Allogene Therapeutics Initiates Industry’s First Allogeneic CAR T Phase 2 Trial

• ALPHA2 Trial, Evaluating ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients, is Designed to Leverage the Ease and Convenience of a Single Dose of ALLO-501A
• Protocol Supported by Clinical and Translational Data from Phase 1 Trial Indicating Deep Responses are Achievable with a Single Dose of ALLO-501A When Used with a Lymphodepletion Regimen That Includes an Optimized Dose of ALLO-647

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Oct. 06, 2022 (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 the initiation of the potentially pivotal Phase 2 clinical trial of ALLO-501A (ALPHA2 trial) in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). The Company is also in the process of initiating the EXPAND trial, which is intended to demonstrate the contribution of ALLO-647 to the standard fludarabine/cyclophosphamide lymphodepletion regimen. Assuming favorable outcomes and subject to discussions with the U.S. Food and Drug Administration (FDA), the Company expects these studies to support the regulatory approval of both ALLO-501A and ALLO-647.

“We are proud to initiate the industry’s first potentially pivotal Phase 2 trial for an allogeneic CAR T product. This milestone paves the road for both ALLO-501A and our broader pipeline of innovative products with the potential to greatly increase patient access to cell therapy,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “It is a culmination of years of hard work and perseverance, which could only be accomplished in collaboration with our dedicated staff, investigators, clinical trial site coordinators, regulatory authorities and most importantly the patients who have participated in our studies.”

Allogene conducted an extensive Phase 1 program designed to evaluate and optimize all aspects of AlloCAR T, including doses and schedules of ALLO-501A and ALLO-647. In addition, the Company recently conducted a review of the Phase 1 program which determined a manufacturing process associated with robust clinical performance. Allogene’s selected manufacturing process, named Alloy, will be deployed in the ALPHA2 and EXPAND trials.

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