Key points from article :
The FDA has sent a clinical hold on all of Allogene’s AlloCAR T clinical trials in response to an abnormality that could cause cancer.
A lymphoma patient suffered a reduction in all blood cell lines after receiving an infusion of anti-CD19 CAR-T candidate ALLO-501A.
Analysis of the biopsy discovered anti-CD19 CAR-T cells with a chromosomal abnormality.
Cells may have acquired the chromosomal change in the gene editing process or as they expanded quickly.
Allogene reported the abnormality to the FDA, prompting to put a clinical hold on all of the biotech’s AlloCAR T clinical trials.
The FDA’s response reflects the potential for chromosomal abnormalities to cause cancer.
The impact could be limited to a delay and the adoption of additional precautions at Allogene.
Allogene’s stock fell more than 30%, tumbling from above $24 to below $17.
A setback to the biotech or the broader off-the-shelf T-cell therapy space.