On October 5, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that a patient in its ongoing Phase 1, dose-escalating, clinical trial evaluating its novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer, exhibited stable disease 90 days after treatment. This represents the first such response in Anixa’s CAR-T cell therapy trial. Correlative studies evaluating presence and durability of CAR positive cells are ongoing.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The patient was treated in the fifth dose cohort and received a dose of 1×10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed in any patients.
The Phase 1 study is evaluating liraltagene autoleucel, or lira-cel, Anixa’s novel CAR-T therapy targeting follicle stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells but has limited expression in healthy tissues. The trial is designed to assess safety, tolerability, and preliminary signs of efficacy across escalating dose levels. The study is being conducted at Moffitt Cancer Center ("Moffitt").
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "While this Phase 1 study is primarily designed to evaluate safety, we are encouraged by our early anecdotal findings of overall survival (OS). In addition, an observation of stable disease for this duration, coupled with multiple patients having surpassed one year of survival following treatment, is very encouraging as we look forward to further evaluating lira-cel at current and future dose levels."
Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt and the principal investigator for the trial, added, "As we advance in this trial we hope to continue observing improved results in patients, from progressive disease to stable disease and eventually to radiological partial response (PR) and hopefully complete response (CR). This result, and the absence of dose-limiting toxicities observed thus far is encouraging as we continue to treat patients in the current and future dose cohorts."
About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells, but not in healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. Anixa’s CAR-T technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine. Anixa holds an exclusive world-wide license to the technology from The Wistar Institute.
(Press release, Anixa Biosciences, OCT 5, 2026, View Source [SID1234673192])