Hospitals, Pharma, Startups

Cleveland Clinic immunologist’s research yields breast cancer vaccine spinoff Shield Biotech

Cleveland Clinic researcher Vincent Tuohy first made waves back in 2010 when he published a […]

Cleveland Clinic researcher Vincent Tuohy first made waves back in 2010 when he published a promising study in Nature Medicine about a breast cancer vaccine he’d been developing. In that study, none of the cancer-prone mice injected with a single dose of the vaccine developed breast cancer, but all of the mice who didn’t get vaccinated did.

Now, three year later, that vaccine is almost ready to be tested in humans. Today Cleveland Clinic Innovations announced it’s created a startup called Shield Biotech to complete pre-clinical development of Tuohy’s technology and seek permission from the FDA to begin testing it in humans.

“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,” Tuohy explained in a statement. “We hope to provide women with a safe, effective and relatively benign alternative to invasive prophylactic mastectomy.”

Triple-negative breast cancer, which accounts to about 10-20 percent of breast cancer cases, does not respond to hormonal drugs or therapies that target HER2 receptors like Herceptin, according to breastcancer.org. The vaccine targets alpha-lactalbumin, a protein found in the majority of breast cancers, but not in healthy women except those who are breast feeding.

According to Cleveland Clinic, if all goes well with its IND application to the FDA, Phase 1 clinical trials are expected to start within two years and will likely take about three years to complete. A Phase 1a trial would test the dosage of the vaccine and study the immune response in women with triple-negative breast cancer who have recovered from current standards of care involving chemotherapy, radiation therapy and/or surgery. A Phase 1b study would test safety of the vaccine in high-risk, healthy women who undergo voluntary bilateral mastectomy to lower their risk of developing cancer.

“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,” said Dr. Thomas Graham, Cleveland Clinic’s chief innovation officer.

Tuohy will become chief scientific officer of the new company.

[Image courtesy of Cleveland Clinic]

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