Anixa Biosciences Announces Completion of Treatment of Fifth Cohort in its Ovarian Cancer CAR-T Clinical Trial

Anixa Biosciences Announces Completion of Treatment of Fifth Cohort in its Ovarian Cancer CAR-T Clinical Trial

First patient in fifth cohort exhibiting stable disease 90 days after treatment

Multiple patients surviving more than one year, including one beyond two years, with no dose-limiting toxicities observed to date

Patients in fifth cohort received 1×10⁷ CAR-positive cells/kg following lymphodepletion

SAN JOSE, Calif., Oct. 26, 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 it has completed dosing of the fifth cohort in its ongoing Phase 1, dose-escalating, clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer. The study is being conducted at Moffitt Cancer Center ("Moffitt"). The sixth cohort is expected to commence following a routine 30-day safety verification that no adverse effects have been observed in the fifth cohort.

The Phase 1 study is evaluating a 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 patients in the fifth cohort 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 across any cohort.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "Ovarian cancer remains one of the deadliest cancers affecting women, and patients with recurrent disease face limited treatment options and poor outcomes. While this Phase 1 study is primarily designed to evaluate safety, we are highly encouraged that the most recently evaluated patient maintained stable disease 90 days after treatment and multiple patients have surpassed one year of survival following treatment, with one patient having survived beyond two years. Typically, these highly pre-treated patients survive a matter of weeks. We look forward to further evaluating this novel solid tumor-specific CAR-T therapy as we continue to increase dosage to 1×10⁸ CAR-positive cells per kilogram of body weight following lymphodepletion in the upcoming cohort."

As of the date of this release, four patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 21, 17, and 17 months post-treatment, respectively. In addition, the first patient treated in the fifth dose cohort exhibited stable disease 90 days after treatment. The Company believes these outcomes are notable in a highly pre-treated, recurrent ovarian cancer population that has progressed after multiple prior lines of therapy and limited treatment options and poor prognosis.

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. The Phase 1 clinical trial is being conducted at Moffitt, under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt. 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.

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.

Contact:
Mike Catelani
President, COO & CFO
mcatelani@anixa.com
408-708-9808

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SOURCE Anixa Biosciences, Inc.