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Anixa Biosciences Awarded Key U.S. Patent Expanding Breast Cancer Vaccine IP Protection into 2040s

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Anixa Biosciences (NASDAQ: ANIX) said the USPTO will issue U.S. Patent No. 12,472,205 on November 18, 2025, covering methods to induce immune responses to α-lactalbumin for a breast cancer vaccine.

The patent is exclusively licensed from Cleveland Clinic and, together with related patents, is described as extending foundational IP protection for the vaccine program into the mid-2040s. The company calls the program a preventive immunotherapy that targets a protein usually limited to lactation and also expressed in certain breast cancers.

The announcement notes the vaccine remains investigational and that no FDA-approved breast cancer vaccine currently exists, while citing U.S. projections of breast cancer incidence and mortality for context.

Anixa Biosciences (NASDAQ: ANIX) ha dichiarato che l'USPTO rilascerà U.S. Patent No. 12,472,205 il 18 novembre 2025, coprendo metodi per indurre risposte immunitarie a α-lattoglobulina per un vaccino contro il cancro al seno.

Il brevetto è concesso in licenza esclusiva dalla Cleveland Clinic e, insieme a brevetti correlati, è descritto come un’estensione della protezione IP fondamentale per il programma di vaccino fino alla metà degli anni 2040. L’azienda lo definisce una immunoterapia preventiva che prende di mira una proteina tipicamente associata alla lattazione e che è anche espressa in alcuni tumori al seno.

L’annuncio nota che il vaccino rimane investigational e che attualmente non esiste un vaccino contro il cancro al seno approvato dalla FDA, citando a titolo di contesto le proiezioni statunitensi sull’incidenza e la mortalità del cancro al seno.

Anixa Biosciences (NASDAQ: ANIX) dijo que la USPTO emitirá la Patente de EE. UU. No. 12,472,205 el 18 de noviembre de 2025, cubriendo métodos para inducir respuestas inmunitarias a α-lactalbumina para una vacuna contra el cáncer de mama.

La patente está licenciada exclusivamente por la Cleveland Clinic y, junto con patentes relacionadas, se describe como una extensión de la protección de propiedad intelectual fundamental para el programa de vacuna hasta mediados de la década de 2040. La empresa denomina al programa como una inmunoterapia preventiva que apunta a una proteína que normalmente se asocia con la lactancia y que también se expresa en ciertos cánceres de mama.

El anuncio señala que la vacuna sigue siendo investigacional y que actualmente no existe una vacuna contra el cáncer de mama aprobada por la FDA, citando para contexto proyecciones de incidencia y mortalidad del cáncer de mama en EE. UU.

Anixa Biosciences (NASDAQ: ANIX)가 USPTO가 미국 특허 No. 12,472,2052025년 11월 18일에 발급할 것이라고 밝혔으며, 이는 α-락토알부민에 대한 면역 반응을 유도하는 방법을 유방암 백신으로 다룹니다.

해당 특허는 클리블랜드 클리닉으로부터 독점 라이선스로 제공되며, 관련 특허와 함께 백신 프로그램에 대한 기초 IP 보호를 2040년대 중반까지 확장하는 것으로 설명됩니다. 회사는 이 프로그램을 수유에 일반적으로 한정된 단백질을 표적으로 하고 특정 유방암에서 발현되는 것을 겨냥한 예방적 면역요법으로 부릅니다.

발표는 백신이 여전히 연구 중이며 현재 FDA에서 승인된 유방암 백신이 없다고 언급하며 맥락상의 참고로 미국의 유방암 발생 및 사망률 전망치를 인용합니다.

Anixa Biosciences (NASDAQ: ANIX) a déclaré que l’USPTO délivrera le Brevet américain n° 12,472,205 le 18 novembre 2025, couvrant des méthodes pour induire des réponses immunitaires à la lactalbumine pour un vaccin contre le cancer du sein.

Le brevet est concédé sous licence exclusive à la Cleveland Clinic et, avec des brevets connexes, il est décrit comme prolongeant la protection de propriété intellectuelle fondamentale du programme de vaccin jusqu’au milieu des années 2040. L’entreprise décrit le programme comme une immunothérapie préventive ciblant une protéine habituellement limitée à la lactation et également exprimée dans certains cancers du sein.

L’annonce précise que le vaccin reste expérimental et qu’il n’existe actuellement aucun vaccin contre le cancer du sein approuvé par la FDA, tout en citant des projections américaines d’incidence et de mortalité du cancer du sein à titre contextuel.

Anixa Biosciences (NASDAQ: ANIX) sagte, dass das USPTO US-Patent Nr. 12,472,205 am 18. November 2025 erteilen wird, das Methoden zur Induktion immunologischer Antworten auf α-Laktalbumin für einen Brustkrebsimpfstoff abdeckt.

Das Patent ist exklusiv von der Cleveland Clinic lizenziert und wird zusammen mit verwandten Patenten beschrieben, um den grundlegenden IP-Schutz für das Impfprogramm bis in die Mitte der 2040er Jahre zu verlängern. Das Unternehmen bezeichnet das Programm als vorbeugende Immuntherapie, die auf ein Protein abzielt, das normalerweise auf die Laktation beschränkt ist und auch in bestimmten Brustkrebsarten exprimiert wird.

Die Ankündigung weist darauf hin, dass der Impfstoff weiterhin experimentell ist und es derzeit keinen von der FDA genehmigten Brustkrebsimpfstoff gibt, während sie zur Einordnung die US-Prognosen zur Inzidenz und Mortalität von Brustkrebs heranzieht.

Anixa Biosciences (NASDAQ: ANIX) قالت إن مكتب براءات الاختراع الأمريكي (USPTO) سيصدر البراءة الأمريكية رقم 12,472,205 في 18 نوفمبر 2025، تغطي طرقاً لاستحداث ردود مناعية لـα-لاكتألبومين من أجل لقاح سرطان الثدي.

البراءة مرخّصة حصرياً من خلال Cleveland Clinic، ومع براءات مماثلة، وُصف أنها توسّع حماية ملكية فكرية أساسية لبرنامج اللقاح حتى أواخر منتصف الأربعينيات من القرن الحالي. وتصف الشركة البرنامج بأنه علاج مناعي وقائي يستهدف بروتيناً عادة ما يقتصر دوره على فترة الرضاعة وأيضاً يُعبَّر عنه في بعض سرطانات الثدي.

تشير الإعلانات إلى أن اللقاح لا يزال قيد التطوير وأنه لا يوجد حتى الآن لقاح لسرطان الثدي تمت الموافقة عليه من إدارة الغذاء والدواء الأمريكية (FDA)، مع الاستشهاد بتوقعات أمريكية حول معدلات الإصابة والوفيات بسرطان الثدي لسياق الحديث.

Positive
  • USPTO will issue U.S. Patent No. 12,472,205 on Nov 18, 2025
  • Patent strengthens IP protection into the mid-2040s
  • Exclusive license from Cleveland Clinic for the vaccine technology
  • Vaccine targets α-lactalbumin, a 'retired' antigen with limited normal expression
Negative
  • No FDA-approved breast cancer vaccine currently exists
  • Vaccine remains investigational and not authorized for prevention or treatment

Insights

New U.S. patent secures exclusive protection for Anixa's α-lactalbumin breast‑cancer vaccine platform through the mid‑2040s.

The issuance of U.S. Patent Number 12,472,205 (to be issued November 18, 2025) formally covers methods to induce immune responses against α-lactalbumin, a protein linked to certain breast cancers and largely restricted to lactation in healthy tissue. This patent, exclusively licensed to Anixa Biosciences, expands their patent estate for the breast cancer vaccine program developed with Cleveland Clinic and therefore strengthens the company’s legal exclusivity around this specific immunoprevention approach.

Key dependencies and risks remain clear and concrete: regulatory approval pathways, clinical efficacy on relevant endpoints, and successful demonstration of safety while avoiding effects on lactating tissue are required before any clinical or commercial value materializes. The claim scope and remaining patent family validity will determine how meaningful the protection is in practice; patent term extension into the mid-2040s gives a multi-decade window but does not by itself change clinical or regulatory uncertainty.

Watch for three concrete items: publication/assignment of U.S. Patent Number 12,472,205 on November 18, 2025, trial milestones or primary endpoint reads for the vaccine program, and any further licensing or partnership disclosures around commercialization or late-stage development within a 12–36 month horizon.

Patent Extends Protection for Novel Vaccine Targeting a Cancer Projected to Strike Nearly 300,000 U.S. Women in 2026

SAN JOSE, Calif., Nov. 12, 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 12,472,205 on November 18, 2025, covering key aspects of the Company's breast cancer vaccine technology. The patent protects novel methods of inducing an immune response to α-lactalbumin protein—a protein typically found only in normal breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies. The co-inventors of the patent are the late Dr. Vincent Tuohy, and Dr. Justin Johnson of Cleveland Clinic.

"Our breast cancer vaccine program is a cornerstone of our strategy to develop next-generation preventive immunotherapies," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "This new patent meaningfully extends the duration of our intellectual property protection and reinforces our commitment to addressing a disease that affects hundreds of thousands of women each year. With a strong and growing global patent portfolio, we are well-positioned to advance a vaccine that could fundamentally change how we prevent breast cancer in healthy women."

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 patent issuance builds upon the Company's broad and expanding intellectual property portfolio, strengthening foundational patent protection for the breast cancer vaccine program into the mid-2040s.

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 healthy tissue except during lactation, the vaccine has the potential to minimize off-target effects and provide long-lasting immune protection.

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

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/anixa-biosciences-awarded-key-us-patent-expanding-breast-cancer-vaccine-ip-protection-into-2040s-302612431.html

SOURCE Anixa Biosciences, Inc.

FAQ

What does Anixa (ANIX) announce about a new U.S. patent on November 18, 2025?

Anixa said the USPTO will issue U.S. Patent No. 12,472,205 on Nov 18, 2025, covering methods to induce immune responses to α-lactalbumin for its breast cancer vaccine.

How long will Anixa's breast cancer vaccine patent protection extend for ANIX?

The company states this patent and related assets strengthen foundational patent protection into the mid-2040s.

Is Anixa's breast cancer vaccine approved by the FDA for ANIX shareholders?

No; the announcement describes the vaccine as investigational and notes there is currently no FDA-approved breast cancer vaccine.

Who invented the vaccine technology licensed to Anixa (ANIX)?

The vaccine was invented at Cleveland Clinic; co-inventors named include the late Dr. Vincent Tuohy and Dr. Justin Johnson.

What target does Anixa's vaccine (ANIX) use to prevent breast cancer?

The vaccine targets α-lactalbumin, a protein typically expressed during lactation and in certain breast cancers.
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