Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that it has completed dosing of the fifth cohort in its ongoing Phase 1, dose-escalating, clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. The study is being conducted at Moffitt Cancer Center ("Moffitt"). The sixth cohort is expected to commence following a routine 30-day safety verification that no adverse effects have been observed in the fifth cohort.

The Phase 1 study is evaluating a novel CAR-T therapy targeting follicle stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells but has limited expression in healthy tissues. The trial is designed to assess safety, tolerability, and preliminary signs of efficacy across escalating dose levels.

The patients in the fifth cohort received a dose of 1×10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed across any cohort.

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