialize margetuximab in the United States, if approved.

    Margetuximab is an investigational, monoclonal antibody derived from MacroGenics' proprietary Fc-Optimization technology platform. A Biologics License Application (BLA) for margetuximab for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the U.S. Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020.

    "We believe that margetuximab, if approved, could become a valuable treatment option for patients living with this devastating disease," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are excited to partner with EVERSANA and leverage their integrated commercial services to efficiently launch margetuximab. We have been working closely with EVERSANA to fully align our commercialization strategies to educate healthcare providers and ensure patient access to margetuximab, while maintaining MacroGenics' cash runway to fund our broader portfolio."

    Jim Lang, CEO of EVERSANA, added, "We've built a suite of comprehensive commercial services for biopharmaceutical innovators like MacroGenics and look forward to entering this risk-sharing arrangement with MacroGenics to support the commercialization of margetuximab, if approved. Our partnership with MacroGenics puts the patient first by supporting broad market access and comprehensive patient support services. We will work closely with MacroGenics on each stage of the product launch and roll-out."

    Under the terms of the agreement, MacroGenics maintains ownership of margetuximab, including all manufacturing, regulatory and development responsibilities for the product. This includes MacroGenics' continued development of margetuximab in combination with immune checkpoint inhibitors in gastroesophageal cancer in the Phase 2/3 MAHOGANY study, as well as other ongoing studies. EVERSANA receives a co-exclusive right to conduct approved commercialization activities. EVERSANA will utilize its internal capabilities to support sales and marketing, market access, channel management services, data and analytics, medical affairs, and other patient access related services.  MacroGenics will book sales for margetuximab.  Upon the potential approval of margetuximab, EVERSANA and MacroGenics will equally share in funding EVERSANA's commercialization expenses. In exchange for co-funding these expenses, EVERSANA will earn future revenue share payments which shall be capped at 125% of EVERSANA's cumulative service fees. The term of the agreement is five years following the date of FDA approval, subject to predefined termination provisions.

    About HER2-Positive Breast Cancer

    Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Antibody-based therapies targeting HER2 have greatly improved outcomes of patients with HER2-positive breast cancer and are now standard of care in both early-and late-stage disease. However, metastatic breast cancer remains an area of unmet need and ongoing HER2 blockade is recommended for the treatment of patients with relapsed or refractory disease.

    About Margetuximab

    Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics' Fc Optimization technology. Margetuximab is also being evaluated in combination with checkpoint blockade in the Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer (NCT04082364), and in combination with tebotelimab (PD-1 × LAG-3 bispecific DART® molecule) in various HER2+ indications (NCT03219268). For more information, please visit www.clinicaltrials.gov.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    About EVERSANA™

    EVERSANA™ is the leading provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life science solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

    MacroGenics' Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for MacroGenics, Inc. (the "Company"), including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    
    MacroGenics, Inc.
    Jim Karrels, Senior Vice President, CFO
    info@macrogenics.com
    1-301-251-5172 
    
    EVERSANA
    Sarah Zwicky
    sarah.zwicky@eversana.com
    1-414-434-4691

    Primary Logo

    View Full Article Hide Full Article
  17. ROCKVILLE, MD, Nov. 30, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that $25 million in milestones have been achieved under its exclusive global collaboration and license agreement with Incyte for retifanlimab, an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012). The milestones were triggered by clinical and regulatory activities related to the further advancement of the molecule, including the recent initiation of POD1UM-303, Incyte's Phase 3 global study in patients with metastatic squamous…

    ROCKVILLE, MD, Nov. 30, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that $25 million in milestones have been achieved under its exclusive global collaboration and license agreement with Incyte for retifanlimab, an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA0012). The milestones were triggered by clinical and regulatory activities related to the further advancement of the molecule, including the recent initiation of POD1UM-303, Incyte's Phase 3 global study in patients with metastatic squamous cell anal carcinoma (SCAC).

    MacroGenics and Incyte have each established multiple development programs for retifanlimab, evaluating the anti-PD-1 molecule either as monotherapy or in combination with other agents. Incyte is conducting clinical trials that are potentially registration-enabling for patients with metastatic non-small cell lung cancer, SCAC, microsatellite instability high endometrial cancer and Merkel cell carcinoma. MacroGenics is conducting a potentially registration-enabling study of retifanlimab in combination with margetuximab, an investigational Fc-engineered, anti-HER2 mAb, in HER2-positive gastric cancer.

    "We are excited to see the continued advancement of the development of retifanlimab across a broad set of monotherapy and combination regimens," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We look forward to continued progress on this program over the coming months."

    Under the collaboration agreement with Incyte, MacroGenics is eligible to receive up to a total of $365 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###



    Contacts:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  18. ROCKVILLE, MD, Nov. 09, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in November and December:

    • Credit Suisse 29th Annual Virtual Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview on November 10, 2020 at 2:45 PM ET.
    • Stifel 2020 Virtual Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and participate in a fireside chat with the analyst on November 17, 2020 at…

    ROCKVILLE, MD, Nov. 09, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in November and December:

    • Credit Suisse 29th Annual Virtual Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview on November 10, 2020 at 2:45 PM ET.
    • Stifel 2020 Virtual Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and participate in a fireside chat with the analyst on November 17, 2020 at 10:40 AM ET.
    • SVB Leerink Oncology 1x1 Day. MacroGenics' management will participate in one-on-one meetings on November 19, 2020.
    • Evercore ISI 3rd Annual HealthCONx Virtual Conference. MacroGenics' management will participate in one-on-one meetings and participate in a fireside chat with the analyst on December 2, 2020 at 3:55 PM ET.

    Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###

    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  19. ROCKVILLE, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended September 30, 2020.

    "MacroGenics continued the advancement of its portfolio of multiple clinical molecules during the third quarter of 2020, with three investigational programs currently in pivotal studies: margetuximab, flotetuzumab and retifanlimab. The PDUFA action date for margetuximab in breast cancer is December 18. Just prior, we look forward to our next presentation of flotetuzumab clinical…

    ROCKVILLE, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended September 30, 2020.

    "MacroGenics continued the advancement of its portfolio of multiple clinical molecules during the third quarter of 2020, with three investigational programs currently in pivotal studies: margetuximab, flotetuzumab and retifanlimab. The PDUFA action date for margetuximab in breast cancer is December 18. Just prior, we look forward to our next presentation of flotetuzumab clinical data at ASH in December, following the publication of data in three separate journals this year highlighting the medical and scientific interest in this DART® molecule," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "At ESMO in September, we and our partner, Incyte, presented clinical data on MGD019 and retifanlimab, respectively. And on the heels of MGC018 data presented at ASCO, we recently commenced the enrollment of patients with mCRPC, TNBC and NSCLC. More near-term, we look forward to providing an update on tebotelimab plus margetuximab in HER2-positive patients at the upcoming SITC Annual Meeting this month. Finally, we look forward to updating you on continued progress through the rest of 2020 and into 2021."

    Key Highlights from Investigational Product Candidates in Pivotal Studies:

    • Margetuximab (Fc-engineered, anti-HER2 mAb): A Biologics License Application (BLA) for margetuximab, in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer, is being reviewed by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date is December 18, 2020. Based on the current accrual rate of overall survival (OS) events in the Phase 3 SOPHIA study, MacroGenics now anticipates accrual of the 385th OS event, which triggers the final OS analysis, in the second half of 2021.



      Enrollment of the global Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade, with or without chemotherapy, as a potential first-line treatment for patients in front-line gastric and gastroesophageal junction cancer is ongoing. MacroGenics' partner in Greater China, Zai Lab, recently announced dosing of the first patient in that region. MacroGenics anticipates providing a clinical update on Module A of the study in the first half of 2021.



    • Flotetuzumab (bispecific CD123 × CD3 DART molecule): During the third quarter, two manuscripts were published in Blood and Blood Advances, two publications of the American Society of Hematology (ASH). The first publication reported on clinical results as of November 2019, while the most recent publication reported on the potential role of flotetuzumab in the immunotherapy of TP53-positive acute myeloid leukemia (AML). In addition, six flotetuzumab and AML abstracts were accepted for presentation at the upcoming ASH Annual Meeting.



      MacroGenics continues to enroll the single-arm, registrational study to evaluate flotetuzumab in up to 200 AML patients with primary induction failure or early relapse (PIF/ER) AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. 



    • Retifanlimab (anti-PD-1 mAb previously known as MGA012 or INCMGA0012): At the European Society for Medical Oncology (ESMO) Virtual Congress 2020 in September, data from potentially registration-enabling monotherapy studies in patients with squamous cell carcinoma of the anal canal and Merkel cell carcinoma were presented. Also in September, a $15 million milestone payment to MacroGenics was triggered under the Company's exclusive global collaboration and license agreement with Incyte Corporation. This milestone was triggered by Incyte's initiation of the Phase 3 clinical trial evaluating the efficacy and safety of retifanlimab with platinum-based chemotherapy in patients with metastatic squamous and non-squamous non-small cell lung cancer (NSCLC). 

    Key Highlights from Other Investigational Product Candidates:

    • MGC018 (B7-H3 antibody-drug conjugate): Encouraged by the MGC018 interim clinical dose escalation data presented at the American Society of Clinical Oncology (ASCO) meeting in May, the Company recently commenced the enrollment of patients with metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) in the dose expansion portion of the Phase 1 clinical study. The Company expects to provide an update on this study in the first half of 2021.

       
    • Enoblituzumab (Fc-engineered, anti-B7-H3 mAb): In the first quarter of 2021, MacroGenics expects to initiate a Phase 2 study of enoblituzumab in a chemo-free regimen in combination with either retifanlimab in front-line patients with squamous cell carcinoma of the head and neck (SCCHN) who are PD-L1 positive or with tebotelimab in SCCHN patients who are PD-L1 negative.

       
    • Tebotelimab (also known as MGD013, a bispecific PD-1 × LAG-3 DART molecule): The Company will present updated data via poster presentation from the ongoing Phase 1 dose expansion study of tebotelimab in combination with margetuximab in a cohort of patients with advanced HER2-positive tumors at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting. 

       
    • MGD019 (bispecific PD-1 × CTLA-4 DART molecule): In September, data from the Phase 1 dose escalation study of MGD019 was presented during an oral session at the ESMO Virtual Congress 2020. Based on the results presented, the Company has expanded the study initially in patients with microsatellite stable colorectal cancer (MSS CRC) and checkpoint-naïve NSCLC at the recommended Phase 2 dose of 6.0 mg/kg.

       
    •  IMGC936 (ADAM9 antibody-drug conjugate): IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types. IMGC936 is being advanced under a co-development agreement with ImmunoGen, Inc. Under the 50/50 collaboration, ImmunoGen is leading clinical development and they are currently screening patients for the Phase 1 dose escalation study in patients with select advanced solid tumors.

    Third Quarter 2020 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2020, were $280.7 million, compared to $215.8 million as of December 31, 2019. During the quarter ended September 30, 2020, $74.0 million in net proceeds were received from the sale of 2,552,333 shares of the Company's common stock pursuant to its at-the-market (ATM) offering. The $15.0 million milestone payment from Incyte was received after September 30, 2020.



    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $18.2 million for the quarter ended September 30, 2020, compared to $18.7 million for the quarter ended September 30, 2019.



    • R&D Expenses: Research and development expenses were $44.7 million for the quarter ended September 30, 2020, compared to $44.9 million for the quarter ended September 30, 2019.



    • G&A Expenses: General and administrative expenses were $9.7 million for the quarter ended September 30, 2020, compared to $11.8 million for the quarter ended September 30, 2019. This decrease is primarily due to a decrease in external costs, including consulting.



    • Net Loss: Net loss was $36.0 million for the quarter ended September 30, 2020, compared to net loss of $44.6 million for the quarter ended September 30, 2019.



    • Shares Outstanding: Shares outstanding as of September 30, 2020 were 56,174,932.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended September 30, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 5986584.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    MACROGENICS, INC.

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

     September 30, 2020 December 31, 2019
     (unaudited)  
    Cash, cash equivalents and marketable securities$280,659   $215,756  
    Total assets374,380   312,501  
    Deferred revenue15,037   19,853  
    Total stockholders' equity291,585   230,628  

    MACROGENICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited)

    (Amounts in thousands, except share and per share data)

     Three Months Ended September 30, Nine Months Ended September 30,
     2020 2019 2020 2019
    Revenues:       
    Revenue from collaborative and other agreements$17,415    $17,984    $46,018    $37,468   
    Revenue from government agreements838    757    6,174    1,528   
    Total revenues18,253    18,741    52,192    38,996   
    Costs and expenses:       
    Research and development44,656    44,852    150,901    143,352   
    General and administrative9,732    11,833    30,181    34,174   
    Total costs and expenses54,388    56,685    181,082    177,526   
    Loss from operations(36,135)  (37,944)  (128,890)  (138,530) 
    Other income (expense)92    (6,687)  1,238    17,115   
    Net loss(36,043)  (44,631)  (127,652)  (121,415) 
    Other comprehensive loss:       
    Unrealized gain (loss) on investments(15)  (11)  (14)  26   
    Comprehensive loss$(36,058)  $(44,642)  $(127,666)  $(121,389) 
            
    Basic and diluted net loss per common share$(0.66)  $(0.91)  $(2.49)  $(2.54) 
    Basic and diluted weighted average common shares outstanding54,463,412   48,902,766   51,176,884   47,796,957  

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts:

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  20. ROCKVILLE, MD, Nov. 04, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced six clinical and preclinical abstracts related to acute myeloid leukemia (AML) and flotetuzumab, an investigational bispecific CD123 × CD3 DART® molecule, and one abstract related to tebotelimab, an investigational bispecific PD-1 × LAG-3 DART molecule, to be presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, December 5-8, 2020.

    "We look forward to presenting clinical and biomarker results for flotetuzumab in patients with relapsed or refractory…

    ROCKVILLE, MD, Nov. 04, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced six clinical and preclinical abstracts related to acute myeloid leukemia (AML) and flotetuzumab, an investigational bispecific CD123 × CD3 DART® molecule, and one abstract related to tebotelimab, an investigational bispecific PD-1 × LAG-3 DART molecule, to be presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, December 5-8, 2020.

    "We look forward to presenting clinical and biomarker results for flotetuzumab in patients with relapsed or refractory acute myeloid leukemia at the 2020 ASH annual meeting," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "The first of our two oral presentations will address results of the role of immune senescence and exhaustion-related RNA profiles in predicting outcomes in AML. The second oral presentation will provide the results on the use of flotetuzumab as salvage therapy in AML patients who failed induction therapy or experienced an early relapse. Together with our four posters, these presentations add to the growing medical and scientific interest in the potential of flotetuzumab in AML. Finally, we are very pleased to present data from the cohort of diffuse large B-cell lymphoma (DLBCL) patients who were treated in the dose expansion study of tebotelimab."

    Oral Presentations

    • An Immune Senescence and Exhaustion-related RNA Profile Predicts Clinical Outcomes in Acute Myeloid Leukemia

      Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Single Cell Profiling and Novel molecular Markers

      Session Date: Saturday, December 5, 2020 

      Session Time: 7:30 AM - 9:00 AM

      Presentation Time: 8:15 AM
    • Flotetuzumab as Salvage Therapy for Primary Induction Failure and Early Relapse Acute Myeloid Leukemia

      Session Name: 613. Acute Myeloid Leukemia: Novel Therapies and Treatment Approaches 

      Session Date: Sunday, December 6, 2020 

      Session Time: 9:30 AM - 11:00 AM 

      Presentation Time: 9:45 AM



    Poster Presentations

    • Prophylactic Ruxolitinib for Cytokine Release Syndrome (CRS) in Relapse/Refractory (R/R) AML Patients Treated with Flotetuzumab

      Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Poster III

      Date: Monday, December 7, 2020
    • Tp53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in Acute Myeloid Leukemia

      Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster II

      Date: Sunday, December 6, 2020
    • Immune Senescence and Exhaustion Correlate with Response to Flotetuzumab, An Investigational CD123 × CD3 Bispecific DART® Molecule, In Acute Myeloid Leukemia

      Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster III

      Date: Monday, December 7, 2020
    • Flotetuzumab and other Cellular Immunotherapies Upregulate MHC Class II Expression on Acute Myeloid Leukemia Cells In Vitro and In Vivo

      Session Name: 704. Immunotherapies: Poster III

      Date: Monday, December 7, 2020
    • A Phase 1, Open-Label Study of MGD013, a Bispecific DART® Molecule Binding PD-1 and LAG-3 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

      Session Name: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III

      Date: Monday, December 7, 2020

    The above abstracts were published today on the ASH website at https://www.hematology.org/meetings/annual-meeting/abstracts.

    About Flotetuzumab

    Flotetuzumab (also known as MGD006) is a clinical-stage bispecific, investigational DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with primary induction failure / early relapse (PIF/ER) AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.

    About Tebotelimab

    Tebotelimab (also known as MGD013) is a clinical-stage bispecific, investigational DART molecule designed to independently or coordinately block PD-1 and LAG-3 checkpoint molecules to sustain or restore the function of exhausted T cells for the treatment of cancer. Data from the Phase 1 dose escalation study in cohorts of patients with advanced solid tumors at escalating flat doses of 1-1200 mg every two weeks were presented at the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program. A maximum tolerated dose was not identified. At the same meeting, it was reported that LAG-3 expression on immune effector cells was shown to be enhanced by margetuximab, MacroGenics' investigational Fc-engineered monoclonal antibody targeting HER2. Given the early signal of activity and acceptable safety profile observed in an initial, small expansion cohort of patients, the Company is evaluating the combination of tebotelimab and margetuximab in patients with HER2-positive tumors. The Company believes that combining Fc-engineering and checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments. For more information about the study design, please visit ClinicalTrials.gov (NCT03219268).

    About MacroGenics, Inc. 

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc. 

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###

    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  21. ROCKVILLE, MD, Oct. 28, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the third quarter of 2020 after the market closes on Wednesday, November 4, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Wednesday, November 4, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 5986584.

    The listen-only…

    ROCKVILLE, MD, Oct. 28, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the third quarter of 2020 after the market closes on Wednesday, November 4, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Wednesday, November 4, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 5986584.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ### 

    CONTACT:
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  22. ROCKVILLE, MD, Oct. 15, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript in Blood Advances, a journal of the American Society of Hematology.  This represents the third publication of flotetuzumab data in 2020. Flotetuzumab (also known as MGD006), is an investigational, clinical-stage bispecific DART® molecule that recognizes both CD123 on leukemic cells and CD3 on T cells, with the intended result of T-cell-mediated killing of leukemic blasts. This most recent publication reports on the role of flotetuzumab in the immunotherapy of…

    ROCKVILLE, MD, Oct. 15, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript in Blood Advances, a journal of the American Society of Hematology.  This represents the third publication of flotetuzumab data in 2020. Flotetuzumab (also known as MGD006), is an investigational, clinical-stage bispecific DART® molecule that recognizes both CD123 on leukemic cells and CD3 on T cells, with the intended result of T-cell-mediated killing of leukemic blasts. This most recent publication reports on the role of flotetuzumab in the immunotherapy of TP53-positive acute myeloid leukemia (AML).

    It has previously been shown1 that an inflammatory (IFN-γ-related) gene expression signature in patients with AML correlated with a lack of response to induction chemotherapy. The same gene signature was shown to be associated with an increased probability of this subset of patients to respond to flotetuzumab. As further described in the article titled "TP53 Abnormalities Correlate with Immune Infiltration and Associate with Response to Flotetuzumab Immunotherapy in AML," AML with TP53 abnormalities was also associated with immune infiltration in the tumor microenvironment (TME); moreover, patients with TP53 abnormalities derived benefit from flotetuzumab immunotherapy.

    "Previous translational studies demonstrated that patients who failed to respond to induction therapy (primary induction failure, or PIF, AML) or those who relapsed within six months of achieving an initial remission (early relapsed, or ER, AML) had an immune-infiltrated TME that not only associated with resistance to standard-of-care chemotherapy regimens, but also with response to flotetuzumab," said Sergio Rutella, M.D., Ph.D., FRCPath, John van Geest Cancer Research Centre, College of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom. "Included in this PIF/ER AML population are patients harboring TP53 abnormalities, a particularly difficult to treat subset of AML associated with poor prognosis. Interestingly, these patients who responded poorly when treated with standard-of-care chemotherapy regimens appeared to benefit from flotetuzumab therapy." 

    "The results published today in Blood Advances, combined with data from previous articles published in Blood and Science Translational Medicine, further support our decision to conduct a pivotal study of flotetuzumab in AML patients who have previously experienced either a primary induction failure or an early relapse when treated with standard-of-care chemotherapy regimens. These individuals represent approximately 40-50% of all AML patients," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our single arm clinical trial is ongoing as an expansion of the Phase 1/2 study, for which we plan to enroll up to 200 patients. We plan to present interim results at a medical conference later this year."



    1 "Flotetuzumab as Salvage Immunotherapy for Refractory Acute Myeloid Leukemia," Blood, 2020; and "Immune Landscapes Predict Chemotherapy Resistance and Immunotherapy Response in Acute Myeloid Leukemia," Science Translational Medicine, 2020.

    About Acute Myeloid Leukemia

    AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure, or PIF) or experience disease recurrence after a short remission duration (<6 months; early relapsed, or ER). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations. The discovery by the Rutella lab of an immunological gene signature in the AML tumor microenvironment forms the basis for a potential predictive biomarker for further clinical validation.

    About Flotetuzumab

    Flotetuzumab (also known as MGD006) is a clinical-stage bispecific, investigational DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. Data from the Phase 1/2 clinical study of flotetuzumab in patients with primary induction failure / early relapse (PIF/ER) AML were presented in December 2019 at the American Society of Hematology (ASH) Annual Meeting.  MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.

    About MacroGenics, Inc. 

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc. 

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. 

    ###

    CONTACT: 
    Jim Karrels, Senior Vice President, CFO 
    MacroGenics, Inc. 
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • Manuscript describes preclinical development of MGC018
    • Phase 1 dose expansion trial evaluating MGC018 in patients with mCRPC, TNBC and NSCLC is currently recruiting patients

    ROCKVILLE, MD, Sept. 23, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research, highlighting the development of MGC018, the Company's investigational antibody-drug conjugate (ADC) targeting B7-H3 for the treatment of solid tumors.

    B7-H3 has been identified as a cell…

    • Manuscript describes preclinical development of MGC018
    • Phase 1 dose expansion trial evaluating MGC018 in patients with mCRPC, TNBC and NSCLC is currently recruiting patients

    ROCKVILLE, MD, Sept. 23, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research, highlighting the development of MGC018, the Company's investigational antibody-drug conjugate (ADC) targeting B7-H3 for the treatment of solid tumors.

    B7-H3 has been identified as a cell surface protein with limited expression on normal tissues but over-expressed on the epithelium and tumor-associated vasculature in solid tumors. Overexpression of this molecule has been shown to be associated with cancer disease severity, risk of recurrence and reduced survival. The Company's early studies showed that ligation of B7-H3 by select monoclonal antibodies (mAbs) led to mAb internalization and antitumor activity toward B7-H3-expressing tumor cells when conjugated to a toxic payload. Based on these results, MacroGenics selected a lead candidate mAb and developed MGC018, an ADC targeting B7-H3 for the treatment of cancer.

    As described in the paper "Preclinical Development of MGC018, a Duocarmycin-based Antibody-drug Conjugate Targeting B7-H3 for Solid Cancer," the authors report on preclinical studies that showed that MGC018 mediated specific in vitro killing across a range of B7-H3-expressing solid tumor cell types. Furthermore, the preclinical studies showed that MGC018 mediated bystander in vitro killing of B7-H3-negative tumor cells in the presence of B7-H3-positive tumor cells.

    MGC018 displayed potent antitumor activity in preclinical tumor xenograft models of breast, ovarian and lung cancer, as well as melanoma. Additionally, antitumor activity was observed toward patient-derived tumor xenograft models of breast, prostate and head and neck cancer displaying heterogeneous expression of B7-H3. Importantly, MGC018 exhibited an acceptable pharmacokinetic and safety profile in cynomolgus monkeys following repeat-dose administration.

    "With its overexpression on a wide range of solid cancers but limited presence on normal tissues, B7-H3 is an attractive candidate for an ADC-targeting approach," said Deryk Loo, Ph.D., Senior Director of Research at MacroGenics and the lead author of the paper. "The published preclinical antitumor activity data and safety profile provided evidence of a potentially favorable therapeutic index to support the development of MGC018 for the treatment of solid tumors."

    Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, further commented: "Encouraged by the MGC018 interim clinical dose escalation data presented at ASCO in May, we have recently initiated recruitment of patients with metastatic castration-resistant prostate, triple negative breast and non-small cell lung cancers in the dose expansion portion of the Phase 1 clinical study. We expect to provide an update on this study next year."

    About MGC018

    MGC018 is comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. MGC018 is being evaluated in a Phase 1 study (NCT03729596). Preliminary clinical results from the dose escalation portion of this study were presented at the 2020 American Society for Clinical Oncology (ASCO) Scientific Program. MacroGenics retains full worldwide rights to MGC018.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###

    CONTACT:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  23. ROCKVILLE, MD, Sept. 22, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript in Blood, a journal of the American Society of Hematology, which highlights interim results of an ongoing Phase 1/2 clinical trial of flotetuzumab in patients with acute myeloid leukemia (AML). Flotetuzumab (also known as MGD006) is an investigational, clinical-stage bispecific DART® molecule that recognizes both CD123 on leukemic cells and CD3 on T cells, with the intended result of T cell mediated killing of leukemic blasts.

    As described in the…

    ROCKVILLE, MD, Sept. 22, 2020 (GLOBE NEWSWIRE) --  

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the publication of a manuscript in Blood, a journal of the American Society of Hematology, which highlights interim results of an ongoing Phase 1/2 clinical trial of flotetuzumab in patients with acute myeloid leukemia (AML). Flotetuzumab (also known as MGD006) is an investigational, clinical-stage bispecific DART® molecule that recognizes both CD123 on leukemic cells and CD3 on T cells, with the intended result of T cell mediated killing of leukemic blasts.

    As described in the article titled "Flotetuzumab as Salvage Immunotherapy for Refractory Acute Myeloid Leukemia," 88 AML patients were enrolled in the Phase 1/2 trial as of November 1, 2019, including 42 in dose escalation and 46 treated with flotetuzumab at the recommended Phase 2 dose (RP2D) of 500ng/kg/day. The majority (56%) had adverse risk by ELN 2017 criteria and 36% had secondary AML. Patients were heavily pretreated, with a median of three lines of prior therapy (range 1-9). Collectively, this group of patients represents a poor-prognosis population having few effective therapies and an otherwise limited life expectancy.

    The most common treatment-related adverse event (TRAE) was infusion-related reaction/cytokine release syndrome (IRR/CRS), the majority reported as grade 1-2. Stepwise dosing during week 1, pre-treatment with dexamethasone, prompt use of tocilizumab and temporary dose reductions/interruptions successfully prevented severe IRR/CRS, resulting in acceptable tolerability.

    As described in the publication, of 50 evaluable patients with relapsed or refractory AML, 30 patients entered the study with no prior response to induction therapy (primary induction failure AML or PIF AML) or having relapsed within six months of achieving an initial remission (early relapsed AML or ER AML), a combined population with poor prognosis and high unmet medical needs. This PIF/ER AML subset of patients showed a 16.7% (5/30) complete remission (CR) rate and a combined CR and complete remission with partial hematological recovery (CRh) rate of 26.7% (8/30) following flotetuzumab treatment. In contrast, only one of 20 patients with late relapsed AML achieved a CR following flotetuzumab treatment. PIF/ER patients who achieved CR/CRh showed median overall survival (OS) of 10.2 months (range 1.87-27.27), with 6- and 12-month survival rates of 75% (95% CI, 0.450-1.05) and 50% (95% CI, 0.154-0.846).

    "The response to flotetuzumab in primary induction failure and early relapsed AML is consistent with our previously published data1 that an IFN-γ-related inflammatory gene expression signature in the AML bone marrow correlated with lack of response to induction chemotherapy but was associated with a greater likelihood to respond to flotetuzumab," said Sergio Rutella, M.D., Ph.D., FRCPath, John van Geest Cancer Research Centre, College of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom, and a co-author on the current paper. "AML is a highly heterogeneous disease. Our translational studies provided a strong mechanistic basis for studying flotetuzumab in these AML patients, who currently have few treatment options."

    "The results recently published in Blood support our decision to conduct a pivotal study of flotetuzumab in the specific subset of AML patients who have previously experienced either a primary induction failure or an early relapse when treated with standard-of-care chemotherapy regimens. These individuals represent approximately 40-50% of all AML patients," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Moreover, the translational research provides a strong mechanistic basis for studying flotetuzumab in these AML patients, who currently have few treatment options. Our single arm clinical trial is ongoing as an expansion of the Phase 1/2 study, for which we plan to enroll a total of up to 200 patients. We plan to present interim results later this year."

    1 "Immune Landscapes Predict Chemotherapy Resistance and Immunotherapy Response in Acute Myeloid Leukemia," Science Translational Medicine, 2020.

    About Acute Myeloid Leukemia

    AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure) or experience disease recurrence after a short remission duration (<6 months; early relapsed). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations. The discovery by the Rutella lab of an immunological gene signature in the AML tumor microenvironment forms the basis for a potential predictive biomarker for further clinical validation.

    About Flotetuzumab

    Flotetuzumab (also known as MGD006) is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. Data from the Phase 1/2 clinical study of flotetuzumab in patients with primary induction failure / early relapse (PIF/ER) AML were presented in December 2019 at the American Society of Hematology (ASH) Annual Meeting.  MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    ###

    CONTACT:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • $15 Million milestone triggered by initiation of Phase 3 clinical trial in NSCLC by Incyte

    ROCKVILLE, MD, Sept. 21, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that a $15 million milestone payment has been triggered under its exclusive global collaboration and license agreement with Incyte for retifanlimab (MGA012), an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA00012). The milestone was triggered by the initiation of the Phase 3 POD1UM-304 clinical trial, evaluating the efficacy and safety of retifanlimab…

    • $15 Million milestone triggered by initiation of Phase 3 clinical trial in NSCLC by Incyte

    ROCKVILLE, MD, Sept. 21, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that a $15 million milestone payment has been triggered under its exclusive global collaboration and license agreement with Incyte for retifanlimab (MGA012), an investigational anti-PD-1 monoclonal antibody designed by MacroGenics and licensed to Incyte (as INCMGA00012). The milestone was triggered by the initiation of the Phase 3 POD1UM-304 clinical trial, evaluating the efficacy and safety of retifanlimab with platinum-based chemotherapy in patients with metastatic squamous and non-squamous non-small cell lung cancer (NSCLC).

    MacroGenics and Incyte have each established multiple development programs for retifanlimab, evaluating the anti-PD-1 molecule either as monotherapy or in combination with other agents. Incyte is conducting clinical trials that are potentially registration-enabling for patients with metastatic NSCLC, squamous carcinoma of the anal canal (SCAC), MSI-high endometrial cancer, Merkel cell carcinoma, and MacroGenics is conducting a potentially registration-enabling study in HER2-positive gastric cancer.

    "Anti-PD-1 therapy has become a mainstay in cancer treatment across multiple tumor types, and we are excited to see our Incyte partnership continue to advance the development of retifanlimab across a broad set of monotherapy and combination regimens," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We look forward to continued progress on this program over the coming months."

    Under the collaboration agreement with Incyte, MacroGenics is eligible to receive up to a total of $390 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones. If retifanlimab is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 to 24 percent, on future worldwide net sales of the molecule.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts:
    
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • MGD019 well-tolerated with early signals of activity in advanced solid tumors not typically responsive to checkpoint inhibition
    • Recommended Phase 2 dose established for MSS CRC, NSCLC expansion cohorts
    • Presentation is available on-demand as part of the ESMO Virtual Congress 2020 

    ROCKVILLE, MD, Sept. 20, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced clinical data from the dose escalation portion of a Phase 1 clinical trial of MGD019. The proffered paper session titled, "A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD019, an Investigational…

    • MGD019 well-tolerated with early signals of activity in advanced solid tumors not typically responsive to checkpoint inhibition
    • Recommended Phase 2 dose established for MSS CRC, NSCLC expansion cohorts
    • Presentation is available on-demand as part of the ESMO Virtual Congress 2020 

    ROCKVILLE, MD, Sept. 20, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced clinical data from the dose escalation portion of a Phase 1 clinical trial of MGD019. The proffered paper session titled, "A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD019, an Investigational Bispecific PD-1 × CTLA-4 DART® Molecule in Patients with Advanced Solid Tumors," was presented orally at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 20, 2020, by Dr. Manish R. Sharma, Associate Director of Clinical Research at START Midwest in Grand Rapids, Michigan.

    MGD019, a bispecific PD-1 × CTLA-4 DART molecule, was designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells. 

    Forty-three patients were enrolled in the Phase 1 dose escalation study of MGD019 within a dose range of 0.03 – 10.0 mg/kg, administered every three weeks initially, in a population of heavily pre-treated patients representing a broad range of different types (23) of solid tumors. There were no dose-limiting toxicities (DLTs). A total of 28 patients were treated at doses ≥ 3.0 mg/kg administered every three weeks initially. MGD019 was well-tolerated in patients who received less than 10 mg/kg; the most common treatment-related adverse events over this dosing range were pruritus (23.3%), arthralgia (18.6%), fatigue (18.6%), rash (18.6%), nausea (16.3%) and infusion-related reaction (16.3%). Several Grade 3 adverse events were observed at the 10.0 mg/kg level; however, none were considered dose limiting.

    In this study, sustained peripheral PD-1 blockade was evident at doses ≥ 1.0 mg/kg.  In addition, dose-dependent upregulation of the inducible costimulator (ICOS) molecule was evident in treated patients, including those who responded to MGD019 therapy.  This is consistent with the previously reported observation that anti-CTLA-4 therapy increases the frequency of CD4 T cells expressing the ICOS molecule.1

    Of the 18 evaluable patients who received doses ≥ 3.0 mg/kg as of the July 21, 2020 cut-off date, four objective responses have been reported in this trial, including a confirmed complete response in metastatic castration-resistant prostate cancer (mCRPC), confirmed partial responses in microsatellite stable colorectal cancer (MSS CRC) and metastatic type AB thymoma, and an unconfirmed partial response in serous fallopian tube carcinoma.

    "We are especially encouraged by the evidence of anti-tumor activity in patients treated with MGD019 who have cancers typically unresponsive to checkpoint inhibition. In addition, we are very pleased that MGD019 was well tolerated," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Based on the results presented today, we plan to expand the study initially in patients with MSS CRC and checkpoint-naïve non-small cell lung cancer at the recommended Phase 2 dose of 6.0 mg/kg."

    These results are available on-demand as part of the ESMO Virtual Congress 2020 Proffered Paper - Investigational Immunotherapy session on September 20, 2020 (Presentation # 1020O). In addition, Dr. Sharma's slides can be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm.

    About MGD019

    MGD019 is an investigational bispecific DART molecule that was designed to enable co-blockade of two immune checkpoint molecules co-expressed on T cells, PD-1 and CTLA-4.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    1Cancer Immunol Res. 2013 Oct; 1(4): 229–234.



    CONTACT:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  24. ROCKVILLE, MD, Sept. 03, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in September:

    • Citi 15th Annual BioPharma Virtual Conference. MacroGenics' management will participate in one-on-one meetings and present in the "Novel Antibodies and Protein Therapeutics in Oncology" panel on September 10, 2020 at 10:45 AM ET.
    • HC Wainwright & Co. 22nd Annual Global Investment Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview…

    ROCKVILLE, MD, Sept. 03, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in September:

    • Citi 15th Annual BioPharma Virtual Conference. MacroGenics' management will participate in one-on-one meetings and present in the "Novel Antibodies and Protein Therapeutics in Oncology" panel on September 10, 2020 at 10:45 AM ET.
    • HC Wainwright & Co. 22nd Annual Global Investment Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview on September 14, 2020 at 10:00 AM ET.
    • Cantor Virtual Global Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview on September 16, 2020 at 8:00 AM ET.
    • Morgan Stanley 18th Annual Global Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and a fireside chat on September 17, 2020 at 2:45 PM ET.

    Webcasts of each presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###

    CONTACTS:
    
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  25. ROCKVILLE, MD, Aug. 05, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in August: 

    • BTIG Virtual Biotechnology Conference. MacroGenics' management will participate in one-on-one meetings and a fire-side chat discussion hosted by the analyst on Monday, August 10, 2020 at 12:30 p.m. ET.
    • Wedbush PacGrow Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview on August 12, 2020, at 8:35 a.m. ET.

    Webcasts of each…

    ROCKVILLE, MD, Aug. 05, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will participate in the following investor conferences in August: 

    • BTIG Virtual Biotechnology Conference. MacroGenics' management will participate in one-on-one meetings and a fire-side chat discussion hosted by the analyst on Monday, August 10, 2020 at 12:30 p.m. ET.
    • Wedbush PacGrow Healthcare Conference. MacroGenics' management will participate in one-on-one meetings and provide a corporate overview on August 12, 2020, at 8:35 a.m. ET.

    Webcasts of each presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after each conference.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    ###

    CONTACT:
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  26. ROCKVILLE, Md., July 30, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended June 30, 2020.

    "We are excited about the momentum we have built to date in 2020. We have presented promising initial clinical data at ASCO from the MGD013 and MGC018 programs. We have defined a potential registration path for flotetuzumab and we have received FDA clearance to initiate clinical testing of our novel antibody-drug conjugate targeting ADAM9 being co-developed with ImmunoGen. Furthermore…

    ROCKVILLE, Md., July 30, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended June 30, 2020.

    "We are excited about the momentum we have built to date in 2020. We have presented promising initial clinical data at ASCO from the MGD013 and MGC018 programs. We have defined a potential registration path for flotetuzumab and we have received FDA clearance to initiate clinical testing of our novel antibody-drug conjugate targeting ADAM9 being co-developed with ImmunoGen. Furthermore, we were able to extend our cash runway into 2023," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "In the coming months, we anticipate presentation of clinical data from other investigational product candidates in our pipeline, including MGD019, a PD-1 × CTLA-4 DART® molecule, and retifanlimab, an anti-PD-1 antibody. Additionally, the PDUFA goal date for the margetuximab BLA is in December."

    Key Highlights from Investigational Product Candidates

    • MGC018 (B7-H3 antibody-drug conjugate): At the American Society of Clinical Oncology (ASCO) Virtual Annual Meeting in May, data were presented from the ongoing Phase 1/2 dose escalation study of MGC018 that suggested manageable safety and preliminary activity in patients with metastatic castration-resistant prostate cancer (mCRPC). The Company expects to commence the enrollment of an expansion cohort of patients with mCRPC as part of the Phase 1/2 study in the third quarter of 2020.

       
    • Flotetuzumab (bispecific CD123 × CD3 DART molecule): In May, MacroGenics announced that the trial of flotetuzumab designed to support registration in the U.S. will be a single arm study in up to 200 patients with AML whose disease is refractory to induction treatment (primary induction failure) or has relapsed after a remission of less than six months (early relapse). The trial will be conducted as an expansion of the ongoing Phase 1/2 study. The primary endpoint is a response rate comprised of complete remission (CR) and CR with partial hematological recovery (CRh). The Company plans to submit updated data for presentation at a scientific conference in the fourth quarter of 2020.

       
    • Margetuximab (Fc-engineered, anti-HER2 mAb): The Food and Drug Administration (FDA) notified MacroGenics in May that it no longer plans to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The Prescription Drug User Fee Act (PDUFA) target action date is December 18, 2020.



      In July, The Lancet Oncology published results from a Phase 2 study of margetuximab and pembrolizumab in second-line patients with advanced HER2-positive gastric or gastroesophageal junction cancer. These data formed the basis for conducting the ongoing Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade in front-line patients.
    • MGD013 (bispecific PD-1 × LAG-3 DART molecule): At the ASCO Virtual Annual Meeting, results were presented from dose escalation and select expansion cohorts from the ongoing Phase 1 study of MGD013 in advanced solid tumors as well as the combination of MGD013 and margetuximab in a cohort of patients with advanced HER2-positive tumors. MacroGenics is expanding enrollment of the combination cohort.

       
    • MGD019 (bispecific PD-1 × CTLA-4 DART molecule): Data from the Phase 1 dose escalation study of MGD019 are scheduled to be presented during an oral session at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 to be held September 19-21.

       
    • IMGC936 (ADAM9 antibody-drug conjugate): In July, MacroGenics received FDA clearance of the Investigational New Drug (IND) application for IMGC936 that is being advanced under a co-development agreement with ImmunoGen, Inc. ADAM9 is a cell surface protein over-expressed in several solid tumor types. ImmunoGen expects to initiate a Phase 1 dose escalation study in patients with select advanced solid tumors in the fourth quarter of 2020.

       
    • Enoblituzumab (Fc-engineered, anti-B7-H3 mAb): MacroGenics expects to initiate a Phase 2 study of enoblituzumab in combination with retifanlimab as a chemo-free regimen in front-line patients with advanced head and neck cancer in the first quarter of 2021.

       
    • Retifanlimab (anti-PD-1 mAb also known as MGA012 or INCMGA0012): Data from POD1UM-201, the ongoing study of retifanlimab monotherapy in patients with Merkel cell carcinoma, are scheduled to be presented during a poster session at the ESMO Virtual Congress 2020. In addition, data from POD1UM-202, the fully-enrolled, potentially registration-enabling monotherapy study in patients with squamous cell carcinoma of the anal canal, are expected to be presented at a medical congress in the second half of 2020. Retifanlimab was invented by MacroGenics and licensed to Incyte.

    Corporate Highlights

    • Stephen Eck, M.D., Ph.D. joined the senior leadership team at MacroGenics as Senior Vice President, Clinical Development and Chief Medical Officer.

    Second Quarter 2020 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2020, were $232.8 million, compared to $215.8 million as of December 31, 2019. During the quarter ended June 30, 2020, $96.5 million in net proceeds were received from the sale of 4,060,482 shares of the Company's common stock pursuant to its at-the-market (ATM) offering. Subsequent to June 30, 2020, an additional $21.3 million net proceeds were received from the sale of 726,380 shares pursuant to the Company's ATM offering and $12.0 million was received from Boehringer Ingelheim GmbH under a 2010 license and collaboration agreement.

       
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $20.3 million for the quarter ended June 30, 2020, compared to $10.6 million for the quarter ended June 30, 2019. This increase was primarily due to $12.0 million recognized from the agreement with Boehringer Ingelheim.

       
    • R&D Expenses: Research and development expenses were $57.4 million for the quarter ended June 30, 2020, compared to $51.4 million for the quarter ended June 30, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs.

       
    • G&A Expenses: General and administrative expenses were $10.2 million for the quarter ended June 30, 2020, compared to $12.1 million for the quarter ended June 30, 2019. This decrease is primarily due to a decrease in consulting costs, with a smaller decrease in travel-related costs due to COVID-19.

       
    • Net Loss: Net loss was $46.9 million for the quarter ended June 30, 2020, compared to net loss of $31.8 million for the quarter ended June 30, 2019.

       
    • Shares Outstanding: Shares outstanding as of June 30, 2020 were 53,365,003.

       
    • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of June 30, 2020, plus the additional proceeds referred to above which were subsequently received, combined with anticipated and potential collaboration payments, should enable it to fund its operations into 2023, assuming the Company's programs and collaborations advance as currently contemplated.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended June 30, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 3236629.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    MACROGENICS, INC.

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (Amounts in thousands)

     June 30, 2020 December 31, 2019
     (unaudited)  
    Cash, cash equivalents and marketable securities$232,799 $215,756
    Total assets327,592 312,501
    Deferred revenue16,086 19,853
    Total stockholders' equity247,784 230,628
        











    MACROGENICS, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (Unaudited)

    (Amounts in thousands, except share and per share data)

        
     Three Months Ended June 30, Six Months Ended June 30,
     2020 2019 2020 2019
    Revenues:       
    Revenue from collaborative and other agreements$15,636  $9,987  $28,603  $19,484 
    Revenue from government agreements4,621  606  5,336  771 
    Total revenues20,257  10,593  33,939  20,255 
    Costs and expenses:       
    Research and development57,351  51,440  106,245  98,500 
    General and administrative10,216  12,122  20,449  22,341 
    Total costs and expenses67,567  63,562  126,694  120,841 
    Loss from operations(47,310) (52,969) (92,755) (100,586)
    Other income425  21,202  1,146  23,802 
    Net loss(46,885) (31,767) (91,609) (76,784)
    Other comprehensive loss:       
    Unrealized gain (loss) on investments(55) 34  1  37 
    Comprehensive loss$(46,940) $(31,733) $(91,608) $(76,747)
            
    Basic and diluted net loss per common share$(0.94) $(0.65) $(1.85) $(1.63)
    Basic and diluted weighted average common shares outstanding50,018,462  48,845,234  49,515,562  47,234,889 
                



























    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts:

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications

    Jim Karrels, Senior Vice President, CFO

    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  27. Rockville, MD, July 23, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the second quarter 2020 after the market closes on Thursday, July 30, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, July 30, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 3236629.

    The listen-only webcast…

    Rockville, MD, July 23, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the second quarter 2020 after the market closes on Thursday, July 30, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, July 30, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 3236629.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  28. Rockville, MD, July 09, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma (GEA) who have previously been treated with chemotherapy and trastuzumab. Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2. Pembrolizumab is an anti-PD-1 monoclonal antibody.

    "Current standard of care treatment for patients with metastatic gastroesophageal…

    Rockville, MD, July 09, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma (GEA) who have previously been treated with chemotherapy and trastuzumab. Margetuximab is an investigational, Fc-engineered, monoclonal antibody targeting HER2. Pembrolizumab is an anti-PD-1 monoclonal antibody.

    "Current standard of care treatment for patients with metastatic gastroesophageal adenocarcinoma is heavily dependent on the use of cytotoxic chemotherapy," said Stephen Eck, M.D., Ph.D., Senior Vice President, Clinical Development & Chief Medical Officer. "The published data suggest that a chemotherapy-free regimen combining the immune-enhancing properties of margetuximab with checkpoint blockade may improve upon clinical outcomes for certain first-line patients with metastatic HER2-positive gastroesophageal adenocarcinoma and provide a strong rationale for the ongoing Phase 2/3 MAHOGANY study."

    The Phase 2 study enrolled patients with gastric cancer (GC) or gastroesophageal junction (GEJ) cancer whose tumors were IHC3-positive or IHC2-positive/FISH-positive at diagnosis. Enrollment was regardless of PD-L1 expression status, which was subsequently determined from available archived tumor tissue.

    Tolerability of margetuximab and pembrolizumab was acceptable in patients treated in this study. Grade 3 or higher treatment-related adverse events (TRAEs) were reported in 20% of patients, with anemia (4%) and infusion-related reactions (3%) being the most common. No treatment-related deaths were reported.

    Patients who had received margetuximab at the recommended Phase 2 dose of 15 mg/kg every three weeks were evaluable for response. In this overall population, the objective response rate (ORR) was 18% (17/92 patients), including complete responses (CR) and partial responses (PR). The disease control rate (DCR), which includes CR, PR, and stable disease (SD), was 53% (49/92 patients). Median progression-free survival (PFS) was 2.7 months (95% CI 1.6–4.3) and median overall survival (OS) was 12.5 months (95% CI 9.1–14.1).

    Activity of margetuximab and anti-PD-1 in this study was more pronounced in key biomarker-positive subgroups. The most pronounced benefit was observed in patients whose tumors had high HER2 expression at diagnosis (HER2 IHC3-positive) and were PD-L1-positive. In this double-positive subgroup, the ORR was 44% (11/25 patients) and the DCR was 72% (18/25 patients). Median PFS was 4.8 months (95% CI 1.6–13.9) and median OS was 20.5 months (95% CI 8.1–NR).

    Patients with initial HER2-positive GEA may lose HER2 expression after trastuzumab-based therapy. In this second-line study, HER2 amplification was not detectable in circulating tumor DNA (ctDNA) in 42% of patients who were tested, suggesting loss of HER2 following prior trastuzumab and before treatment with margetuximab and pembrolizumab. The presence of HER2 amplification in ctDNA was associated with better response rates in this study. HER2amp-positive/HER2 IHC3-positive/PD-L1-positive ORR was 60% (9/15 patients) and DCR was 80% (12/15 patients).

    Consistent with prior studies of margetuximab in other tumor types, correlative analyses of samples from GEA patients treated in the study showed an increase in anti-HER2 specific T-cell immunity, suggesting the potential for engagement of both innate and adaptive immune responses.

    These data in second-line patients who were refractory to trastuzumab provide the rationale for the ongoing Phase 2/3 MAHOGANY clinical trial of margetuximab in combination with checkpoint blockade, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive GC or GEJ cancer (NCT04082364). The data published in Lancet Oncology are reported as of July 10, 2019 and were presented at the European Society for Medical Oncology (ESMO) Annual Congress in September 2019.

    About Gastric and Gastroesophageal Junction Cancer

    Cancer of the stomach (gastric cancer) or the gastroesophageal junction (where the esophagus joins the stomach) is collectively known as gastroesophageal adenocarcinoma. According to the American Cancer Society, approximately 27,600 new cases of gastric cancer will be diagnosed in the U.S in 2020 and more than 11,000 people will die from the disease. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2-positive.

    About Margetuximab

    Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered using MacroGenics' Fc Optimization technology to enhance the engagement of the immune system. A Biologics License Application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020. A Phase 2/3 MAHOGANY clinical trial in of margetuximab in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive GC or GEJ cancer (NCT04082364) is ongoing. Margetuximab has been granted an orphan drug designation by the FDA for the treatment of GC or GEJ cancer.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  29. Rockville, MD, June 22, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced presentations at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24, 2020.

    "We are pleased to present data at this year's AACR that highlight three platform technologies upon which multiple molecules are being developed at MacroGenics. We are presenting preclinical data for MGC018, our investigational antibody-drug conjugate targeting B7-H3, that provide evidence for an immune-mediated anti-tumor mechanism, as well as a…

    Rockville, MD, June 22, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced presentations at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, taking place June 22-24, 2020.

    "We are pleased to present data at this year's AACR that highlight three platform technologies upon which multiple molecules are being developed at MacroGenics. We are presenting preclinical data for MGC018, our investigational antibody-drug conjugate targeting B7-H3, that provide evidence for an immune-mediated anti-tumor mechanism, as well as a rationale for clinical investigation of this molecule in combination with checkpoint blockade. Separately, we are presenting data from our novel Fc-engineered, bispecific DART® molecule that binds CD25 and CTLA-4 that is capable of depleting tumor-infiltrating regulatory T cells with high specificity in vitro," said Ezio Bonvini, M.D., Senior Vice President and Chief Scientific Officer of MacroGenics. "Finally, one of the clinical investigators for flotetuzumab, our investigational CD123 x CD3 DART molecule, will be presenting preclinical data from his research with this molecule during an oral Education Session."

    AACR II Presentations

    MGC018, a duocarmycin-based antibody-drug conjugate targeting B7-H3, exhibits immunomodulatory activity and enhanced antitumor activity in combination with checkpoint inhibitors

    Poster Session: PO.ET07.01 - Cell Surface Antigens and Receptors as Drug Targets

    MGC018 is an investigational antibody-drug conjugate targeting B7-H3 that has shown preliminary anti-tumor activity in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors. The poster presented at AACR describes preclinical data suggesting that MGC018 can promote immune surveillance or stimulate immune responses to dying cancer cells that led to immunological memory, and when combined with checkpoint blockade may enhance anti-tumor activity.

    These studies used a mouse model system designed to evaluate anti-tumor activity in an intact and functioning immune system. In this in vivo model, MGC018 demonstrated targeted activity against tumors expressing human B7-H3. Mechanistically, in vitro data suggested that MGC018 induced immunogenic cell death of target cells with the translocation of calreticulin to the cell surface during apoptosis. In addition, treatment with MGC018 in this model system led to an increased infiltration of T cells into the tumor microenvironment. Depleting these T cells attenuated the anti-tumor activity by MGC018, demonstrating their role in mediating response. Furthermore, MGC018 combined with an anti-PD-1 antibody enhanced anti-tumor activity observed in this study. Finally, mice that had achieved a complete response to initial treatment with MGC018 with or without checkpoint blockade survived longer when re-challenged with tumor without subsequent treatment compared to mice that had not received treatment with MGC018, suggesting immunological memory.

    Investigational CD25 x CTLA-4 bispecific DART® molecule for depletion of tumor infiltrating Tregs via an enhanced Fc-dependent effector mechanism

    Poster Session: PO.IM02.23 - Therapeutic Antibodies 1

    The poster presented at AACR described a preclinical bispecific CD25 x CTLA-4 DART molecule containing an Fc region engineered to enhance clearance of target cells by antibody-dependent cellular cytotoxicity. This molecule was designed to deplete tumor-associated regulatory T cells co-expressing CD25 and CTLA-4 to reduce immune suppression mediated by these cells but preserve effector T cell function. CD25 is the alpha subunit of IL-2 receptor and CTLA-4 is a molecule involved in regulatory T cell function.

    In vitro studies showed that the Fc-engineered bispecific CD25 x CTLA-4 DART molecule depleted regulatory T cells, with minimal effect on effector T cells. This depletion of regulatory T cells was shown to occur through an Fc-dependent mechanism, as a control CD25 x CTLA-4 DART molecule with an inactivated Fc domain had no effect in this assay. In addition, the bispecific CD25 x CTLA-4 DART molecule preserved cytotoxic T cell effector function in vitro compared to a combination of Fc-engineered monoclonal antibodies independently targeting CD25 and CTLA-4.

    Immune escape after bone marrow transplantation: Hiding in plain sight

    Educational Session: ED52 - Immunotherapy, Immune Evasion in Myeloid Malignancies, and Therapeutic Implications

    John F. DiPersio, M.D., Ph.D., from Washington University School of Medicine in St. Louis, will present an overview of his research related to immune evasion and mechanisms of relapse after allogeneic hematopoietic cell transplantation (allo-HCT). The presentation will include preclinical data on flotetuzumab (MGD006), an investigational CD123 x CD3 bispecific DART molecule, suggesting a potential role for this molecule in treating patients with acute myeloid leukemia whose disease is relapsing after allo-HCT.

    Date: June 24, 2020

    Time: 5:30 - 5:50pm ET

    Location: AACR Virtual Annual Meeting II at www.aacr.org

    The posters will be available on the Events & Presentations page on MacroGenics' website at http://ir.macrogenics.com/events.cfm.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  30. Rockville, MD, June 16, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the appointment of Stephen Eck, M.D., Ph.D. as Senior Vice President, Clinical Development & Chief Medical Officer, effective beginning July 1, 2020.

    "We are excited to announce the addition of Stephen Eck to the MacroGenics leadership team. Stephen is a hematologist/oncologist who brings to MacroGenics more than 20 years of broad pharmaceutical and biotech industry experience with proven leadership in the development and commercialization of oncology therapeutics," said Scott Koenig…

    Rockville, MD, June 16, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced the appointment of Stephen Eck, M.D., Ph.D. as Senior Vice President, Clinical Development & Chief Medical Officer, effective beginning July 1, 2020.

    "We are excited to announce the addition of Stephen Eck to the MacroGenics leadership team. Stephen is a hematologist/oncologist who brings to MacroGenics more than 20 years of broad pharmaceutical and biotech industry experience with proven leadership in the development and commercialization of oncology therapeutics," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Stephen will be a tremendous asset to our company."

    Dr. Eck most recently served as chief medical officer of Immatics US, a company focused on TCR-based immunotherapies, and as president and chief executive officer of Aravive Biologics. Prior to these roles, Dr. Eck was Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma, managing a portfolio of assets which included enzalutamide (Xtandi®), erlotinib (Tarceva®) and gilteritinib (Xospata®). Dr. Eck has also held leadership positions in drug development as Vice President of Translational Medicine and Pharmacogenomics at Eli Lilly and as Head of Clinical Oncology at Pfizer. He began his professional career at Monsanto in cancer target discovery and later joined the University of Pennsylvania, where he was the Anne B. Young Assistant Professor of Cancer Research and the Director of the Cancer Gene Therapy Program. Dr. Eck currently serves as a director for Luminex Corporation and Circulogene, and on the boards of directors for the Personalized Medicine Coalition and the Central Pennsylvania Clinic. He is also a fellow of the American Association for the Advancement of Science.

    Dr. Eck holds a B.A. from Kalamazoo College, an M.S. and a Ph.D. from Harvard University, and an M.D. from the University of Mississippi School of Medicine with Residency and Fellowship training at the University of Michigan.

    "MacroGenics has a rich pipeline of immuno-oncology programs," said Dr. Eck. "I look forward to working together with the MacroGenics team to advance these promising programs and bring new treatment options to patients."

    Ezio Bonvini, M.D., Senior Vice President, Research and Chief Scientific Officer, who was overseeing MacroGenics' clinical development and related functions on an interim basis will return to serving as the Company's Chief Scientific Officer.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Attachment

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  31. Rockville, MD, June 05, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer. 

    Margetuximab is currently being evaluated in the Phase 2/3 MAHOGANY clinical trial in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC…

    Rockville, MD, June 05, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer. 

    Margetuximab is currently being evaluated in the Phase 2/3 MAHOGANY clinical trial in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. The MAHOGANY study is based on results from an ongoing Phase 2 study of margetuximab plus pembrolizumab, an anti-PD-1 monoclonal antibody, for patients with advanced HER2-positive GC or GEJ cancer who have previously been treated with chemotherapy and trastuzumab in the metastatic setting. Data were presented at the European Society for Medical Oncology (ESMO) Annual Congress in September 2019.

    "We are pleased that the FDA has granted orphan status to margetuximab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We believe that our immune-enhancing antibody targeting HER2 has the potential to improve upon the clinical activity of existing standard of care for patients with gastric or gastroesophageal cancer."

    The FDA grants ODD to medicines intended for the treatment, diagnosis or prevention of rare diseases of disorders that affect fewer than 200,000 people in the U.S. The designation provides certain incentives, which may include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits and waiver of certain FDA fees.

    About Gastric and Gastroesophageal Junction Cancer

    Cancer of the stomach (gastric cancer) or the gastroesophageal junction (where the esophagus joins the stomach) is collectively known as gastroesophageal adenocarcinoma. According to the American Cancer Society, approximately 27,600 new cases of gastric cancer will be diagnosed in the U.S in 2020 and more than 11,000 people will die from the disease. Both GC and GEJ cancer are often diagnosed at an advanced stage and therefore have very poor prognosis, with a 5-year survival of 5-20%. Chemotherapy is the standard of care for first-line therapy and may be combined with trastuzumab for the approximately 20% of patients whose tumors are HER2-positive.

    About Margetuximab

    Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics' Fc Optimization technology. A Biologics License Application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of December 18, 2020. Margetuximab is also being evaluated in combination with checkpoint blockade. The Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer is ongoing (NCT04082364). For more information please visit www.clinicaltrials.gov.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  32. Jon Wigginton, M.D. Joins as Chief Medical Officer

    Jennifer Michaelson, Ph.D. Promoted to Chief Development Officer, Biologics

    Cullinan Oncology, LLC announced today the closing of a $98.5 million Series B financing, which will be used to support ongoing clinical trials across its small molecule and biologics portfolio. New institutional investors and family offices participated in the financing alongside original commitments from founding investors MPM Capital and F2 Ventures. Following the completion of the fundraising, Tim Anderson of Cowen Healthcare investments (CHI) has joined the Board.

    "This capital infusion positions us well to execute our vision of bringing a diversified portfolio of innovative oncology assets into the clinic…

    Jon Wigginton, M.D. Joins as Chief Medical Officer

    Jennifer Michaelson, Ph.D. Promoted to Chief Development Officer, Biologics

    Cullinan Oncology, LLC announced today the closing of a $98.5 million Series B financing, which will be used to support ongoing clinical trials across its small molecule and biologics portfolio. New institutional investors and family offices participated in the financing alongside original commitments from founding investors MPM Capital and F2 Ventures. Following the completion of the fundraising, Tim Anderson of Cowen Healthcare investments (CHI) has joined the Board.

    "This capital infusion positions us well to execute our vision of bringing a diversified portfolio of innovative oncology assets into the clinic," stated Owen Hughes, Cullinan's CEO. "We are encouraged with the pipeline progress to date and appreciate the confidence of both our existing as well as new investors."

    Cullinan Oncology utilizes a portfolio approach to shepherd externally sourced as well as internally developed oncology assets from bench to bedside, focusing primarily on single asset opportunities that can be efficiently developed through the company's global network of strategic partners. Since the company's founding in October 2017, Cullinan has progressed a total of 7 assets through in vivo proof-of-concept studies or into human clinical testing, most notably Cullinan Pearl, an orally available tyrosine kinase inhibitor that targets EGFR (Epidermal Growth Factor Receptor) exon 20 mutations.

    Concurrent with the financing, Cullinan has hired Jon Wigginton, M.D. as its Chief Medical Officer to lead the clinical development of its small molecule and biologics programs. "We are delighted to have someone of Jon's caliber and experience join Cullinan at this point in time," stated Patrick Baeuerle, Cullinan's Chief Scientific Officer, Biologics, and Co-Founder. "Alongside our existing team, Jon rounds out a distinguished group of senior researchers at Cullinan who have dedicated their careers to developing breakthrough therapeutics for cancer patients."

    "I am very excited to be joining the talented team here at Cullinan Oncology," said Dr. Wigginton. "I look forward to serving as the Chief Medical Officer for all of the Cullinan portfolio companies. With such a diversified portfolio, including targeted small molecules, novel, first-in-class immunotherapies, bispecific antibodies and unique multifunctional fusion proteins, I'm hopeful that we will be able to deliver real advances for those living with cancer." In addition to his role at Cullinan Oncology LLC, Dr. Wigginton will serve as an Advisor to MPM Capital, where he will provide input on potential oncology investments and clinical development plans for portfolio companies.

    Dr. Wigginton most recently served as the Chief Medical Officer at MacroGenics (NASDAQ:MGNX), where he led the company's evolution of a fully-integrated, clinical-stage cancer immunotherapy organization. This included the translation of ten new molecules into the clinic, including early phase and/or proof-of-concept studies with bispecific molecules, checkpoint inhibitors, Fc-optimized antibodies and antibody drug conjugates, as well as the design and execution of registration-directed studies. Previously, he served as the Therapeutic Area Head, Immuno-Oncology, Early Clinical Research at Bristol-Myers Squibb (NYSE:BMY). There, he oversaw early clinical development of the BMS Immuno-Oncology portfolio and co-led the BMS International Immuno-Oncology Network (II-ON). These efforts included several studies defining proof-of concept for both anti-PD-1 and anti-PD-L1 antibodies in patients with melanoma, lung cancer and renal cancer, and for the anti-PD-1/anti-CTLA-4 combination in patients with melanoma, work published subsequently in the New England Journal of Medicine. Additional trials from his group established proof-of-concept for anti-PD-1 in patients with hepatocellular carcinoma and Hodgkin's disease.

    During his academic career, Dr. Wigginton served as Head of the Investigational Biologics Section, Center for Cancer Research, NCI, where he led an integrated basic, translational and clinical research effort focused on combination immunotherapy in preclinical models and early clinical studies. He also served previously as president of the Society for Immunotherapy of Cancer (SITC). Dr. Wigginton received his M.D. and B.S. in Biology, with distinction, from the University of Michigan.

    Lastly, Cullinan is very pleased to announce the promotion of Jennifer Michaelson, Ph.D. to Chief Development Officer, Biologics. "Jen is a key contributor to the Cullinan team; her expertise, knowledge and bandwidth are second-to-none," stated Hughes. "We are quite fortunate to have Jen leading the early development of our biologics programs and her promotion is simply a reflection of her importance to the Cullinan team across multiple functions and her many contributions to our emerging pipeline."

    Prior to joining Cullinan, Dr. Michaelson served as Senior Director and Executive Program Leader at Jounce Therapeutics, where she led their flagship anti-ICOS antibody program, JTX-2011, from inception into Phase 2 development. An employee since company launch, she built and led multiple disciplines at Jounce, including Tumor Immunology, Pharmacology, and Preclinical Development. Jennifer was also a member of the Leadership Team at Jounce.

    Previously, during her 10-year tenure at Biogen, Dr. Michaelson served as project leader for several monoclonal antibody and bispecific antibody programs in both the Oncology and Immunology therapeutic areas. She has also worked as a consultant at Third Rock Ventures for multiple stealth companies.

    Dr. Michaelson received her B.A. in Biology from Princeton University and her Ph.D. from the Department of Cell Biology at Albert Einstein College of Medicine and completed a post-doctoral fellowship in Philip Leder's laboratory in the Department of Genetics at Harvard Medical School.

    About Cullinan Oncology LLC

    Cullinan's business model is predicated on distributing risk while maximizing optionality inherent in novel science through the construction of a diversified portfolio of internally developed as well as externally sourced oncology assets. Cullinan's scalable model minimizes the fixed costs and inefficiencies of many traditional development approaches through strategic partnerships and a shared services platform. For more information, visit www.cullinanoncology.com

    View Full Article Hide Full Article
  33. Rockville, MD, June 03, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced research published in the journal Science Translational Medicine that describes a gene expression signature of the tumor microenvironment in patients with acute myeloid leukemia (AML) that is associated with resistance to chemotherapy and response to flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule currently in clinical development for the treatment of primary induction failure and early relapsed AML. The research was led by Sergio Rutella, M.D., Ph.D., FRCPath…

    Rockville, MD, June 03, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced research published in the journal Science Translational Medicine that describes a gene expression signature of the tumor microenvironment in patients with acute myeloid leukemia (AML) that is associated with resistance to chemotherapy and response to flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule currently in clinical development for the treatment of primary induction failure and early relapsed AML. The research was led by Sergio Rutella, M.D., Ph.D., FRCPath, Professor of Cancer Immunotherapy, John van Geest Cancer Research Centre at Nottingham Trent University in the UK.

    The study analyzed several hundred primary bone marrow samples from independent cohorts of pediatric and adult AML patients to identify differences in immune gene expression in the bone marrow tumor microenvironment across age groups and molecular subtypes. The data indicated that an inflammatory signature related to INF-γ gene expression was predictive of resistance to chemotherapy and potential response to flotetuzumab immunotherapy in patients with primary refractory or early relapsed AML.

    "Patients with AML who have failed primary induction therapy or relapsed early after an initial response represent a challenging patient population to treat," said Ezio Bonvini, M.D., Senior Vice President and Chief Scientific Officer of MacroGenics. "These data provide a molecular basis to understand why AML patients who are refractory to chemotherapy may be responsive to immunotherapy with flotetuzumab and offer a rationale for further development of the molecule in a planned pivotal study in this patient population with unmet medical needs."

    About Acute Myeloid Leukemia

    AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure; PIF) or experience disease recurrence after a short remission duration (<6 months; early relapsed; ER). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations. The discovery by the Rutella lab of an immunological gene signature in the AML tumor microenvironment forms the basis for a potential predictive biomarker for further clinical validation.

    About Flotetuzumab

    Flotetuzumab (also known as MGD006) is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells. Data from the Phase 1/2 clinical study of flotetuzumab in patients with PIF/ER AML were presented in December 2019 at the American Society of Hematology (ASH) Annual Meeting. MacroGenics plans a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint. The study will be conducted as a continuation of the ongoing Phase 1/2 study (NCT02152956; to be updated). The FDA has granted orphan drug designation to flotetuzumab for the treatment of AML.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  34. - Advisory committee meeting not required; PDUFA goal date unchanged

    Rockville, MD, May 28, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that during the recent mid-cycle communication with the U.S. Food and Drug Administration (FDA), the FDA notified the Company that it is no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab. The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review…

    - Advisory committee meeting not required; PDUFA goal date unchanged

    Rockville, MD, May 28, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that during the recent mid-cycle communication with the U.S. Food and Drug Administration (FDA), the FDA notified the Company that it is no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab. The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020.

    "Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency's questions as they arise," said Scott Koenig, M.D., President and CEO of MacroGenics. "We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer."

    MacroGenics is seeking approval of margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2, for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy.

    About HER2-Positive Breast Cancer

    Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Antibody-based therapies targeting HER2 have greatly improved outcomes of patients with HER2-positive breast cancer and are now standard of care in both early-and late-stage disease. However, metastatic breast cancer remains an unmet need and ongoing HER2 blockade is recommended for the treatment of patients with relapsed or refractory disease.

    About Margetuximab

    Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics' Fc Optimization technology. Margetuximab is also being evaluated in combination with checkpoint blockade. The Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer is ongoing (NCT04082364). For more information please visit www.clinicaltrials.gov.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  35. Rockville, MD, May 21, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced it will host a conference call and audio webcast on Friday, May 29 at 4:30 p.m. ET. MacroGenics management will be joined by external guest presenters to review the preliminary clinical results from the ongoing Phase 1 studies of MGD013 and MGC018 that are part of the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program.

    To participate in the MacroGenics ASCO 2020 Conference Call, please dial (833) 651-1036 (domestic) or (918) 922-6233 (international) ten minutes…

    Rockville, MD, May 21, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced it will host a conference call and audio webcast on Friday, May 29 at 4:30 p.m. ET. MacroGenics management will be joined by external guest presenters to review the preliminary clinical results from the ongoing Phase 1 studies of MGD013 and MGC018 that are part of the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program.

    To participate in the MacroGenics ASCO 2020 Conference Call, please dial (833) 651-1036 (domestic) or (918) 922-6233 (international) ten minutes prior to the start of the call and provide the Conference ID: 7765546. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days.

    Selected Presentations at ASCO to be Reviewed on Conference Call

    • A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms (Abstract #3004)
    • Preliminary dose escalation results from a phase I/II, first-in-human study of MGC018 (anti-B7-H3 antibody-drug conjugate) in patients with advanced solid tumors (Abstract #3071, Poster #135)

    About MGD013

    MGD013 is an investigational, first-in-class bispecific, tetravalent DART® molecule targeting PD-1 and LAG-3. MGD013 has been engineered to concomitantly or independently bind to PD-1 and LAG-3 and disrupt these non-redundant inhibitory pathways to further restore exhausted T-cell function. MGD013 is being evaluated in a Phase 1 dose expansion study as monotherapy in several tumor types, including both solid tumors and hematological malignancies, and in combination with margetuximab, an investigational Fc-engineered monoclonal antibody targeting HER-2, in a cohort of patients with advanced HER2-positive cancers (NCT03219268). MGD013 will also be evaluated in combination with margetuximab and chemotherapy as part of the ongoing Phase 2/3 MAHOGANY study in patients with HER2-positive gastric or gastroesophageal junction cancer (NCT04082364). MacroGenics' regional partner in Greater China, Zai Lab, plans to participate in MAHOGANY and is also evaluating MGD013 independently in Phase 1 combination studies with niraparib, a PARP inhibitor, and brivanib, a dual target tyrosine kinase inhibitor of the VEGF and FGF receptors, for the study of advanced gastric cancer and hepatocellular carcinoma, respectively.

    About MGC018

    MGC018 is an investigational antibody-drug conjugate (ADC) that is designed to target solid tumors expressing B7-H3, a protein in the B7 family of immune regulator proteins. B7-H3 is widely expressed on many different solid tumor types, with limited expression on normal tissues. Over-expression of B7-H3 is associated with disease severity, risk of recurrence, and reduced survival. MGC018 uses a synthetic duocarmycin-based payload with a cleavable peptide linker that was licensed from Byondis (formerly Synthon Biopharmaceuticals). Duocarmycins are potent cell cycle independent DNA-damaging alkylating agents and are not subject to multi-drug resistance. MGC018 is being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors (NCT03729596).

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  36. Rockville, MD, May 13, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary results from two of its investigational pipeline molecules. Data covering safety and preliminary anti-tumor activity from the Phase 1 dose escalation and expansion clinical trial of MGD013, a bispecific, tetravalent DART® molecule binding PD-1 and LAG-3, and the Phase 1 dose expansion study of MGC018, an antibody-drug conjugate (ADC) targeting B7-H3, will be presented at the American Society of Clinical Oncology (ASCO) upcoming ASCO20 Virtual Scientific Program to be held May…

    Rockville, MD, May 13, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced preliminary results from two of its investigational pipeline molecules. Data covering safety and preliminary anti-tumor activity from the Phase 1 dose escalation and expansion clinical trial of MGD013, a bispecific, tetravalent DART® molecule binding PD-1 and LAG-3, and the Phase 1 dose expansion study of MGC018, an antibody-drug conjugate (ADC) targeting B7-H3, will be presented at the American Society of Clinical Oncology (ASCO) upcoming ASCO20 Virtual Scientific Program to be held May 29-31, 2020.

    "We are encouraged by the early demonstration of activity of MGD013, our PD-1 x LAG-3 DART molecule, particularly in combination with margetuximab, our investigational Fc-engineered monoclonal antibody targeting HER-2, where preliminary observations in a Phase 1 trial suggest a response in approximately 40% of late-stage HER-2-positive tumors that compares favorably to low response rates for HER-2-directed agents and checkpoint blockade reported historically. Our rationale for combining MGD013 and margetuximab is based on early scientific insights that antibody Fc-engineering could potentially activate immune effector cells, resulting in upregulation of checkpoint molecules, such as LAG-3, PD-1 and PD-L1, which could be targeted for blockade by bispecific DART molecules like MGD013," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Separately, we are also very encouraged by early results from an ongoing Phase 1 study of MGC018, an ADC directed against B7-H3, a molecule highly expressed on solid tumors and associated with poor clinical outcome. In this dose-escalation study, we have observed preliminary signals of anti-tumor effects, including prostate-specific antigen, or PSA, reductions of 50% or more in five of seven patients with late-stage prostate cancer."

    Summary of Selected ASCO Presentations

    "A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms" (Abstract #3004)

    MGD013 is designed to independently or coordinately block PD-1 and LAG-3 checkpoint molecules to sustain or restore the function of exhausted T cells for the treatment of cancer. In the dose-escalation part of the study, 53 patients with advanced tumors were treated with MGD013 given intravenously in cohorts of escalating flat doses of 1-1200 mg every two weeks. A maximum tolerated dose was not identified. A flat dose of 600 mg every two weeks was selected for tumor-specific expansion cohorts. At the April 25, 2020 data cut-off, 205 patients with advanced solid and hematologic neoplasms have been treated with MGD013 monotherapy in the ongoing dose-expansion part of the study, of which 152 were evaluable for response. An additional 21 patients with advanced HER2-positive tumors, including 14 who were evaluable for response, were treated with the combination of margetuximab, an investigational Fc-engineered monoclonal antibody targeting HER-2, at 15 mg/kg and MGD013 at flat doses of 300 mg or 600 mg, both given every three weeks. Anti-tumor activity was assessed by Response Evaluation Criteria in Solid Tumors (RECIST). For more information about the study design, please visit ClinicalTrials.gov (NCT03219268).

    The overall safety profile of MGD013 in the Phase 1 study, including the incidence of immune-mediated adverse events, appears generally consistent with anti-PD-1 antibody monotherapy with respect to event type and frequency. Anti-tumor activity of MGD013 as monotherapy has been observed in evaluable patients across several of the tumor types in the selected dose expansion cohorts. Objective response rates (ORR), including both confirmed and unconfirmed responses, and disease control rates (DCR), comprising both confirmed objective responses and stable disease, were observed as follows: triple negative breast cancer (17% ORR, 4 of 23 patients; 39% DCR, 9 of 23 patients), epithelial ovarian cancer (9% ORR, 2 of 23 patients; 52% DCR, 12 of 23 patients) and non-small cell lung cancer (checkpoint inhibitor naïve: 21% ORR, 3 of 14 patients; 64% DCR, 9 of 14 patients; and post anti-PD-1: 13% ORR, 2 of 15 patients; 53% DCR, 8 of 15 patients). Response to MGD013 monotherapy was associated with LAG-3 expression and an IFN-γ gene signature at baseline.

    Immune effector cell activation and LAG-3, PD-1 and PD-L1 expression are enhanced in vitro by Fc-engineered margetuximab. An expansion cohort of patients with advanced HER2-positive tumors is being treated with margetuximab plus MGD013 to evaluate whether Fc-engineering can enhance tumor responsiveness to checkpoint blockade and improve clinical outcomes in patients. Objective responses were observed in 6 of 14 (43%) evaluable patients treated with margetuximab and MGD013, of which four have been confirmed, with tumor-shrinkage observed in other patients. Responses were observed in patients with a range of relapsed or refractory HER2-positive tumor types. In contrast with the monotherapy finding, in the combination cohort, the majority of responders whose baseline tumors were evaluated were negative for (or expressed low levels of) LAG-3 or PD-L1. All responders remain on therapy.

    These results and additional details will be presented during an oral session titled: Developmental Therapeutics—Immunotherapy.  

    "Preliminary dose escalation results from a phase I/II, first-in-human study of MGC018 (anti-B7-H3 antibody-drug conjugate) in patients with advanced solid tumors" (Abstract #3071, Poster #135)

    MGC018 is designed to deliver a DNA alkylating duocarmycin payload to dividing and non-dividing cells that express B7-H3, a ligand that is highly expressed on many solid tumors and is associated with a poor clinical outcome. At the May 6, 2020 data cut-off, 23 patients with advanced solid tumors had been enrolled in four dose escalation cohorts of 0.5 mg/kg to 3 mg/kg given intravenously every three weeks. Enrollment is ongoing in a fifth cohort at 4 mg/kg every three weeks. For information about the study design, please visit ClinicalTrials.gov (NCT03729596).

    The safety profile of MGC018, which includes hematologic and skin toxicities, has been generally manageable to date. At least one treatment related adverse event occurred in 22 of 24 patients (92%), including Grade ≥3 reported in 14 of 24 patients (58%). Three treatment-related serious adverse events occurred in one patient each: pneumonitis in a patient with concurrent bacterial pneumonia; non-infectious gastroenteritis; and stasis dermatitis in a patient with chronic venous insufficiency. One dose-limiting toxicity of Grade 4 neutropenia that resolved to baseline was reported​. No febrile neutropenia was observed.

    Preliminary evidence of anti-tumor activity by MGC018 has been observed, particularly in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Reductions in PSA levels of ≥50% were observed in five of seven mCRPC patients treated, including one with substantial regression of bone disease. Six mCRPC patients had bone only disease, and one patient with measurable peripheral disease had a 29% reduction in target lesions that did not qualify as a response per RECIST. Four PSA responders remain on therapy. Patients with mCRPC had received a median of four therapies prior to MGC018, including taxane chemotherapy (six patients) and next generation hormonal agents (six patients were treated with both abiraterone and enzalutamide, and one with abiraterone only).

    These results and additional details will be presented during a poster session titled: Developmental Therapeutics—Immunotherapy.

    ASCO Virtual Presentations

    Abstracts for these presentations submitted in February 2020 are available on the ASCO website at www.asco.org. Presentations will be available for on-demand viewing online at https://meetings.asco.org/am/virtual-program beginning on May 29, 2020 at 8:00 a.m. ET.

    The static slides and poster will be available on the Events & Presentations page on MacroGenics' website at http://ir.macrogenics.com/events.cfm.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com
    

    Primary Logo

    View Full Article Hide Full Article
  37. ROCKVILLE, Md., May 05, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended March 31, 2020.

    "We are encouraged by the progress and clinical activity that we continue to observe across our broad portfolio of seven antibody-based product candidates, and we anticipate presenting clinical data from all these molecules this year. In the near-term, we look forward to sharing the initial data from our Phase 1 studies of MGD013 and MGC018 at ASCO and our plans for further development…

    ROCKVILLE, Md., May 05, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its corporate progress and reported financial results for the quarter ended March 31, 2020.

    "We are encouraged by the progress and clinical activity that we continue to observe across our broad portfolio of seven antibody-based product candidates, and we anticipate presenting clinical data from all these molecules this year. In the near-term, we look forward to sharing the initial data from our Phase 1 studies of MGD013 and MGC018 at ASCO and our plans for further development of these promising candidates," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "While we expect some near-term impact on clinical trial site initiation and patient enrollment due to the unprecedented challenges posed by the COVID-19 pandemic, we have not changed our guidance for the timing of anticipated 2020 clinical data read-outs or regulatory events."

    Recent and Anticipated Presentation of Clinical Data

    • At the recent American Association for Cancer Research (AACR) Virtual Annual Meeting I held April 27-28, an academic collaborator presented data during a plenary session suggesting that TP53 mutational status in patients with acute myeloid leukemia (AML) correlated with an immune-infiltrated tumor microenvironment that was associated with response to flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule.
       
    • At the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in May, MacroGenics plans to present the following clinical data:
       
      • An oral presentation covering dose escalation and select expansion cohorts from the ongoing Phase 1 study of MGD013, an investigational, bispecific PD-1 x LAG-3 DART molecule;
         
      • A poster presentation covering initial dose escalation data from the ongoing Phase 1/2 study of MGC018, an investigational antibody-drug conjugate targeting B7-H3; and
         
      • A poster presentation covering results stratified by chemotherapy from the Phase 3 SOPHIA study of chemotherapy plus margetuximab, an investigational, Fc-engineered, anti-HER2 monoclonal antibody, compared to chemotherapy plus trastuzumab in patients with HER2-positive metastatic breast cancer.
         
    • MacroGenics also anticipates the presentation of the following clinical data in the second half of 2020: 
       
      • Final overall survival (OS) analysis for the Phase 3 SOPHIA study of margetuximab;
         
      • Initial data from the Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade in patients with advanced gastric cancer;  
         
      • Data from the Phase 1 dose escalation study of MGD019, an investigational, bispecific, PD-1 x CTLA-4 DART molecule;
         
      • Additional data on flotetuzumab in AML patients who are refractory to induction treatment (primary induction failure); and
         
      • Incyte expects to present data from its study of retifanlimab (formerly known as MGA012 or INCMGA0012) in patients with anal cancer, which is now fully enrolled, and is one of three ongoing potentially registration-enabling monotherapy studies. Retifanlimab is an investigational anti-PD-1 monoclonal antibody invented by MacroGenics and licensed to Incyte.

    Regulatory Interactions and Events

    • MacroGenics anticipates a Prescription Drug User Fee Act (PDUFA) target action date in December 2020 for margetuximab in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer. The Food and Drug Administration (FDA) has indicated its plan to schedule an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.
       
    • MacroGenics will meet with the FDA this quarter to gain feedback on the planned registration path in the U.S. for flotetuzumab for the treatment of patients with AML who are refractory to induction treatment (primary induction failure).

    Clinical Trial Updates and Status

    • In consideration of current global and domestic COVID-19 pandemic, the planned Phase 2 study initiation of enoblituzumab will be delayed. Enoblituzumab is an investigational, Fc-engineered, anti-B7-H3 monoclonal antibody which is being studied in combination with checkpoint blockade for the treatment of patients with advanced head and neck cancer. The Company expects to provide updates on the timing for initiating the study in the second half of 2020.
       
    • MacroGenics has stopped enrollment in an ex-U.S. Phase 1/2 study combining flotetuzumab with retifanlimab in patients with relapsed or refractory AML. The decision was not due to any safety finding or lack of activity, and the Company plans to resume the study in the U.S. in the future.
       
    • MacroGenics continues to open clinical sites globally to enroll patients in the Phase 2/3 MAHOGANY study evaluating the combination of margetuximab and retifanlimab as a front-line treatment for advanced gastric and gastroesophageal junction cancer. Zai Lab, MacroGenics' regional partner in Greater China, has stated that it expects sites in its territory to enroll patients starting in the second half of 2020.
       
    • MacroGenics and Zai Lab, its regional partner in Greater China, are continuing to broadly explore the development of MGD013 across multiple indications. MGD013 is being studied both as a monotherapy and in combination with other pipeline assets. Zai Lab has initiated combination studies with niraparib, a PARP inhibitor, and brivanib, a dual target tyrosine kinase inhibitor of the VEGF and FGF receptors, for the study of advanced gastric cancer and hepatocellular carcinoma, respectively.

    First Quarter 2020 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2020, were $170.8 million, compared to $215.8 million as of December 31, 2019.
       
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $13.7 million for the quarter ended March 31, 2020, compared to $9.7 million for the quarter ended March 31, 2019. This increase was primarily due to revenue recognized for manufacturing services under the Clinical Supply Agreements with Incyte and Zai Lab, as well as milestone payments under the Zai Lab Agreement for clinical trial initiations in Greater China.
       
    • R&D Expenses: Research and development expenses were $48.9 million for the quarter ended March 31, 2020, compared to $47.1 million for the quarter ended March 31, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs.
       
    • G&A Expenses: General and administrative expenses were $10.2 million for the quarter ended March 31, 2020, compared to $10.2 million for the quarter ended March 31, 2019.
       
    • Net Loss: Net loss was $44.7 million for the quarter ended March 31, 2020, compared to net loss of $45.0 million for the quarter ended March 31, 2019.
       
    • Shares Outstanding: Shares outstanding as of March 31, 2020 were 49,131,150.
       
    • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of March 31, 2020, combined with anticipated and potential collaboration payments, should enable it to fund its operations into 2022, assuming the Company's programs and collaborations advance as currently contemplated.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended March 31, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 2993147.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    MACROGENICS, INC.
    SELECTED CONSOLIDATED BALANCE SHEET DATA
    (Amounts in thousands)

           
      March 31, 2020   December 31, 2019
      (unaudited)    
    Cash, cash equivalents and marketable securities $ 170,849   $ 215,756
    Total assets 265,413   312,501
    Deferred revenue 17,606   19,853
    Total stockholders' equity 190,573   230,628
           

    MACROGENICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (Unaudited)

    (Amounts in thousands, except share and per share data)

       
      Three Months Ended March 31,
      2020   2019
    Revenues:      
    Revenue from collaborative and other agreements $ 12,967     $ 9,497  
    Revenue from government agreements 715     165  
    Total revenues 13,682     9,662  
    Costs and expenses:      
    Research and development 48,894     47,060  
    General and administrative 10,233     10,219  
    Total costs and expenses 59,127     57,279  
    Loss from operations (45,445 )   (47,617 )
    Other income 721     2,600  
    Net loss (44,724 )   (45,017 )
    Other comprehensive income:      
    Unrealized gain on investments 56     3  
    Comprehensive loss $ (44,668 )   $ (45,014 )
           
    Basic and diluted net loss per common share $ (0.91 )   $ (0.99 )
    Basic and diluted weighted average common shares outstanding 49,012,663     45,606,651  
               

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts:

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  38. Rockville, MD, April 29, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced three clinical presentations at the American Society of Clinical Oncology (ASCO) upcoming ASCO20 Virtual Scientific Program to be held May 29-31, 2020.

    ASCO Virtual Presentations

    Title: A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms
    Authors: Jason J. Luke, et al.
    Session: Developmental Therapeutics—Immunotherapy
    Session Type: Oral Abstract Session
    Abstract: 3004…

    Rockville, MD, April 29, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced three clinical presentations at the American Society of Clinical Oncology (ASCO) upcoming ASCO20 Virtual Scientific Program to be held May 29-31, 2020.

    ASCO Virtual Presentations

    Title: A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD-1 and LAG-3, in patients with unresectable or metastatic neoplasms
    Authors: Jason J. Luke, et al.
    Session: Developmental Therapeutics—Immunotherapy
    Session Type: Oral Abstract Session
    Abstract: 3004

    Title: Preliminary dose escalation results from a phase I/II, first-in-human study of MGC018 (anti-B7-H3 antibody-drug conjugate) in patients with advanced solid tumors
    Authors: John D. Powderly, et al.
    Session: Developmental Therapeutics—Immunotherapy
    Session Type: Poster Abstract Session
    Abstract: 3071
    Poster: 135

    Title: SOPHIA analysis by chemotherapy (Ctx) choice: A phase III (P3) study of margetuximab (M) + Ctx versus trastuzumab (T) + Ctx in patients (pts) with pretreated HER2+ metastatic (met) breast cancer (MBC)
    Authors: Santiago Escrivá, et al.
    Session: Breast Cancer—Metastatic
    Session Type: Poster Abstract Session
    Abstract: 1040
    Poster: 125

    Presentations will be available for on-demand viewing online at https://meetings.asco.org/am/virtual-program beginning on May 29, 2020 at 8:00 a.m. ET.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  39. Rockville, MD, April 28, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that its 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting") will now be held by means of a virtual format only due to the public health and safety concerns related to the novel coronavirus (COVID-19) pandemic and related recommendations and orders from federal and state governmental authorities.

    The date and time of the meeting, May 14, 2020 at 9:00 a.m. ET, as disclosed in MacroGenics' proxy statement for the meeting, has not changed. Stockholders will not be able to attend…

    Rockville, MD, April 28, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that its 2020 Annual Meeting of Stockholders (the "2020 Annual Meeting") will now be held by means of a virtual format only due to the public health and safety concerns related to the novel coronavirus (COVID-19) pandemic and related recommendations and orders from federal and state governmental authorities.

    The date and time of the meeting, May 14, 2020 at 9:00 a.m. ET, as disclosed in MacroGenics' proxy statement for the meeting, has not changed. Stockholders will not be able to attend the 2020 Annual Meeting in person.

    As described in the proxy materials for the 2020 Annual Meeting previously distributed, stockholders are entitled to participate in the meeting if they were a stockholder as of the close of business on March 20, 2020, the record date, or hold a legal proxy for the meeting provided by their broker, bank or other agent. The virtual format of the 2020 Annual Meeting will provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting.

    Whether or not you plan to attend the 2020 Annual Meeting, you are encouraged to vote your shares prior to the meeting by one of the methods described in the proxy materials for the meeting. If you have already voted, you do not need to vote again.

    Attending the Virtual Meeting

    In order to attend the meeting, stockholders must access www.proxydocs.com/MGNX and enter the control number on the proxy card, notice or voting instruction form previously received, and complete the registration page no later than 5:00 p.m. ET on May 12, 2020. A confirmation email will be sent, followed by a second confirmation email on the morning of the 2020 Annual Meeting with instructions on joining the virtual meeting. Online access to the meeting will open at 8:45 a.m. ET on May 14, 2020. Stockholders may ask questions during the meeting using the online platform. Only questions pertinent to meeting matters will be answered during the meeting, subject to time constraints.

    Voting Shares at the Virtual Meeting

    If you have not voted your shares prior to the 2020 Annual Meeting, you will be able to vote your shares electronically at the 2020 Annual Meeting, or revoke or change a previously submitted vote, by clicking "Vote Now" on the meeting website. Whether or not you plan to attend the 2020 Annual Meeting, you are encouraged to vote your shares prior to the meeting by one of the methods described in the proxy materials you previously received.

    The proxy materials you previously received may continue to be used to vote your shares in connection with the meeting. The previously distributed proxy materials will not be updated to reflect the change to a virtual format. If you have already voted, you do not need to vote again.

    About MacroGenics

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  40. Rockville, MD, April 28, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the first quarter 2020 after the market closes on Tuesday, May 5, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, May 5, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 2993147.

    The listen-only webcast of…

    Rockville, MD, April 28, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the first quarter 2020 after the market closes on Tuesday, May 5, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, May 5, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 2993147.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  41. Rockville, MD, April 27, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced data related to flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule being evaluated in patients with refractory acute myeloid leukemia (AML). The data will be presented during a plenary session at the American Association for Cancer Research (AACR) Virtual Annual Meeting I, taking place April 27-28, 2020.

    "Patients with TP53 mutated AML respond poorly to induction therapy and have a dismal prognosis. The current study suggests that TP53 mutational status correlated…

    Rockville, MD, April 27, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced data related to flotetuzumab, an investigational, bispecific CD123 x CD3 DART® molecule being evaluated in patients with refractory acute myeloid leukemia (AML). The data will be presented during a plenary session at the American Association for Cancer Research (AACR) Virtual Annual Meeting I, taking place April 27-28, 2020.

    "Patients with TP53 mutated AML respond poorly to induction therapy and have a dismal prognosis. The current study suggests that TP53 mutational status correlated with an immune-infiltrated tumor microenvironment that was associated with response to flotetuzumab in our ongoing Phase 1/2 study in refractory disease," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "This analysis further elucidates potential immune drivers of response to flotetuzumab and supports its potential for treating patients with particularly challenging disease and who have limited treatment options."

    The current study was conducted by Professor Sergio Rutella, M.D., Ph.D., FRCPath, at the John van Geest Cancer Research Centre at Nottingham Trent University in the UK, in collaboration with MacroGenics and NanoString Technologies, Inc. The data suggests that TP53 mutations in AML associate with an immune-infiltrated tumor microenvironment (TME) characterized by high expression of IFN-γ signaling molecules and immune checkpoints. This inflammation signature was previously found to be associated with response to flotetuzumab immunotherapy in a Phase 1/2 study in patients with AML who were refractory to induction treatment (primary induction failure). In this new study, among patients with TP53 mutated AML who were treated with flotetuzumab, 45.5% (5/11) showed evidence of anti-leukemic activity, including two patients with complete remission (CR), one patient with a CR with partial hematologic recovery (CRh), and one patient with morphologic leukemia-free state (MLFS) per International Working Group (IWG) criteria. Furthermore, median overall survival (OS) of flotetuzumab-treated patients with TP53 abnormalities was 4 months (range 1.25-21.25), compared to an estimated median OS of 1 month (Stichting Hemato-Oncologie voor Volwassenen Nederland, HOVON, Rotterdam, NL).

    AACR Virtual Presentation

    Title: TP53 abnormalities correlate with immune infiltration and are associated with response to flotetuzumab, an investigational immunotherapy, in acute myeloid leukemia
    Session: VCTPL03 - Immunotherapy Clinical Trials 1
    Date: April 27, 2020
    Time: 1:25 pm - 1:35 pm ET
    Location: AACR Virtual Annual Meeting I at www.aacr.org

    After the presentation, Dr. Rutella's slides will be available on the Events & Presentations page on MacroGenics' website at http://ir.macrogenics.com/events.cfm.

    About Acute Myeloid Leukemia

    AML is a hematological malignancy characterized by differentiation arrest and uncontrolled clonal proliferation of neoplastic precursors that prevent normal bone marrow hematopoiesis. Nearly 20,000 new cases of AML are diagnosed in the U.S. each year, with a median age of 69 years at diagnosis. Approximately 40-50% of newly diagnosed patients fail to achieve a complete remission with intensive induction therapy (primary induction failure) or experience disease recurrence after a short remission duration (<6 months; early relapsed). A very small number of these patients are expected to respond to salvage therapy. Although new targeted agents have been approved for the treatment of frontline or relapsed/refractory AML in recent years, approximately 50% of patients have no known targetable mutations.

    About Flotetuzumab

    Flotetuzumab (also known as MGD006) is a clinical-stage bispecific DART molecule that recognizes both CD123 and CD3. CD123, the interleukin-3 receptor alpha chain, has been reported to be over-expressed on malignant cells in AML and other hematologic malignancies. The primary mechanism of action of flotetuzumab is believed to be its ability to redirect T lymphocytes to kill CD123-expressing cells. To achieve this, the DART molecule combines a portion of an antibody recognizing CD3, an activating molecule expressed by T cells, with an arm that recognizes CD123 on the target cells.

    Flotetuzumab is currently being evaluated in the U.S. and Europe in a Phase 1/2 study (NCT02152956) designed to assess the safety, tolerability, and initial anti-leukemic activity of the molecule in patients with relapsed/refractory AML. Data from the ongoing clinical study were presented in December 2019 at the American Society of Hematology (ASH) Annual Meeting. The U.S. Food and Drug Administration has granted orphan drug designation to flotetuzumab for the treatment of AML. Pending discussions with FDA, MacroGenics plans to define a registration path for flotetuzumab in the U.S. for patients with AML who are refractory to induction treatment (primary induction failure) in the first half of 2020.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  42. Rockville, MD, March 04, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced that Jon Wigginton, M.D., Senior Vice President, Clinical Development & Chief Medical Officer, will be leaving the Company effective March 27, 2020 to pursue a new opportunity.

    "Over the past seven years, Jon has played a leadership role in establishing and executing the clinical development strategy to advance our immuno-oncology product candidates. I would like to thank him for his significant contributions to MacroGenics, and wish him the best in his future endeavors," said Scott Koenig…

    Rockville, MD, March 04, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, announced that Jon Wigginton, M.D., Senior Vice President, Clinical Development & Chief Medical Officer, will be leaving the Company effective March 27, 2020 to pursue a new opportunity.

    "Over the past seven years, Jon has played a leadership role in establishing and executing the clinical development strategy to advance our immuno-oncology product candidates. I would like to thank him for his significant contributions to MacroGenics, and wish him the best in his future endeavors," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Our clinical programs are progressing as planned, and we look forward to a productive 2020."

    While the executive search for a new Chief Medical Officer is ongoing, Ezio Bonvini, M.D., Senior Vice President, Research and Chief Scientific Officer, will assume Dr. Wigginton's responsibilities on an interim basis, including overseeing clinical development and related functions. Dr. Bonvini joined MacroGenics in June 2003. He was previously with the Food and Drug Administration (FDA) in the Center for Biologics Evaluation and Research (CBER) for 18 years, ultimately serving as Acting Deputy Director, Division of Monoclonal Antibodies. Dr. Bonvini received his M.D. and Specialty Certification in Clinical Hematology from the University of Genoa, School of Medicine.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  43. ROCKVILLE, MD, Feb. 27, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will attend the following investor conferences in March:

    • Cowen and Company 40th Annual Health Care Conference. MacroGenics' management will present an overview of the company in Boston, MA on Tuesday, March 3, 2020, at 10:40 a.m. ET.
    • Barclays Global Healthcare Conference. MacroGenics' management will present an overview of the company in Miami Beach, FL on Wednesday, March 11, 2020, at 10:45 a.m. ET.

    Webcasts of the presentations may be accessed under "Events…

    ROCKVILLE, MD, Feb. 27, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will attend the following investor conferences in March:

    • Cowen and Company 40th Annual Health Care Conference. MacroGenics' management will present an overview of the company in Boston, MA on Tuesday, March 3, 2020, at 10:40 a.m. ET.
    • Barclays Global Healthcare Conference. MacroGenics' management will present an overview of the company in Miami Beach, FL on Wednesday, March 11, 2020, at 10:45 a.m. ET.

    Webcasts of the presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after the conference.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
    • Margetuximab: BLA for metastatic HER2-positive breast cancer accepted for review by the FDA; Phase 2/3 MAHOGANY study ongoing in front-line advanced HER2-positive gastric cancer

    • First clinical data from Phase 1/2 studies of MGD013, MGC018 and MGD019 anticipated in 2020

    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., Feb. 25, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2019.

    "2019 was an important year for MacroGenics, with the submission…

    • Margetuximab: BLA for metastatic HER2-positive breast cancer accepted for review by the FDA; Phase 2/3 MAHOGANY study ongoing in front-line advanced HER2-positive gastric cancer

    • First clinical data from Phase 1/2 studies of MGD013, MGC018 and MGD019 anticipated in 2020

    • Conference call scheduled for today at 4:30 p.m. ET.

    ROCKVILLE, Md., Feb. 25, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today provided an update on its recent corporate progress and reported financial results for the year ended December 31, 2019.

    "2019 was an important year for MacroGenics, with the submission of our BLA for margetuximab for HER2-positive breast cancer. We also initiated a registration directed clinical study with margetuximab in combination with checkpoint blockade in advanced HER2-positive gastric cancer," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "During 2020, we anticipate additional key events. Following promising data presented at ASH in 2019, we plan to define a registration path for flotetuzumab in refractory AML, pending further discussions with FDA. We also look forward to presenting initial clinical data from several of our programs currently in Phase 1, potentially including our two bispecific DART molecules that provide dual checkpoint blockade, MGD013 and MGD019, as well as MGC018, our ADC targeting B7-H3. We look forward to a productive year for MacroGenics in 2020."

    Key Pipeline Updates

    Recent progress and anticipated events in 2020 related to MacroGenics' investigational product candidates in clinical development are highlighted below.

    Margetuximab is an Fc-engineered, anti-HER2 monoclonal antibody being evaluated for the treatment of patients with advanced HER2-positive cancers.

    • Metastatic Breast Cancer. In December 2019, MacroGenics submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The safety and efficacy results provided in the BLA are primarily from the pivotal Phase 3 SOPHIA study, which is evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer who have received prior anti-HER2 therapies. Updated results from the study were presented at the San Antonio Breast Cancer Symposium in December 2019. In February 2020, the BLA was accepted for review by the FDA. MacroGenics expects that there will be a Standard Review process and we anticipate a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. In addition, the Company believes that the FDA will require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.

      Separately, in February 2020, MacroGenics' regional partner in Greater China, Zai Lab Limited (Zai Lab), announced the initiation of a registrational bridging study of margetuximab plus chemotherapy for the treatment of patients with metastatic HER2-positive breast cancer who have received prior anti-HER2 therapies.

    • Advanced Gastric and Gastroesophageal Junction Cancer. In October 2019, MacroGenics announced the initiation of the Phase 2/3 MAHOGANY study designed to evaluate the combination of margetuximab with anti-PD-1-based therapies as a front-line treatment. Initial safety and efficacy data are expected in the second half of 2020 from Module A of this study, which is evaluating a chemotherapy-free regimen. Module A has been designed to support a potential accelerated approval in the U.S. based on evaluation of objective response rate in a single-arm study.

    Flotetuzumab is a bispecific CD123 x CD3 DART® molecule being evaluated for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). At the American Society of Hematology (ASH) annual meeting in December 2019, MacroGenics presented updated results from patients with AML who are refractory to induction treatment (primary induction failure) in a Phase 1/2 dose expansion study. The Company intends to define a potential registration path in the U.S. for the treatment of patients with primary induction failure AML in the first half of 2020, pending continued discussions with the FDA.

    In October 2019, MacroGenics initiated a Phase 1/2 study outside of the U.S. combining flotetuzumab with MGA012, an anti-PD-1 antibody, based on preclinical and translational data that indicate the combination may enhance CD123-directed T cell killing.

    MGA012 (INCMGA0012) is an anti-PD-1 monoclonal antibody that has been exclusively licensed to Incyte Corporation. There are currently six registration-directed clinical studies ongoing or planned in 2020 across a broad range of tumor types.

    MGD013 is a first-in-class, bispecific PD-1 x LAG-3 DART molecule being evaluated in a Phase 1 dose expansion study. MacroGenics is selecting one or more indications for further development and has submitted data from select cohorts in the ongoing study for presentation at a scientific conference in the first half of 2020. Separately, in February 2020, MacroGenics' regional partner in Greater China, Zai Lab, announced the initiation of a Phase 1 study of MGD013 in combination with niraparib, a PARP (poly [ADP-ribose] polymerase) inhibitor, for the treatment of patients with advanced gastric or gastroesophageal junction cancer.

    Enoblituzumab is an Fc-engineered, anti-B7-H3 monoclonal antibody. In 2020, MacroGenics plans to evaluate the activity of both enoblituzumab plus MGA012 and enoblituzumab plus MGD013 as chemotherapy-free regimens in front-line patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) as a lead-in module before proceeding with one of these combinations in a Phase 2/3 study.

    MGC018 is an antibody-drug conjugate (ADC) targeting B7-H3 and MGD019 is a bispecific PD-1 x CTLA-4 DART molecule. The Company expects to complete dose escalation for each of these molecules in 2020 and then initiate focused dose expansion studies in select tumor types. In addition, MacroGenics expects to submit data from the dose escalation cohorts for presentation at scientific conferences in 2020.

    2019 Financial Results

    • Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2019 were $215.8 million, compared to $232.9 million as of December 31, 2018.
       
    • Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $64.2 million for the year ended December 31, 2019, compared to $60.1 million for the year ended December 31, 2018. This increase was primarily due to the timing of revenue recognition under our collaborative agreements.
       
    • R&D Expenses: Research and development expenses were $195.3 million for the year ended December 31, 2019, compared to $190.8 million for the year ended December 31, 2018. This increase was primarily due to continued enrollment in multiple ongoing clinical trials.
       
    • G&A Expenses: General and administrative expenses were $46.1 million for the year ended December 31, 2019, compared to $40.5 million for the year ended December 31, 2018. This increase was primarily due to an increase in consulting costs related to market research and other commercial preparation activities.
       
    • Net Loss: Net loss was $151.8 million for the year ended December 31, 2019, compared to net loss of $171.5 million for the year ended December 31, 2018.
       
    • Shares Outstanding: Shares outstanding as of December 31, 2019 were 48,958,763.
       
    • Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of December 31, 2019, combined with anticipated and potential collaboration payments, will enable it to fund its operations into 2021, assuming the Company's programs and collaborations advance as currently contemplated. Through the prioritization of programs and ongoing realignment of its resources, MacroGenics is focused on extending its cash runway into 2022.

    Conference Call Information

    MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the year ended December 31, 2019 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 5581596.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    MACROGENICS, INC.
    SELECTED CONSOLIDATED BALANCE SHEET DATA
    (Amounts in thousands)

      As of December 31,
      2019   2018
    Cash, cash equivalents and marketable securities $ 215,756     $ 232,863  
    Total assets 312,501     332,130  
    Deferred revenue 19,853     40,722  
    Total stockholders' equity 230,628     242,877  
               

    MACROGENICS, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    (Amounts in thousands, except share and per share data)

      Year Ended December 31,
      2019   2018   2017
    Revenues:          
    Revenue from collaborative and other agreements $ 62,024     $ 58,644     $ 155,516  
    Revenue from government agreements 2,164     1,477     2,226  
    Total revenues 64,188     60,121     157,742  
               
    Costs and expenses:          
    Research and development 195,309     190,827     147,232  
    General and administrative 46,064     40,500     32,653  
    Total costs and expenses 241,373     231,327     179,885  
               
    Loss from operations (177,185 )   (171,206 )   (22,143 )
               
    Other income (expense) 25,374     (247 )   2,517  
    Net loss (151,811 )   (171,453 )   (19,626 )
               
    Other comprehensive loss:          
    Unrealized gain on investments 19     58     21  
    Comprehensive loss $ (151,792 )   $ (171,395 )   $ (19,605 )
               
               
    Basic and diluted net loss per common share $ (3.16 )   $ (4.19 )   $ (0.54 )
    Basic and diluted weighted average number of common shares 48,082,728     40,925,318     36,095,080  
               

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo, DART and TRIDENT are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    Contacts:

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  44. Rockville, MD, Feb. 13, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the fourth quarter and full year 2019 after the market closes on Tuesday, February 25, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, February 25, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 5581596…

    Rockville, MD, Feb. 13, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will release its financial results for the fourth quarter and full year 2019 after the market closes on Tuesday, February 25, 2020. MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, February 25, 2020 at 4:30 p.m. ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID 5581596.

    The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  45. ROCKVILLE, MD, Feb. 10, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will attend the following investor conferences in February:

    • Guggenheim Healthcare Talks 2nd Annual Oncology Day. MacroGenics' management will participate in a fireside chat with the analyst in New York City on Thursday, February 13, 2020, at 4:00 p.m. ET.
    • SVB Leerink 9th Annual Global Healthcare Conference. MacroGenics' management will participate in a fireside chat with the analyst in New York City on Wednesday, February 26, 2020, at 10:00 a.m. ET.

    Webcasts…

    ROCKVILLE, MD, Feb. 10, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company's management will attend the following investor conferences in February:

    • Guggenheim Healthcare Talks 2nd Annual Oncology Day. MacroGenics' management will participate in a fireside chat with the analyst in New York City on Thursday, February 13, 2020, at 4:00 p.m. ET.
    • SVB Leerink 9th Annual Global Healthcare Conference. MacroGenics' management will participate in a fireside chat with the analyst in New York City on Wednesday, February 26, 2020, at 10:00 a.m. ET.

    Webcasts of the fireside chats may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain archived replays of these webcasts on its website for 30 days after the conference.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  46. Rockville, MD, Jan. 13, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 16, 2020, at 9:00 a.m. PT.

    An audio and slide webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain an archived replay of this webcast on its website for 30 days after the conference.

    About MacroGenics, Inc.

    MacroGenics is…

    Rockville, MD, Jan. 13, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 16, 2020, at 9:00 a.m. PT.

    An audio and slide webcast of the presentation may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics' website at http://ir.macrogenics.com/events.cfm. The Company will maintain an archived replay of this webcast on its website for 30 days after the conference.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    MacroGenics, Inc.
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  47. Rockville, MD, Jan. 09, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced its corporate and program priorities for 2020.

    "Following the submission in 2019 of our first BLA with the FDA, 2020 has the potential to be a transformative year for MacroGenics. As the product candidates in our deep pipeline enter later-stage clinical trials, we are prioritizing certain programs in order to efficiently utilize our financial, human and intellectual capital on programs with the highest commercial and scientific merit and the potential to achieve regulatory approval," said…

    Rockville, MD, Jan. 09, 2020 (GLOBE NEWSWIRE) --

    MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced its corporate and program priorities for 2020.

    "Following the submission in 2019 of our first BLA with the FDA, 2020 has the potential to be a transformative year for MacroGenics. As the product candidates in our deep pipeline enter later-stage clinical trials, we are prioritizing certain programs in order to efficiently utilize our financial, human and intellectual capital on programs with the highest commercial and scientific merit and the potential to achieve regulatory approval," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We are excited to advance multiple product candidates in registration-directed studies and believe our program prioritization positions us to capitalize on what we hope will be a pivotal year for the Company."

    Program Prioritization

    The Company's research and development priorities for its investigational molecules in 2020 are highlighted below.

    Margetuximab is an Fc-engineered, anti-HER2 monoclonal antibody being evaluated for the treatment of patients with advanced HER2-positive cancers.

    • Biologics Licensing Application (BLA) for Metastatic Breast Cancer. Pending acceptance and review of the BLA submitted in December 2019 to the Food and Drug Administration (FDA) based on the Phase 3 SOPHIA study results, the Company anticipates a Prescription Drug User Fee Act (PDUFA) date by the end of 2020. MacroGenics expects a Standard Review process in which the FDA will likely require an Oncologic Drugs Advisory Committee (ODAC) meeting in the second half of 2020.
    • Phase 2/3 MAHOGANY Study in Advanced Gastric and Gastroesophageal Junction Cancer. MacroGenics is enrolling patients in this front-line study designed to evaluate the combination of margetuximab with anti-PD-1 based therapies. Initial safety and efficacy data are expected in the second half of 2020 from Module A of this study, which is evaluating a chemotherapy-free regimen. Module A has been designed to support a potential accelerated approval in the U.S. based on evaluation of objective response rate in a single-arm study.

    Flotetuzumab is a bispecific CD123 x CD3 DART® molecule being evaluated for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). MacroGenics intends to define a potential registration path in the U.S. for the treatment of patients with primary induction failure and early relapsed AML in the first half of 2020, pending continued discussions with the FDA.

    MGA012 (INCMGA0012) is an anti-PD-1 monoclonal antibody that has been exclusively licensed to Incyte Corporation. There are currently 18 disclosed Phase 1-3 clinical studies evaluating MGA012 in monotherapy and combination regimens across a broad range of tumor types.1

    MGD013 is a first-in-class, bispecific PD-1 x LAG-3 DART molecule being evaluated in a Phase 1 dose expansion study. MacroGenics is selecting indications for further development and expects to submit data from the ongoing study for presentation at a scientific conference in the first half of 2020.

    Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 monoclonal antibody. To further inform the development of this molecule, MacroGenics plans to evaluate the activity of both enoblituzumab plus MGA012 and enoblituzumab plus MGD013 as chemotherapy‐free regimens in front‐line patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) before proceeding with the full Phase 2/3 study.

    MGC018 is an antibody-drug conjugate (ADC) targeting B7-H3 and MGD019 is a bispecific PD-1 x CTLA-4 DART molecule. The Company expects to complete dose escalation for each of these molecules in early 2020 and then initiate a focused dose expansion in select tumor types.

    MGD009 is a B7-H3 x CD3 DART molecule and MGD007 is a gpA33 x CD3 DART molecule. In connection with its strategic prioritization, the Company will discontinue development of these programs.

    Cash Balance and Cash Runway

    The Company's estimated cash, cash equivalents and marketable securities balance as of December 31, 2019 was approximately $215 million (unaudited), compared to $232.9 million as of December 31, 2018. Through the prioritization of programs and ongoing realignment of its resources, as well as anticipated and potential collaboration payments, MacroGenics is focused on extending its cash runway through 2021. The Company will provide further guidance in connection with reporting 2019 fourth quarter and annual financial results and company progress in late February 2020.

    Slide Presentation

    A slide presentation describing these corporate priorities, research and development goals and other information will be available on the Investors page on the Company's website at www.macrogenics.com after the market close on Friday, January 10, 2020.

    About MacroGenics, Inc.

    MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc.

    Cautionary Note on Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

    1 Clinicaltrials.gov and MacroGenics' website as of January 8, 2020.


    Anna Krassowska, Ph.D., Vice President, Investor Relations & Corporate Communications
    Jim Karrels, Senior Vice President, CFO
    1-301-251-5172, info@macrogenics.com

    Primary Logo

    View Full Article Hide Full Article
  48. ROCKVILLE, MD, Dec. 19, 2019 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2. The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study, which were first presented at the 2019 American Society of Clinical Oncology annual meeting, with updated…

    ROCKVILLE, MD, Dec. 19, 2019 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2. The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study, which were first presented at the 2019 American Society of Clinical Oncology annual meeting, with updated data recently presented at the 2019 San Antonio Breast Cancer Symposium.

    "As the Company's first BLA submission, this is a key milestone for MacroGenics. We are grateful to the patients who participated in this study, as well as their families, and all involved in developing margetuximab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "With this submission, we look forward to working with the Agency to bring margetuximab to appropriate patients. We believe the positive clinical trial results in SOPHIA demonstrate margetuximab's potential as a treatment option for patients living with this devastating disease."

    About the SOPHIA Study

    The SOPHIA study (NCT02492711) is a randomized, open-label Phase 3 clinical trial evaluating margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with HER2-positive metastatic breast cancer, who have previously been treated with anti-HER2-targeted therapies. All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine, or T-DM1.

    The study enrolled 536 patients who were randomized 1:1 to receive either margetuximab (n=266) given intravenously at 15 mg/kg every three weeks or trastuzumab (n=270) given intravenously at 6 mg/kg (or 8 mg/kg for loading dose) every three weeks in combination with one of four chemotherapy ag