Anixa Biosciences and Moffitt Cancer Center Advance Ovarian Cancer CAR-T Clinical Trial to Highest Dose Level to Date

Anixa Biosciences, Inc. has announced that the first patient has been treated in the fifth cohort of its ongoing Phase 1 clinical trial evaluating its FSHR-targeted CAR-T/CER-T therapy for recurrent ovarian cancer. The trial is being conducted at Moffitt Cancer Center.

The Phase 1 study is designed to assess the safety, tolerability, and preliminary signs of efficacy of the therapy, which targets the follicle stimulating hormone receptor (FSHR) found on ovarian cancer cells. The patient in this cohort received a dose of 1×10⁷ CAR-positive cells/kg following lymphodepletion, marking the highest dose level tested so far in the study. No dose-limiting toxicities have been observed across any cohort up to the previous dose level of 3x10⁶ CAR-T cells.

As of the latest update, five patients in the study have survived more than one year after treatment, with survival times of approximately 28, 20, 17, 17, and 13 months. The company considers these results significant, particularly given the historically poor prognosis and limited treatment options for patients with recurrent ovarian cancer who have undergone multiple prior therapies.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, highlighted the advancement to the fifth cohort and the absence of dose-limiting toxicities as a meaningful milestone. He noted the seriousness of ovarian cancer and the challenges faced by patients with recurrent disease.

The ongoing Phase 1 trial is enrolling adult women who have experienced recurrence of ovarian cancer after receiving at least two previous therapies. Anixa's CAR-T therapy, known as liraltagene autoleucel (lira-cel), uniquely targets FSHR, which is selectively expressed on ovarian tumor cells and certain cancer cells. The company aims to further evaluate this novel therapy as enrollment continues.