Anixa Biosciences and Cleveland Clinic Share New Positive Phase 1 Breast Cancer Vaccine Data at SITC Annual Meeting

Anixa Biosciences, a biotechnology company based in San Jose, California, has shared new promising results from its ongoing Phase 1 clinical trial of a breast cancer vaccine. The announcement was made at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Houston, Texas. This trial is a collaboration with Cleveland Clinic and funded by a grant from the U.S. Department of Defense.

The presentation titled "Phase I Trial of alpha-lactalbumin vaccine in high-risk operable triple negative breast cancer (TNBC) and patients at high genetic risk for TNBC" was delivered by Dr. Emily Rhoades from Cleveland Clinic. G. Thomas Budd, M.D., principal investigator of the study, highlighted the challenges in treating triple-negative breast cancer, expressing optimism that this vaccine could become a preventive measure for individuals at risk of this aggressive disease.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, expressed satisfaction with the trial's progress and announced their plans for a Phase 2 study to begin in 2025. Dr. Kumar extended gratitude to all participants and the broad team of scientists and physicians involved in the study.

The investigational vaccine, originating from the research of the late Vincent Tuohy, Ph.D., targets the lactation protein α-lactalbumin, which is typically only produced during lactation but is also found in malignant breast cancer cells, including TNBC. Dr. Tuohy's work demonstrated that stimulating the immune system to target α-lactalbumin could prevent breast tumors in mice. This research was partly funded by philanthropic contributions to Cleveland Clinic.

The clinical trial aims to test this vaccine in three cohorts. Cohort 1a includes women who have undergone standard treatment for TNBC. Key results from this cohort show the vaccine to be safe, with no severe side effects and successful immune responses in over 70% of patients. Cohort 1b involves women with high genetic risk for breast cancer who opted for preventative mastectomies. The vaccine's safety and tolerability were confirmed in this group as well, and further immune response analysis is ongoing. Cohort 1c examines the vaccine in conjunction with pembrolizumab (Keytruda) in post-surgery TNBC patients. Early results indicate no significant side effects from the combination treatment, though one patient experienced a higher level of injection site irritation, leading to a protocol amendment for future participants.

Looking forward, Anixa plans to test the vaccine in a Phase 2 study involving newly diagnosed breast cancer patients undergoing neoadjuvant treatment. This study will assess immune responses, safety, and the potential efficacy of the vaccine in preventing the recurrence of breast cancer. If successful, the data might pave the way for a strategic partnership with a pharmaceutical company for commercialization.

Anixa Biosciences continues to advance its portfolio in cancer treatment and prevention, including collaborations on ovarian cancer immunotherapy and further vaccine developments targeting various malignancies. The company's unique approach leverages partnerships with renowned research institutions, facilitating the exploration and commercialization of emerging technologies.