- Anixa Biosciences has signed a development and manufacturing agreement with Cytovance Biologics to support its Phase 2 breast cancer vaccine trial.
- Phase 1 results showed the vaccine was safe, well tolerated, and generated immune responses in 74% of participants.
Anixa Biosciences has entered into a development and manufacturing agreement with Cytovance Biologics to support the cGMP production of clinical materials for its planned Phase 2 breast cancer vaccine trial. Cytovance, a CDMO specializing in biologics, will provide contract manufacturing services for the program.
The vaccine, developed in collaboration with Cleveland Clinic, targets α-lactalbumin, a protein typically expressed during lactation but also found in certain breast cancers. The approach is designed to generate an immune response against cells expressing this protein, with the aim of delivering both therapeutic and preventive effects.
Phase 1 clinical data showed that the investigational vaccine met all primary endpoints, was safe and well tolerated at the maximum tolerated dose, and generated immune responses in 74% of participants. Based on these results, Anixa plans to advance the program into Phase 2 clinical development.
The agreement with Cytovance Biologics supports the transition into the next clinical stage by enabling cGMP manufacturing of the required materials. The CDMO will leverage its capabilities in biologics production to support the clinical trial.
“Selecting Cytovance for cGMP manufacturing marks a critical step as we prepare to advance our breast cancer vaccine into Phase 2.”
Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences
