A groundbreaking Phase 1 clinical trial for an alpha-lactalbumin (aLA) vaccine targeting breast cancer has been completed, funded by the U.S. Department of Defense, marking a significant milestone in cancer prevention and treatment.

The trial focused on assessing safety, tolerability, and preliminary efficacy, with the results described as 'exceeding expectations' by the CEO, Dr. Amit Kumar, who emphasized its promising potential.

Comprehensive data, including blood and tissue analysis, will be presented at the upcoming San Antonio Breast Cancer Symposium by Dr. Justin Johnson, providing critical insights to guide future Phase 2 development and discussions with the FDA and Department of Defense.

The vaccine's development is rooted in extensive preclinical work at Cleveland Clinic, and its positive early results suggest it could significantly impact breast cancer prevention and treatment.

Beyond breast cancer, Anixa's portfolio includes vaccines for ovarian and other cancers, developed in collaboration with Cleveland Clinic and Moffitt Cancer Center, utilizing innovative immunotherapy approaches.

Recent progress also includes completing dosing in a higher-dose cohort for a CAR-T therapy targeting recurrent ovarian cancer, which showed no dose-limiting toxicities.

Despite operating at a loss, Anixa maintains a strong financial position with more cash than debt and significant liquid assets, positioning it well for ongoing development.

This first-in-class vaccine, developed at Cleveland Clinic and licensed to Anixa Biosciences, builds on decades of preclinical research led by Vincent Tuohy, Ph.D., and has the potential to revolutionize breast cancer strategies.

The final results of this trial will be formally presented at the symposium on December 11, 2025, with the full report submitted to regulatory agencies to support subsequent clinical phases.

In addition to the breast cancer vaccine, Anixa has secured patents in the U.S., China, and Canada extending into the 2040s, reinforcing its intellectual property position in cancer therapeutics.

While specific efficacy data from the trial has not been disclosed, early indications and the CEO's comments suggest the results are very encouraging and could have a transformative impact.

The vaccine technology, based on decades of research by Vincent Tuohy, has been licensed exclusively to Anixa and is seen as a potential game-changer in cancer prevention and treatment.