On May 21, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported that treatment has commenced for the fifth patient in its ongoing Phase 1 clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, MAY 21, 2024, View Source [SID1234643481]). The study is being conducted through a research partnership with Moffitt Cancer Center.
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Anixa’s first-in-human trial (NCT05316129) is enrolling female adult patients with recurrent/progressing ovarian cancer who were unresponsive to at least two prior therapies. Safety was confirmed in the first three-patient cohort. The patients in the second cohort, including patient #5, receive triple the dose of engineered T-cells compared with the first cohort of three patients. The study will identify the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR), found only on ovarian cells
"With our fifth patient treated, our trial is progressing, and we continue to see that our therapy appears to be safe and well-tolerated," said Dr. Amit Kumar, Chairman and CEO of Anixa. "The technology behind our novel CAR-T therapy differs from traditional CAR-T therapies by targeting the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females. We developed this approach to tackle preexisting difficulties with CAR-T cell therapies in solid ovarian tumors. In our trial, we will also explore several parameters for applying our CAR-T therapy to solid tumors in general."
Anixa’s FSHR-mediated CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.
About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.