Anixa Biosciences (ANIX) announced that, in collaboration with Cleveland Clinic, it has initiated the transfer of the Investigational New Drug, or IND, application that supported the Phase 1 clinical trial of its breast cancer vaccine. 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 U.S. regulatory agent regarding the assigned application. Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets alpha-lactalbumin. By establising an immune response against alpha-lactalbumin-expressing cells, the vaccine may offer both therapeutic and preventive benefits for patients with tumors expressing this protein.
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