The new company, known as Shield Biotech, will use research from Cleveland Clinic's Lerner Research Institute for preclinical development of the drug. With permission from the Food and Drug Administration, Shield Biotech will then test the vaccine in proof-of-concept, first-in-human clinical trials that are anticipated to start within two years and take approximately three years to complete.
Cleveland Clinic Innovations offshoot to focus on breast cancer vaccine
When the new vaccine is ready for human trials, it will first be tested on women with triple-negative breast cancer who have recovered from care and then on healthy cancer-free women at high risk for developing breast cancer. The two phases are intended to determine the safety of the vaccine for women and to optimize the immune response.
“The mission of Shield Biotech will be to translate the scientific research on a breast cancer vaccine … into a viable preventive alternative for the patients who may benefit,” Dr. Thomas Graham, Cleveland Clinic's chief innovation officer, said in a news release. “We believe that the vaccine has the potential to stop the more lethal forms of breast cancer, as well as inhibiting the recurrence of triple-negative breast cancer in women after they have recovered from their initial disease.”
Scientists at the Lerner Research Institute discovered several years ago that a single vaccination had the ability to prevent breast tumors from occurring in mice that were genetically bred to develop breast cancer, as well as inhibit the growth of existent breast tumors. Results from that study, led by Vincent Tuohy, an immunologist at the institute, were published in Nature Medicine in 2010. Tuohy will also serve as Shield Biotech's chief science officer.
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