San Jose, California, U.S., October 26, 2026
Anixa Biosciences, Inc. has announced the completion of treatment in the fifth cohort of its ongoing Phase 1 clinical trial evaluating an investigational CAR-T cell therapy for recurrent ovarian cancer. The study is assessing a novel therapy targeting the follicle-stimulating hormone receptor (FSHR), which is expressed on ovarian cancer cells and has limited expression in healthy tissues. Conducted at Moffitt Cancer Center, the trial is designed to evaluate safety, tolerability and preliminary signs of clinical activity as researchers investigate increasing doses of the experimental treatment. Anixa reported that the latest cohort received the highest dose level evaluated in the study to date, marking another milestone in the development of its ovarian cancer immunotherapy program.
Fifth Cohort Completes Treatment at the Highest Dose Level
The fifth cohort received 1 × 10⁷ CAR-positive cells per kilogram of body weight following lymphodepletion, a preparatory treatment intended to reduce existing immune cells before the engineered cell therapy is administered. According to Anixa, this represents the highest dose level evaluated so far in the ongoing study. The company also reported that no dose-limiting toxicities have been observed to date across the trial cohorts. The next cohort is expected to begin after a routine 30-day safety verification period confirms that no adverse effects have been observed in patients treated in the fifth cohort. Anixa plans to continue dose escalation, with the upcoming cohort expected to evaluate a dose of up to 1 × 10⁸ CAR-positive cells per kilogram following lymphodepletion. These steps are intended to help investigators understand the treatment’s safety and tolerability at higher dose levels. As a Phase 1 study, the trial primarily focuses on safety rather than establishing whether the therapy is effective.
Early Patient Observations Highlight Continued Evaluation
Anixa reported encouraging preliminary observations among heavily pretreated patients with recurrent ovarian cancer, a population that may have limited treatment options after disease progression following multiple previous therapies. The company stated that four patients had survived more than one year after treatment, with reported survival durations of approximately 28, 21, 17 and 17 months, respectively. In addition, the first patient treated in the fifth cohort demonstrated stable disease 90 days after treatment, meaning the cancer had not shown progression at that assessment point. The observation follows the company’s earlier report of stable disease in the same patient. While these findings provide a basis for continued clinical investigation, they should be interpreted cautiously. The trial is small, early-stage and designed primarily to evaluate safety. Survival observations and stable disease in individual patients do not establish that the treatment caused these outcomes or demonstrate a confirmed clinical benefit. Further patient follow-up, additional dose-level evaluation and more comprehensive clinical data will be needed to understand the therapy’s potential.
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FSHR-Targeted Cell Therapy Advances Development
The investigational therapy, liraltagene autoleucel (lira-cel), uses a specialized form of cell therapy based on Anixa’s chimeric endocrine receptor-T cell (CER-T) technology. The approach targets follicle-stimulating hormone receptor (FSHR), a protein found on ovarian cancer cells, by using the receptor’s natural ligand rather than the antibody fragment typically used in conventional CAR-T designs. The technology was developed by Jose R. Conejo-Garcia, M.D., Ph.D., of Duke University School of Medicine, and Anixa holds an exclusive worldwide license from The Wistar Institute. Moffitt Cancer Center is conducting the clinical trial under the direction of its gynecologic oncology program. The collaboration brings together biotechnology development and specialist cancer research to investigate a potential new approach for patients with recurrent disease. The therapy remains investigational and has not been established as an approved treatment for ovarian cancer. Future clinical findings will be important for determining its safety profile, potential activity and appropriate role in cancer care. For cGxP.wire, the completion of the fifth cohort represents a notable development in ovarian cancer immunotherapy and investigational cell therapy research. The next phase of evaluation will help determine whether dose escalation can continue safely and whether the early patient observations are supported by further clinical evidence.
Source: Anixa Biosciences press release
