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Anixa Biosciences Appoints Suyasha Gupta as Senior Director of Clinical Development

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Anixa Biosciences (NASDAQ: ANIX) has appointed Suyasha Gupta as Senior Director of Clinical Development. Ms. Gupta will oversee the company's ongoing Phase 1 breast cancer vaccine and Phase 1 ovarian cancer CAR-T therapy clinical trials, as well as the upcoming Phase 2 breast cancer vaccine trial. She brings extensive experience in managing late-stage oncology and hematology clinical trials from her previous role at Genentech.

Dr. Pamela Garzone, Chief Development Officer, highlighted Ms. Gupta's expertise in oncology trial design and execution as important for Anixa's strategic goals. The company recently announced plans for their breast cancer vaccine Phase 2 trial, focusing on a therapeutic approach rather than prevention, aiming for a faster and more cost-effective path to approval.

Anixa Biosciences (NASDAQ: ANIX) ha nominato Suyasha Gupta come Direttore Senior dello Sviluppo Clinico. La sig. Gupta supervisionerà gli attuali studi clinici di fase 1 per il vaccino contro il cancro al seno e la terapia CAR-T per il cancro ovarico di fase 1, oltre al prossimo studio clinico di fase 2 per il vaccino contro il cancro al seno. Porta con sé un'esperienza approfondita nella gestione di studi clinici avanzati in oncologia e ematologia, grazie al suo ruolo precedente presso Genentech.

La dr.ssa Pamela Garzone, Direttore dello Sviluppo, ha sottolineato che l'expertise della sig. Gupta nella progettazione ed esecuzione di studi oncologici è fondamentale per gli obiettivi strategici di Anixa. L'azienda ha recentemente annunciato i piani per il loro studio clinico di fase 2 del vaccino contro il cancro al seno, concentrandosi su un approccio terapeutico piuttosto che sulla prevenzione, puntando a un percorso più rapido ed economico verso l'approvazione.

Anixa Biosciences (NASDAQ: ANIX) ha nombrado a Suyasha Gupta como Directora Senior de Desarrollo Clínico. La Sra. Gupta supervisará los ensayos clínicos en curso de vacuna contra el cáncer de mama de fase 1 y terapia CAR-T para el cáncer de ovario de fase 1, así como el próximo ensayo de vacuna contra el cáncer de mama de fase 2. Aporta una amplia experiencia en la gestión de ensayos clínicos en oncología y hematología en etapas avanzadas por su anterior trabajo en Genentech.

La Dra. Pamela Garzone, Directora de Desarrollo, destacó que la experiencia de la Sra. Gupta en el diseño y ejecución de ensayos oncológicos es crucial para los objetivos estratégicos de Anixa. La compañía anunció recientemente planes para su ensayo de fase 2 de la vacuna contra el cáncer de mama, enfocándose en un enfoque terapéutico en lugar de en la prevención, con el objetivo de un camino más rápido y rentable hacia la aprobación.

Anixa Biosciences (NASDAQ: ANIX)는 Suyasha Gupta를 임상 개발의 선임 이사로 임명했습니다. Gupta 씨는 현재 진행 중인 1상 유방암 백신 및 1상 난소암 CAR-T 치료 임상 시험과 곧 시작될 2상 유방암 백신 임상 시험을 감독할 것입니다. 그녀는 Genentech에서의 이전 역할을 통해 후기 단계의 종양학 및 혈액학 임상 시험 관리에 대한 광범위한 경험을 가지고 있습니다.

개발 최고 책임자(Pamela Garzone 박사)는 Gupta 씨의 종양학 시험 설계 및 실행에 대한 전문성이 Anixa의 전략적 목표에 중요하다고 강조했습니다. 회사는 최근 예방보다는 치료적 접근을 초점으로 한 유방암 백신 2상 시험 계획을 발표했으며, 승인 절차를 더 빠르고 비용 효과적으로 진행하기를 목표로 하고 있습니다.

Anixa Biosciences (NASDAQ: ANIX) a nommé Suyasha Gupta au poste de Directrice Senior du Développement Clinique. Mme Gupta supervisera les essais cliniques de phase 1 pour le vaccin contre le cancer du sein et la thérapie CAR-T pour le cancer de l'ovaire, ainsi que l'essai clinique à venir du vaccin contre le cancer du sein en phase 2. Elle possède une vaste expérience dans la gestion d'essais cliniques en oncologie et en hématologie à un stade avancé, acquise lors de son poste précédent chez Genentech.

Dr. Pamela Garzone, Directrice du Développement, a souligné que l'expertise de Mme Gupta en matière de conception et d'exécution d'essais oncologiques est essentielle pour les objectifs stratégiques d'Anixa. L'entreprise a récemment annoncé ses projets pour l'essai de phase 2 de leur vaccin contre le cancer du sein, en mettant l'accent sur une approche thérapeutique plutôt que préventive, visant à établir un chemin plus rapide et plus rentable vers l'approbation.

Anixa Biosciences (NASDAQ: ANIX) hat Suyasha Gupta zur Senior Director of Clinical Development ernannt. Frau Gupta wird die laufenden Phase-1-Studien zum Brustkrebs-Impfstoff und zur CAR-T-Therapie bei Eierstockkrebs sowie die bevorstehende Phase-2-Studie zum Brustkrebs-Impfstoff überwachen. Sie bringt umfangreiche Erfahrung in der Leitung von späten klinischen Studien in der Onkologie und Hämatologie aus ihrer vorherigen Rolle bei Genentech mit.

Dr. Pamela Garzone, Chief Development Officer, hob hervor, dass Frau Guptas Expertise in der Planung und Durchführung von Onkologiestudien für die strategischen Ziele von Anixa wichtig ist. Das Unternehmen hat kürzlich Pläne für die Phase-2-Studie ihres Brustkrebs-Impfstoffs angekündigt, die sich auf einen therapeutischen Ansatz anstelle von Prävention konzentriert, mit dem Ziel, einen schnelleren und kostengünstigeren Weg zur Genehmigung zu finden.

Positive
  • Appointment of experienced Senior Director of Clinical Development
  • Ongoing Phase 1 trials for breast cancer vaccine and ovarian cancer CAR-T therapy
  • Upcoming Phase 2 trial for breast cancer vaccine
  • Strategic shift to therapeutic approach for faster and more cost-effective approval path
Negative
  • None.

SAN JOSE, Calif., Oct. 7, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the appointment of Suyasha Gupta as Senior Director of Clinical Development. In this role, Ms. Gupta will work closely with Dr. Pamela Garzone, Chief Development Officer, to oversee the Company's ongoing Phase 1 breast cancer vaccine and Phase 1 ovarian cancer CAR-T therapy clinical trials, as well as the upcoming Phase 2 breast cancer vaccine clinical trial.

Suyasha Gupta is an accomplished clinical development scientist with deep expertise in executing late-stage oncology and hematology clinical trials. Prior to joining Anixa, Ms. Gupta served as a Clinical Scientist at Genentech, where she managed critical Phase 2 and 3 studies across the cancer immunotherapy pipeline. Her experience spans multiple indications (renal cell and bladder cancer, follicular lymphoma) and molecules (Atezolizumab, Mosunetuzumab). Her strength in clinical development also stems from her prior experience in clinical operations where she managed biomarker strategies for global trials across a diverse range of therapeutic areas, including Oncology and Ophthalmology. Ms Gupta is a dedicated leader in inclusive research, advancing multiple initiatives to bolster diverse patient recruitment at Genentech. She holds a Master's in Bioengineering from the University of California, Berkeley.

"We are pleased to welcome Suyasha to our team," said Dr. Garzone. "Her extensive experience managing complex oncology trials, coupled with her proven ability to lead clinical development programs, will be an invaluable asset as we advance our pipeline of innovative therapies. Suyasha's expertise in oncology, particularly in the design and execution of late-stage clinical trials, aligns perfectly with our strategic goals. Her contributions will be especially critical, not only for our current trials, but also as we embark on later stage trials."

"I am excited to join Anixa, working on advancing cutting edge science to develop therapies in areas with critical unmet need. Their cancer vaccine and CAR-T program have a strong potential to provide patients with new treatment options. I am looking forward to working with the team as we take these platforms into late-stage development," stated Ms. Gupta.

"We recently unveiled plans for our breast cancer vaccine Phase 2 trial, which will focus on a therapeutic approach rather than prevention, a strategy we believe will lead to a faster and more cost-effective path to approval. This strategy not only offers a faster route to regulatory success but also ensures a more cost-effective approach, maximizing the impact of our resources. With Suyasha's leadership and expertise, we are confident that we will bring this promising therapy to patients more efficiently and effectively," concluded Dr. Garzone.

About Anixa Bioscience's Breast Cancer Vaccine

Anixa's breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in certain breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.

Initial Phase 1 data was presented at the San Antonio Breast Cancer Symposium in December 2023. The data showed no safety concerns, with protocol defined immune responses observed in a majority of patients. Additional data from the Phase 1 trial will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in early November 2024.

The Phase 1 trial is conducted in collaboration with Cleveland Clinic and is funded by a grant from the U.S. Department of Defense. Anixa is the exclusive worldwide licensee of the novel breast cancer vaccine technology developed at Cleveland Clinic. The grant funding from the U.S. Department of Defense was provided to Cleveland Clinic.

This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute. Cleveland Clinic exclusively licensed this technology to Anixa Biosciences. Dr. Tuohy was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.

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. The Company's vaccine portfolio includes vaccines being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple negative breast cancer (TNBC), the most lethal form of the disease – 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. 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 Twitter, LinkedIn, 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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SOURCE Anixa Biosciences, Inc.

FAQ

What is Anixa Biosciences' (ANIX) latest appointment?

Anixa Biosciences has appointed Suyasha Gupta as Senior Director of Clinical Development to oversee ongoing Phase 1 trials and the upcoming Phase 2 breast cancer vaccine trial.

What clinical trials is Anixa Biosciences (ANIX) currently conducting?

Anixa Biosciences is currently conducting Phase 1 trials for a breast cancer vaccine and an ovarian cancer CAR-T therapy.

What is Anixa Biosciences' (ANIX) new strategy for their breast cancer vaccine?

Anixa Biosciences is shifting to a therapeutic approach for their breast cancer vaccine in the upcoming Phase 2 trial, aiming for a faster and more cost-effective path to approval.

How does Suyasha Gupta's experience benefit Anixa Biosciences (ANIX)?

Suyasha Gupta's extensive experience in managing complex oncology trials and late-stage clinical development aligns with Anixa's strategic goals and will be important for advancing their pipeline of innovative therapies.

Anixa Biosciences, Inc.

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