Anixa Biosciences: Pioneering CAR-T Therapy for Ovarian Cancer

Anixa Biosciences, a clinical-stage biotechnology company focused on cancer treatment and prevention, has initiated dosing in the third cohort of its Phase 1 clinical trial for recurrent ovarian cancer using a novel chimeric antigen receptor T-cell (CAR-T) therapy. This significant milestone marks a step forward in the fight against ovarian cancer, a challenging area for traditional CAR-T therapies.

The trial, conducted in collaboration with Moffitt Cancer Center, is evaluating the safety and efficacy of Anixa's FSHR-mediated CAR-T technology, which targets the follicle-stimulating hormone receptor (FSHR) exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed on at least two prior therapies.

The escalating doses in the trial, from the initial cohort to the third cohort (a tenfold increase), suggest a safe and tolerable profile, with no dose-limiting toxicity observed in the first two cohorts. The relative stability and mild improvement seen in one patient from the first cohort, along with necrosis and T cell infiltration in a tumor biopsy, are encouraging signs of efficacy. As the trial progresses, the potential for higher cell doses to increase efficacy and improve response rates and durability becomes more apparent.

The initiation of the third cohort in Anixa Biosciences' ovarian cancer CAR-T clinical trial marks a significant milestone in the exploration of CAR-T therapies in solid tumors. The trial's design, targeting the follicle-stimulating hormone receptor (FSHR), offers a novel approach to CAR-T therapy, potentially addressing preexisting difficulties in treating solid ovarian tumors. The absence of dose-limiting toxicity in the first two cohorts and the stability of one patient for over a year indicate the therapy's safety and potential efficacy.

If the trial continues to demonstrate positive results, it could pave the way for broader application of CAR-T therapies in solid tumors, revolutionizing cancer treatment. However, long-term implications depend on further clinical data and regulatory approval.



In conclusion, Anixa Biosciences' Phase 1 clinical trial of its novel CAR-T therapy for recurrent ovarian cancer is a promising development in the fight against this challenging disease. The trial's strategic dose escalation approach, targeting the follicle-stimulating hormone receptor (FSHR), offers hope for improved efficacy and safety in solid tumors. As the trial progresses, investors and the scientific community eagerly await further data on the potential of this innovative therapy.