Anixa Biosciences-linked TNBC vaccine trial posts completed results after five-year run

The main development is the results posting for a long-running early-phase trial of an alpha-lactalbumin cancer vaccine, on which Anixa Biosciences is a collaborator rather than the lead sponsor.

• The trial, "Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence" (NCT04674306), is sponsored by George T. Budd with the U.S. Department of Defense and Anixa Biosciences, Inc. listed as collaborators.¹ The study is listed as completed, with primary completion on 2025-12-15 and study completion on 2025-12-29, and results were first posted 2026-07-17.
• The study is an open-label, phase I dose-escalation trial using a traditional "3+3" design across three successive cohorts to determine the Maximum Tolerated Dose.¹ Cohorts included patients with high-risk triple-negative breast cancer¹, those with a genetic risk of triple-negative breast cancer scheduled for bilateral prophylactic mastectomy¹, and those who had completed treatment for triple-negative breast cancer and were receiving adjuvant pembrolizumab.¹
• Total enrollment was 35 participants¹, and the vaccine is described as experimental because it is not approved by the Food and Drug Administration (FDA).¹