Anixa Biosciences announced on October 7, 2025 that it has completed the final patient visit in its Phase 1 breast cancer vaccine clinical trial. The announcement was issued via a press release on October 8, 2025, and confirms the milestone was achieved the day before. This completion marks the end of the study’s active enrollment and visit schedule.
The trial enrolled 35 women across three cohorts: 26 patients with triple‑negative breast cancer, four in a prevention cohort, and five receiving pembrolizumab. All participants received the vaccine developed at Cleveland Clinic, and the study was fully funded by a U.S. Department of Defense grant. Preliminary data indicate the vaccine is well tolerated, with over 70% of participants showing protocol‑defined immune responses.
Following the final visit, Anixa will conduct comprehensive data analysis, submit a final study report to the Department of Defense, and file a Clinical Study Report with the FDA. Cleveland Clinic will present the full clinical results at the San Antonio Breast Cancer Symposium on December 11, 2025. The presentation will provide the scientific community with the complete safety and immunogenicity data.
Dr. G. Thomas Budd, Principal Investigator, said the data are encouraging and that the vaccine could represent a new paradigm in immuno‑oncology. CEO Amit Kumar added that targeting a novel antigen could offer both preventive and therapeutic benefits for breast cancer patients. The milestone underscores Anixa’s progress toward advancing its vaccine platform toward regulatory submission.
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