Anixa Biosciences Completes Dosing in Fourth Ovarian Cancer CAR-T Trial Cohort

SAN JOSE-September 08, 2025– Anixa Biosciences, a biotechnology company focused on cancer treatment and prevention, has completed dosing of the fourth patient cohort in its Phase 1 clinical trial for a novel CAR-T/CER-T therapy targeting recurrent ovarian cancer. The study is being conducted in partnership with Moffitt Cancer Center. The fifth cohort is expected to begin after a standard 30-day safety review.

To date, several patients treated in the trial have survived beyond disease-specific median survival benchmarks. Notably, a patient from the first cohort is still alive 28 months after treatment. However, officials noted these are preliminary observations from a small number of patients and dose levels.

The fourth cohort received a dose of 3×10⁶ CAR-positive cells per kilogram of body weight, which is roughly a 30-fold increase over the first cohort’s dose. No dose-limiting toxicities (DLTs) have been observed in this cohort so far. The fifth cohort is planned at a higher dose of approximately 1×10⁷ cells/kg, pending safety review.

The therapy, known as FSHR-mediated CAR-T, is designed to target the follicle-stimulating hormone receptor (FSHR), a protein that is found on ovarian cells, tumor vasculature, and certain cancer cells. The trial is enrolling adult women with recurrent ovarian cancer who have progressed after at least two previous therapies. Its primary goals are to evaluate safety, determine the maximum tolerated dose, and look for early signs of therapeutic activity.

“With the completion of the fourth cohort, we are gaining important insights into the potential of our CAR-T therapy for ovarian cancer at higher dose levels,” said Dr. Amit Kumar, Chairman and CEO of Anixa. “While this study is primarily designed to assess safety, we are encouraged by the early indications of potential efficacy and look forward to initiating the next dose cohort following the standard safety review.”

Anixa’s CAR-T technology was invented by Dr. Jose R. Conejo-Garcia of Duke University School of Medicine. The clinical trial is led by Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt. Anixa holds an exclusive worldwide license for the technology from The Wistar Institute.