FDA slaps a hold on Moffitt’s next-gen CAR-T as regulators demand another delay on clinical work — shares crater
Close to a year-and-a-half after tapping the brakes on one of its preclinical programs to do some added genetic engineering work on their next-gen CAR-T, Anixa $ANIX Therapeutics says the regulatory light is flashing red on their IND.
The San Jose, CA-based biotech — which changed its name from ITUS in 2018 — explained in late 2019 that they were taking a knee for at least a year so that researchers could go back and amp up the expression of follicle stimulating hormone on T cells to improve targeting of the FSH receptor on a specific set of ovarian cells. That required new vector engineering work by their partners at Moffitt Cancer Center.
The work, though, has evidently spurred questions at the FDA, which slapped a clinical hold on the program, the biotech announced Monday morning.
Their shares plunged 28% on the news.
According to Anixa:
The study under the Investigational New Drug application has been placed on clinical hold pending submission of additional information requested by the FDA. Within the next 30 days, it is expected that the FDA will provide a letter to MCC with detailed and specific information requested. MCC will assemble and submit information addressing the request as soon as possible thereafter. Successive to the submission, the FDA will continue its review of the IND.
Jose Conejo-Garcia, the chair of the department of immunology at Moffitt, is credited as the chief inventor of the CAR-T tech that Anixa is using.
Social: Moffitt Cancer Center website