On July 28, 2020 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that its prophylactic breast cancer vaccine is making progress towards clinical trials (Press release, Anixa Biosciences, JUL 28, 2020, View Source [SID1234562432]).
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Anixa and Cleveland Clinic intend to file the Investigational New Drug (IND) Application with the US Food and Drug Administration by the end of the current quarter. Despite government-mandated laboratory closures, disruptions and constraints due to the coronavirus pandemic, there has not been a significant delay in this vaccine’s development timeline.
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.
The underlying 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 the age of childbirth, the immune system could be trained to destroy the cancer cells as they arise, 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.
"We are extremely excited to move forward with this technology. At the current time, the bulk of the IND application is completed. The main portion that remains to be finished is the CMC section (Chemistry, Manufacture and Control)," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences. "After completion of the IND, it will be reviewed by our regulatory experts and committees and then filed with the FDA. We have already had two pre-IND meetings with the FDA as this is a novel vaccine technology."