Patent Expands Immunogenic Coverage of α-Lactalbumin-Based Vaccine Platform

Technology Addresses Substantial Unmet Need in Preventive Oncology with Multi-Billion Dollar Market Potential

SAN JOSE, Calif., July 24, 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 United States Patent and Trademark Office (USPTO) will issue U.S. Patent Number 12,370,244 on July 29, 2025, covering key aspects of the Company's breast cancer vaccine technology. The patent protects novel methods of immunizing patients against breast cancer by administering an immunogenic composition containing human α-lactalbumin protein—a protein typically found in breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies.

Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, represents a novel approach to the prevention and treatment of breast cancer. The vaccine was invented at Cleveland Clinic, and this patent—along with others related to this technology—has been exclusively licensed to Anixa Biosciences. This issuance builds upon the Company's broad and expanding intellectual property portfolio, extending foundational patent protection for the breast cancer vaccine program into the mid-2040s. The expanded claims provide additional coverage for immunogenic formulations, further enhancing Anixa's ability to develop and commercialize differentiated immunopreventive solutions.

Despite significant progress in breast cancer treatment, the disease remains the most commonly diagnosed cancer among women worldwide. In the United States alone, over 297,000 new cases of invasive breast cancer are projected in 2025, with approximately 43,000 women expected to die from the disease. No FDA-approved vaccine currently exists to prevent breast cancer, representing a major and unmet need in the field of preventive oncology.

Anixa's investigational vaccine aims to stimulate the immune system to recognize and eliminate pre-malignant and malignant cells expressing α-lactalbumin—while sparing normal tissue. By targeting this "retired" protein, which is generally absent from adult tissues except during lactation, the vaccine has the potential to minimize off-target effects and provide long-lasting immune protection.

The breast cancer vaccine platform represents a potential multi-billion dollar market opportunity, particularly among women at elevated risk of developing triple-negative breast cancer (TNBC)—an aggressive subtype with limited treatment options and poor long-term prognosis. As clinical data and regulatory frameworks evolve, the technology may also have broader applications for average-risk populations.

"Our breast cancer vaccine program is a cornerstone of our long-term strategy to develop next-generation preventive immunotherapies, and this patent issuance further secures our leadership in this field," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "With a robust portfolio of issued and pending patents in the U.S. and internationally, we are well-positioned to bring forward a vaccine that could transform how we address breast cancer risk in healthy women."

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.

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

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SOURCE Anixa Biosciences, Inc.