Anixa Biosciences Inc. (NASDAQ: ANIX) reported that its experimental CAR-T therapy, lira-cel, extended survival in patients with recurrent ovarian cancer, with one patient living 28 months after treatment in a Phase 1 study. The results, presented at the International Society for Cell & Gene Therapy 2026 Annual Meeting, substantially exceed the three- to four-month median expected survival for this advanced patient population.
"The updated survival observations from this ongoing Phase 1 trial continue to be encouraging, particularly given the advanced disease status and limited treatment options for patients with recurrent ovarian cancer," Amit Kumar, Chairman and Chief Executive Officer of Anixa, said. "While this remains an early-stage study, lira-cel has continued to demonstrate a favorable preliminary safety profile."
The updated data showed several patients living significantly longer than expected. Beyond the single patient who survived 28 months, three patients have survived for 18, 17, and 17 months, respectively. Four other patients have survived for 11, 11, eight, and seven months. Critically, three of the patients who reached 18, 17, and 11 months are still alive. Preliminary safety data from the first three dose cohorts showed no dose-limiting toxicities, no instances of neurotoxicity, and no significant Cytokine Release Syndrome (CRS), a common and dangerous side effect of CAR-T therapies.
For investors, the positive data provides an early but crucial proof-of-concept for Anixa’s unique therapeutic approach in a cancer with few effective treatments. The company plans to advance to a higher-dose cohort, which will also add lymphodepletion, a step designed to improve the expansion and persistence of the CAR-T cells. This next stage will be critical in determining if the promising survival signals can be amplified.
A Novel Approach to Ovarian Cancer
Lira-cel is a chimeric antigen receptor T-cell (CAR-T) therapy, a treatment that reprograms a patient's own immune T-cells to fight cancer. It targets the follicle-stimulating hormone receptor (FSHR), which is expressed on ovarian cells and tumor vasculature but not on most other healthy tissues, offering a specific target to minimize off-tumor effects.
Developed in collaboration with the Moffitt Cancer Center, Anixa's therapy uses a novel chimeric endocrine receptor-T cell (CER-T) technology. Unlike conventional CAR-T therapies that use an antibody fragment to recognize the tumor, lira-cel uses the natural follicle-stimulating hormone (FSH) ligand to bind to the FSHR on cancer cells. This may offer a different binding and activation profile. All doses in the trial have been administered directly into the peritoneal cavity, the abdominal space where ovarian cancer often recurs.
Pipeline and Investor Context
The positive lira-cel data provides a key validation point for Anixa's strategy, which relies on partnering with world-class research institutions like Moffitt and the Cleveland Clinic to develop its pipeline. Beyond lira-cel, Anixa is also developing vaccines to prevent breast and ovarian cancer, targeting "retired" proteins expressed in certain tumors.
The company's stock (ANIX) may see increased interest as the lira-cel program advances. The next major catalyst will be data from the upcoming higher-dose cohort including lymphodepletion, which could create a more favorable environment for the therapy to work. Continued positive survival and safety data would position Anixa for larger, pivotal trials and potential partnerships to bring the therapy to market, offering hope for patients with a high unmet medical need.
This article is for informational purposes only and does not constitute investment advice.
