Confidence in gene-edited T cell therapies from donor cells has faltered as Allogene Therapeutics paused all clinical development following the detection of an unexpected genetic change in a clinical trial. Industry experts see these events as a reality check for the nascent field.
Off-the-shelf treatments that use genetically engineered T cells to treat diseases suffered a blow to their image earlier this month when a gene-edited Chimeric Antigen Receptor (CAR)-T cell therapy, developed by the US biotech Allogene Therapeutics, encountered a safety concern in a phase I/II trial.
According to Allogene, a biopsy from a blood cancer patient infused with its CAR-T cell therapy revealed CAR-T cells with an unexplained chromosomal change. The company noted that the abnormality was found on a chromosome that’s also targeted by TALEN-based gene-editing technology used by the firm. It’s still unclear if the change originated from the gene-editing process, and what its clinical impact could be.
The FDA has put a hold on all clinical trials involving Allogene’s CAR-T cell therapy,
The post Gene-Edited T Cell Therapy Players Battle Safety Doubts appeared first on Labiotech.eu.
© Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.
Published on Fri, 22 Oct 2021 07:00:00 +0000 on behalf of power apps shorten link