Fourth cohort dose is three million CAR positive cells; thirty times higher than the first cohort dose
SAN JOSE, Calif., June 23, 2025 /PRNewswire/ -- 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 dosed its first patient in the fourth dosage cohort in the ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer. The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt") under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt, the principal investigator.
The fourth cohort in the trial will receive a dose of three million CAR-positive cells per kilogram of body weight, representing a thirtyfold increase from the first cohort. No dose-limiting toxicities were observed in the third cohort, enabling advancing to the fourth dosage cohort. This planned escalation marks a key step in assessing the safety and therapeutic effect of CAR-T cell therapy in patients with ovarian cancer.
Anixa's FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is 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 after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy.
Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With no dose-limiting safety issues observed in the third cohort, we have advanced to a higher dose level that is thirty times greater than the starting dose. Although the study is primarily focused on safety at these early, low-dose levels, we have seen promising signs of potential efficacy. "
About Anixa Biosciences, Inc.
Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of an ovarian cancer immunotherapy program being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on Twitter, LinkedIn, Facebook and YouTube.
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SOURCE Anixa Biosciences, Inc.
