• Long-Term Follow Up Data from Phase 1 ALPHA/ALPHA2 Trials Demonstrates Potential of Allogeneic CD19 CAR T to Generate Durable Complete Responses Similar to Approved Autologous Therapies
  • Presentation Recaps 12 Patients Treated with Phase 2 Dose Regimen and Includes Additional Data on All 33 CAR T Naïve Patients Treated with the Alloy™ Manufacturing Process
  • Potentially Pivotal Phase 2 ALPHA2 Trials Ongoing in the US; Sites in Europe, Canada and Australia Expected to Enroll During 2023

SOUTH SAN FRANCISCO, CA, USA I June 09, 2023 I 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 data from the Phase 1 ALPHA/ALPHA2 trials of ALLO-501/501A in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL) in an oral presentation at the International Conference on Malignant Lymphoma (ICML) on June 13–17, 2023 in Lugano, Switzerland. This presentation will feature additional data on the 33 CAR T naïve patients treated with the Alloy™ manufacturing process across different CAR T dosing and lymphodepletion regimens. Earlier in June, data from the 12 patients who received a single ALLO-501/A cell infusion following the lymphodepletion regimen being utilized in the ongoing potentially pivotal Phase 2 trials was presented at American Society of Clinical Oncology (ASCO) Annual Meeting.

The ALPHA/ALPHA2 Phase 1 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 multiple cell doses and dosing schedules (consolidation), these studies evaluated various 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 LBCL and expects to complete enrollment in 1H2024. The Company expects to open trial sites in Europe, Canada and Australia during 2023.

Allogene Presentation at the 2023 ICML Lugano:

Durable responses with anti-CD19 allogeneic CAR T ALLO-501/501A in phase 1 trials of 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
Abstract: #48
Oral Presentation Date and Time: June 15, 2023, 15:30 CEST / 9:30am EST / 6:30am PST

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.

SOURCE: Allogene Therapeutics