#USA #Anixa Biosciences #CAR-T therapy #San Jose, California #Ovarian Cancer

Anixa Biosciences Advances Ovarian Cancer CAR-T Clinical Trials

Anixa Biosciences, Inc., a leading biotechnology firm listed on NASDAQ as ANIX, has recently initiated the dosing of its fourth cohort in a pioneering clinical trial focused on treating recurrent ovarian cancer via CAR-T cell therapy. This significant milestone in the company's research endeavors was announced on June 23, 2025, and marks an important step in the fight against this challenging form of cancer.

Background of the Clinical Trial

Conducted in collaboration with the esteemed Moffitt Cancer Center, under the leadership of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program, this ongoing Phase 1 clinical trial aims to evaluate the safety and efficacy of the novel chimeric antigen receptor-T cell (CAR-T) therapy. Targeting the follicle-stimulating hormone receptor (FSHR), which is specifically expressed in ovarian cells and tumor vasculature, Anixa’s unique CAR-T therapy seeks to improve treatment outcomes for patients with limited options.

The latest cohort will receive an impressive dose of three million CAR-positive cells per kilogram of body weight, which is a staggering thirtyfold increase compared to the initial dosage given to participants in the first cohort. This upward escalation in dosing was made possible after observing no dose-limiting toxicities in the previous cohort, thereby allowing for increased evaluation of the therapy's safety as well as its potential therapeutic effects.

Significance of the New Clinical Findings

Dr. Amit Kumar, Chairman and CEO of Anixa, expressed optimism regarding the trial's progress. He elaborated that while the key focus remains on safety, emerging data has also revealed promising signs of efficacy as the trial advances into higher dosage levels. The expectation is that the escalating doses will continue to shed light on both the safety profile and effectiveness of the therapy as more data accumulates from ongoing participant monitoring.

This clinical study primarily enrolls adult women diagnosed with recurrent ovarian cancer that has persisted despite multiple previous treatment attempts. Its structure is designed not only to rigorously assess safety but also to identify the maximum tolerated dose, a crucial factor in the management of any cancer treatment regimen.

Innovative Technology Behind the Treatment

The CAR-T technology employed by Anixa uses a first-of-its-kind approach known as chimeric endocrine receptor-T cell (CER-T) technology. This innovative method distinguishes itself by utilizing the natural ligand of the FSHR receptor — FSH — to target cancer cells, as opposed to conventional methods which often rely on antibody fragments.

Anixa’s collaboration with Moffitt Cancer Center brings together leading experts in cancer therapy, known for developing next-generation cell therapies, including CAR-T treatments and tumor infiltrating lymphocytes (TILs). This partnership not only enhances the trial’s breadth and credibility but also positions Anixa at the forefront of generating cutting-edge cancer treatment solutions.

Broader Cancer Focus and Future Aspirations

Aside from its ovarian cancer initiatives, Anixa is actively developing a robust vaccine portfolio, including collaborations with the prestigious Cleveland Clinic aimed at combating breast cancer and other aggressive malignancies. These developments focus on cultivating immune responses against specific cancer-related proteins, paving the road for potentially life-saving interventions in the oncology space.

In conclusion, as Anixa Biosciences embarks on this crucial phase of its clinical trial, the company continues to embody innovation and resilience in oncology through collaborative partnerships and groundbreaking therapeutic strategies. Industry stakeholders and cancer advocates alike are now awaiting further updates on the trial's results and advancements in CAR-T therapies for ovarian cancer.