Human trial of first breast cancer vaccine begins

Researchers at Cleveland Clinic’s Lerner Research Institute have begun the first human clinical trials of a vaccine to prevent triple negative breast cancer, the most aggressive and lethal form of the disease.

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 characterize and optimize the body’s immune response.

The US Food and Drug Administration (FDA) has authorized the continuation of research on this vaccine, which has allowed Cleveland Clinic and its partner Anixa Biosciences to begin their study.

“We are hopeful that this investigation lead to more advanced trials to determine vaccine efficacy against this highly aggressive type of breast cancer, “explained G. Thomas Budd, of the Taussig Cancer Institute at the Cleveland Clinic and principal investigator of the study.

“In the long term, we hope that this can be a true preventive vaccine that it would be administered to healthy women to prevent them from developing triple negative breast cancer, the form of breast cancer for which we have less effective treatments, “he highlighted.

There is a great need for improved treatments for triple negative breast cancer, which does not have biological characteristics that are typically responsive to hormonal or targeted therapies. Despite representing only about 12-15% of all breast cancers, triple negative breast cancer accounts for a disproportionately higher percentage of deaths and it has a higher recurrence rate.

This type of breast cancer has twice as likely to occur in African American women, and approximately 70% to 80% of breast tumors that occur in women with BRCA1 gene mutations are triple negative breast cancer.

The investigational vaccine targets a specific lactation protein in the breast, lactalbumin, which is no longer found after infancy in normal and aging tissues, but is present in most triple negative breast cancers.

Activation of the immune system against this “withdrawn” protein provides preventive immune protection against tumors emerging breast cells expressing lactalbumin.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.