On September 8, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported it has completed dosing of the fourth cohort in its ongoing Phase 1 clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T/CER-T therapy for recurrent ovarian cancer (Press release, Anixa Biosciences, SEP 8, 2025, View Source [SID1234655841]). The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt"). The fifth cohort is expected to commence following a routine 30-day safety verification that no adverse effects have been observed in the fourth cohort.
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To date several treated patients remain alive beyond disease-specific median survival benchmarks. Notably, one patient from the 1st cohort remains alive 28 months post-treatment. These observations are preliminary and from a small number of patients and dose levels.
The fourth cohort in the trial received 3×10⁶ CAR-positive cells per kilogram of body weight—approximately a 30-fold increase versus the first cohort (1×10⁵ cells/kg). No dose-limiting toxicities (DLTs) have been observed to date in the fourth cohort. Pending safety review, the fifth cohort is planned at approximately 1×10⁷ cells/kg.
Anixa’s FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. This first-in-human trial is enrolling adult women with recurrent ovarian cancer who have progressed following at least two prior therapies and is designed to evaluate safety, identify the maximum tolerated dose, and explore preliminary signals of activity.
Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "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. 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 Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. The ongoing clinical trial is being conducted at Moffitt under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program. Anixa holds an exclusive worldwide license to the FSHR-targeting CAR-T technology from The Wistar Institute.