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Anixa Biosciences Awarded New U.S. Patent Extending Breast Cancer Vaccine IP Protection into 2040s

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Anixa Biosciences (NASDAQ: ANIX) has been awarded U.S. Patent Number 12,370,244, extending protection for its breast cancer vaccine technology into the mid-2040s. The patent covers novel immunization methods using human α-ٲܳ protein, which is expressed during lactation and in certain breast cancers.

Developed in collaboration with Cleveland Clinic, this vaccine represents a pioneering approach to breast cancer prevention, targeting a significant unmet need. With 297,000 new cases of invasive breast cancer projected in 2025 and 43,000 expected deaths in the U.S., the technology addresses a potential multi-billion dollar market opportunity, particularly for women at risk of triple-negative breast cancer (TNBC).

Anixa Biosciences (NASDAQ: ANIX) ha ottenuto il brevetto statunitense numero 12.370.244, che estende la protezione per la sua tecnologia di vaccino contro il cancro al seno fino alla metà degli anni '40 del 2040. Il brevetto riguarda nuovi metodi di immunizzazione che utilizzano la proteina umana α-lattalbumina, espressa durante l'allattamento e in alcuni tipi di cancro al seno.

Sviluppato in collaborazione con la Cleveland Clinic, questo vaccino rappresenta un approccio innovativo alla prevenzione del cancro al seno, rispondendo a un bisogno ancora insoddisfatto. Con 297.000 nuovi casi di cancro al seno invasivo previsti per il 2025 e 43.000 decessi attesi negli Stati Uniti, questa tecnologia si rivolge a un’opportunità di mercato potenzialmente multimiliardaria, in particolare per le donne a rischio di carcinoma mammario triplo negativo (TNBC).

Anixa Biosciences (NASDAQ: ANIX) ha recibido la patente estadounidense número 12,370,244, que extiende la protección de su tecnología de vacuna contra el cáncer de mama hasta mediados de la década de 2040. La patente cubre nuevos métodos de inmunización que utilizan la proteína humana α-ٲܳa, la cual se expresa durante la lactancia y en ciertos cánceres de mama.

Desarrollada en colaboración con la Cleveland Clinic, esta vacuna representa un enfoque pionero para la prevención del cáncer de mama, abordando una necesidad significativa no cubierta. Con 297,000 nuevos casos de cáncer de mama invasivo proyectados para 2025 y 43,000 muertes esperadas en EE.UU., la tecnología apunta a una oportunidad de mercado multimillonaria, especialmente para mujeres en riesgo de cáncer de mama triple negativo (TNBC).

Anixa Biosciences (NASDAQ: ANIX)가 미국 특허 번호 12,370,244� 획득하여 유방� 백신 기술� 대� 보호 기간� 2040년대 중반까지 연장했습니다. � 특허� 수유 � � 특정 유방암에� 발현되는 인간 α-락타알부� 단백�� 이용� 새로� 면역� 방법� 포함합니�.

클리블랜� 클리닉과 협력하여 개발� � 백신은 유방� 예방� 있어 선구적인 접근법을 제시하며, 중요� 미충� 수요� 겨냥합니�. 2025년에 297,000건의 새로� 침습� 유방� 사례43,000명의 사망�가 미국에서 예상되는 가운데, � 기술은 특히 삼중음성 유방�(TNBC) 위험� 있는 여성들을 위한 수십� 달러 규모� 시장 기회� 제공합니�.

Anixa Biosciences (NASDAQ : ANIX) s’est vu attribuer le brevet américain numéro 12 370 244, prolongeant la protection de sa technologie de vaccin contre le cancer du sein jusqu’au milieu des années 2040. Le brevet couvre des méthodes d’immunisation innovantes utilisant la protéine humaine α-ٲܳe, exprimée durant la lactation et dans certains cancers du sein.

Développé en collaboration avec la Cleveland Clinic, ce vaccin représente une approche pionnière dans la prévention du cancer du sein, répondant à un besoin important non satisfait. Avec 297 000 nouveaux cas de cancer du sein invasif prévus en 2025 et 43 000 décès attendus aux États-Unis, cette technologie cible une opportunité de marché potentiellement de plusieurs milliards de dollars, notamment pour les femmes à risque de cancer du sein triple négatif (TNBC).

Anixa Biosciences (NASDAQ: ANIX) wurde das US-Patent Nummer 12.370.244 erteilt, das den Schutz für seine Brustkrebs-Impfstofftechnologie bis Mitte der 2040er Jahre verlängert. Das Patent umfasst neuartige Immunisierungsmethoden unter Verwendung des menschlichen α-Laktalbumin-Proteins, das während der Laktation und bei bestimmten Brustkrebserkrankungen exprimiert wird.

In Zusammenarbeit mit der Cleveland Clinic entwickelt, stellt dieser Impfstoff einen bahnbrechenden Ansatz zur Brustkrebsvorsorge dar und adressiert einen bedeutenden ungedeckten Bedarf. Mit 297.000 neuen Fällen von invasivem Brustkrebs, die für 2025 prognostiziert werden, und 43.000 erwarteten Todesfällen in den USA, bietet die Technologie eine potenzielle Milliardenmarktchance, insbesondere für Frauen mit Risiko für triple-negativen Brustkrebs (TNBC).

Positive
  • Patent protection extended into mid-2040s for breast cancer vaccine technology
  • Addresses multi-billion dollar market opportunity in preventive oncology
  • Targets unmet need with no current FDA-approved breast cancer prevention vaccine
  • Potential broader applications beyond high-risk populations
Negative
  • Vaccine still in early development stages
  • Clinical efficacy and regulatory approval yet to be demonstrated

Insights

Anixa's new patent significantly strengthens their breast cancer vaccine IP portfolio, extending protection into the 2040s for a potential multi-billion dollar market.

This patent issuance represents a substantial strengthening of Anixa's intellectual property position for their breast cancer vaccine technology. The new patent (No. 12,370,244) specifically covers methods of immunizing against breast cancer using human α-ٲܳ protein compositions. This is strategically significant as it extends protection into the mid-2040s, providing nearly two decades of market exclusivity for their potential commercial product.

The patent's value lies in its coverage of a unique immunoprevention approach targeting α-ٲܳ—a protein normally expressed during lactation but also found in certain breast cancers. This creates an elegant targeting mechanism: since this protein is essentially "retired" in normal adult tissues except during lactation, it offers a way to potentially target cancer cells while minimizing off-target effects.

What makes this particularly valuable is the expanded claims covering immunogenic formulations, which broadens Anixa's protection beyond basic methods to include various potential product formulations. This comprehensive IP coverage is critical for a technology addressing the substantial breast cancer market—over 297,000 new invasive cases projected in 2025 in the US alone.

For investors, this patent strengthens Anixa's competitive positioning in preventive oncology, particularly for high-risk populations such as those susceptible to triple-negative breast cancer, where treatment options remain limited. The lack of any FDA-approved breast cancer vaccine creates a significant first-mover opportunity in what the company identifies as a multi-billion dollar market.

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" 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-ٲܳ 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-ٲܳ—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  or follow Anixa on , , and .

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
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[email protected]
408-708-9808

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SOURCE Anixa Biosciences, Inc.

FAQ

What is the significance of Anixa's new breast cancer vaccine patent (NASDAQ: ANIX)?

The patent (No. 12,370,244) extends protection for Anixa's breast cancer vaccine technology into the mid-2040s and covers novel immunization methods using α-ٲܳ protein.

How does Anixa's breast cancer vaccine work?

The vaccine stimulates the immune system to target cells expressing α-ٲܳ, a protein present during lactation and in certain breast cancers, while sparing normal tissue.

What is the market potential for Anixa's breast cancer vaccine?

The vaccine addresses a multi-billion dollar market opportunity, particularly for women at risk of triple-negative breast cancer (TNBC), with 297,000 new breast cancer cases projected in 2025 in the U.S. alone.

Who developed Anixa's breast cancer vaccine technology?

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

What makes Anixa's breast cancer vaccine unique?

It's designed to prevent breast cancer by targeting α-ٲܳ, a 'retired' protein typically only present during lactation, potentially minimizing off-target effects while providing long-lasting immune protection.
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