On July 24, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported 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 (Press release, Anixa Biosciences, JUL 24, 2025, View Source [SID1234654510]). 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.
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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."