First-of-its-Kind Breast Cancer Vaccine Study Launches in Cleveland
California-based Anixa Biosciences, Inc. announced on October 26, 2021, that, in conjunction with its partner, Cleveland Clinic, it has commenced dosing of patients for a novel study of its vaccine that is being investigated for preventing triple-negative breast cancer, the most aggressive and lethal form of the disease.
Anixa has a worldwide, exclusive license to the vaccine technology originating from Cleveland Clinic.
Funded by the U.S. Department of Defense, the new study is a multiple ascending dose Phase 1 trial to determine the maximum tolerated dose of the vaccine in patients with early-stage, triple-negative breast cancer and monitor immune response.
The study will be conducted at Cleveland Clinic. It will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.
During the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The study is estimated to be completed in the third quarter of 2022.
Dr. Amit Kumar, President and CEO of Anixa Biosciences, stated in a press release, "Our vaccine has the potential to prevent the development of the most aggressive form of breast cancer – triple-negative breast cancer."
Despite representing only about 12-15% of all breast cancers, triple-negative breast cancer accounts for a disproportionately higher percentage of breast cancer deaths and has a higher recurrence rate.
Furthermore, this form of breast cancer is twice as likely to occur in African-American women.
And approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.
Anixa's investigational vaccine takes advantage of endogenously produced proteins that function at certain times in life but become "retired" and disappear from the body.