Developing a Vaccine to Prevent Breast Cancer


Vincent K. Tuohy, PhD, the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research

What is a preventive breast cancer vaccine?

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.

What is Shield Biotech?

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.

When will clinical trials begin?

Phase I trials are expected to start within two years and will take about three years to complete.

Who will be in the Phase I trial?

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.

What will the Phase I trials tell us?

These trials are designed to establish the safety of the vaccine in women and to characterize and optimize the immune response. How can a patient enroll in the clinical trials?

Patients are not being enrolled yet, and the trials won’t begin until 2015. To stay updated on information on the clinical trial, please continue visiting this web site and for information on other breast cancer trials visit the NIH’s

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