Anixa Biosciences Announces Treatment of First Patient in its Ovarian Cancer CAR-T Clinical Trial

Anixa Biosciences, Inc. (NASDAQ: ANIX) (“Anixa”) a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, today announced that, in conjunction with its partner Moffitt Cancer Center, it has commenced treatment of the first patient in the clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer.

The study is a dose-escalation Phase 1 trial to determine safety and the maximum tolerated dose of follicle stimulating hormone receptor T-cells and to preliminarily assess efficacy.  The study is being conducted at Moffitt Cancer Center and will consist of up to 48 patients.

The CAR-T approach used for Anixa’s therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs a specific antigen to recognize that is only present on target cancer cells in order to avoid negatively affecting healthy cells. The CER-T therapy being evaluated in Anixa’s Phase 1 study differs from traditional CAR-T in that it targets the follicle stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells in healthy adult females.

“We are pleased that the first patient has been treated in our ovarian cancer CAR-T clinical study,” stated Amit Kumar, Ph.D., Chairman and CEO of Anixa Biosciences. “This is truly an exciting time for Anixa, as we have now begun treating patients in our second clinical trial. With our CAR-T study, we hope to determine whether our unique targeting approach will work in solid tumors—a difficult challenge for traditional CAR-T therapies.”

Robert Wenham, M.D., MS, FACOG, FACS, the trial’s lead investigator and Chair of the Department of Gynecologic Oncology at Moffitt Cancer Center, added, “With limited treatment options for recurrent, chemo-resistant ovarian cancer, I am hopeful that this program can provide a unique opportunity to make a meaningful impact on patients of this devastating disease.”

Jose R. Conejo-Garcia, M.D., Ph.D., Chair of the Department of Immunology at Moffitt Cancer Center and co-inventor of the CER-T technology, added, “It is exciting to see our novel FSHR-mediated CAR-T technology reaching patients, and if our unique CAR-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types.”

Dr. Conejo-Garcia and his research team developed the FSHR-mediated CAR-T technology when he was at the Wistar Institute where he contributed to report for the first time on the role of T-cell responses in the outcome of ovarian cancer patients.  The clinical trial being conducted today is based on this pre-clinical work, originally published in Clinical Cancer Research. Anixa has an exclusive, world-wide license to this technology.