A breast cancer vaccine can now be tested in human trials after its investigational new drug application was accepted by the U.S. Food and Drug Administration (FDA).
A Phase 1 clinical trial is expected to test the vaccine, developed by Anixa Biosciences and the Cleveland Clinic, for triple-negative breast cancer (TNBC).
“We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting vaccine for the prevention of breast cancer,” Amit Kumar, PhD, Anixa’s president and CEO, said in a press release. “This approval triggers a cascade of events and activities, that will eventually lead to recruitment of patients and initiation of the trial.”
This vaccine technology was invented and developed at the Cleveland Clinic by immunologist Vincent Tuohy, PhD, and his research team. The clinical trial will be led by Thomas Budd, MD, an oncologist at the clinic.
“This is a significant milestone for our program,” said Tuohy, of the Cleveland Clinic’s Lerner Research Institute. “Our vision has always been to prevent cancer before it arises. We are looking forward to beginning clinical trials in patients.”
The vaccine targets certain proteins produced by a patient’s own body — so-called self proteins — that are made only at certain times during development, before “retiring” and disappearing.
One proposed vaccine target is alpha-lactalbumin. This protein is normally produced in the mammary glands only during lactation, but then goes away. However, alpha-lactalbumin reappears in certain breast cancer cells, particularly in the case of TNBC, the disease’s deadliest form.
Tuohy and his team hypothesized that a vaccine targeting the alpha-lactalbumin protein could help prevent the occurrence of breast cancer if given after a woman’s child-bearing years, since in this period of time, the appearance of this protein would theoretically be in the context of cancer.
In vaccinated women, the immune system would be able to specifically destroy cancer cells before the tumors could grow.
A study conducted in live animals showed that the vaccine was able to protect against breast cancer development and stop tumor growth in mice without causing an autoimmune reaction. In a later study, Cleveland Clinic researchers demonstrated that vaccination against alpha-lactalbumin completely prevented breast cancer in mice that were specifically bred to develop the disease.
Although the initial focus of this technology is TNBC, it is expected to potentially prevent against other types of breast cancer.
The U.S. Department of Defense is funding the preclinical studies and clinical trials of this vaccine.