Anixa Biosciences Takes Charge of Breast Cancer Vaccine Development
Anixa Biosciences, Inc. announced a significant milestone on December 15, 2025, as it successfully completed the transfer of the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic. This transition allows Anixa to take on the role of trial sponsor, paving the way for continued development and future clinical trials of the innovative vaccine.
The progress comes after the completion of the Phase 1 trial, which has yielded promising data regarding immune response and safety. With draws of enthusiasm, Anixa expressed its intention to elevate the vaccine into Phase 2 trials and utilize various clinical sites, inclusive of Cleveland Clinic, for the upcoming phases of research.
The breast cancer vaccine, a product of collaborative efforts with Cleveland Clinic, is designed to target a unique protein called α-lactalbumin. This protein is typically present in breast tissue during lactation; however, it has been observed to re-emerge in various breast cancer forms. By triggering an immune response against cells expressing α-lactalbumin, the vaccine could provide both therapeutic and preventive benefits for patients with such tumors.
Developed under the expertise of the late Dr. Vincent Tuohy, who held the distinguished position as the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic, the vaccine reflects a significant advancement in the bio-pharmaceutical landscape.
In a statement, Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, expressed excitement over the transfer, emphasizing the potential of the vaccine to transform cancer treatment. “We are eager to advance this potentially game-changing cancer vaccine into future clinical trials,” he remarked, highlighting the favorable outcomes from the recent Phase 1 clinical study, which were showcased at the San Antonio Breast Cancer Symposium on December 11.
The Phase 1 data is accessible for review at Anixa's investor relations site, which reflects the transparency and dedication of the company towards its research.
Anixa Biosciences is a clinical-stage biotechnology firm concentrating on innovative cancer treatment and prevention strategies. Its current portfolio not only includes the breast cancer vaccine but also encompasses an ovarian cancer immunotherapy program developed in partnership with Moffitt Cancer Center. This program utilizes a cutting-edge CAR-T technology known as chimeric endocrine receptor-T cell (CER-T) technology, which distinguishes itself from traditional cell therapies.
Through collaboration with leading research institutions, Anixa leverages emerging technologies to enhance its product offerings and increase accessibility to effective cancer treatments. Their vaccine initiatives also extend to combat various difficult-to-treat cancers, including those affecting the lung, colon, and prostate, targeting specific proteins expressed in these malignancies.
This ongoing commitment reflects the company’s strategic approach to advance its research in tandem with renowned experts, ensuring that breakthrough innovations are not just researched but also developed and commercialized effectively.
For more information about Anixa Biosciences and their promising immunotherapy advancements, visit their official site or follow their journey on social media platforms.