Approval of clinical trials for the first breast cancer vaccine

Researchers at the Cleveland Clinic in the US have embarked on a new study of the triple-negative breast cancer vaccine.

This is the most aggressive and dangerous form of the disease. Triple-negative breast cancer differs from other types of breast cancer in that it lacks biological characteristics that would normally be amenable to hormonal or targeted therapy.

Although it accounts for only about 15% of all breast cancers, it is responsible for a disproportionate number of deaths and recurrences of breast cancer.

“We hope that this study will lead to successful tests of the vaccine’s efficacy against this aggressive type of breast cancer,” said study lead author Dr Thomas Budd.

Phase I clinical trials will determine the maximum tolerable dose of the vaccine for early-stage triple-negative breast cancer patients, as well as improve the body’s immune response.

The U.S. Food and Drug Administration (FDA) recently approved a new vaccine research application that allows the Cleveland Clinic and its partner Anixa Biosciences, Inc., to begin the study.

The experimental vaccine targets a specific lactation protein, alpha-lactalbumin, which, after a period of breastfeeding, is not present in normal aging tissues. However, it is present in most triple negative breast cancers.

Activation of the immune system against this “inappropriate” protein provides immune protection against emerging breast tumors that cause alpha-lactalbumin to appear in tissues. The vaccine also contains an adjuvant that activates the innate immune response, allowing the immune system to respond to emerging tumors and prevent their growth.

The work is based on a preclinical study that showed that immune system activation against alpha-lactalbumin is safe and effective in preventing breast tumors in mice. The study also showed that a single vaccine could prevent mice from developing breast tumors, as well as prevent the growth of existing tumors.

The new study, funded by the US Department of Defense, will involve 18 to 24 patients who have completed early-stage triple-negative breast cancer treatment in the past three years and currently do not have tumors but are at risk of relapse.

During the study, participants will receive three vaccinations two weeks apart and will be closely monitored for side effects and immune responses. The study is expected to be completed in September 2022.