FDA greenlights human clinical trials for Cleveland Clinic’s breakthrough breast cancer vaccine

FDA greenlights human clinical trials for Cleveland Clinic’s breast cancer vaccine

CLEVELAND, Ohio — The U.S. Food and Drug Administration on Monday cleared the way for human clinical trials to begin on a promising breast cancer vaccine, invented and developed by Cleveland Clinic researchers, who are confident the technology could be applied to a host of “preventable” ailments.

“We know enough about the immune system now to try these things. We have the ability, but we’re on snail pace. We need to be on warp speed pace,” immunologist Dr. Vincent Tuohy, the vaccine technology’s creator, told WJW.

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The clinic is partnering with San Jose, California-based Anixa Biosciences, which holds the exclusive worldwide license for the new technology, on the project that has been 10 years in the making, the TV station reported.

“This is a significant milestone for our program. Our vision has always been to prevent cancer before it arises. We are looking forward to beginning clinical trials in patients,” Tuohy said in a prepared statement.

The human trials are expected to begin by spring 2021, WJW reported.

According to a news release issued by Anixa, the technology immunizes against a protein called alpha-lactalbumin that is “expressed” in the mammary glands of women only during the latter part of gestation and during lactation. Researchers have only ever detected the protein outside of those circumstances when a woman develops breast cancer, so the hope is that vaccinating women will allow the immune system to destroy the invading cells “before they have the opportunity to grow into a mature cancer.”

“It’s not absolutely clear why, but (alpha-lactalbumin) starts being made again, and we simply have to teach the immune system to destroy the cells making that protein. Because those are cancer cells,” Anixa President and CEO Dr. Amit Kumar stated in the news release.

In preclinical trials conducted on animals, 100% of mice that were not vaccinated and got the placebo developed breast cancer and died, WJW reported.

“So we envision a 21st-century vaccine program here at the Cleveland Clinic that prevents diseases that we confront with age that we think are completely preventable,” Tuohy told the TV station.

“We think breast cancer, ovarian cancer, perhaps prostate cancer, are all preventable diseases, and that’s why we want to bring our vaccine program up to the 21st-century,” he added.