Allogene Therapeutics, a clinical-stage biotechnology company focused on developing allogeneic CAR T products for cancer, has announced that it will present updated data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, to be held from June 2 – 6, 2023, in Chicago, Illinois. The ALPHA/ALPHA2 trials are designed to evaluate the safety, tolerability, and preliminary efficacy of increasing doses of ALLO-501 and ALLO-501A, allogeneic CAR T cell product candidates that target CD19. These studies also explored escalating doses of Allogene’s proprietary lymphodepleting antibody, ALLO-647, which is designed to prevent premature rejection of AlloCAR T cells. Allogene is currently enrolling patients for 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 Executive Vice President, Research & Development and Chief Medical Officer, Zachary Roberts, M.D., Ph.D. “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.”
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According to a press release by the company, the presentation will discuss Phase 1 results with anti-CD19 allogeneic CAR T ALLO-501/501A in relapsed/refractory large B cell lymphoma (r/r LBCL), with Dr. Frederick Locke, M.D., Chair, Department of Blood and Marrow Transplant and Cellular Immunotherapy, program co-leader, Immuno-Oncology, Moffitt Cancer Center in Tampa, Florida, presenting the data. The presentation will be held during the Poster Discussion Session – Developmental Therapeutics – Immunotherapy on June 3, 2023. The abstract number is #2517, poster board number is #359, and the poster session display time is between 8:00 AM-11:00 AM CT. The discussion session date and time are June 3, 2023, 3:00 PM-4:30 PM CT.
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 its use in a broader patient population, including NHL patients with recent rituximab exposure. This product candidate is 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.
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Allogene Therapeutics, headquartered in South San Francisco, is a clinical-stage biotechnology company focused on 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.
The press release also provided a cautionary statement on forward-looking statements for Allogene, stating that the press release contains forward-looking statements for the purpose 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
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