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.
Key points
- 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
The filing
Written by AI on Nov 9, 2026, 8:51 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on December 11, 2025.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.