Anixa Biosciences Treats Sixth Ovarian Cancer CAR-T Patient

Anixa Biosciences, Inc., a company specializing in cancer treatment and prevention, recently announced the treatment of the sixth patient in its ongoing Phase 1 clinical trial for a novel chimeric antigen receptor T-cell (CAR-T) therapy targeting ovarian cancer. This patient is anticipated to be the final one in the second dosage cohort of the trial, carried out in partnership with Moffitt Cancer Center. If the second cohort participants continue to experience no adverse effects, the third dosage cohort may begin within the next month.

Anixa’s CAR-T technology, known as chimeric endocrine receptor T-cell (CER-T), is designed to target the follicle-stimulating hormone receptor (FSHR). Notably, FSHR is uniquely expressed on ovarian cells, including tumor vasculature. This first-in-human trial (NCT05316129) involves female adult patients with recurrent or progressing ovarian cancer who have undergone at least two prior therapies. The trial's primary objectives are to evaluate safety and determine the maximum tolerated dose, while also monitoring the therapy's efficacy.

The first three-patient cohort confirmed the therapy's safety. In the second cohort, the fourth through sixth patients received triple the initial dose of CAR-T cells, with no dose-limiting toxicities observed. Following a month-long waiting period to confirm safety, the trial plans to commence enrolling patients in the third dose cohort, which will administer a dose ten times higher than the initial one.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, expressed optimism about the observed safety profile in both the first and second cohorts. He highlighted a notable response in one of the first cohort patients, despite the dosage being considered subtherapeutic. Dr. Kumar conveyed the company’s aim to maintain a positive safety profile while escalating doses to demonstrate additional objective evidence of efficacy. Unlike conventional CAR-T therapies, which have been highly effective in hematological cancers but not in solid tumors, Anixa’s technology shows promise for ovarian cancer and potentially other solid tumors. The targeted CER-T approach aims to attack tumor vasculature and ovarian cells directly by focusing on the FSHR, which is exclusively found on ovarian cells.

Dr. Kumar further emphasized the potential benefits of intraperitoneal (IP) delivery of the CAR-T cells, which allows direct trafficking to tumor sites, minimizing side effects such as cytokine release syndrome (CRS). This delivery method not only enhances tumor targeting but also improves the overall safety profile of the treatment. Anixa anticipates that IP delivery may enable the use of higher dosages than would be possible with intravenous delivery.

Anixa Biosciences, Inc. is a clinical-stage biotechnology company dedicated to cancer treatment and prevention. The company's therapeutic portfolio includes an ovarian cancer immunotherapy program developed with Moffitt Cancer Center, using the innovative CER-T technology. Additionally, Anixa is working on vaccines in collaboration with Cleveland Clinic to prevent breast cancer, particularly triple-negative breast cancer (TNBC), and ovarian cancer. The company’s vaccine technologies aim to immunize against "retired" proteins that are expressed in certain cancers. Anixa’s unique business model involves partnering with eminent research institutions at all development stages, allowing the company to explore and commercialize emerging technologies.