Researchers from from Cleveland Clinic’s Lerner Research Institute have launched first-of-its kind preventive breast cancer vaccine study aimed at eventually preventing triple-negative breast cancer, the most aggressive and lethal form of the disease.
There is a great need for improved treatments for triple-negative breast cancer, which does not have biological characteristics that typically respond to hormonal or targeted therapies.
The investigational vaccine targets a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues but is present in the majority of triple-negative breast cancers. Activating the immune system against this “retired” protein provides pre-emptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response that allows the immune system to mount a response against emerging tumors to prevent them from growing.
This phase I trial is designed to determine the maximum tolerated dose of the vaccine in patients with early-stage triple-negative breast cancer and to characterise and optimise the body’s immune response. The U.S. Food and Drug Administration recently approved an investigational new drug application for the vaccine, which permits Cleveland Clinic and partner Anixa Biosciences, Inc. (ANIX:NASDAQ) to start the study.
The study is based on pre-clinical research published in Nature Medicine and led by Dr Vincent Tuohy, the primary inventor of the vaccine and staff immunologist at Cleveland Clinic’s Lerner Research Institute, that showed that activating the immune system against the α-lactalbumin protein was safe and effective in preventing breast tumours in mice.
“This vaccine strategy has the potential to be applied to other tumour types,” added Dr Tuohy. “Our translational research program focuses on developing vaccines that prevent diseases we confront with age, like breast, ovarian and endometrial cancers. If successful, these vaccines have the potential to transform the way we control adult-onset cancers and enhance life expectancy in a manner similar to the impact that the childhood vaccination program has had.”