Allogene Therapeutics announces publication of case review in Molecular Therapy

Allogene Therapeutics 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 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 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 products, this case highlights the need to understand cell-intrinsic biology as well as the theoretical effects of genomic manipulations. Through the efficient investigation of this event, we have increased our understanding of the frequency and mechanisms of chromosomal variability in normal mature T cells without connection to genomic manipulations."