Cleveland Clinic to Present Final Results of Phase 1 Clinical Trial for Anixa Biosciences' Breast Cancer Vaccine at 2025 San Antonio Breast Cancer Symposium
Anixa Biosciences (NASDAQ: ANIX) announced that Cleveland Clinic will present final results from the Phase 1 clinical trial of its breast cancer vaccine at the 2025 San Antonio Breast Cancer Symposium on December 11, 2025. The trial evaluated the safety and immunogenicity of an alpha-lactalbumin (aLA) vaccine for breast cancer, funded by the U.S. Department of Defense.
The presentation, led by Dr. Justin Johnson, Program Manager at Cleveland Clinic and co-inventor of the vaccine technology, will provide the most comprehensive data release to date. The findings will be submitted to both the Department of Defense and FDA to guide Phase 2 planning discussions. The vaccine technology, based on decades of preclinical work by the late Dr. Vincent Tuohy at Cleveland Clinic, shows promising potential for breast cancer prevention and treatment.
Anixa Biosciences (NASDAQ: ANIX) ha annunciato che la Cleveland Clinic presenterà i risultati finali dello studio clinico di fase 1 del suo vaccino contro il cancro al seno al San Antonio Breast Cancer Symposium 2025, in programma per l'11 dicembre 2025. Lo studio ha valutato la sicurezza e l’immunogenicità di un vaccino a base di alpha-lattalbumina (aLA) per il cancro al seno, finanziato dal Dipartimento della Difesa degli Stati Uniti.
La presentazione, guidata dal Dott. Justin Johnson, Program Manager presso la Cleveland Clinic e co-inventore della tecnologia vaccinante, offrirà la più ampia condivisione di dati finora. I risultati saranno sottoposti sia al Dipartimento della Difesa sia alla FDA per guidare le discussioni sulla pianificazione della fase 2. La tecnologia vaccinale, basata su decenni di lavoro preclinico del compianto Dott. Vincent Tuohy presso la Cleveland Clinic, mostra un potenziale promettente per la prevenzione e il trattamento del cancro al seno.
Anixa Biosciences (NASDAQ: ANIX) anunció que la Cleveland Clinic presentará los resultados finales del ensayo clínico de Fase 1 de su vacuna contra el cáncer de mama en el San Antonio Breast Cancer Symposium 2025 el 11 de diciembre de 2025. El ensayo evaluó la seguridad e inmunogenicidad de una vacuna de alfa-lactalbúmina (aLA) para el cáncer de mama, financiada por el Departamento de Defensa de EE. UU.
La presentación, dirigida por el Dra. Justin Johnson, Gerente de Programa en la Cleveland Clinic y coinventor de la tecnología de la vacuna, proporcionará la divulgación de datos más completa hasta la fecha. Los hallazgos se someterán tanto al Departamento de Defensa como a la FDA para guiar las discusiones sobre la planificación de la fase 2. La tecnología de la vacuna, basada en décadas de trabajos preclínicos del fallecido Dra. Vincent Tuohy en la Cleveland Clinic, muestra un potencial prometedor para la prevención y el tratamiento del cáncer de mama.
Anixa Biosciences (NASDAQ: ANIX)가 Cleveland Clinic이 유방암 백신의 1상 임상시험 최종 결과를 2025년 San Antonio 유방암 심포지엄에서 2025년 12월 11일에 발표할 것이라고 발표했습니다. 이 연구는 미국 국방부가 자금을 지원하는 알파-락투알부민(aLA) 백신의 안전성 및 면역원성을 평가했습니다.
발표는 Cleveland Clinic의 프로그램 매니저이자 백신 기술의 공동 발명자인 Dr. Justin Johnson이 주도하며, 지금까지 공개된 데이터 중 가장 포괄적일 것입니다. 결과는 2상 계획 논의를 안내하기 위해 국방부와 FDA에 모두 제출될 예정입니다. 수십 년의 전임상 연구를 바탕으로 한 이 백신 기술은 고(故) Dr. Vincent Tuohy의 연구로 시작되었으며, 유방암 예방 및 치료에 대한 유망한 가능성을 보여줍니다.
Anixa Biosciences (NASDAQ: ANIX) a annoncé que la Cleveland Clinic présentera les résultats finaux de l’essai clinique de phase 1 de son vaccin contre le cancer du sein lors du San Antonio Breast Cancer Symposium 2025 le 11 décembre 2025. L’essai a évalué la sécurité et l’immunogénicité d’un vaccin à base d’ alpha-lactalbumine (aLA) pour le cancer du sein, financé par le Department of Defense des États‑Unis.
La présentation, dirigée par le Dr Justin Johnson, gestionnaire de programme à la Cleveland Clinic et co-inventeur de la technologie vaccinale, offrira la diffusion de données la plus complète à ce jour. Les résultats seront soumis à la fois au Department of Defense et à la FDA afin d’orienter les discussions sur la planification de la phase 2. La technologie vaccinale, fondée sur des décennies de travaux précliniques du défunt Dr Vincent Tuohy à la Cleveland Clinic, démontre un potentiel prometteur pour la prévention et le traitement du cancer du sein.
Anixa Biosciences (NASDAQ: ANIX) gab bekannt, dass die Cleveland Clinic die Endergebnisse der Phase-1-Studie ihres Brustkrebsimpfstoffs beim 2025 San Antonio Breast Cancer Symposium am 11. Dezember 2025 präsentieren wird. Die Studie bewertete die Sicherheit und Immunogenität eines Alpha-Lactalbumin-(aLA)-Impfstoffs gegen Brustkrebs, finanziert vom US-Verteidigungsministerium.
Die Präsentation, unter der Leitung von Dr. Justin Johnson, Programmmanager an der Cleveland Clinic und Miterfinder der Impfstoff-Technologie, wird die bislang umfassendsten Datensätze liefern. Die Ergebnisse werden sowohl dem Verteidigungsministerium als auch der FDA vorgelegt, um Planungen für die Phase-2-Studien zu unterstützen. Die Impfstofftechnologie, basierend auf jahrzehntelanger präklinischer Arbeit des verstorbenen Dr. Vincent Tuohy an der Cleveland Clinic, zeigt vielversprechendes Potenzial zur Prävention und Behandlung von Brustkrebs.
Anixa Biosciences (NASDAQ: ANIX) أعلنت أن مركز كليفلاند كلينك سيعرض النتائج النهائية من تجربة المرحلة الأولى للقاحها ضد سرطان الثدي في مؤتمر سان أنطونيو لسرطان الثدي 2025 في 11 ديسمبر 2025. درست التجربة سلامة ومناعة لقاح يعتمد على ألفا-لاكتألومين (aLA) لسرطان الثدي، بتمويل من وزارة الدفاع الأمريكية.
ستقاد العرض الدكتورة جاستن جونسون، مديرة البرنامج في كليفلاند كلينك ومخترعة مشاركة لتقنية اللقاح، وسيقدم أحدث إصدار من البيانات حتى الآن. ستُعرض النتائج على كل من وزارة الدفاع وFDA لتوجيه مناقشات التخطيط للمرحلة 2. التقنية اللقاحية، المستندة إلى عقود من العمل قبل السريري للراحل الدكتور فينسنت تويي في كليفلاند كلينك، تُظهر إمكانات واعدة للوقاية من سرطان الثدي وعلاجه.
Anixa Biosciences（NASDAQ: ANIX）宣布，克利夫兰诊所将于 2025 年圣安东尼奥乳腺癌研讨会 于 2025 年 12 月 11 日公布其乳腺癌疫苗一阶段临床试验的最终结果。该试验评估了基于 α-乳清蛋白（aLA） 的疫苗对乳腺癌的安全性和免疫原性，资助方为美国国防部。
报告由克利夫兰诊所的项目经理、疫苗技术的共同发明人 Justin Johnson 博士 主导，将提供迄今为止最全面的数据。结果将同时提交给国防部和 FDA，以指导第 2 期的规划讨论。该疫苗技术基于已故的 Vincent Tuohy 博士 在克利夫兰诊所多年的前期研究，显示出在预防和治疗乳腺癌方面的潜在前景。
- Trial data reportedly 'exceeded expectations' according to CEO
- U.S. Department of Defense funding support demonstrates institutional backing
- Potential breakthrough in breast cancer prevention and treatment
- Progress towards Phase 2 development discussions with FDA
- Phase 1 results not yet publicly disclosed
- Long development timeline ahead before potential commercialization
Insights
Anixa's breast cancer vaccine phase 1 trial completion represents progress toward FDA discussions, though actual efficacy data remains unreported.
Anixa Biosciences has completed its Phase 1 trial for a potentially first-in-class breast cancer vaccine targeting alpha-lactalbumin (aLA), with full results to be presented at the San Antonio Breast Cancer Symposium this December. This represents a critical milestone in the company's development pipeline, as completed Phase 1 data will inform upcoming FDA discussions and Phase 2 planning.
The most noteworthy aspect is what isn't explicitly stated in this announcement. While the CEO describes the data as "very encouraging" and "exceeding expectations," the release contains no specific efficacy or immunogenicity results. The trial was designed to evaluate both safety and immune response, yet no concrete findings are shared ahead of the December presentation.
This vaccine technology has several distinctive characteristics worth highlighting:
- It targets alpha-lactalbumin, a protein expressed in lactating breast tissue and in many breast cancers
- It received Department of Defense funding support
- It builds on decades of preclinical work by the late Dr. Vincent Tuohy
- It represents a preventative approach rather than just a treatment
For context, most cancer vaccines have historically struggled in late-stage development despite promising early results. The pathway from successful Phase 1 to market approval remains exceptionally challenging. What will matter most is whether the vaccine demonstrated robust immune responses specifically targeting breast cancer cells without concerning safety signals.
Phase 1 Data Highlights Potential of First-in-Class Vaccine to Transform Breast Cancer Treatment and Prevention
Comprehensive Results, Supported by
The trial, conducted at Cleveland Clinic and funded by a grant from the
With the trial now complete and comprehensive analyses of blood and tissue samples underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to the
Presentation Details:
- Abstract Number: 765
- Presentation Number: PS4-06-19
- Presentation Title: Final Results of a Phase I Trial of an Alpha-lactalbumin (aLA) Vaccine for Breast Cancer
- Poster Presentation: Thursday, December 11, 2025, 5:00–6:30 PM CST
"We are very encouraged by the data generated in this human clinical trial, which continues to exceed our expectations," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "This vaccine builds on decades of pioneering preclinical work led by the late Vincent Tuohy, Ph.D. and his team at Cleveland Clinic. His visionary research, has brought us to this pivotal moment—one that has the potential to transform the future of breast cancer prevention and treatment."
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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