Anixa Biosciences, Inc. announced that Cleveland Clinic presented the most up-to-date data from the Phase 1 Trial of its breast cancer vaccine.  The data presented showed that in the vaccinated women who have been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels.  The presentation was made by G. Thomas Budd, M.D., of Cleveland Clinic's Taussig Cancer Institute and principal investigator of the study.  This breast cancer vaccine technology was invented at Cleveland Clinic, where the trial is being conducted, and Anixa is the exclusive worldwide licensee.  The trial is funded by a grant from the U.S. Department of Defense to Cleveland Clinic. The Phase 1a study is designed to evaluate the safety of the vaccine, identify the Maximum Tolerated Dose (MTD), and monitor the immune response in vaccinated women.  All participants in the Phase 1a study are women who have had triple negative breast cancer (TNBC) within the last three years and have been curatively treated having undergone standard of care.  At the time of vaccination, these participants are tumor-free, as determined by standard diagnostic techniques, but are at high risk of recurrence.

About Triple-Negative Breast Cancer: One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence.  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.

About Anixa Bioscience's Breast Cancer Vaccine: Anixa's breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body.  One such protein is a breast-specific lactation protein, a-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers.  Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express a-lactalbumin.  The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.  This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic's Lerner Research Institute.  Dr. Tuohy was inventor of the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences.  He was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.