A vaccine to prevent breast cancer being developed by Cleveland Clinic researchers has shown “overwhelmingly favorable results” in animals and could be on its way to conquering the disease that kills more than 40,000 American women each year.
Researchers led by Vincent Tuohy, an immunologist at the Clinic’s Lerner Research Institute, have found that a single vaccination with the antigen alpha-lactalbumin prevents breast cancer tumors from forming in mice and inhibits the growth of existing tumors.
Enrollment in human trials could begin next year. If successful, the vaccine would be the first to prevent breast cancer and could point the way to vaccines for other cancers. It also could be a huge commercial success for the Clinic, which typically licenses or spins off its discoveries to companies that take them to market.
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“We believe that this vaccine will someday be used to prevent breast cancer in adult women in the same way that vaccines have prevented many childhood diseases,” said Tuohy, the study’s principal investigator, in a press release. “If it works in humans the way it works in mice, this will be monumental. We could eliminate breast cancer.”
Tuohy’s research will be published online today at Nature.com and in the June 10 issue of the Nature Medicine journal.
In Tuohy’s study, cancer-prone mice were vaccinated — half with a vaccine containing alpha-lactalbumin and half with a vaccine that did not contain the antigen. Not one of the mice vaccinated with alpha-lactalbumin developed breast cancer, while all of the other mice did.
The Food and Drug Administration has approved cancer-preventing vaccines for cervical and liver cancers — both act on viruses that cause the cancers, not on cancer formation.
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In developing his vaccine, Tuohy solved the quandary of targeting cancer — an overdevelopment of the body’s own cells — rather than a foreign substance, such as a virus. Vaccinating against a virus destroys the virus, but vaccinating against a person’s own cells destroys healthy cells.
So Tuohy and his colleagues created a vaccine that seeks alpha-lactalbumin, which is a protein found in the majority of breast cancers, but is not found in healthy women except when they breast-feed. The vaccine would destroy healthy breast tissue of women who are lactating, so these women likely would not get the vaccine.
Because the protein is linked to lactation, the strategy behind the new vaccine would be to vaccinate women who are over 40 years old — when the risk of breast cancer begins to rise and pregnancy becomes less likely. Younger women at heightened risk for breast cancer could consider the vaccine as an alternative to prophylactic mastectomy.
“Most attempts at cancer vaccines have targeted viruses or cancers that have already developed,” said Dr. Joseph Crowe, director of the Clinic’s Breast Center, in the release. “Dr. Tuohy is not a breast cancer researcher, he’s an immunologist, so his approach is completely different — attacking the tumor before it can develop. It’s a simple concept, yet one that has not been explored until now.”
A year ago, Tuohy, who studies autoimmune diseases such as multiple sclerosis, was surprised when the National Institutes of Health backed development of his breast cancer vaccine after his first request. Usually, it takes several requests to land grants in the neighborhood of $1.3 million.
Several clinical trials are underway for breast cancer vaccines. The University of Arkansas is working on a therapeutic vaccine that tricks the body into producing cancer-fighting antigens, while Generex Biotechnology has had successful early phase trials with breast cancer patients on its therapeutic vaccine.
But few if any researchers appear to be going for a prophylactic vaccine — one that prevents cancer. Tuohy envisions an adult vaccination program like those that vaccinate children against diseases like polio and measles.
“When you are an adult, you could be vaccinated against adult diseases like breast cancer, ovarian cancer, prostate cancer and so forth. Maybe even Alzheimer’s,” Tuohy said.
