Anixa Secures Cytovance Deal After Phase 1 Yields 74% Immune Response
Anixa's Phase 1 breast cancer vaccine trial achieved safety and tolerability at the maximum tolerated dose and elicited protocol-defined immune responses in 74% of participants. The company signed a cGMP manufacturing agreement with Cytovance Biologics to supply clinical materials for its planned Phase 2 trial.
1. Positive Phase 1 Results
Anixa's investigational breast cancer vaccine met all primary endpoints in Phase 1, demonstrating safety and tolerability at the maximum tolerated dose. The study elicited immune responses in 74% of participants, supporting progression to the next development phase.
2. Cytovance Manufacturing Partnership
Anixa entered into a development and manufacturing agreement with Cytovance Biologics, a full-service CDMO, to produce cGMP-compliant clinical materials. This partnership secures supply chain capacity for the upcoming Phase 2 trial.
3. Vaccine Mechanism and Collaboration
The vaccine targets α-lactalbumin, a lactation-associated protein re-expressed in certain breast tumors, to generate targeted immune responses. Development was conducted in collaboration with Cleveland Clinic, leveraging preclinical research led by Vincent Tuohy, Ph.D.
4. Next Steps and Timeline
Anixa is advancing preparations for its Phase 2 clinical trial and expects to deliver near-term updates on trial design and patient enrollment milestones. The company continues to scale its manufacturing support and regulatory activities.