Cleveland Clinic Breast Cancer Vaccine Goes To Clinical Trials

Cleveland Clinic researchers are getting ready to embark on a clinical trial testing a breast cancer vaccine.

The Food and Drug Administration (FDA) recently greenlighted a breast cancer vaccine technology developed at Cleveland Clinic, which allows clinical trials for the vaccine to move forward.

If effective, the vaccine could become a regular part of women’s health care, said Dr. Vincent Tuohy, a cancer researcher at the clinic who invented the vaccine.

“The long-term vision is a woman reaches 40 years old or so, she reaches the high-risk area age for breast cancer, she… could come in to her doctor and get her breast cancer vaccine,” Tuohy said.

The vaccine is for triple negative breast cancer, one of the most lethal forms of the disease. So far, the vaccine has only been tested in animals.

The shot protects against alpha-lactalbumin, a protein in women's mammary glands that no longer appears after childbearing years but shows up in many cases of triple negative breast cancer, he said.

The idea behind taking this vaccine is the body’s immune response would destroy cancer cells before they develop and mature, Tuohy said.

“Why do these tumors express these proteins? We don’t know. They make a mistake,” he said. “I’m trying to take advantage of the mistake the tumors make. We’d have to be crazy not to.”

In animal trials, the vaccine was shown to be very effective, Tuohy added.

If the clinical trial is approved by regulatory boards, researchers will first study the vaccine’s effectiveness in women who currently have triple negative breast cancer. They will be looking to see how much of the dose and how many doses are needed to achieve an immune response, he said.

Researchers hope to eventually test the vaccine on women in the general population.

If the trials are successful, Tuohy said he hopes people could eventually get the vaccine as part of their normal preventative care. 

Down the line, researchers hope the vaccine could work for other forms of breast cancer as well, Tuohy said.

“What I’m thinking of, here at the clinic, is a much broader vision of updating this wonderful 20 ^th century vaccine program for childhood diseases, infectious diseases, to also include primary vaccination for adults, against diseases they confront with age – like breast, ovarian cancer, prostate cancer,” he added.

The Cleveland Clinic is working in partnership with biotechnology company Anixa Biosciences. The study is set to begin in the spring of 2021.