Anixa Biosciences and Moffitt Cancer Center Report US FDA Request of Additional Information for CAR-T Therapy

On April 19, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Food and Drug Administration (US FDA) has requested additional information regarding its Chimeric Antigen Receptor-T cell therapy (CAR-T) being developed in partnership with Moffitt Cancer Center (MCC) (Press release, Anixa Biosciences, APR 19, 2021, View Source [SID1234578176]).

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The study under the Investigational New Drug (IND) application has been placed on clinical hold pending submission of additional information requested by the FDA. Within the next 30 days, it is expected that the FDA will provide a letter to MCC with detailed and specific information requested. MCC will assemble and submit information addressing the request as soon as possible thereafter. Successive to the submission, the FDA will continue its review of the IND.

This technology is an autologous cell therapy that requires the manufacture of a unique drug product for each individual patient. The therapeutic product is comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunological levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.

Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated, "We are eagerly awaiting guidance from the FDA with details about the specific information requested to clear the IND, enabling initiation of clinical trials."