Anixa Biosciences announces agreement with Cytovance Biologics

Anixa Biosciences (ANIX) announced that it has entered into a development and manufacturing agreement with Cytovance Biologics, a leading full-service contract development and manufacturing organization, or CDMO, specializing in mammalian and microbially expressed biologics, to produce cGMP clinical materials for its planned Phase 2 clinical trial of its breast cancer vaccine. The agreement follows positive final Phase 1 results in which the investigational vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and generated protocol-defined immune responses in 74% of participants. Based on these results, Anixa is advancing preparations for a Phase 2 clinical trial. Anixa’s breast cancer vaccine, developed in collaboration with Cleveland Clinic, targets alpha-lactalbumin-a lactation-associated protein that is typically expressed only in breast tissue during lactation, but which re-emerges in many forms of breast cancer. By generating an immune response against alpha-lactalbumin-expressing cells, the vaccine is designed to potentially provide both therapeutic and preventive benefits for patients with tumors expressing this protein.