The FDA has OK’d human clinical trials for Anixa Biosciences (NASDAQ: ANIX) and Cleveland Clinic’s novel breast cancer vaccine that immunizes against the alpha-lactalbumin protein.
Within the mammary gland, the alpha-lactalbumin protein is involved in lactose synthase production, which, in turn, is required to make lactose and milk. Typically expressed later in pregnancy and during lactation, the alpha-lactalbumin protein is also expressed in many breast cancer tissues.
The researchers at Anixa and the Cleveland Clinic anticipate the vaccine will enable the immune system to kill cancer cells before they grow into mature cancer.
“This is paradigm-shifting in the way the vaccine works,” said Dr. Amit Kumar, CEO of Anixa. “We have identified a protein that is ‘retired’ from service,” Kumar explained, referring to the alpha-lactalbumin protein. “Once the woman stops breastfeeding, lactation ceases and the protein disappears until the woman has another child, and goes away again after ceasing breastfeeding.” But as described earlier, the protein can return outside of the context of breastfeeding in breast cancer cells.
“Our vaccine immunizes women, teaching the immune system to attack and destroy the cells producing this protein only,” Kumar said. “Thus, the immune system destroys the aberrant cells before they can reproduce and eventually gain critical mass and become a tumor.”
Kumar thus describes the vaccine as prophylactic in that it “prevents the tumor from even forming.” The mechanism works in animals, and “now we have been given clearance to see if it works in humans as described here,” Kumar added.
By contrast, other breast cancer vaccines target tumors that have already developed. “Those [therapeutic cancer] vaccines try to create an immune response to destroy the tumor,” Kumar said. “All therapeutic cancer vaccines, regardless of mechanism of action, have failed,” he added.
Therapeutic vaccines are also difficult to develop. “Using a layperson’s analogy, trying to destroy the tumor once it has already formed is like running a race against Usain Bolt, and giving him a 100 meter head start,” Kumar noted. “Ordinarily, one would lose the race anyway, and now with the 100-meter head start, there is no chance of winning.”
By contrast, a prophylactic vaccine gives a runner a 100-meter head start. “It will still be a tough race, but there is a good chance one could win,” Kumar said. “Basically, our vaccine wants to be prepared to destroy the cancer when it begins and it is only a few cells in size as opposed to a tumor that is billions or trillions of cells in size.”
Anixa plans on first focusing on using the vaccine to treat triple-negative breast cancer.
Cleveland Clinic immunologist Dr. Vincent Tuohy invented the vaccine. Cleveland Clinic oncologist Dr. Thomas Budd will lead the clinical trial associated with the IND.
Anixa Biosciences holds the exclusive license to the vaccine.
“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,” Kumar said. “This approval triggers a cascade of events and activities, that will eventually lead to recruitment of patients and initiation of the trial.”
The U.S. Department of Defense is helping fund the research.
Mayo Clinic and Johns Hopkins Kimmel Cancer Center researchers are also developing breast cancer vaccines.
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