ALXO ALX Oncology Holdings Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
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ALX148 and trastuzumab (Herceptin) - (ASPEN-01)
Solid Tumors and Lymphoma
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Phase 1
Phase 1
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ALX148 and azacitidine (ASPEN-02)
Myelodysplastic syndromes (MDS)
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Phase 1
Phase 1
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Drug Pipeline
| Drug | Stage | Notes |
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ALX148 and Keytruda (ASPEN-03 and ASPEN-04)
Head and neck squamous cell carcinoma (HNSCC)
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Phase 2
Phase 2
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Phase 2 trial to be initiated 1H 2021.
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ALX148 in combination with azacitidine and venetoclax (ASPEN-05)
Acute myeloid leukemia (AML)
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Phase 1
Phase 1
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Phase 1 trial to be initiated 2H 2021.
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ALX148 + Herceptin (trastuzumab) + Cyramza ramucirumab and paclitaxel (ASPEN-06)
2nd line or greater gastric/gastroesophageal junction cancer
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Phase 2
Phase 2
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Phase 2 trial to be initiated 2H 2021.
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Latest News
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- The post-grant review period for U.S. Patent 10,696,730 covering the composition of matter of ALX148 ended on March 30, 2021.
- This patent provides coverage of ALX148 until at least 2036, not including term adjustments or extensions.
BURLINGAME, Calif., April 05, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, announces that the post-grant review period for granted U.S. Patent No. 10,696,730 ended on March 30, 2021. This patent covers the lead product candidate ALX148, a next generation CD47-blocking therapeutic that combines a high-affinity signal regulatory protein-alpha ("SIRP") CD47-binding domain fused with an inactivated, proprietary Fc domain. The U.S. patent is not expected to expire before August 5, 2036, excluding patent term adjustments or extensions.
ALX Oncology's engineered fusion protein ALX148 is designed to enhance the activity of a wide range of leading anti-cancer agents and has shown promising clinical activity in both solid tumors and hematologic malignancies. ALX148's proprietary inactive Fc domain maintains antibody-like pharmacokinetics, while improving tolerability when compared to other CD47 blocking approaches and their associated cytopenias.
ALX148 has a lower molecular weight compared to a typical antibody, which enables it to deliver the molar equivalent of an antibody at one half the dose. This may facilitate increased solid tumor penetration and, coupled with ALX148's very high affinity for CD47, may provide greater potency within the tumor microenvironment.
The U.S. Patent and Trademark Office ("USPTO") issued U.S. Patent No. 10,696,730 on June 30, 2020, which is part of a portfolio covering ALX148 that includes U.S. Patent No. 10,259,859 granted on April 16, 2019. The latter patent covers sequences for a wide variety of high-affinity SIRP domains fused to inactivated Fc domains.
Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology commented, "We are excited about the grant of the ‘730 patent and the expiration of the post-grant review period as we prepare to initiate randomized Phase 2 studies in myelodysplastic syndromes, gastric/gastroesophageal junction cancer, and head and neck squamous cell carcinoma. The USPTO's issuance of this patent reinforces the strength of our intellectual property portfolio, and further supports our ongoing and planned clinical trials in treating patients with cancer."
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.Investor Contact: Peter Garcia Chief Financial Officer, ALX Oncology (650) 466-7125 Ext. 113 [email protected] Argot Partners (212)-600-1902 [email protected] Media Contact: Karen Sharma MacDougall (781) 235-3060 [email protected]
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BURLINGAME, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided clinical development and operational highlights.
"ALX made substantial progress in 2020 towards advancing our lead development candidate, ALX148, marked by a growing body of positive data reported in solid tumors, including encouraging Phase 1b clinical data in combination with antibodies and standard chemotherapy in patients with gastric/gastroesophageal junction ("G/GEJ") cancer and head and neck squamous cell carcinoma ("HNSCC")," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology.
"In 2021, we are focused on reporting our Phase 1b full clinical results and initiating several clinical trials, including two randomized Phase 2 studies of ALX148 in combination with KEYTRUDA® (pembrolizumab) in patients with HNSCC, and the start of a Phase 1b clinical trial with ALX148 in combination with Zymeworks' zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors in the first half of the year. In addition, randomized Phase 2 studies in myelodysplastic syndromes ("MDS") and G/GEJ cancer will initiate in the second half of a very exciting year," Dr. Pons continued.
Anticipated Key Clinical Milestones for 2021
- Full results of a Phase 1b clinical trial with ALX148 in combination with Herceptin® (trastuzumab), Cyramza® (ramucirumab) and paclitaxel in patients with second line or greater ("≥2L") G/GEJ cancer (ASPEN-01) is planned to be presented in mid-2021.
- Initiation of two randomized Phase 2 studies with ALX148 in combination with KEYTRUDA in patients with HNSCC are planned in the first half of 2021. The first study (ASPEN-03) will evaluate the efficacy of ALX148 in combination with KEYTRUDA for the first line ("1L") treatment of patients with PD-L1 expressing metastatic or unresectable, recurrent HNSCC. The second study (ASPEN-04) will evaluate ALX148 in combination with KEYTRUDA and standard 5-fluorouracil and platinum chemotherapy for the 1L treatment of patients with metastatic or unresectable, recurrent HNSCC.
- Initiation of a Phase 1b clinical trial with ALX148 in combination with Zymeworks' zanidatamab in patients with advanced HER2-expressing breast cancer and other solid tumors in the first half of 2021.
- Full results of a Phase 1b study of ALX148 in combination with Merck's KEYTRUDA (pembrolizumab) and chemotherapy for the treatment of patients with HNSCC (ASPEN-01) is planned to be presented in the second half of 2021.
- Initiation of a Phase 1 clinical trial evaluating ALX148 in combination with azacitidine and venetoclax in patients with acute myeloid leukemia ("AML") (ASPEN-05) in the second half of 2021.
- Initiation of a randomized Phase 2 trial of ALX148 in combination with Herceptin (trastuzumab), Cyramza (ramucirumab) and paclitaxel in second- or third-line ("2L or 3L") treatment of patients with G/GEJ cancer (ASPEN-06) is expected in the second half of 2021.
- Results of a Phase 1 clinical trial of ALX148 in combination with azacitidine in patients with MDS and the initiation of the Phase 2 clinical trial in MDS (ASPEN-02) are expected in the fourth quarter 2021.
Recent Clinical Developments for ALX148
- Announced Collaboration with Tallac Therapeutics on Novel Class of Cancer Immunotherapeutics
- In March 2021, ALX Oncology and Tallac Therapeutics ("Tallac"), a privately held biopharmaceutical company, announced a collaboration to jointly develop, manufacture, and commercialize a novel class of cancer immunotherapeutics. The collaboration builds on ALX Oncology's expertise in developing therapies that block the CD47 checkpoint pathway and expands its immuno-oncology pipeline with Tallac's pipeline of next generation immunotherapies derived from its novel Toll-like Receptor Agonist Antibody Conjugate ("TRAAC") platform. ALX Oncology and Tallac expect to submit an Investigational New Drug application by the end of 2022.
- Presented Updated Data at the 62nd American Society of Hematology Annual Meeting from the ASPEN-01 Phase 1b Study of ALX148 in Combination with Rituximab in Patients with Advanced Relapsed/Refractory ("r/r") non-Hodgkin lymphoma ("NHL")
- In December 2020, ALX Oncology reported updated clinical data from its ongoing trial evaluating ALX148 in combination with rituximab for the treatment of advanced r/r NHL. ALX148 in combination with rituximab was well tolerated with no dose limiting toxicities observed.
- As of the data cutoff of October 1, 2020, 33 subjects had been treated with ALX148 administered at 10 or 15 mg/kg once weekly ("QW") with standard regimens of rituximab. In response-evaluable subjects (n=10) who received ALX148 at 15 mg/kg QW, the objective response rate ("ORR") was 70.0%. In response-evaluable subjects (n=22) who received ALX148 at 10 mg/kg QW, the ORR was 40.9%. A statistically significant improvement in clinical response was demonstrated with increased ALX148 exposure across the doses evaluated (p=0.023).
- Announced Collaboration with Zymeworks Inc. to Conduct Phase 1b Study to Evaluate Zanidatamab with ALX148 in Patients with HER2 Expressing Breast Cancer
- In November 2020, ALX Oncology announced a collaboration with Zymeworks to jointly run a clinical trial to evaluate the combination of Zymeworks' zanidatamab, a HER2-targeted bispecific antibody, and ALX148, a next-generation CD47 blocker, for the treatment of patients with advanced HER2-expressing breast cancer and other solid tumors. Under the collaboration, Zymeworks will conduct an open label, multi-center Phase 1b study to assess the safety and efficacy of the combination of zanidatamab and ALX148 in subjects with HER2-positive breast cancer, HER2-low breast cancer, and non-breast HER2-expressing solid tumors.
- Presented New Data at the SITC 35th Anniversary Annual Meeting from ASPEN-01 Phase 1b Study of ALX148 in Combination with Standard Chemotherapy and Antibody Regimens in Patients with G/GEJ Cancer and HNSCC.
- In November 2020, ALX Oncology reported preliminary data from the G/GEJ cancer patient cohort receiving ALX148 plus trastuzumab plus chemotherapy. In patients with ≥2L HER2 positive G/GEJ cancer (n=14), whose tumors have progressed upon prior trastuzumab therapy, ALX148 in combination with trastuzumab plus ramucirumab and paclitaxel demonstrated an initial ORR of 64.3% that compares favorably with historical data. In addition, updated data from patients with ≥2L HER2 positive G/GEJ cancer receiving ALX148 plus trastuzumab suggested promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.
- ALX Oncology also reported preliminary data from a HNSCC patient cohort receiving ALX148 plus pembrolizumab plus chemotherapy. In patients with first line HNSCC who have not received prior treatment for advanced disease (n=4), ALX148 demonstrated an initial ORR of 75.0%, including a complete response, in combination with pembrolizumab plus 5-fluorouracil and platinum. In addition, updated data from subjects who were treatment naïve to a PD-1/PD-L1 inhibitor for their ≥2L HNSCC and who received ALX148 plus pembrolizumab suggested greater clinical activity than with pembrolizumab as a monotherapy.
Recent Operational Highlights:
- Appointed New Member to the Board of Directors. In March 2021, ALX Oncology appointed Sophia Randolph, M.D., Ph.D. to its Board of Directors. Dr. Randolph has served as Chief Medical Officer of ALX Oncology since June 2016 and will continue in this role.
- Added to the NASDAQ Biotechnology Index®. In December 2020, ALX Oncology was added to the NASDAQ Biotechnology Index® (NASDAQ:NBI) effective Monday, December 21, 2020.
- Raised Gross Proceeds of $208 Million in Oversubscribed Follow-on Public Offering. In December 2020, ALX Oncology announced the closing of an oversubscribed underwritten follow-on public offering yielding aggregate gross proceeds of approximately $208.0 million. All of the shares in the offering were offered by ALX Oncology.
Full Year and Fourth Quarter 2020 Financial Results:
- Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020 were $434.2 million. ALX Oncology believes its current cash and cash equivalents are sufficient to fund planned operations through 2024.
- Related-party Revenue: There was no related-party revenue for the three months ended December 31, 2020, compared to $1.2 million for the prior-year period. There was $1.2 million related-party revenue for the year ended December 31, 2020, compared to $4.8 million for the prior-year period. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac in July 2020.
- Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of ALX148. These expenses for the three months ended December 31, 2020, were $12.1 million, compared to $6.7 million for the prior-year period. These expenses for the year ended December 31, 2020, were $29.0 million, compared to $16.3 million for the prior-year period.
- General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended December 31, 2020, were $5.7 million, compared to $1.1 million for the prior-year period. These expenses for the year ended December 31, 2020, were $14.8 million, compared to $3.3 million for the prior-year period.
- Net Loss: GAAP net loss attributable to common stockholders was $18.8 million for the fourth quarter ended December 31, 2020, or $0.50 per basic and diluted share, as compared to a net loss of $8.8 million for the fourth quarter ended December 31, 2019, or $2.83 per basic and diluted share. GAAP net loss for the year ended December 31, 2020 was $50.9 million, or $2.76 per basic and diluted share, as compared to $23.3 million, or $7.56 per basic and diluted share, for the year ended December 31, 2019. Non-GAAP net loss was $16.3 million for the fourth quarter ended December 31, 2020, as compared to a net loss of $8.7 million for the fourth quarter ended December 31, 2019. Non-GAAP net loss for the year ended December 31, 2020 was $43.8 million, as compared to $23.0 million for the year ended December 31, 2019. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include, but are not limited to, statements regarding ALX Oncology's financial condition, results of operations and sufficiency of its cash and cash equivalents to fund its planned operations as well as statements about ALX Oncology's clinical pipeline, including the timing of clinical trial initiations and data releases, and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Annual Report on Form 10-K, filed with the SEC on March 18, 2021, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
ALX ONCOLOGY HOLDINGS INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(in thousands, except share and per share amounts)Three Months Ended Year Ended December 31, December 31, 2020 2019 2020 2019 Related-party revenue $ — $ 1,213 $ 1,182 $ 4,796 Operating expenses: Research and development 12,142 6,735 28,961 16,306 General and administrative 5,683 1,108 14,809 3,313 Cost of services for related-party revenue — 1,103 1,075 4,360 Total operating expenses 17,825 8,946 44,845 23,979 Loss from operations (17,825 ) (7,733 ) (43,663 ) (19,183 ) Interest expense (151 ) (21 ) (811 ) (21 ) Other expense, net 5 (1 ) (404 ) (5 ) Loss on early debt extinguishment (621 ) — (621 ) — Loss before income taxes (18,592 ) (7,755 ) (45,499 ) (19,209 ) Income tax provision (182 ) (9 ) (241 ) (34 ) Net loss and comprehensive loss (18,774 ) (7,764 ) (45,740 ) (19,243 ) Cumulative dividends allocated to preferred stockholders — (1,071 ) (5,202 ) (4,028 ) Net loss attributable to common stockholders $ (18,774 ) $ (8,835 ) $ (50,942 ) $ (23,271 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.50 ) $ (2.83 ) $ (2.76 ) $ (7.56 ) Weighted-average shares of common stock used to compute net loss per share attributable to common stockholders, basic and diluted 37,642,897 3,122,204 18,485,343 3,076,461 Condensed Consolidated Balance Sheet Data
(unaudited)
(in thousands)December 31, 2020 December 31, 2019 Cash and cash equivalents $ 434,219 $ 9,017 Total assets $ 436,054 $ 10,676 Total liabilities $ 6,209 $ 10,952 Convertible preferred stock $ — $ 70,363 Total stockholders' equity (deficit) $ 429,845 $ (70,639 ) GAAP to Non-GAAP Reconciliation
(unaudited)
(in thousands)Three Months Ended Year Ended December 31, December 31, 2020 2019 2020 2019 GAAP net loss attributable to common stockholders, as reported $ (18,774 ) $ (8,835 ) $ (50,942 ) $ (23,271 ) Adjustments: Stock-based compensation expense 1,743 75 5,436 297 Accretion of term loan 82 11 421 11 Mark-to-market adjustment on financial
instruments— — 650 — Loss on early debt extinguishment 621 — 621 — Total adjustments 2,446 86 7,128 308 Non-GAAP net loss attributable to common stockholders $ (16,328 ) $ (8,749 ) $ (43,814 ) $ (22,963 ) Use of Non-GAAP Financial Measures
We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.
"Non-GAAP net loss attributable to common stockholders" is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) accretion of term loan (interest expense related to ALX Oncology's amortization of debt discount), (3) mark-to market adjustment on financial instruments (which include preferred stock warrants and derivatives) and (4) loss on early debt extinguishment within our reconciliation of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.
Investor Contact:
Peter Garcia
Chief Financial Officer, ALX Oncology
(650) 466-7125 Ext. 113
[email protected]Argot Partners
(212)-600-1902
[email protected]Media Contact:
Karen Sharma
MacDougall
(781) 235-3060
[email protected] - Full results of a Phase 1b clinical trial with ALX148 in combination with Herceptin® (trastuzumab), Cyramza® (ramucirumab) and paclitaxel in patients with second line or greater ("≥2L") G/GEJ cancer (ASPEN-01) is planned to be presented in mid-2021.
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BURLINGAME, Calif., March 15, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the appointment of Sophia Randolph, M.D., Ph.D., to its Board of Directors. Dr. Randolph brings over fifteen years of biopharmaceutical industry experience and serves as Chief Medical Officer of ALX Oncology and will continue in this role.
"Dr. Randolph brings significant pharmaceutical research and development expertise to ALX Oncology and has been a crucial member of our management team over the last five years," said Corey Goodman, Ph.D., Executive Chairman of ALX Oncology. "This appointment represents another strong addition to our Board of Directors and complements the expertise of the current board members, as well as adding a valuable new perspective, and positions us well for continued clinical development and growth."
"It is a privilege to be joining ALX Oncology's Board of Directors and contribute to corporate strategy as ALX prepares to initiate numerous clinical trials this year," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "I look forward to working closely with the Board and continuing my role as Chief Medical Officer through what I believe will be a momentous time for the Company, while making a positive impact on people living with cancer."
Dr. Randolph has served as the Chief Medical Officer of ALX Oncology since June 2016. Prior to joining us, she was with Pfizer Oncology Early and Late Development Groups, where she served most recently as Executive Director, Oncology and was the global clinical franchise lead for Ibrance® (palbociclib) at Pfizer, where she oversaw the program from first-in-human trials to regulatory approval. Previously, Dr. Randolph was Director, Clinical Sciences, Oncology at Merck & Co., Inc. She holds an A.B. in Biochemistry from Harvard University and an M.D. and a Ph.D. in Cellular and Molecular Biology from the University of Michigan. Dr. Randolph completed her oncology fellowship training at Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding ALX Oncology's clinical pipeline and the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of ALX148 in addition to key milestones such as anticipated clinical trial data readouts and cash and other financial expectations. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact: Peter Garcia Chief Financial Officer, ALX Oncology (650) 466-7125 Ext. 113 [email protected] Argot Partners (212)-600-1902 [email protected] Media Contact: Karen Sharma MacDougall (781) 235-3060 [email protected]
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- Companies will combine their unique scientific and technical expertise to develop a first-in-class anti-SIRPα antibody conjugated to TLR9 agonist ("SIRPα TRAAC") that delivers targeted immune activation
- ALX expands anti-cancer therapeutics pipeline targeting the CD47 checkpoint pathway
- Collaboration extends Tallac's pipeline of next generation immunotherapies derived from its Toll-like Receptor Agonist Antibody Conjugate ("TRAAC") platform
- ALX Oncology to Host Conference Call on March 5 at 8:30 a.m. EST
BURLINGAME, Calif., March 04, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, and Tallac Therapeutics, Inc. ("Tallac"), a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, today announced a collaboration to jointly develop, manufacture, and commercialize a novel class of cancer immunotherapeutics. Under the terms of the agreement, ALX Oncology and Tallac will share equally in the cost of research and development and any profits or losses incurred.
The collaboration builds on ALX Oncology's expertise in developing therapies that block the CD47 checkpoint pathway and expands its immuno-oncology pipeline. The collaboration also extends Tallac's pipeline of next generation immunotherapies derived from its novel Toll-like Receptor Agonist Antibody Conjugate ("TRAAC") platform. The companies will leverage their respective scientific and technical expertise to advance an anti-SIRPα antibody conjugated to a Toll-like receptor 9 ("TLR9") agonist for targeted activation of both the innate and adaptive immune systems.
"We are excited to partner with ALX Oncology in the development of next-generation breakthrough cancer immunotherapies," said Hong I. Wan, Ph.D., President, Chief Executive Officer and co-founder of Tallac. "TLR9 agonists are a class of immunotherapy that generate both innate and adaptive immune responses which may produce robust and durable anti-cancer immunity for patients with advanced-stage cancers. While intratumoral TLR9 agonists have clinically validated this pathway, systemic administration has been unsuccessful, limiting clinical utility in broader patient populations. With Tallac's TRAAC technology, we now have a way to target this pathway systemically, which could expand the clinical benefit to a much broader patient population. To date, we have generated promising preclinical data with multiple TRAAC molecules that demonstrates the potential of this pathway. The goal of our collaboration with ALX Oncology is to advance SIRPα TRAAC, a systemically delivered TLR9 agonist targeting dendritic cells via SIRPα receptors, enabling a powerful innate and adaptive anti-tumor immune response."
"Collaborating with Tallac and their novel TRAAC platform broadens ALX Oncology's therapeutic strategies to activate the innate immune system and SIRPα TRAAC complements our lead product candidate, ALX148," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "While ALX148 is an antagonistic molecule designed to maximize the activity of a wide array of anticancer agents by the blockade of the CD47 myeloid checkpoint, SIRPα TRAAC is an agonistic molecule that directly activates dendritic cells and enables a coordinated innate and adaptive immune response against cancer. Since SIRPα is expressed on both dendritic cells and a range of tumor types, SIRPα TRAAC may enable an effective immune activation response in advanced cancer settings. We are excited about this potentially transformative approach and the possible benefits to patients that are in need of new treatment options."
Conference Call on March 5 at 8:30 a.m. ESTALX Oncology and Tallac will host a conference call on Friday, March 5, 2021 at 8:30 a.m. EST to further discuss the collaboration.
To access the conference call, please dial (844) 467-7655 (local) or (409) 983-9840 (international) at least 10 minutes prior to the start time and refer to conference ID 4117088. Presentation slides will be available to download under "News & Events" (see "Events") in the investors section of the ALX Oncology website at www.alxoncology.com.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit www.alxoncology.com.About Tallac
Tallac Therapeutics is a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer. Tallac's pipeline of immunotherapy candidates are derived from the company's novel Toll-like Receptor Agonist Antibody Conjugate (TRAAC) platform to deliver a potent Toll-like receptor (TLR9) agonist (T-CpG) for targeted immune activation via systemic administration. Several TRAAC molecules are in various stages of discovery and preclinical development. For more information, please visit www.tallactherapeutics.com.Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These statements include but are not limited to statements regarding the expectations of the collaboration with Tallac and the beneficial characteristics and potential therapeutic effects of SIRPα TRAAC. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology's Quarterly Report on Form 10-Q, filed with the SEC on November 12, 2020, and other documents ALX Oncology subsequently files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.ALX Oncology Investor Contact: Peter Garcia Chief Financial Officer, ALX Oncology (650) 466-7125 Ext. 113 [email protected] Argot Partners (212) 600-1902 [email protected] Media Contact: Karen Sharma MacDougall (781) 235-3060 [email protected] Tallac Therapeutics Media Contact: Tara Cooper The Grace Communication Group (650) 303-7306 [email protected]
- Companies will combine their unique scientific and technical expertise to develop a first-in-class anti-SIRPα antibody conjugated to TLR9 agonist ("SIRPα TRAAC") that delivers targeted immune activation
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BURLINGAME, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology") (NASDAQ:ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that Jaume Pons, Ph.D., Founder, President and Chief Executive Officer and other senior executives, will participate in a fireside chat at H.C. Wainwright's Global Life Sciences Conference, being held virtually on March 9-10, 2021.
The prerecorded fireside chat will be available on Tuesday, March 9, 2021 at 7:00 a.m. Eastern Time here and can be accessed by visiting the Investors section of ALX Oncology's website at www.alxoncology.com and selecting Events under the News and Events tab. A replay of the webcast will be archived for up to 30 days following the presentation date.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway and bridge the innate and adaptive immune system. ALX Oncology's lead product candidate, ALX148, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications as well as MDS and AML. For more information, please visit ALX Oncology's website at www.alxoncology.com.
Investor Contact: Peter Garcia Chief Financial Officer, ALX Oncology (650) 466-7125 Ext. 113 [email protected] Argot Partners (212) 600-1902 [email protected] Media Contact: Karen Sharma MacDougall (781) 235-3060 [email protected]
