Precision BioSciences Inc (DTIL)

[MI Dendream]

Looks as though the entire gene editing market took a hit with the news of Allogene’s HOLD for their Car-T program…I am not certain this is a bad thing at all for Precision Biosciences. Time will tell but this could be a process specific issue.

After the U.S. Food and Drug Administration (FDA) ordered to hold the clinical-stage biotechnology company’s AlloCAR T clinical trials. Notably, the company develops allogeneic CAR T (AlloCAR T) therapies for cancer.

The U.S. regulator’s decision followed a report of a chromosomal abnormality in ALLO-501A CAR T cells in a patient, who was treated in the ALPHA2 study. The abnormality was detected in a bone marrow biopsy that was undertaken to assess pancytopenia (low blood counts). Notably, an investigation is in progress to detect further implications, if any.

Following discussions with the FDA, the company is likely to provide additional updates. Markedly, the end of Phase 1 materials, which were submitted in anticipation of an ALLO-501A pivotal Phase 2 trial, is under the FDA’s review.

Balanced chromosomal abnormalities can be due to insertions or deletions of genes. This could be a misfire that is known to occur more often with CRSPR process. The anemia may be an autoimmune reaction triggered by the anomaly. ARCUS may be a safer play when it comes to these types of risks.