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First patient in current dose cohort exhibited no progression of her cancer three months after treatment
Multiple patients have survived more than one year, including one beyond two years
No dose-limiting toxicities observed to date
SAN JOSE, Calif., Oct. 5, 2026 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced 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.
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.
About Anixa Biosciences, Inc. Anixa is a clinical-stage biotechnology company focused on the treatment and prevention of cancer. Anixa's therapeutic portfolio consists of liraltagene autoleucel, or lira-cel, an ovarian cancer immunotherapy being developed in collaboration with Moffitt Cancer Center, which uses a novel type of CAR-T, known as chimeric endocrine receptor-T cell (CER-T) technology. This technology is differentiated from other cell therapies as the natural ligand of the FSHR receptor, FSH, binds to the FSHR receptor on the tumor cell instead of an antibody fragment. Moffitt is a world leader in cancer immunotherapy treatments, pioneering next-generation cell therapies such as CAR-T, and tumor infiltrating lymphocytes (TILs) to harness the power of the immune system. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to treat and prevent breast cancer and ovarian cancer, as well as additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon, and prostate. These vaccine technologies focus on immunizing against "retired" proteins that have been found to be expressed in certain forms of cancer. The breast and ovarian cancer vaccines were developed at Cleveland Clinic and exclusively licensed to Anixa. Cleveland Clinic is entitled to royalties and other commercialization revenues from the Company related to these vaccine technologies. Anixa's unique business model of partnering with world-renowned research institutions on all stages of development allows the Company to continually examine emerging technologies in complementary fields for further development and commercialization. To learn more, visit www.anixa.com or follow Anixa on LinkedIn, X, Facebook and YouTube.
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