Anixa Biosciences Granted First Australian Patent for its Breast Cancer Vaccine, Broadening Global Protection Through 2040

New Australian patent extends protection of Anixa’s breast cancer vaccine to 2040 and supports ongoing global development based on positive Phase 1 data.

Rhea-AI Summary

Anixa Biosciences (ANIX) received its first Australian composition-of-matter patent for its breast cancer vaccine technology, providing exclusive protection in Australia through 2040. The patent, issued by IP Australia as Patent Number 2020221280 and titled “Vaccine Adjuvants and Formulations,” covers a vaccine approach exclusively licensed from Cleveland Clinic.

The Australian patent complements Anixa’s existing portfolio in the United States and other markets including Europe, China and Japan, broadening its global intellectual property estate. A completed Phase 1 trial at Cleveland Clinic, funded by the U.S. Department of Defense, met all major primary endpoints, showed the vaccine was safe and well tolerated, and produced protocol-defined immune responses in more than 74% of participants, supporting further clinical development.

Positive

• Australian patent protection for the breast cancer vaccine technology through 2040
• Phase 1 trial met all major primary endpoints and was safe and well tolerated
• Immune responses achieved in more than 74% of Phase 1 participants
• Global IP coverage expanded across the U.S., Europe, China, Japan and Australia

Negative

• None.

News Explained

The issued Australian patent strengthens Anixa’s exclusive intellectual-property protection through 2040, while the company describes regulatory approval and commercialization as future opportunities; the disclosure therefore does not establish an approved vaccine.

Market Context

ANIX was up 0.36% before publication of the Australian patent grant; its active S-3 shelf dated Sep ...

Analysis

ANIX was up 0.36% before publication of the Australian patent grant; its active S-3 shelf dated Sep 10, 2025 was not effective and had zero reported usage, providing financing context.

Key Figures

Australian patent protection: through 2040 Immune response rate: more than 74% of participants

Australian patent protection

through 2040

Composition-of-matter patent for the breast cancer vaccine

Immune response rate

more than 74% of participants

Recently completed Phase 1 trial at Cleveland Clinic

Key Terms

composition-of-matter patent, phase 1, human α-lactalbumin, triple-negative breast cancer

4 terms

composition-of-matter patent regulatory

"Composition of matter patent secures exclusive protection for Anixa's breast cancer vaccine"

A composition-of-matter patent protects a new chemical or biological substance, molecular structure, formulation, or compound and the way its atoms are arranged. It is like a legal lock on a specific “recipe” for a molecule, blocking others from making, using, or selling that exact substance without permission. Investors care because such patents can create exclusive rights that underlie product sales, licensing income, and company valuation, or conversely become a key legal or commercial risk if challenged or expired.

phase 1 medical

"In a recently completed Phase 1 trial at Cleveland Clinic"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

human α-lactalbumin medical

"Anixa's vaccine is based on immunizing against human α-lactalbumin"

A small whey protein naturally found in human breast milk that helps mammary cells make lactose and supports baby nutrition; think of it as a key ingredient that helps milk carry energy and nutrients. It matters to investors because the protein is used as an active ingredient or raw material in infant formulas, medical foods and some biotech products, so its supply, purity, regulatory approval and manufacturing scale can affect product markets and company valuations.

triple-negative breast cancer medical

"particularly in aggressive forms of the disease such as triple-negative breast cancer"

Triple-negative breast cancer is a type of breast cancer that lacks three common markers used to identify and treat the disease effectively. Because it doesn’t respond to some targeted therapies, it can be more difficult to treat and may have a more aggressive progression. This impacts the development of new treatments and can influence the outlook for healthcare companies involved in cancer research and pharmaceuticals.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Composition of matter patent secures exclusive protection for Anixa's breast cancer vaccine in Australia through 2040, expanding the Company's growing global IP estate

Continues expansion of global intellectual property coverage in markets with increasing breast cancer incidence rates

SAN JOSE, Calif., Sept. 21, 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 IP Australia has issued Patent Number 2020221280 related to Anixa's breast cancer vaccine technology, exclusively licensed from Cleveland Clinic. This composition-of-matter patent protects the Company's novel approach to breast cancer prevention and treatment in Australia through 2040, addressing a disease for which no preventive vaccine is currently approved anywhere in the world. The patent is titled, "Vaccine Adjuvants and Formulations," and the co-inventors are Dr. Justin Johnson and the late Dr. Vincent Tuohy, both of Cleveland Clinic.

With this issued patent, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Australian patent complements Anixa's existing patent portfolio in the United States and other key international markets, including Europe, China, and Japan, among others, further strengthening the Company's global intellectual property estate. The expanded patent protection enhances Anixa's ability to pursue future regulatory approvals, strategic partnerships and commercialization opportunities.

In a recently completed Phase 1 trial at Cleveland Clinic, funded by the U.S. Department of Defense, the vaccine met all major primary endpoints, was safe and well tolerated, and generated protocol defined immune responses in more than 74% of participants. These results support continued clinical development of the Company's novel preventive and therapeutic breast cancer vaccine.

"This newly issued patent strengthens the global foundation we are building for our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue clinical development in the U.S., our growing international patent estate further strengthens our ability to pursue global opportunities and potentially partner with larger pharmaceutical companies for worldwide commercialization."

Breast cancer remains the most commonly diagnosed cancer among women worldwide, and while survival rates are high in Australia, the incidence rate has continued to increase. Despite significant advances in screening and treatment, there are currently no approved vaccines designed to prevent breast cancer.

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, particularly in aggressive forms of the disease such as triple-negative breast cancer.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company's vaccine technology is designed to transform how the medical community approaches cancer prevention. If successful, the Company's vaccine technology could represent one of the first preventive vaccine approaches targeting breast cancer, representing a potentially transformative advancement in 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 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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What exactly does the newly issued Australian patent cover for Anixa Biosciences?

The Australian patent, Number 2020221280, is a composition-of-matter patent titled “Vaccine Adjuvants and Formulations.” It protects Anixa’s novel breast cancer vaccine approach, which is exclusively licensed from Cleveland Clinic, in Australia through 2040.

How is Anixa’s breast cancer vaccine designed to work?

The vaccine targets human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain breast cancers. This “retired” protein strategy aims to prime the immune system to prevent tumor formation while avoiding harm to normal tissue, including in aggressive disease such as triple-negative breast cancer.

Who developed the breast cancer vaccine technology and who funded the Phase 1 trial?

The vaccine strategy was developed at Cleveland Clinic by co-inventors Dr. Justin Johnson and the late Dr. Vincent Tuohy, and is licensed exclusively to Anixa. The recently completed Phase 1 clinical trial at Cleveland Clinic was funded by the U.S. Department of Defense.