Anixa Biosciences Announces Positive Phase 1 Data for Investigational Breast Cancer Vaccine; Primary Endpoints Were Met and Immune Response Observed in 74% of Participants
Vaccine Was Safe and Well Tolerated at the Maximum Tolerated Dose
Results Support Advancement of the Program into Phase 2 Development
Combination of Keytruda® and the vaccine generated T cell responses and showed no major additional side effects, supporting plans for a Phase 2 neoadjuvant combination study in newly diagnosed breast cancer patients
Excerpt from the Press Release:
SAN JOSE, Calif., Dec. 11, 2025 /PRNewswire/ — Anixa Biosciences, Inc. (“Anixa” or the “Company”) (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced the presentation of final data from the Phase 1 clinical trial of its investigational breast cancer vaccine (NCT04674306) at the 2025 San Antonio Breast Cancer Symposium (SABCS). The trial was conducted in collaboration with Cleveland Clinic and funded by a grant from the U.S. Department of Defense.
Final Phase 1 findings showed the investigational vaccine met all major primary endpoints, was safe and well tolerated at the maximum tolerated dose (MTD), and elicited protocol-defined immune responses in 74% of participants. The presentation, titled “Final Results of a Phase I Trial of Alpha-lactalbumin (aLA) Vaccine for Breast Cancer,” was delivered by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the breast cancer vaccine technology. The SABCS poster presentation is available at https://ir.anixa.com/events.
“Triple-negative breast cancer remains one of the most challenging subtypes to address, and Phase 1 trials are an important step in determining whether a new approach can be administered safely and activate the immune system as intended,” said G. Thomas Budd, M.D., of Cleveland Clinic’s Cancer Institute and principal investigator of the study.
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