Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company dedicated to cancer prevention and treatment, has begun the process of transferring the Investigational New Drug (IND) application for its breast cancer vaccine from Cleveland Clinic to its own sponsorship. This move supports the planned initiation of a Phase 2 clinical trial following positive results from the Phase 1 study.
The Phase 1 trial, conducted in collaboration with Cleveland Clinic, demonstrated that the vaccine was well tolerated, with over 70% of participants showing a protocol-defined immune response. These promising findings provide a foundation for advancing to the next stage of development. To facilitate the IND transfer and future regulatory interactions, Anixa has partnered with Advyzom, a consultancy specializing in FDA regulatory processes.
The investigational vaccine targets α-lactalbumin, a protein typically expressed only during lactation but often reappearing in breast cancer cells. By training the immune system to recognize and attack cells expressing this protein, the vaccine may offer both preventive and therapeutic benefits for certain breast cancer patients.
Dr. Amit Kumar, Chairman and CEO of Anixa, stated, “The IND transfer marks a significant step toward launching our Phase 2 trial. We’re excited to build on the encouraging Phase 1 data and continue our collaboration with Cleveland Clinic, Advyzom, and the FDA to bring this vaccine closer to patients.”
The upcoming Phase 2 study aims to further evaluate the safety, immune response, and potential clinical benefits of this novel breast cancer vaccine candidate.
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