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Allogene Therapeutics Announces Publication of Industry-Advancing Case Study on Chromosomal Rearrangement in Molecular Therapy
Publication Reviews Investigation of a Chromosomal Rearrangement Observed in a Single Patient Receiving Gene-Edited Allogeneic CAR T Treatment for Large B
About this update from Allogene Therapeutics, Inc.
[{"type":"text","content":"Publication Reviews Investigation of a Chromosomal Rearrangement Observed in a Single Patient Receiving Gene-Edited Allogeneic CAR T Treatment for Large B Cell LymphomaCase Reveals Normal T Cell Biology Occurring in CAR T Cells, Including Notable Finding of Continued Chromosomal Rearrangement in Mature LymphocytesResults Reinforce Previous Findings that the Rearrangement was Not Related to Cell Manufacturing or Gene Editing, and Not Associated with Clinical Significance SOUTH SAN FRANCISCO, Calif., March 01, 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 the publication of a case review in Molecular Therapy of the single patient treated with ALLO-501A who presented with a chromosomal rearrangement. The findings from this report advance the understanding of the presence of genomic variability at the chromosomal level in mature lymphocytes expanding the knowledge in the field of gene and cell therapy. The development of “off-the-shelf” (allogeneic) CAR T products that utilize cells from healthy donors have the potential to make CAR T therapies scalable and accessible to more patients. Gene editing is a common technique deployed to create allogeneic CAR T cells and other engineered cell therapy candidates. Gene editing has the potential to induce chromosomal inversions as a consequence of post cleavage genetic recombination. The Company’s case report details a chromosome 14 inversion in a patient treated with gene edited cells. Initial caution surrounding this case led to a U.S. Food and Drug Administration (FDA) clinical hold in October 2021 across the Company’s AlloCAR T clinical trials. An extensive investigation concluded that the chromosomal inversion was unrelated to TALEN® gene editing or Allogene’s manufacturing process and had no clinical significance, resulting in a lift of the clinical hold three months later. “As the leader in the development of allogeneic CAR T cell treatments, we understand our responsibility to patients as well as the important role we play in advancing this rapidly developing field,” said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. “As we look to deliver on the promise of allogeneic CAR T cell produc...