Anixa Biosciences Takes Major Step in Breast Cancer Vaccine Development with FDA IND Transfer

Anixa Biosciences Advances Breast Cancer Vaccine through FDA IND Transfer

On August 4, 2025, Anixa Biosciences, Inc. announced the initiation of a significant step in its clinical development process for a breast cancer vaccine, supported by the FDA's Investigational New Drug (IND) application transfer. This process is essential for moving towards Phase 2 of the clinical trial, following encouraging results from the Phase 1 study.

Anixa, in collaboration with Cleveland Clinic, has successfully completed the enrollment of patients in the Phase 1 trial, where more than 70% of participants demonstrated positive immune responses to the vaccine. This is a major milestone that not only validates the vaccine's efficacy but also its tolerability among patients. Given that the IND application is currently held by Cleveland Clinic, Anixa is now stepping into the role of full sponsor, a move that underscores its commitment to bringing this innovative treatment to market.

To facilitate this transition, Anixa has partnered with Advyzom, a prominent regulatory consulting firm known for its expertise in FDA interactions. Advyzom will serve as Anixa's regulatory agent throughout the IND transfer and Phase 2 trial preparations. This collaboration will ensure that all regulatory requirements are seamlessly met, paving the way for the next stage of testing.

The breast cancer vaccine itself is particularly notable as it targets a unique protein known as α-lactalbumin. This protein is generally present in breast tissue during lactation but can reappear in various breast cancer forms. By inducing an immune response specifically against α-lactalbumin-expressing cells, the vaccine has the potential to provide therapeutic and preventive benefits for patients with tumors expressing this protein. Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, expressed optimism about the trial's progress, citing the significant immune responses observed.

The implications of this vaccine reach beyond immediate treatment possibilities. Anixa’s broader portfolio also includes investigational therapies for ovarian cancer, developed alongside Moffitt Cancer Center. This partnership leverages cutting-edge CAR-T technology aimed at utilizing the body’s immune system to combat cancer more effectively. The company is committed to innovating and exploring various treatment avenues by collaborating with leading research institutions, ensuring they remain at the forefront of biotechnology advancements.

As Anixa looks forward to the upcoming trials, the company is poised to navigate the complexities of clinical research, regulatory compliance, and eventual commercialization of their cancer treatment solutions. This momentous IND transfer not only highlights Anixa's strategic progression but also reinforces its dedication to improving patient outcomes in the battle against cancer.

For further information on Anixa Biosciences and their initiatives, you can visit Anixa's official website or follow them on social media platforms to stay updated on their latest advancements in cancer research and treatment facilities.

Anixa’s endeavor serves as a beacon of hope in oncology, illuminating a pathway towards potentially life-saving therapies for millions affected by breast cancer.