Anixa's Novel CAR-T Therapy Gains Momentum in Fight Against Ovarian Cancer

NEW YORK, NY – November 17, 2025 – Anixa Biosciences has received a significant boost in its quest to address a critical unmet need in ovarian cancer treatment. The World Health Organization (WHO) has approved ‘liraltagene autoleucel’ (or ‘lira-cel’) as the International Nonproprietary Name (INN) for the company’s FSHR-targeted CAR-T therapy. This recognition not only streamlines future regulatory processes but also underscores the potential of this innovative approach in the fight against recurrent ovarian cancer.

Pioneering a New Approach to CAR-T Therapy

CAR-T cell therapy has revolutionized cancer treatment, particularly in hematological malignancies. However, extending its success to solid tumors like ovarian cancer has proven challenging. Anixa’s ‘liraltagene autoleucel’ aims to overcome these hurdles through a unique design. Unlike traditional CAR-T therapies that rely on antibody fragments to recognize tumor antigens, Anixa’s approach utilizes the natural ligand of the Follicle-Stimulating Hormone Receptor (FSHR). This receptor is expressed on ovarian cancer cells, tumor vasculature, and, crucially, has limited expression on healthy tissues, potentially minimizing off-target effects.

“The FSHR-targeting approach is a compelling one,” says an anonymous oncology expert. “By leveraging a natural ligand, they’re potentially enhancing specificity and reducing the risk of immune-related toxicities, which is a major concern with CAR-T in solid tumors.”

This strategy, known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, is currently undergoing a Phase 1 clinical trial at Moffitt Cancer Center. Preliminary data has shown promising safety profiles and early signs of efficacy, with some patients demonstrating prolonged survival beyond established benchmarks. The company recently announced positive results from the fourth cohort of the trial, showing no dose-limiting toxicities and warranting further investigation.

Navigating the Ovarian Cancer Treatment Landscape

Ovarian cancer is often diagnosed at a late stage, making treatment challenging. While initial treatment with surgery and platinum-based chemotherapy can be effective, most patients experience recurrence. Currently, treatment options for recurrent disease are limited, with many patients failing to respond to chemotherapy. “There's a desperate need for new therapies that can overcome chemoresistance and provide durable responses,” a leading gynecologic oncologist commented anonymously. “The existing treatments are often only palliative.”

The current standard of care for patients with platinum-resistant recurrence is often limited to single-agent chemotherapy or palliative care. Novel therapies, such as PARP inhibitors and antibody-drug conjugates, are emerging, but are not effective for all patients. This unmet need has fueled research into innovative approaches, including immunotherapies like CAR-T cell therapy. Anixa's therapy has the potential to address this crucial gap by targeting a unique antigen and offering a personalized treatment option. The WHO approval of 'liraltagene autoleucel' is therefore a step forward in providing novel treatments for patients with limited options.

Commercialization and Future Prospects

The INN approval from the WHO is a crucial regulatory milestone that paves the way for further clinical development and potential commercialization. “It streamlines the regulatory process and provides a universally recognized name for the therapy,” explains a regulatory affairs consultant. “This facilitates communication with regulatory agencies worldwide and simplifies future submissions.”

Anixa Biosciences is actively collaborating with Moffitt Cancer Center to advance ‘liraltagene autoleucel’ through clinical trials and prepare for potential commercial launch. The company has also established a strategic partnership with Cleveland Clinic to develop cancer vaccines, further diversifying its pipeline. Investors are watching closely, as successful commercialization of this innovative therapy could generate significant revenue. Anixa is also exploring manufacturing options to ensure scalability and cost-effectiveness. The company hopes to initiate further clinical trials and potentially expand the therapy to other solid tumor indications if the results continue to be promising.

“The company is navigating the complex landscape of cell therapy development with a clear vision,” notes an analyst. “The WHO approval is a significant validation of their technology and a positive signal for investors.”

The company also continues to work on strengthening its intellectual property portfolio to protect its innovative technologies and maintain a competitive advantage in the rapidly evolving field of cancer immunotherapy. The novel manufacturing approach for the CER-T therapy could also allow for lower costs and quicker turnaround times for treatment, which would allow for a wider patient population to benefit.