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Cleveland Clinic's preventive breast cancer vaccine development takes step forward
Date:9/17/2013

Tuesday, Sept. 17, 2013, Cleveland: Cleveland Clinic Innovations has created a spin-off company to develop a preventive breast cancer vaccine based on research from Cleveland Clinic's Lerner Research Institute.

The new company, Shield Biotech, will complete preclinical development and seek permission from the FDA to test the vaccine as an investigational new drug in proof-of-concept, first-in-human clinical trials. The trials are expected to start within two years and will take about three years to complete.

"The mission of Shield Biotech will be to translate the scientific research on a breast cancer vaccine, led by Vincent Tuohy, Ph.D., at Cleveland Clinic, into a viable preventive alternative for the patients who may benefit," said Thomas Graham, MD, Cleveland Clinic's Chief Innovation Officer. "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."

Initially, Shield Biotech will extend the development to the clinical stage in which the vaccine will be tested in two Phase I clinical trials as part of the process to obtain FDA approval. These trials are designed to establish the safety of the vaccine in women and to characterize and optimize the immune response.

Researchers at Cleveland Clinic's Lerner Research Institute found that a single vaccination could prevent breast tumors from occurring in mice genetically bred to develop breast cancer, while also inhibiting the growth of already existing breast tumors. The research was originally published in Nature Medicine in 2010.

Tuohy, the principal investigator on the original vaccine study, and an immunologist in Cleveland Clinic's Lerner Research Institute, will be Shield Biotech's chief science officer.

"We have proposed that breast cancer may be effectively controlled by provid
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Contact: Joe Milicia
milicij2@ccf.org
216-636-5873
Cleveland Clinic
Source:Eurekalert

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