Anixa Biosciences announced an IND (Investigational New Drug) application for its ovarian cancer CAR-T (Chimeric Antigen Receptor T-cell) therapy has been filed with the U.S. Food and Drug Administration (FDA).

This CAR-T therapy was invented by a team led by Dr. Jose Conejo-Garcia, while he was at the Wistar Institute. Dr. Conejo-Garcia is currently Chair of the Department of Immunology at Moffitt Cancer Center (MCC), where the IND enabling studies were performed, and where the clinical trial will be conducted, under the leadership of Dr. Robert Wenham, Chair of Gynecological Oncology at MCC. Anixa has worldwide, exclusive commercial license to the technology.

The technology targets the follicle stimulating hormone receptor (FSHR) with engineered T-cells that use the follicle stimulating hormone as a homing mechanism. 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.

"We are pleased to file this IND application, since women who have recurrent ovarian cancer have very few options. We hope the work of our scientific and clinical team at Anixa and MCC yields results that will address a critical unmet medical need," Dr. Wenham said.

"We are looking forward to the response from the FDA, and to eventually testing this therapy in humans," said Dr. Conejo-Garcia. "This is a very high-profile program at MCC, as we believe this could be the first CAR-T therapy that has the potential to achieve clinical success in a solid tumor indication."

"This IND application is a major milestone for Anixa and our partners at MCC," said Dr. Amit Kumar, President and CEO of Anixa Biosciences. "This is our second IND application filed within the last few months. Upon clearance from the FDA and commencement of the trial, we expect to have two programs in the clinic."