Anixa Biosciences Reports Updated Positive Survival Observations from Ongoing Phase 1 Trial of Lira-Cel Ovarian Cancer Car-T Therapy

Published: 2026-05-11 14:05:31 ET ANIX

Published on 05/11/2026 at 02:05 pm EDT

Anixa Biosciences, Inc. announced updated positive survival observations from its ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, the Company's follicle-stimulating hormone receptor (FSHR)-targeted CAR-T therapy being developed for the treatment of recurrent ovarian cancer. Updated data were presented on May 7, 2026, at the International Society for Cell & Gene Therapy 2026 Annual Meeting by Cheryl Cox, MHA, Operations Director of the Cell Therapies and Gene Expression Engineering Facility at Moffitt Cancer Center. The presentation, titled 'A Phase I clinical trial of an infusion of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor in patients with recurrent ovarian cancer,' reviewed the trial design, objectives and current clinical status of Anixa's ongoing Phase 1 trial of lira-cel.

Several trial participants have lived significantly beyond their median expected survival of three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment, at 18, 17 and 17 months, respectively, and four additional patients have survived 11, 11, 8 and 7 months, respectively. Three of the patients who reached 18, 17 and 11 months, respectively, remain alive, and one additional patient who was treated more recently is also currently alive.

Preliminary safety observations presented at ISCT include: No dose-limiting toxicities (DLTs) have been encountered in the first three dose cohorts. All doses have been administered successfully by the intraperitoneal (IP) route. There have been no observations of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or significant Cytokine Release Syndrome (CRS).

All significant adverse events observed to date have been unrelated to lira-cel administration. Liraltagene autoleucel, or lira-cel, is Anixa's investigational autologous CAR-T therapy designed to target the follicle-stimulating hormone receptor (FSHR), which Anixa believes represents a unique CAR-T target in ovarian cancer. FSHR is selectively expressed on ovarian cells, tumor vasculature and certain cancer cells, but not in most healthy tissue.

The ongoing Phase 1 trial (ClinicalTrials.gov Identifier: NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The trial is designed to evaluate the safety and tolerability of lira-cel, determine the maximum tolerated dose, and assess preliminary evidence of clinical activity.