Anixa Biosciences Initiates Second Ovarian Cancer CAR-T Trial Dosing

Anixa Biosciences, Inc., a clinical technology company focused on treating and preventing cancer, announced that it has started treatment for the fourth patient in its Phase 1 clinical trial of its novel T cell chimeric antigen receptor (CAR-T)   Treatment of ovarian cancer. This study is being conducted in collaboration with the Moffitt Cancer Center.

This first-in-human clinical trial is enrolling patients with relapsed/refractory ovarian cancer that has progressed on at least two prior lines of therapy. CAR T was safe and effective in the first three patients treated. The fourth patient, the first patient in the second group, received three times the dose of CAR-T cells compared to the first group. Anixaands Follicle Stimulating Hormone Receptor (FSHR)-mediated CAR-T technology, also known as chimeric endocrine receptor T-cell (CER-T), differs from traditional CAR-T therapy by targeting FSHR, which research indicates is expressed on ovarian cells, as well as in the vasculature of tumors.

Dr. Amit Kumar, chairman and CEO of Anixa, commented, With no safety issues observed in the first cohort of patients, we have successfully advanced to the next cohort to evaluate a 3x higher dose. As the trial progresses, we seek to demonstrate the efficacy of our cell therapy in solid tumors—a difficult challenge for traditional CAR-T therapies that are efficacious in hematological tumors and lymphoma.

Dr. Robert Wenham, the Principal Investigator of the trial and the Chair of Gynecologic Oncology at Moffitt, stated, First, we have the advantage of a target that is much more specific to our tumor tissue, which should minimize any on-target, off-tumor effect. Additionally, we are administering the engineered T-cells directly into the peritoneum (IP), which is the location of most of the ovarian tumor lesions. We hope this delivery approach will enable direct trafficking of the CER-T-cells to the tumor sites and minimize adverse events such as cytokine release syndrome (CRS).

Anixachimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy consisting of engineered T cells that target the follicle-stimulating hormone receptor (FSHR). FSHR is only found at immunologically relevant levels in ovarian granulosa cells. Since the target is a chimeric endocrine receptor and the target binding domain is derived from a natural ligand, this technology is known as CER-T (chimeric endocrine receptor T cell), a new form of CAR-T.

Anixa is a biotechnology company focused on the treatment and prevention of cancer. Anixaand's therapeutic portfolio includes an ovarian cancer treatment program developed in collaboration with the Moffitt Cancer Center using a new type of CAR-T known as chimeric endocrine receptor T-cell technology (CER-T).