Moffit Cancer Center, Anixa Biosciences File IND Application for CAR-T Therapy

An investigational new drug (IND) application has been filed with the US FDA by Anixa Biosciences and Moffit Cancer Center (MCC) for ovarian cancer CAR-T (Chimeric Antigen Receptor T-cell) therapy. CAR-T therapy was invented by a team led by Jose Conejo-Garcia, MD, PhD, currently Chair of the Department of Immunology at MCC, while he was at the Wistar Institute. The clinical trial will be conducted at MCC under the leadership of Robert Wenham, MD, Chair of Gynecological Oncology.

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,” says Dr. Wenham. 

"This IND application is a major milestone for Anixa and our partners at MCC," states Amit Kumar, PhD, 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."