ALXO ALX Oncology Holdings Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
ALX148 and HERCEPTIN (Trastuzumab) - (ASPEN-01)
Solid Tumors and Lymphoma
|
Phase 1
Phase 1
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
|
ALX148 and KEYTRUDA (pembrolizumab) - ASPEN-04
Head and Neck Squamous Cell Carcinoma
|
Phase 2
Phase 2
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
|
ALX148 and KEYTRUDA (pembrolizumab) - (ASPEN-03)
Head and neck squamous cell carcinoma (HNSCC)
|
Phase 2
Phase 2
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
|
ALX148 and Vidaza (azacitidine) - (ASPEN-02)
Myelodysplastic syndromes (MDS)
|
Phase 1
Phase 1
|
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
ALX148 in combination with VIDAZA (azacitidine) and VENCLEXTA (venetoclax) - (ASPEN-05)
Acute myeloid leukemia (AML)
|
Phase 1/2
Phase 1/2
|
Phase 1/2 first patient dosed, noted October 21, 2021.
|
|
Zanidatamab and Evorpacept (ALX148)
HER2 Breast cancer and solid tumors
|
Phase 1/2
Phase 1/2
|
Phase 1b/2 first patient dosed, October 5, 2021.
|
|
ALX148 (evorpacept) + rituximab and lenalidomide
non-Hodgkin lymphoma (NHL)
|
Phase 1/2
Phase 1/2
|
Phase 1/2 trial commencement September 16, 2021
|
|
ALX148 + HERCEPTIN (Trastuzumab) + CYRAMZA (ramucirumab) and TAXOL (paclitaxel) - (ASPEN-06)
2nd line or greater gastric/gastroesophageal junction cancer
|
Phase 2
Phase 2
|
Phase 2 trial to be initiated 2H 2021.
|
Latest News
-
View Full Article Hide Full Article
SOUTH SAN FRANCISCO, Calif., Oct. 21, 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 first patient has been dosed in the Phase 1/2 ASPEN-05 study evaluating the combination of evorpacept, a next-generation CD47 blocker, with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia ("AML").
The Phase 1 portion of the ASPEN-05 study will characterize the safety and confirm the dose of evorpacept in combination with venetoclax and azacitidine in patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy. The Phase 2 portion of the study will evaluate the efficacy of the combination in patients with previously untreated AML who are not candidates for intensive induction therapy.
ASPEN-05 is based on promising preclinical data with evorpacept in combination with venetoclax and azacitidine in non-clinical models of leukemia, as well as clinical data from an ongoing phase 1 study (NCT03013218) evaluating evorpacept in combination with multiple anti-cancer agents in both solid and hematologic malignancies.
"Patients with either relapsed/refractory AML or previously untreated AML who are not considered eligible for intensive induction regimens remain in urgent need of tolerable and effective new therapies," said Harry Erba, M.D., Ph.D., Director of the Leukemia Program at the Duke Cancer Institute. "We are looking forward to evaluating the addition of evorpacept to venetoclax and azacitidine. ALX148 was specifically designed for use in combination to maximize phagocytosis of tumor cells while minimizing the toxicities commonly associated with other CD47-targeted approaches."
"ASPEN-05 builds upon compelling evorpacept combination activity observed in non-clinical models of leukemia. With demonstrated tolerability of evorpacept in multi-agent chemotherapy regimens, we are excited to characterize evorpacept with this standard backbone of AML therapy," said Sophia Randolph, M.D., Ph.D., Chief Medical Officer of ALX Oncology. "Through blockade of the CD47 myeloid checkpoint, evorpacept in combination with venetoclax and azacitidine may potentially transform treatment options for patients with AML."
The ASPEN-05 trial is registered under NCT04755244. ALX Oncology owns worldwide commercial rights to evorpacept.
About Acute Myeloid Leukemia
AML is an aggressive blood cell cancer that can rapidly progress and lead to death if not treated promptly. AML is the most common form of acute leukemia in adults, with an estimated 19,940 new cases and 11,180 deaths from AML in the United States. Due to advanced age and comorbidities at the time of diagnosis, a significant number of patients are not considered eligible for intensive and potentially curative therapies. Despite advances in available care, the estimated 5-year survival for patients in the United States with AML remains only 29%.
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, evorpacept (also known as ALX148), is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept 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 evorpacept for the treatment of multiple solid tumor indications and hematologic malignances, including acute myeloid leukemia and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. 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 Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology 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 peter@alxoncology.com Argot Partners (212)-600-1902 alxoncology@argotpartners.com Media Contact: Karen Sharma MacDougall (781) 235-3060 alx@macbiocom.com
-
View Full Article Hide Full Article
- Acquisition adds novel and proprietary SHIELD platform for conditional activation of antibodies in tumor microenvironment and proprietary cytotoxic payloads for antibody drug conjugates
- Expands ALX Oncology's pipeline of drug candidates based on expertise in protein engineering and oncology
SOUTH SAN FRANCISCO, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology") (NASDAQ:ALXO), a clinical-stage immuno-oncology company, and ScalmiBio, Inc. ("ScalmiBio") announced today that ALX Oncology has acquired ScalmiBio.
ALX Oncology further expands its pipeline with plans to develop new anti-cancer drug candidates based on ScalmiBio's platform; these new molecules will be designed to address unmet cancer patient needs as stand-alone therapeutics and in combination with ALX Oncology's lead product candidate, evorpacept, a next-generation CD47 blocker designed to leverage the immune activation of broadly used anti-cancer agents through combination strategies.
"ALX Oncology was founded to address limitations of CD47 blockade through protein engineering," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "ScalmiBio's universal SHIELD technology allows us to expand our pipeline and bring more treatment options to patients. We are building on our foundational strength of utilizing protein engineering to more broadly address limitations of other clinically and commercially validated anti-cancer targets through the design of conditionally activated antibodies and novel antibody-drug conjugates or ADCs."
ScalmiBio's SHIELD technology is designed to minimize interaction of an antibody therapeutic with normal tissue and maximize its target binding capability within tumor microenvironment. Many cancer targets are relatively abundant in cancer cells but also expressed in normal cells leading to on-target, off-tumor toxicities that limit patient access to potentially life changing treatments. ScalmiBio's conditional activation technology aims to increase therapeutic index by minimizing dose limiting toxicities of existing checkpoint inhibitors and other targeted anti-cancer biologics as well as enable the design of ADCs with higher drug-to-antibody ratios for improved anti-cancer activity. ALX Oncology has also acquired ScalmiBio's proprietary cytotoxic payloads for the development of ADCs.
Under the terms of the share purchase agreement, ALX Oncology made an initial payment to the stockholders of ScalmiBio at closing on October 4, 2021 of approximately $4.5 million in cash, net of certain expenses and adjustments, and will make an additional payment of $2.0 million in cash at the one-year anniversary of the transaction subject to certain conditions. In addition, ALX Oncology has agreed to pay certain milestones based on the clinical development of the acquired ScalmiBio technology and has also agreed to pay a low single digit royalty on net sales of any products developed from the ScalmiBio acquired technology for a defined term.
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, evorpacept (also known as ALX148), is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept 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 evorpacept for the treatment of multiple solid tumor indications and hematologic malignances, including acute myeloid leukemia and myelodysplastic syndromes.
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, the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of evorpacept and the expectations regarding ALX Oncology's ability to use ScalmiBio's technology to expand its pipeline of drug candidates. 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 forward-looking 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 peter@alxoncology.com Argot Partners (212)-600-1902 alxoncology@argotpartners.com Media Contact: Karen Sharma MacDougall (781) 235-3060 alx@macbiocom.com
- Acquisition adds novel and proprietary SHIELD platform for conditional activation of antibodies in tumor microenvironment and proprietary cytotoxic payloads for antibody drug conjugates
-
View Full Article Hide Full Article
Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, and ALX Oncology Holdings Inc. (NASDAQ:ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the first patient has been dosed in an open-label, multi-center Phase 1b/2 clinical trial conducted by Zymeworks.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211005005450/en/
The trial is designed to evaluate the safety and efficacy of zanidatamab, Zymeworks' lead HER2‑targeted bispecific antibody, in combination with evorpacept (ALX148), ALX's CD47 blocker, in patients with advanced HER2-positive breast cancer, HER2-low breast cancer and additional non-breast HER2-expressing solid tumors.
This collaboration builds on the promising antitumor activity observed in clinical trials of evorpacept combined with a HER2-targeted antibody in patients with advanced HER2‑positive gastric or gastroesophageal junction cancer. The addition of CD47 blockade is designed to enhance zanidatamab's immunotherapeutic effects and has the potential to provide benefit to a broad population of patients, including those with advanced HER2‑expressing breast cancer and potentially other HER2‑expressing cancers.
About the Zanidatamab-Evorpacept Combination
Zanidatamab is designed to have multiple mechanisms of action, including immune clearance of HER2‑expressing tumor cells by macrophages through antibody-dependent cellular phagocytosis (ADCP). CD47 is a "don't eat me" signal that acts as a checkpoint inhibitor to macrophages. Cancer cells that express CD47 are resistant to immune clearance even when targeted with therapeutic antibodies. Treatment with zanidatamab plus evorpacept has the potential to increase the immune clearance of HER2-expressing cancer cells by combining a biparatopic antibody capable of binding at higher density than monospecific antibodies with a molecule that blocks CD47 on the same targeted cancer cells.
About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks' Azymetric™ platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab's unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA as well as the European Medicines Agency for the treatment of biliary tract and gastric cancers.
About Evorpacept
Evorpacept is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept is designed to avoid the limitations caused by hematologic toxicities inherent in other CD47 blocking approaches, and to leverage the immune activation of broadly used anti-cancer agents through combination strategies. ALX Oncology is developing evorpacept in multiple Phase 1 and Phase 2 clinical trials globally across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents. The FDA has granted two Fast Track designations to evorpacept, one for the first-line treatment of patients with head and neck squamous cell carcinoma, and one for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma. The FDA's Fast Track designation provides the opportunity for more frequent meetings with the FDA over the course of drug development and allows for eligibility for Accelerated Approval and Priority Review if relevant criteria are met, as well as for Rolling Review.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks' suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks' lead clinical candidate, zanidatamab (ZW25), is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, and breast cancers. Zymeworks' second clinical candidate, ZW49, is a novel bispecific HER2-targeting antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks' proprietary ZymeLink™ linker and cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.
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, evorpacept, 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 evorpacept for the treatment of multiple solid tumor indications and hematologic malignances, including acute myeloid leukemia and myelodysplastic syndrome. ALX Oncology has entered into strategic partnerships with multiple biopharmaceutical companies to support indications that entail large unmet medical needs. For additional information about ALX Oncology, visit www.alxoncology.com and follow @AlxOncology on Twitter.
Zymeworks Cautionary Note Regarding Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks' expectations regarding the beneficial characteristics, safety, and therapeutic effects of zanidatamab, its trial combining zanidatamab and evorpacept, the potential benefits of that combination, and other information that is not historical information. When used herein, words such as "may", "potential", and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks' current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under "Risk Factors" in Zymeworks' Quarterly Report on Form 10-Q for its quarter ended June 30, 2021 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks' current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
ALX Oncology Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. 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 Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211005005450/en/
-
View Full Article Hide Full Article
SOUTH SAN FRANCISCO, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company"), a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, today announced that four abstracts have been accepted for presentation at the SITC 36th Annual Meeting in Washington D.C. from November 10 –14, 2021. The abstracts, which will be presented in a poster session, include new clinical data from ASPEN-01, the ongoing Phase 1b study of evorpacept (also known as ALX148) in patients with head and neck squamous cell carcinoma and with gastric/gastroesophageal cancer, and clinical trial in progress presentations on ASPEN-03 and ASPEN-04, our Phase 2 head and neck cancer studies in collaboration with Merck. In addition, preclinical data will be presented on ALTA-002, a first-in-class SIRPα-directed TLR9 agonist antibody conjugate, which is being developed in collaboration with Tallac Therapeutics.
Poster Presentation Details
Title: Evorpacept (ALX148), a CD47 myeloid checkpoint inhibitor, in patients with head and neck squamous cell carcinoma (HNSCC) and with gastric/gastroesophageal cancer (GC); ASPEN-01 (Abstract 498)
Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET
Location: Poster Hall
Title: A phase 2 study of evorpacept (ALX148) in combination with pembrolizumab in patients with advanced head and neck squamous cell carcinoma (HNSCC); ASPEN-03 (Abstract 439)
Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET
Location: Poster Hall
Title: A phase 2 study of evorpacept (ALX148) in combination with pembrolizumab and chemotherapy in patients with advanced head and neck squamous cell carcinoma (HNSCC); ASPEN-04 (Abstract 433)
Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET
Location: Poster Hall
Title: ALTA-002, a SIRPα-directed TLR9 agonist antibody conjugate activates myeloid cells and promotes anti-tumor immunity (Abstract 780)
Presentation Time: November 12 – 14, 2021, 7:00am – 5:00pm ET
Location: Poster Hall
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, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept 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 evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. 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 Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology 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 peter@alxoncology.com Argot Partners (212)-600-1902 alxoncology@argotpartners.com Media Contact: Karen Sharma MacDougall (781) 235-3060 alx@macbiocom.com
-
View Full Article Hide Full Article
BURLINGAME, Calif., Sept. 16, 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 initiation of a Phase 1/2 investigator-sponsored trial of evorpacept (also known as ALX148), a next generation CD47 blocker, in combination with rituximab and lenalidomide for the treatment of patients with indolent and aggressive non-Hodgkin lymphoma ("NHL"). This study is being led by Dr. Paolo Strati at The University of Texas M.D. Anderson Cancer Center ("MDACC"), one of the largest multidisciplinary programs in the U.S. for treating NHL.
"We are excited to launch this study that builds upon the promising anti-tumor activity and tolerability observed from ASPEN-01, ALX Oncology's Phase 1b study to investigate the combination of evorpacept and rituximab in patients with advanced relapsed and refractory NHL," said Paolo Strati, M.D., Assistant Professor, Department of Lymphoma-Myeloma and Department of Translational Molecular Pathology, MDACC. "NHL remains a difficult-to-treat cancer and patients are in desperate need for more therapeutic options to help improve disease outcomes. From a mechanistic perspective, the combination of a CD47 blocker and rituximab, as well as the combination of lenalidomide and rituximab, have demonstrated clinical activity against NHL. As these doublet combinations act through different but synergistic mechanisms, and have non-overlapping individual toxicity profiles, we anticipate the triplet combination of evorpacept, rituximab and lenalidomide will positively impact efficacy without increasing toxicity."
About Non-Hodgkin Lymphoma
Approximately 500,000 people worldwide are diagnosed with NHL each year. In the U.S., NHL is the seventh most common type of cancer, and over 80,000 newly diagnosed cases of NHL are estimated in 2021. Treatment options are currently limited and resistance to existing therapies or relapse following treatment is common. The most prevalent form of NHL, accounting for about 40% of newly diagnosed NHL cases, is an aggressive form called diffuse large B-cell lymphoma ("DLBCL"). Patients with relapsed or refractory DLBCL have an extremely poor prognosis with a median survival of approximately 6 months. Indolent lymphomas comprise another common form of NHL, especially among elderly individuals, where safe and effective chemotherapy-free options for these patients are urgently needed.
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, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated, proprietary Fc domain. Evorpacept 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 evorpacept for the treatment of multiple solid tumor indications and hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndromes.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. 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 Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology 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 peter@alxoncology.com Argot Partners (212)-600-1902 alxoncology@argotpartners.com Media Contact: Karen Sharma MacDougall (781) 235-3060 alx@macbiocom.com