Allogene Therapeutics Announces Presentation of Phase 1 Data from the ALLO-501/501A Trials in Large B Cell Lymphoma at the American Society of Clinical Oncology (ASCO) Annual Meeting
Allogene Therapeutics, Inc. (Nasdaq: ALLO) announced it will present updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501 and ALLO-501A at the ASCO Annual Meeting from June 2-6, 2023. These trials assess the safety and preliminary efficacy of the allogeneic CAR T cell products targeting CD19. Allogene is also enrolling patients in the Phase 2 ALPHA2 trial for large B cell lymphoma (LBCL). The data presentation will feature results that highlight the potential of ALLO-501 and ALLO-501A to induce durable responses in relapsed/refractory LBCL. The FDA has granted ALLO-501A RMAT designation, indicating its potential for expedited development. Allogene aims to set a new standard in CAR T therapies.
- Presentation of updated data from Phase 1 ALPHA/ALPHA2 trials at ASCO indicates progress in treatment options.
- ALLO-501A received RMAT designation from the FDA, highlighting its potential in treating relapsed/refractory LBCL.
- The trials suggest durable responses in relapsed/refractory LBCL, supporting Allogene's position in the CAR T market.
- None.
SOUTH SAN FRANCISCO, Calif., April 26, 2023 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today announced it will present updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A at the American Society of Clinical Oncology (ASCO) Annual Meeting June 2 – 6, 2023 in Chicago, Illinois.
The ALPHA/ALPHA2 trials were designed to assess the safety, tolerability, and preliminary efficacy at increasing dose levels of ALLO-501 and ALLO-501A, allogeneic CAR T cell product candidates that target CD19. In addition to exploring cell doses, these studies evaluated escalating doses of ALLO-647, Allogene’s proprietary lymphodepleting antibody designed to prevent premature rejection of AlloCAR T cells. Allogene is currently enrolling the potentially pivotal Phase 2 ALPHA2 trial of ALLO-501A in large B cell lymphoma (LBCL).
“We are looking forward to sharing updated data from our Phase 1 ALPHA/ALPHA2 trials,” said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research & Development and Chief Medical Officer. “Prior updates from the ALPHA/ALPHA2 trials provided clear proof-of-concept for the ability of an allogenic CAR T product candidate to induce deep and durable responses in LBCL, a crucial finding as we seek to establish a new era in CAR T.”
Allogene presentation at the 2023 ASCO Annual Meeting:
Phase 1 Results with Anti-CD19 Allogeneic CAR T ALLO-501/501A in Relapsed/Refractory Large B Cell Lymphoma (r/r LBCL)
Presenter: Dr. Frederick Locke, M.D., Chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy; program co-leader, Immuno-Oncology, Moffitt Cancer Center
Tampa, Florida
Session Title: Poster Discussion Session – Developmental Therapeutics – Immunotherapy
Abstract: #2517
Poster Board: #359
Poster Session Display Date and Time: June 3, 2023, 8:00AM-11:00AM CT
Poster Discussion Session Date and Time: June 3, 2023, 3:00PM-4:30PM CT
About ALLO-501 and ALLO-501A
ALLO-501 and ALLO-501A are anti-CD19 AlloCAR T™ investigational products for the treatment of large B cell lymphoma. ALLO-501A, a next-generation anti-CD19 AlloCAR T™, eliminates the rituximab recognition domains in ALLO-501, which could allow for use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is currently being studied in an ongoing Phase 2 trial. In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in r/r LBCL.
About Allogene Therapeutics
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements for Allogene
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "continue," “designed,” “indicate,” “may,” “possible,” "potential," “preliminary,” "suggest," "will" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the potential of the Phase 2 ALPHA2 trial to be a pivotal trial; data results that may be implied from prior results; and the potential benefits of AlloCAR T products. Various factors may cause material differences between Allogene’s expectations and actual results, including, risks and uncertainties related to: our product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; Phase 1 data from our clinical trials is limited and may change as more patient data become available or may not be validated in any future or advanced clinical trial; our ability to maintain intellectual property rights necessary for the continued development of our product candidates, including pursuant to our license agreements; our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval or limit their commercial potential; the extent to which COVID-19 adversely impacts our business, including our clinical trials; the extent to which the FDA disagrees with our clinical or regulatory plans, which could cause future delays to our clinical trials or require additional clinical trials; we may encounter difficulties enrolling patients in our clinical trials; we may not be able to demonstrate the safety and efficacy of our product candidates in our clinical trials, which could prevent or delay regulatory approval and commercialization; challenges with manufacturing or optimizing manufacturing of our product candidates; and our ability to obtain additional financing to develop our products and implement our operating plans. These and other risks are discussed in greater detail in Allogene’s filings with the SEC, including without limitation under the “Risk Factors” heading of its Form 10-K for the year ended December 31, 2022. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
AlloCAR T™ is a trademark of Allogene Therapeutics, Inc.
Allogene’s AlloCAR T™ programs utilize the Cellectis TALEN® technologies. ALLO-501 and ALLO-501A are anti-CD19 products being jointly developed under a collaboration agreement between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. Servier grants to Allogene exclusive rights to ALLO-501 and ALLO-501A in the U.S.
Allogene Media/Investor Contact:
Christine Cassiano
Chief Communications Officer
(714) 552-0326
Christine.Cassiano@allogene.com
Additional Allogene Media Contact:
Madeleine Goldstein
Manager, Corporate & Pipeline Communications
Madeleine.Goldstein@allogene.com
FAQ
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