Anixa Biosciences and Moffitt Cancer Center Receive Additional Information Request from US FDA for CAR-T IND Application

On May 20, 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 provided details of the additional information it is requesting regarding its Chimeric Antigen Receptor-T cell therapy (CAR-T) being developed in partnership with Moffitt Cancer Center (Press release, Anixa Biosciences, MAY 20, 2021, View Source [SID1234580336]).

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The Investigational New Drug (IND) application for this study was submitted in March, and the US FDA subsequently requested additional information before approving the trial. The details of that information request have now been provided by the FDA. Anixa and Moffitt feel that the requested information can be assembled and provided to the FDA within approximately 30 days, after which the FDA will again respond within 30 days after the submission.

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 pleased to receive this letter with the detailed information request. While we hope to comply with the request within 30 days, certain assays may require additional time for validation before submission. We will strive to file our submission as soon as possible and we will seek to initiate this clinical trial before the end of the year."