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Anixa Biosciences and Moffitt Cancer Center Announce FDA Clearance to Initiate Clinical Trial of Ovarian Cancer CAR-T Immunotherapy
SAN JOSE, Calif., Aug. 30, 2021 /PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of
About this update from Anixa Biosciences, Inc.
[{"type":"text","content":"SAN JOSE, Calif., Aug. 30, 2021 /PRNewswire/ -- Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its CAR-T (Chimeric Antigen Receptor-T cell) therapy, which is being developed in partnership with Moffitt Cancer Center (Moffitt).\n\n \n \n \n \n \n \n\n \nDr. Robert Wenham, Chair of Gynecological Oncology at Moffitt will lead the clinical trial. This CAR-T therapy was developed by Dr. Jose Conejo-Garcia and his research team, when he was at the Wistar Institute. Dr. Conejo-Garcia is currently the Chairman of Immunology at Moffitt. Anixa Biosciences has an exclusive worldwide license to the technology. This technology is an autologous cell therapy. The therapeutic product is 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 receptor, and the target-binding domain is derived from its natural ligand, 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 stated, \"We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting therapy. Outcomes for women with late-stage ovarian cancer are poor, so if this approach demonstrates efficacy, it would have a dramatic impact on patients for whom there are no other options.\"\n\"This is a major milestone for our program. CAR-T therapy has had major successes in B-cell malignancies, but no clinical success in other types of tumors. We feel that our technology could be the first CAR-T approach that will demonstrate efficacy in a solid tumor indication, and we are looking forward to testing and verifying that assertion in human trials,\" said Dr. Wenham.\nIn addition to Drs. Wenham and Conejo-Garcia, other key members of the team at Moffitt include: \nDr. Marco Davila, Clinician and Director of the Cell Therapy Facility at Moffitt Dr. Daniel Abate Daga, Assistant Director of the Cell Therapy Facility at Moffitt Dr. Ana Marie Landin, Experimental Cell Therapy Manager...