Anixa Biosciences Announces World Health Organization (WHO) Approval of International Non-Proprietary Name for its CAR-T Therapy, Marking a Key Milestone Toward Global Recognition and Future Commercialization
Anixa (NASDAQ: ANIX) announced that the WHO INN Expert Committee approved "liraltagene autoleucel" as the International Nonproprietary Name for its FSHR-targeted CAR-T therapy for recurrent ovarian cancer on Nov. 17, 2025. The company said the INN enables a universally recognized, conflict-free drug name and that it will transition communications to liraltagene autoleucel (lira-cel). Anixa reported its ongoing Phase 1 trial is being conducted with Moffitt Cancer Center and expects to commence the 5th dose cohort in the coming weeks. Company leadership and a co-inventor at Duke highlighted the INN approval as a key step toward potential future commercialization.
Anixa (NASDAQ: ANIX) ha annunciato che il WHO INN Expert Committee ha approvato "liraltagene autoleucel" come International Nonproprietary Name per la sua terapia CAR-T mirata a FSHR per il carcinoma ovarico ricorrente il 17 novembre 2025. L'azienda ha dichiarato che l'INN consente un nome farmacologico universalmente riconosciuto e senza conflitti e che passerà a comunicazioni su liraltagene autoleucel (lira-cel). Anixa ha riportato che il suo ongoing Phase 1 è condotto con il Moffitt Cancer Center e prevede di iniziare la quinta coorte di dosi nei prossimi settimane. La direzione aziendale e un co-inventore di Duke hanno evidenziato l'approvazione dell'INN come passaggio chiave verso una potenziale futura commercializzazione.
Anixa (NASDAQ: ANIX) anunció que el Comité Experto INN de la OMS aprobó "liraltagene autoleucel" como International Nonproprietary Name para su terapia CAR-T dirigida a FSHR para el cáncer de ovario recurrente el 17 de noviembre de 2025. La empresa dijo que el INN facilita un nombre de fármaco reconocido universalmente y libre de conflictos y que migrará las comunicaciones a liraltagene autoleucel (lira-cel). Anixa informó que su ensayo Phase 1 en curso se está llevando a cabo con el Moffitt Cancer Center y espera comenzar la quinta cohorte de dosis en las próximas semanas. La dirección de la empresa y un coinventor de Duke destacaron la aprobación del INN como un paso clave hacia una posible futura comercialización.
Anixa (NASDAQ: ANIX)는 WHO INN Expert Committee가 "liraltagene autoleucel"를 재발성 난소암을 표적으로 하는 CAR-T 요법의 국제 비독점명으로 승인했다고 2025년 11월 17일에 발표했습니다. 회사는 INN이 보편적으로 인정되고 충돌 없는 약물명을 가능하게 하며 향후 커뮤니케이션을 liraltagene autoleucel (lira-cel)로 전환할 것이라고 말했습니다. Anixa는 현재 진행 중인 Phase 1 시험이 무피트 암센터(Moffitt Cancer Center)와 함께 수행되고 있으며 향후 몇 주 내에 다섯 번째 용량 코호트에 진입할 것으로 기대한다고 전했습니다. 회사 경영진과 듀크 대학교의 공동발명자는 INN 승인으로 향후 상용화 가능성에 한 걸음 더 다가갔다고 강조했습니다.
Anixa (NASDAQ: ANIX) a annoncé que le Comité d'experts INN de l'OMS a approuvé "liraltagene autoleucel" comme nom international non propriétaire pour sa thérapie CAR-T ciblant FSHR pour le cancer de l'ovaire récidivant le 17 novembre 2025. L'entreprise a déclaré que l'INN permet un nom de médicament universellement reconnu et sans conflit et qu'elle va passer à des communications sur liraltagene autoleucel (lira-cel). Anixa a fait savoir que son essai en Phase 1 en cours est mené avec le Moffitt Cancer Center et prévoit de commencer la cinquième cohorte de doses dans les prochaines semaines. La direction de l'entreprise et un co-inventeur de Duke ont souligné l'approbation de l'INN comme une étape clé vers une éventuelle commercialisation.
Anixa (NASDAQ: ANIX) gab bekannt, dass das WHO INN Expert Committee "liraltagene autoleucel" als International Nonproprietary Name für seine FSHR-gerichtete CAR-T-Therapie bei rezidivierendem Eierstockkrebs am 17. November 2025 genehmigt hat. Das Unternehmen erklärte, dass der INN einen universell anerkannten, konfliktfreien Medikamentennamen ermöglicht und dass die Kommunikation auf liraltagene autoleucel (lira-cel) umgestellt wird. Anixa berichtete, dass seine laufende Phase 1-Studie in Zusammenarbeit mit dem Moffitt Cancer Center durchgeführt wird und erwartet, in den kommenden Wochen die fünfte Dosiskohorte zu beginnen. Führungskräfte des Unternehmens und ein Mit-Erfinder von Duke hoben die INN-Zulassung als wichtigen Schritt in Richtung einer potenziellen zukünftigen Kommerzialisierung hervor.
Anixa (NASDAQ: ANIX) أعلنت أن لجنة الخبراء INN في OMS وافقت على "liraltagene autoleucel" كاسم دواء غير مملوك دولياً لعلاج CAR-T المستهدف لـ FSHR لسرطان المبيض المتكرر في 17 نوفمبر 2025. قالت الشركة إن INN يتيح اسم دواء معترف به عالمياً وخالٍ من النزاعات وإنها ستنتقل إلى التواصل بـliraltagene autoleucel (lira-cel). ذكرت Anixa أن تجربتها في Phase 1 الجارية تُجرى بالتعاون مع مركز Moffitt Cancer Center وتتوقع البدء في المجموعة الخامسة من الجرعات في الأسابيع المقبلة. أكد قادة الشركة ومخترع مشارك من Duke أن موافقة INN تعد خطوة رئيسية نحو احتمال التسويق في المستقبل.
- WHO INN approval of liraltagene autoleucel (Nov 17, 2025)
- Phase 1 trial advancing to 5th dose cohort in coming weeks
- Clinical partnership with Moffitt Cancer Center
- Therapy remains in Phase 1; clinical benefit unproven
- No efficacy or numeric clinical readouts disclosed in announcement
"The assignment of the non-proprietary name represents an important step in the development and potential future commercialization of our CAR-T therapy. The INN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review. With this INN approval, we have the ability to establish a universally recognized and conflict-free non-proprietary drug name for our CAR-T therapy," said Dr. Amit Kumar, Chairman and CEO of Anixa. "Looking ahead, we remain focused on the successful execution of our ongoing Phase 1 trial of liraltagene autoleucel for the treatment of ovarian cancer, and look forward to commencing the 5th dose cohort in the coming weeks. The Phase 1 study is being conducted in partnership with Moffitt Cancer Center."
Each INN name is unique and is used to identify active pharmaceutical ingredients. Each active substance that is to be marketed as a pharmaceutical must be granted a unique name of worldwide acceptability to ensure the clear identification, safe prescription and dispensing of medicines to patients. Anixa will transition to the use of liraltagene autoleucel, or lira-cel, in future communications.
Jose R. Conejo-Garcia, M.D., Ph.D., Professor of Immunology in the Department of Integrative Immunobiology at the Duke University School of Medicine and the co-inventor of Anixa's CAR-T technology, stated, "It is gratifying to see this technology advance under Anixa's guidance and through the work being performed at Moffitt Cancer Center. Receiving its non-proprietary name from the WHO is an exciting step in the process toward commercialization of this technology."
About liraltagene autoleucel
Liraltagene autoleucel, or lira-cel, is a follicle stimulating hormone receptor (FSHR)-mediated chimeric antigen receptor-T cell (CAR-T) technology that targets FSHR, which is exclusively expressed on normal ovarian cells, tumor vasculature, and certain cancer cells. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (chimeric endocrine receptor-T cell) therapy, a new type of CAR-T. Liraltagene autoleucel is currently being evaluated in a first-in-human trial (NCT05316129) that is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity. Lira-cel is based on technology exclusively licensed to Anixa by The Wistar Institute.
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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