Anixa Biosciences and the Cleveland Clinic have filed an investigational new drug application for a breast cancer vaccine with the U.S. Food and Drug Administration.
The vaccine technology was developed by researchers at the Cleveland Clinic. Funding from the U.S. Department of Defense is expected to enable completion of two Phase 1 clinical trials, according to a press release.
The vaccine, for which Anixa holds an exclusive worldwide license, 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 normally is produced in the mammary glands only during lactation, but then goes away. Scientists at the Cleveland Clinic, however, discovered that alpha-lactalbumin reappears in certain breast cancer cells, particularly in the case of triple-negative breast cancer (TNBC), the disease’s deadliest form.
This raises the possibility of administering a vaccine against alpha-lactalbumin in the span after a woman’s child-bearing years and the occurrence of breast cancer. If and when alpha-lactalbumin once again appears, it theoretically would be in the context of cancer and the immune system would specifically target only cancerous cells — limiting, if not preventing, tumors from taking root.
“This has the potential to be a paradigm-shifting clinical study,” Vincent Tuohy, PhD, of the Cleveland Clinic’s Lerner Research Institute, said in the press release. Tuohy discovered alpha-lactalbumin’s on-again, off-again activity and invented the potential vaccine technology.
“This initial clinical trial will be with women who have been diagnosed with high-risk early stage TNBC and are receiving standard of care at Cleveland Clinic,” said G. Thomas Budd, MD, of the Taussig Cancer Center at Cleveland Clinic, the clinical investigator who will be conducting the trial. “We look forward to commencing the Phase 1 clinical trial and evaluating these patients.”
A mouse study led by Tuohy in 2010 showed that a vaccination against alpha-lactalbumin conferred resistance to breast cancer without causing autoimmune reactions.
A later study in mice and also in human cells and tissue, confirmed that alpha-lactalbumin was expressed significantly in TNBC cells, showing that humans probably could mount an immune response against alpha-lactalbumin, and that this could occur regardless of having a history of breastfeeding and lactation.
“If our data demonstrate results similar to the pre-clinical studies, this vaccine could have a significant impact on breast cancer, the most common malignancy in women. Furthermore, the way we think about controlling breast cancer may completely change,” Tuohy added.