Dec 11, 6:34 PM ET
Anixa Biosciences Final Phase 1 Breast Cancer Vaccine Data Meets Primary Endpoints
On December 11, 2025, Anixa Biosciences and Cleveland Clinic presented final Phase 1 data for its investigational breast cancer vaccine at the 2025 San Antonio Breast Cancer Symposium. The company said the trial met all major primary endpoints, the vaccine was safe and well tolerated at the maximum tolerated dose, and 74% of participants showed protocol-defined immune responses. The filing discloses clinical results only, with no financial figures, and the data will inform planned Phase 2 study design.
- Trial enrolled 35 participants across three cohorts; 74% of participants demonstrated protocol-defined immune responses
- Primary adverse event was injection-site irritation; two participants in Cohort Ic had Grade 3 adverse events of greater injection-site irritation
- Data will inform a planned Phase 2 study, including a potential neoadjuvant combination study with Keytruda in newly diagnosed breast cancer patients
- Trial was funded by a grant from the U.S. Department of Defense and conducted with Cleveland Clinic