Overview
- Presented at the San Antonio Breast Cancer Symposium, the study reported a 74% immune-response rate with an acceptable safety profile.
- The single-center trial at Cleveland Clinic enrolled 35 participants across three high-risk cohorts (26 in Phase 1a, 4 in 1b, 5 in 1c).
- Investigators established the maximum tolerated dose, with mostly mild injection-site inflammation and a few Grade 3 ulcerations at higher doses that guided dosing decisions.
- The vaccine targets α-lactalbumin, a lactation protein absent after breastfeeding in normal tissue but expressed in most triple-negative breast cancers, to prime cellular and humoral immunity.
- Funded by the U.S. Department of Defense and licensed exclusively to Anixa, the program now advances toward a Phase II study expected to run two to three years.