Published: Oct 27, 2021 By Vanessa Doctor, RN
The decision to move forward with the trial comes on the heels of the U.S. Food and Drug Administration’s approval of its Investigational New Drug (IND) application, allowing Cleveland Clinic and its partner, Anixa Biosciences, to proceed. The study will evaluate the maximum dose that can be tolerated for the vaccine in patients who are diagnosed with early-stage triple-negative breast cancer and optimize the body’s immune response.
Triple-negative breast cancer occurs in only about 10% to 15% of breast cancer cases. However, it has a high mortality rate and rate of recurrence. The vaccine is designed to target α-lactalbumin, a breast-specific lactation protein that remains high in patients with the disease but should already be gone as tissues age. By activating the immune system against this type of protein, scientists believe it is possible to prevent the formation of tumors that express it.
The Phase I trial, supported by funding from the U.S. Department of Defense, will study 18 to 24 patients who have undergone treatment for early-stage triple-negative breast cancer within the last years and are diagnosed as tumor-free but with a high risk for recurrence. Participants will receive three vaccine doses spaced two weeks apart. Cleveland Clinic hopes to complete the study by September 2022.
Aside from this trial, the researchers are anticipating another study on the same vaccine, involving participants who are healthy and without breast cancer but at risk for developing the disease and have undergone a voluntary mastectomy to reduce their risk. These participants usually carry gene mutations in either BRCA1 or BRCA2, which predisposes them to triple-negative breast cancer or any other type of breast cancer.
“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,” said Dr. Vincent Tuohy, Ph.D., the primary inventor of the vaccine and immunologist at the Lerner Research Institute of the Cleveland Clinic, in a statement.
Dr. Tuohy also said that there is a high potential for the same vaccine to be applied to other tumor types. The Phase I study is based on pre-clinical research done by Dr. Tuohy, which demonstrated a positive immune response in mouse models. The same research also observed that a single vaccination could prevent breast tumors and inhibit the growth of already existing ones in mice. The details of this study are published in Nature Medicine.
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