Cleveland Clinic Phase 1 trial: Preventive vaccine for triple-negative breast cancer shows immune re
The Cleveland Clinic, in partnership with Anixa Biosciences, launched a Phase 1 clinical trial in October 2021 for a preventive vaccine against triple-negative breast cancer (TNBC). The vaccine targets alpha-lactalbumin, a protein found in TNBC tumors. Final Phase 1 results, presented in December 2025, showed the vaccine produced an immune response in 74% of participants and was safe and well-tolerated, with mild injection site reactions as the primary side effect. Phase 2 of the trial is expected to begin in late 2026, focusing on vaccine efficacy in preventing recurrence and potentially preventing TNBC in high-risk individuals.
Timeline
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2021
3 updatesThe first human participants, including Jennifer Davis, began receiving the experimental vaccine in the fall of 2021. [4]
Dr. Thomas Budd, principal investigator, discussed the trial's focus on patients with a history of triple-negative breast cancer and the long-term goal of a preventive vaccine for healthy women. [14]
The U.S. Food and Drug Administration (FDA) approved an investigational new drug application for the vaccine, clearing the way for the clinical trial to proceed. [8, 12]
Story began · 4 years, 6 mo ago