Anixa Biosciences presented the final results of its phase 1 study of an α‑lactalbumin breast‑cancer vaccine at the 2025 San Antonio Breast Cancer Symposium, confirming that the vaccine met all primary safety and immunogenicity endpoints and supporting a move into a phase 2 trial. The presentation, delivered on December 11, 2025, marked a pivotal step toward regulatory approval and potential licensing opportunities for the company’s lead product.
The phase 1 study enrolled 35 participants across three distinct cohorts: women who had completed treatment for early‑stage triple‑negative breast cancer, BRCA‑mutation carriers undergoing preventive mastectomy, and patients receiving pembrolizumab (Keytruda) in the adjuvant setting. At the maximum tolerated dose, the vaccine was safe and well tolerated, and 74 % of participants achieved protocol‑defined immune responses, a rate that exceeds expectations for a first‑in‑class vaccine and demonstrates robust immunogenicity.
Anixa’s work was conducted in partnership with the Cleveland Clinic and funded by a U.S. Department of Defense grant, underscoring the strategic importance of the program to national health priorities. The collaboration provided access to a large, well‑characterized patient population and advanced clinical expertise, while the DoD grant helped offset development costs and accelerate the timeline to phase 2.
Building on the phase 1 success, Anixa plans to launch a phase 2 study that will evaluate the vaccine alone and in combination with Keytruda in a neoadjuvant setting for newly diagnosed breast‑cancer patients. The company also intends to pursue licensing agreements that could broaden the commercial reach of the vaccine and generate additional revenue streams, thereby strengthening its financial position and investor confidence.
Management emphasized the significance of the data: “The final phase 1 data met all major primary endpoints, with a favorable tolerability profile at the maximum tolerated dose and protocol‑defined immune responses in the majority of participants,” said Dr. Amit Kumar, Chairman and CEO. Dr. G. Thomas Budd, principal investigator at the Cleveland Clinic, added, “These results support continued clinical evaluation and position the vaccine as a promising candidate for early‑stage breast‑cancer treatment.”
The announcement was met with a positive market reaction, as investors and analysts highlighted the strong safety and immunogenicity profile and the potential for a new therapeutic option in a high‑need patient population. The data also reinforce Anixa’s broader immuno‑oncology pipeline and signal progress toward future regulatory milestones.
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