Anixa Biosciences Announces Commencement of US FDA Approved IND Transfer to Support Upcoming Phase 2 Breast Cancer Vaccine Trial
Anixa Biosciences (NASDAQ: ANIX) has initiated the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic to support an upcoming Phase 2 trial. The vaccine, targeting 伪-lactalbumin protein, has shown promising results in Phase 1, with over 70% of patients demonstrating protocol-defined immune responses.
The vaccine is designed to target 伪-lactalbumin, a protein normally expressed during lactation but also present in many breast cancers, potentially offering both therapeutic and preventive benefits. Anixa has engaged Advyzom as its regulatory consultant to manage FDA interactions during the IND transfer process.
Anixa Biosciences (NASDAQ: ANIX) ha avviato il trasferimento della domanda di Nuovo Farmaco Sperimentale (IND) per il suo vaccino contro il cancro al seno dalla Cleveland Clinic, in vista di un prossimo trial di Fase 2. Il vaccino, che prende di mira la proteina 伪-lattalbumina, ha mostrato risultati promettenti nella Fase 1, con oltre il 70% dei pazienti che ha evidenziato risposte immunitarie definite dal protocollo.
Il vaccino 猫 progettato per colpire 伪-lattalbumina, una proteina normalmente espressa durante l'allattamento ma presente anche in molti tumori al seno, offrendo potenziali benefici sia terapeutici che preventivi. Anixa ha coinvolto Advyzom come consulente regolatorio per gestire le interazioni con la FDA durante il processo di trasferimento dell'IND.
Anixa Biosciences (NASDAQ: ANIX) ha iniciado la transferencia de la solicitud de Nuevo F谩rmaco en Investigaci贸n (IND) para su vacuna contra el c谩ncer de mama desde Cleveland Clinic, para apoyar un pr贸ximo ensayo de Fase 2. La vacuna, que tiene como objetivo la prote铆na 伪-lactoalb煤mina, ha mostrado resultados prometedores en la Fase 1, con m谩s del 70% de los pacientes demostrando respuestas inmunitarias definidas por el protocolo.
La vacuna est谩 dise帽ada para dirigirse a la 伪-lactoalb煤mina, una prote铆na normalmente expresada durante la lactancia pero tambi茅n presente en muchos c谩nceres de mama, ofreciendo potenciales beneficios tanto terap茅uticos como preventivos. Anixa ha contratado a Advyzom como su consultora regulatoria para gestionar las interacciones con la FDA durante el proceso de transferencia del IND.
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Anixa Biosciences (NASDAQ : ANIX) a lanc茅 le transfert de la demande de m茅dicament exp茅rimental (IND) pour son vaccin contre le cancer du sein depuis la Cleveland Clinic, afin de soutenir un prochain essai de phase 2. Le vaccin, ciblant la prot茅ine 伪-lactalbumine, a montr茅 des r茅sultats prometteurs en phase 1, avec plus de 70 % des patients pr茅sentant des r茅ponses immunitaires d茅finies par le protocole.
Ce vaccin est con莽u pour cibler l'伪-lactalbumine, une prot茅ine normalement exprim茅e pendant la lactation mais 茅galement pr茅sente dans de nombreux cancers du sein, offrant potentiellement des b茅n茅fices th茅rapeutiques et pr茅ventifs. Anixa a fait appel 脿 Advyzom comme consultant r茅glementaire pour g茅rer les interactions avec la FDA durant le processus de transfert de l'IND.
Anixa Biosciences (NASDAQ: ANIX) hat mit der 脺bertragung des Antrags auf ein Pr眉fpr盲parat (IND) f眉r seinen Brustkrebs-Impfstoff von der Cleveland Clinic begonnen, um eine bevorstehende Phase-2-Studie zu unterst眉tzen. Der Impfstoff, der auf das 伪-Laktalbumin-Protein abzielt, zeigte vielversprechende Ergebnisse in Phase 1, wobei 眉ber 70 % der Patienten eine protokolldefinierte Immunantwort zeigten.
Der Impfstoff ist darauf ausgelegt, 伪-Laktalbumin zu targetieren, ein Protein, das normalerweise w盲hrend der Laktation exprimiert wird, aber auch in vielen Brustkrebsarten vorkommt, und bietet potenziell sowohl therapeutische als auch pr盲ventive Vorteile. Anixa hat Advyzom als regulatorischen Berater beauftragt, um die FDA-Interaktionen w盲hrend des IND-脺bertragungsprozesses zu managen.
- None.
- IND transfer process could potentially cause delays
- Still in early clinical development stages with no guaranteed success
Insights
Anixa's breast cancer vaccine shows promising Phase 1 results with IND transfer underway for upcoming Phase 2 trial.
The announcement from Anixa Biosciences reveals meaningful progression in their breast cancer vaccine development program. The company has initiated the transfer of the Investigational New Drug (IND) application from Cleveland Clinic to Anixa, signaling a transition to sponsor-led development as they prepare for Phase 2 trials. This is a significant operational milestone that typically indicates confidence in a program's potential.
The preliminary Phase 1 results mentioned are particularly noteworthy, with
The vaccine's mechanism targets 伪-lactalbumin, which represents a sophisticated approach to breast cancer immunotherapy. This protein is normally only expressed during lactation but reappears in many breast cancer cells, creating a relatively specific target that may minimize off-target effects while potentially offering both therapeutic and preventive benefits. This dual-purpose potential distinguishes Anixa's approach from many cancer vaccines that focus solely on treatment.
The engagement of Advyzom as regulatory consultant suggests Anixa is preparing for more complex regulatory interactions that typically accompany Phase 2 studies. This trial progression also indicates that Cleveland Clinic, a prestigious research institution, has generated sufficient data to warrant continued development - an important external validation of the technology.
For biotechnology investors, this news represents tangible progress in Anixa's clinical pipeline and suggests the company is methodically advancing toward potential commercialization, though several years of additional clinical development would still be required.
Progress Follows Positive Immune Response Observed in Phase 1 Study
With enrollment completed and encouraging immune response data observed in the Phase 1 trial, Anixa plans to advance the vaccine into a Phase 2 clinical trial and will assume full sponsorship of the IND. The IND, currently held by Cleveland Clinic, is in the process of being transferred to Anixa. To oversee this process, Anixa has engaged Advyzom, a leading regulatory consulting firm specializing in strategic FDA interactions, to act as its
Anixa's breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets 伪-lactalbumin鈥攁 lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By establising an immune response against 伪-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein.
"We are pleased with the progress and preliminary findings from our Phase 1 clinical trial, which show that the vaccine is well tolerated, with more than
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.
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Mike Catelani
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[email protected]
408-708-9808
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