Anixa's CAR-T Therapy for Ovarian Cancer Earns FDA IND Approval

The FDA approved a second dose of CAR-T therapy for ovarian cancer developed by Anixa Biosciences following promising initial results. This therapy, which has shown potential in reducing tumor size and enhancing immune response, offers new hope for patients with advanced ovarian cancer who have exhausted other treatment options.

Anixa Biosciences, in collaboration with Moffitt Cancer Center, has announced that the US Food and Drug Administration (FDA) has approved a second dose of their pioneering CAR-T therapy, for ovarian cancer under an individual patient Investigational New Drug (IND) application. This approval, prompted by promising results from the initial treatment, includes significant findings such as tumor marker reductions and histological improvements suggesting an immune response.

Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt and the trial’s principal investigator, highlighted these outcomes which, despite initial tumor enlargement, have shown sustained disease control in a patient with no other treatment options.

Encouraged by these findings, the team secured FDA approval to administer a second treatment dose aimed at enhancing the patient's response, which could range from partial to complete remission.  

Dr. Amit Kumar, CEO of Anixa Biosciences, expressed optimism about the early indications of the therapy's effectiveness, which could represent a substantial advancement in treating a notoriously difficult cancer type. "We were somewhat surprised and quite encouraged to see such a notable response this early, given the low dose in the first cohort. We truly hope we can help this patient, as well as all other women fighting this terrible disease," he commented.

The ongoing trial focuses on patients with recurrent ovarian cancer who have not responded to standard therapies. With six patients already treated across two different dosing cohorts, the trial will proceed with dose escalation to ensure safety before increasing the dosage further.

Anixa Biosciences, a clinical-stage biotechnology firm, is developing innovative immunotherapies and vaccines. In partnership with Moffitt Cancer Center, Anixa is pioneering a novel form of CAR-T therapy known as Chimeric Endocrine Receptor T-cell (CER-T) technology. The company’s extensive research portfolio also includes preventative vaccines against triple-negative breast cancer and other forms of cancer, developed in collaboration with Cleveland Clinic.