Anixa Biosciences Receives Notice of Allowance from Canadian Intellectual Property Office for Patent Covering Breast Cancer Vaccine Technology

Rhea-AI Summary

Anixa Biosciences (NASDAQ: ANIX) has received a Notice of Allowance from the Canadian Intellectual Property Office for a patent covering its breast cancer vaccine technology. The patent, exclusively licensed from Cleveland Clinic, provides composition-of-matter protection for their novel immunogenic approach in Canada.

The vaccine targets human α-lactalbumin, a protein expressed during lactation and in certain breast cancers. This technology addresses a significant market need, as breast cancer represents 25% of new cancer cases in Canadian women and 13% of female cancer deaths annually. The patent strengthens Anixa's international intellectual property portfolio and supports future regulatory and commercial efforts outside the U.S.

Positive

• Secured patent protection in Canada for breast cancer vaccine technology
• Expands international IP portfolio in key markets with high breast cancer incidence
• Addresses unmet medical need with no current approved breast cancer vaccine
• Exclusive license from Cleveland Clinic strengthens competitive position

Negative

• Early-stage technology still requiring clinical development
• Commercialization timeline and regulatory approval uncertain

Insights

Biotechnology Patent Expert

Anixa's Canadian patent allowance strengthens global IP protection for its novel breast cancer vaccine, enhancing commercialization potential in key markets.

The Canadian Intellectual Property Office's Notice of Allowance for Anixa's breast cancer vaccine technology represents a significant IP milestone that extends composition-of-matter protection to another major market. This patent, licensed from Cleveland Clinic, secures exclusive rights to their innovative α-lactalbumin-targeting approach in Canada, where breast cancer accounts for approximately 25% of female cancer diagnoses.

The strategic value of this patent extends beyond simple geographic expansion. Canada represents a sophisticated pharmaceutical market with robust regulatory standards and serves as a potential gateway to other international markets. Composition-of-matter patents offer the strongest form of protection, covering the actual molecular components of the vaccine rather than just methods of use.

This patent allowance enhances Anixa's competitive positioning in two critical ways: First, it creates barriers to entry for potential competitors in a country with high breast cancer prevalence. Second, it increases the company's attractiveness for potential partnerships or licensing deals with global pharmaceutical companies seeking to expand their oncology portfolios.

The timing is particularly valuable as Anixa progresses its clinical development program in the US. Building a comprehensive international patent estate before late-stage clinical trials significantly strengthens negotiating positions with potential commercialization partners and protects market exclusivity during the crucial early commercialization years.

While still in clinical development, securing this protection in a market with significant unmet need (no approved breast cancer prevention vaccines) positions Anixa to potentially capture substantial value if their α-lactalbumin targeting approach proves successful in trials.

Patent Strengthens International Protection for First-of-Its-Kind Immunopreventive Platform

Expands Global IP Coverage in Markets with High Incidence of Breast Cancer

SAN JOSE, Calif., July 30, 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 Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology. This patent, exclusively licensed from Cleveland Clinic, will provide composition-of-matter protection for the Company's novel immunogenic approach to breast cancer prevention and treatment in Canada.

With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunoprevention. The Canadian patent complements issued and pending patents in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S.

"This newly allowed patent further illustrates the international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this allowance further strengthens our ability to pursue strategic global opportunities in regions with a high burden of breast cancer."

Breast cancer remains the most commonly diagnosed cancer in women globally and a leading cause of cancer-related death. In Canada, breast cancer accounts for approximately 25% of all new cancer cases in women and 13% of female cancer deaths annually. Despite widespread awareness and screening efforts, there is currently no approved vaccine for the prevention of breast cancer—highlighting a significant and unaddressed need in public health.

Anixa's vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company's broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention.

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.

FAQ

What is the significance of Anixa Biosciences' (NASDAQ: ANIX) new Canadian patent?

The patent provides composition-of-matter protection for Anixa's breast cancer vaccine technology in Canada, strengthening their international IP portfolio and enabling future commercialization in a market where breast cancer accounts for 25% of new female cancer cases.

How does Anixa's breast cancer vaccine technology work?

The vaccine targets human α-lactalbumin, a protein associated with lactation that is abnormally expressed in certain breast cancers. This 'retired' protein strategy aims to prime the immune system to prevent tumor formation while avoiding damage to normal tissue.

What is the market opportunity for Anixa's breast cancer vaccine in Canada?

In Canada, breast cancer represents 25% of all new cancer cases in women and 13% of female cancer deaths annually, with no currently approved vaccine for prevention, presenting a significant market opportunity.

Who developed the breast cancer vaccine technology licensed by Anixa?

The vaccine technology was developed at Cleveland Clinic and is exclusively licensed to Anixa Biosciences for development and commercialization.

What stage of development is Anixa's breast cancer vaccine currently in?

The vaccine is currently in clinical development in the United States, with the company pursuing strategic global opportunities in regions with high breast cancer incidence.