Fourth Cohort Receiving 30x Initial Dose with No Dose-Limiting Toxicities Observed to Date
SAN JOSE, Calif., Aug. 18, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the second patient in the fourth dose cohort has been treated in the ongoing Phase 1 clinical trial evaluating the Company's novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer. The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt").
Patients in the fourth cohort are receiving a dose of three million CAR-positive cells per kilogram of body weight-representing a 30-fold increase over the initial dose level. To date, no dose-limiting toxicities (DLTs) have been observed in the fourth cohort.
Anixa's proprietary CAR-T program targets the follicle-stimulating hormone receptor (FSHR), which preclinical research indicates is selectively expressed on ovarian cells, tumor vasculature, and certain cancer cells-but not in healthy tissue. The ongoing first-in-human clinical trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior lines of therapy. The Phase 1 study is designed to evaluate safety, determine the maximum tolerated dose, and monitor initial signals of clinical activity.
"Our therapy continues to demonstrate a favorable safety profile, even at significantly higher cell doses," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "While this study is primarily designed to assess safety, we remain encouraged by early indications of potential efficacy as the trial progresses."
Anixa's CAR-T technology was invented 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. The ongoing clinical trial is being conducted at Moffitt under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program. Anixa holds an exclusive worldwide license to the FSHR-targeting CAR-T 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 an ovarian cancer immunotherapy program 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.
Forward-Looking Statements
Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect Anixa's current expectations concerning future events and results. We generally use the words "believes," "expects," "intends," "plans," "anticipates," "likely," "will" and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in "Item 1A - Risk Factors" and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
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SOURCE Anixa Biosciences, Inc.
