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Researchers Open Clinical Trial for Triple-Negative Breast Cancer Vaccine

Dr. Tuohy and his research team will begin vaccinating patients in a phase I trial to study how their triple-negative breast cancer vaccine immunizes against the protein alpha-lactalbumin.


Researchers at Cleveland Clinic, led by Vincent Tuohy, PhD, and G. Thomas Budd, MD, are now enrolling patients for a phase I clinical trial to test their triple-negative breast cancer (TNBC) vaccine, the first vaccine developed to prevent TNBC.

The study will enroll 18 to 24 women diagnosed with early-stage TNBC within the past three years who have completed treatment. Triple-negative breast cancer is the most aggressive and lethal form of breast cancer and often occurs in women with mutations in their BRCA1 gene. The trial, in partnership with San Jose, California-based Anixa Biosciences, will determine the vaccine’s safety and optimal dosing in humans, as well as its ability to induce immune responses in participants.

“Transitioning our research from the laboratory to patients in the clinic is a significant milestone for our program,” said Dr. Tuohy, primary inventor of the vaccine and researcher in the Department of Inflammation & Immunity. “Our vision has always been to prevent cancer before it develops, so we are enthusiastic about moving forward and beginning to vaccinate our first patients.”

How does the vaccine work?

The vaccine targets the protein α-lactalbumin, which is expressed in the mammary glands of women during the latter part of pregnancy and during lactation. Normally, the protein “retires” from expression in aging tissues. The only other time the protein is expressed is when a woman develops TNBC.  

“Modern vaccines are made of two parts: what we call target antigens and adjuvants,” explained Dr. Tuohy. “On a basic level, adjuvants help stimulate the immune response to respond to the target antigen. When primed, we believe that the immune system can destroy the breast cancer cells as they arise so that cancerous cells don’t have the opportunity to grow into mature tumors that are difficult to treat.”

Dr. Tuohy’s preclinical work found that vaccinating against α-lactalbumin was safe and effective in preventing breast cancer in mice. The research was originally published in 2010 in Nature Medicine.

Long-term goals for the vaccine

“The vaccine aims to provide immune protection against emerging breast tumors related to α-lactalbumin,” said Dr. Budd, an oncologist in Taussig Cancer Institute. “Our future goal, following extensive multi-phase research studies and FDA review, is to make a vaccine available to women at high risk for developing TNBC who are otherwise healthy and cancer-free.”

In December, 2020, the FDA cleared the vaccine for use in human clinical trials. The Department of Defense-funded trial will take place at Cleveland Clinic and is expected to run through September 2022.

Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences, Inc. He will receive a portion of commercialization revenues received by Cleveland Clinic for this technology and also holds personal equity in the company.

Dr. Tuohy holds the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research and Dr. Budd holds the Lula and Xen Zapis Endowed Chair in Breast Cancer Research. 


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