Benzinga | Jan 10, 2022 08:31AM EST

Allogene Therapeutics Reports Removal Of FDA Clinical Hold Across All AlloCAR T Trials

* Investigation Confirmed the Chromosomal Abnormality in a Single Patient was Not Observed in Any AlloCAR T Product and Not Related to Allogene Manufacturing Process or TALEN(r) Gene Editing

* Clinical Trials Across the AlloCAR T Platform to Resume

* Pivotal Phase 2 Trial of ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Expected to Commence in Mid-Year 2022 Pending FDA Discussions

* Company to Host Conference Call Today at 8:30 am PT/11:30 am ET

SOUTH SAN FRANCISCO, Calif., Jan. 10, 2022 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (NASDAQ:ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T(tm)) products for cancer, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on all of the Company's AlloCAR T clinical trials. Allogene previously announced on October 7, 2021 that the FDA had placed a hold on all five of the Company's AlloCAR T clinical trials based on a report of a chromosomal abnormality detected post-AlloCAR T administration in a single patient treated with ALLO-501A in the ALPHA2 study.

Investigations concluded that the chromosomal abnormality was unrelated to TALEN(r) gene editing or Allogene's manufacturing process and had no clinical significance. The abnormality was not detected in any manufactured AlloCAR T product or in any other patient treated with the same ALLO-501A lot. The abnormality occurred in the patient after the cell product was administered. It involved regions of the T cell receptor and immunoglobulin genes known to undergo rearrangement as part of the T cell or B cell maturation process.

Allogene will be working with clinical trial investigators to resume study activities across AlloCAR T development programs as quickly as possible. Pending final discussions with the FDA, the Company also plans to initiate its pivotal Phase 2 trial of ALLO-501A in relapsed/refractory Large B Cell Lymphoma (LBCL) mid-year 2022.

"We are thankful for the partnership between our teams at Allogene, our clinical trial investigators who remain steadfast in their support of our investigational therapies, and the FDA which expeditiously completed its review of our Complete Response Letter," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "Allogeneic CAR T therapy is a rapidly developing field that continues to evolve both in scope and impact, and the findings from our investigation will help advance innovation in the fields of gene editing and cell and gene therapy. As the leading developer of allogeneic cell products, we look forward to resuming our clinical trials as we work to fulfill our commitment to bring patients the first allogeneic CAR T product."

Conference Call and Webcast Details

Allogene will host a live conference call and webcast today at 8:30 a.m. Pacific Time / 11:30 a.m. Eastern Time to provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 8598466. The webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.