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 providing healthy cancer-free women with pre-emptive immunity against emerging breast tumors," said Tuohy. "We propose to provide women with an immune defense or shield that will protect them from developing breast cancer. Our data show that safe and effective immune protection against this disease can be induced by vaccinating against proteins that are no longer expressed in aging breast tissues but are significantly overexpressed in triple-negative breast cancer, the most aggressive and lethal form of this disease. We hope to provide women with a safe, effective and relatively benign alternative to invasive prophylactic mastectomy."
Triple-negative breast cancer has a higher recurrence rate than other forms of breast cancer and is insensitive to current forms of adjuvant therapy. It's the predominant form of breast cancer that occurs, for example, in women with BRCA1 mutations.
G. Thomas Budd, M.D., of Cleveland Clinic's Taussig Cancer Institute, will be on the company's scientific advisory board charged with the design and execution of the clinical trial protocol.
The first (Phase Ia) trial will involve women with triple-negative breast cancer who have recovered from current standard of care involving chemotherapy, radiation therapy, and/or surgery. This trial will determine the dose and frequency of vaccination needed to provide an optimum immune response. The second (Phase Ib) trial will involve healthy cancer-free women at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk. This trial will focus on the safety of the vaccine by examining the removed breast tissue for any potential changes.
"We expect these clinical trials to lead to more advanced trials designed to determine the effectiveness of the vaccine in treating triple-negative breast cancer, as well as its potential for immunoprevention," said Dr. Budd.