Allogene Therapeutics, Inc. (ALLO) stock declined 0.84% in the pre-market trading session at the price of $13.02 despite no fundamental reason. ALLO is a clinical-stage biotechnology company that develops AlloCAR T medicines to treat cancer. 

FDA Clinical Hold of AlloCAR T Trials 

On 7th October 2021, ALLO reported the clinical hold by U.S. Food and Drug Administration on the AlloCAR T clinical trials. FDA has placed hold due to chromosomal abnormality in ALLO-501A CAR T cells in patients treated in the ALPHA2 study. Allogene anticipates presenting further updates in the upcoming weeks following the conference with the FDA. The FDA is actively evaluating the Phase 1 materials submitted for ALLO-501A pivotal Phase 2 trial. This clinical hold of a chromosomal abnormality had detected in a bone marrow biopsy undertaken to evaluate pancytopenia. An examination is underway to describe the observed abnormal behavior. The investigation includes clinical relevance and evidence related to clonal expansion or gene editing.  

Chief Medical Officer, Rafael Amado, remarked that patient protection is their highest priority. They are collaborating with FDA to evaluate the potential clinical implications of this finding for developing ALLO-501A. As the leader of allogeneic cell therapies, they have acknowledged their responsibilities to fully assess all the aspects of the ALLO-501A. They are grateful for the cooperation with the patient community, clinical investigators, and the FDA. They work toward understanding the clinical importance and the development of allogeneic CAR T therapy to treat cancer, Mr. Amado added.   

ALLO Appointed Jae Park to Scientific Advisory Board 

On 20th September 2021, ALLO announced that it had appointed Jae Park to its Scientific Advisory Board. Mr. Jae had previously worked at Memorial Sloan Kettering Cancer Center as acting Chief of Cellular Therapeutics. He is the chief examiner of clinical trials to treat patients of non-Hodgkin lymphoma and acute lymphoblastic leukemia. Mr. Jae has also served as an Associate Attending Physician at the Hematologic Oncology, Leukemia Service. Earlier, he has worked at Memorial Sloan Kettering Cancer Center as an Acting Chief of Cellular Therapeutics Service. He got his medical degree from the Johns Hopkins School of Medicine. 

CMO of ALLO, Rafael Amado, commented that they were excited to welcome Dr. Park to their Scientific Advisory Board (SAB). He has extensive research and experience in treating patients with CAR T and other immunotherapies. His addition to the team will help them to support their leadership position, he added.