Anixa Reports Updated Survival Observations from Phase 1 Lira-Cel CAR-T Trial in Recurrent Ovarian Cancer

May 11, 2026-

Anixa Biosciences announced updated positive survival observations from its ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, an investigational FSHR-targeted CAR-T therapy being developed for recurrent ovarian cancer. The data were presented at the International Society for Cell & Gene Therapy 2026 Annual Meeting.

Lira-cel is an autologous CAR-T therapy designed to target the follicle-stimulating hormone receptor, or FSHR. Anixa believes FSHR represents a differentiated target in ovarian cancer because it is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, while being absent from most healthy tissues. The ongoing Phase 1 trial is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies.

According to the update, several participants treated with lira-cel have survived substantially beyond their expected median survival of approximately three to four months, based on disease stage and prior treatment history. One patient survived 28 months after treatment, three patients survived more than one year, reaching 18, 17, and 17 months, respectively, and four additional patients survived 11, 11, 8, and 7 months. Several patients remain alive with continued follow-up.

The company also reported encouraging preliminary safety observations. No dose-limiting toxicities have been observed in the first three dose cohorts, and all doses have been successfully administered through the intraperitoneal route. No cases of immune effector cell-associated neurotoxicity syndrome or significant cytokine release syndrome have been reported, and all significant adverse events observed to date were considered unrelated to lira-cel administration.

Anixa plans to continue dose escalation. The next cohort is expected to evaluate a dose approximately three times higher than the previous cohort and will include lymphodepletion with cyclophosphamide and fludarabine, which may help create a more favorable environment for CAR-T expansion, persistence, and anti-tumor activity.

While the study remains early and primarily focused on safety and tolerability, the updated survival observations and favorable preliminary safety profile support continued clinical evaluation of lira-cel. For recurrent ovarian cancer, where treatment options remain limited after multiple prior therapies, FSHR-targeted CAR-T therapy represents a novel approach to watch.