On November 23, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that an IND (Investigational New Drug) application for its prophylactic breast cancer vaccine has been filed with the U.S. Food and Drug Administration (Press release, Anixa Biosciences, NOV 23, 2020, View Source [SID1234571562]).
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This vaccine technology was invented by a research team from Cleveland Clinic, led by Dr. Vincent Tuohy, 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. Anixa has a worldwide, exclusive license to this technology.
The technology takes advantage of self-proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein, alpha-lactalbumin, is expressed only in the mammary glands during lactation and then disappears once lactation ceases. Dr. Tuohy discovered that this protein is abnormally expressed again when a woman contracts breast cancer, especially Triple Negative Breast Cancer (TNBC), the most deadly form of this disease. Dr. Tuohy postulated that if women could be immunized against this protein after their childbearing years, the immune system could be trained to destroy cancer cells as they arise while ignoring normal cells that no longer express this protein, thus making it difficult for the cancer to gain critical mass. Early studies to test this theory demonstrated highly significant prevention of breast cancer in animal models.
The technology is being developed at Cleveland Clinic with funding from the U.S. Department of Defense. The funding is expected to enable completion of two Phase 1 clinical trials.
"This has the potential to be a paradigm-shifting clinical study," said Dr. Tuohy. "If our data demonstrate results similar to the pre-clinical studies, this vaccine could have a significant impact on breast cancer, the most common malignancy in women. Furthermore, the way we think about controlling breast cancer may completely change."
"We look forward to moving this novel technology into the clinical stage of development," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "If the data in humans is comparable to the data in animals, Dr. Tuohy’s ‘retired’ protein hypothesis will usher in a new way to prevent breast cancer, as well as other types of tumors."
"This initial clinical trial will be with women who have been diagnosed with high-risk early stage TNBC and are receiving standard of care at Cleveland Clinic," said Dr. G. Thomas Budd, Department of Medical Oncology at the Taussig Cancer Center at Cleveland Clinic, and the Clinical Investigator who will be conducting the trial. "We look forward to commencing the Phase 1 clinical trial and evaluating these patients."