Anixa Biosciences announced today that it will present data from its Phase 1 clinical trial of a novel CAR-T cell therapy for recurrent ovarian cancer at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3, 2025, in Chicago.
The presentation will showcase Anixa's innovative chimeric endocrine receptor-T cell (CER-T) technology, which targets the follicle-stimulating hormone receptor (FSHR) expressed on ovarian cancer cells. Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center and principal investigator of the trial, will lead the poster presentation scheduled for June 2.
"Our approach represents a significant departure from conventional CAR-T therapies," said Dr. Pamela D. Garzone, Chief Development Officer at Anixa Biosciences. "By targeting the FSHR receptor with its natural ligand rather than an antibody fragment, we believe our technology may overcome some of the challenges that have limited CAR-T efficacy in solid tumors."
Innovative Mechanism of Action
The CER-T technology developed by Anixa in collaboration with Moffitt Cancer Center uses a novel mechanism that distinguishes it from traditional CAR-T approaches. While conventional CAR-T therapies typically rely on antibody fragments to recognize cancer cells, Anixa's technology employs the natural ligand of the FSHR receptor—follicle-stimulating hormone (FSH)—to bind to ovarian cancer cells.
This approach may offer several advantages, including potentially improved tumor penetration and reduced off-target effects. FSHR is expressed at high levels in ovarian cancer cells but has limited expression in normal tissues, making it an attractive target for immunotherapy.
Clinical Trial Design and Progress
The Phase 1 trial (Abstract ID: TPS2682) is evaluating the safety and preliminary efficacy of autologous T-cells genetically engineered to target FSHR in patients with recurrent ovarian cancer. The study is being conducted at Moffitt Cancer Center, a recognized leader in cancer immunotherapy research.
Ovarian cancer represents a significant unmet medical need, with approximately 20,000 new cases diagnosed annually in the United States. Despite advances in treatment, the five-year survival rate for advanced ovarian cancer remains below 50%, highlighting the urgent need for novel therapeutic approaches.
Expanding Immunotherapy Portfolio
In addition to its ovarian cancer program, Anixa is developing several other innovative cancer therapies. The company's vaccine portfolio includes candidates for breast cancer, ovarian cancer, and other high-incidence malignancies, developed in collaboration with Cleveland Clinic.
"Our business model centers on strategic partnerships with world-class research institutions," said Dr. Amit Kumar, Chairman and CEO of Anixa, who will also be presenting an overview of the company's cancer treatment programs at the upcoming CAGLA NeauxCancer Conference on March 28, 2025, in New Orleans. "These collaborations allow us to advance cutting-edge technologies while maintaining a lean operational structure."
Market Impact and Future Directions
The CAR-T therapy market is projected to grow significantly in the coming years, with increasing focus on extending this technology to solid tumors. While CAR-T therapies have shown remarkable success in hematological malignancies, their application to solid tumors like ovarian cancer has been challenging.
If successful, Anixa's approach could represent a significant advancement in the field. The company's stock (NASDAQ: ANIX) has shown increased trading activity following the announcement of the ASCO presentation.
"The presentation at ASCO provides an important opportunity to share our progress with the oncology community," noted Mike Catelani, President, COO & CFO of Anixa. "We look forward to discussing our findings and their potential implications for patients with recurrent ovarian cancer."
The ASCO Annual Meeting represents one of the most significant gatherings of oncology professionals worldwide, with over 40,000 attendees expected at the 2025 event. The poster session on "Developmental Therapeutics—Immunotherapy" will take place on June 2, 2025, from 1:30 PM to 4:30 PM CT.
