NEW YORK – Anixa Biosciences said on Monday that the US Food and Drug Administration has cleared its investigational new drug application for an autologous, follicle stimulating hormone receptor-targeting CAR T-cell product, allowing it to begin studying the drug in late-stage ovarian cancer patients.
California-based Anixa and Moffitt Cancer Center are jointly developing the product, which is a new type of CAR T-cell therapy called chimeric endocrine receptor T-cell, or CER-T, therapy. Follicle stimulating hormone receptors are found on granulosa cells of the ovaries. Since Anixa and Moffitt's therapeutic product comprises T cells engineered to home in on FSHR, a hormone receptor, the therapy is dubbed a CER-T.
Earlier this year, the FDA put a clinical hold on Anixa and Moffitt's IND application for this product and requested additional information. The sponsors provided that information and have now received the agency's permission to proceed with human trials of the product.
"This is a major milestone for our program," Robert Wenham, Moffitt's gynecological oncology chair who will lead the product's clinical trial, said in a statement. "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."