Anixa Biosciences (NASDAQ: ANIX) announced that the first patient has been treated in the fifth cohort of its ongoing Phase 1 clinical trial evaluating an FSHR-targeted CAR-T therapy for recurrent ovarian cancer, conducted at Moffitt Cancer Center.

The patient received a dose of 1×10⁷ CAR-positive cells per kilogram following lymphodepletion, the highest dose level evaluated in the study to date. No dose-limiting toxicities have been observed across any cohort through the prior dose level of 3×10⁶/kg CAR-T cells.

According to the company's press release, five patients in the trial have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 20, 17, 17, and 13 months post-treatment. The trial enrolls adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

The therapy, known as liraltagene autoleucel or lira-cel, targets the follicle-stimulating hormone receptor (FSHR), which the company states is expressed on ovarian cancer cells but has limited expression in healthy tissues.

Amit Kumar, chairman and CEO of Anixa Biosciences, said in the release: "Advancing to the fifth cohort and highest dose level while observing no dose-limiting toxicities across the study to date is a meaningful milestone for the program."

The Phase 1 trial is primarily designed to evaluate safety and tolerability, with preliminary efficacy signals also being assessed across escalating dose levels. The study is registered on ClinicalTrials.gov under identifier NCT05316129.