Phase one trial explores novel immunotherapy for breast cancer

A groundbreaking phase one clinical trial exploring a novel cell-based immunotherapy for breast cancer has been accepted for publication in JAMA Oncology. The technology tested in the trial was co-developed by Gary Koski, Ph.D., professor in Kent State University's Department of Biological Sciences, and Brian J. Czerniecki, M.D., Ph.D., chair and senior member in the Moffitt Cancer Center's Department of Breast Oncology. The study focuses on a new treatment approach that aims to harness the body's immune system to enhance patient responses and reduce the need for conventional chemotherapy and its associated toxicities.

The trial involved 12 patients with locally advanced stage I-III HER2 breast cancer. This research builds upon insights gained from previous studies funded by a Department of Defense Breakthrough Award research grant.

We are hopeful that we will be able to use this new immunotherapy instead of chemotherapy, or at least dramatically reduce the need for chemotherapy, for all types of breast cancer."

Brian J. Czerniecki, M.D., Ph.D., chair and senior member in the Moffitt Cancer Center's Department of Breast Oncology

The immunotherapy leverages dendritic cells, critical components of the immune system that normally identify infection and mobilize other elements of immunity to repel a microbial attack. By removing some of these dendritic cells from the body, biochemically reprogramming them for anti-cancer activity and injecting them directly into breast tumors, the researchers could trigger a powerful, organized immune system attack on the cancer. This led to the significant shrinkage of tumors before standard chemotherapy was administered.

Eight out of the 12 patients demonstrated at least a 50% reduction in tumor volume after just six weeks of immunotherapy. This treatment produced only minimal side effects, primarily mild flu-like symptoms, compared with the severe side effects often associated with traditional chemotherapy.

"These exciting results are the culmination of nearly 30 years of collaborative research between my laboratory and Dr. Czerniecki's," Koski said.

The researchers have already begun a larger phase two trial to test higher doses of the immunotherapy, further exploring the potential effectiveness of this new technology.

The published clinical trial was supported by the Moffitt Breast Cancer Research Fund, the Don Shula Foundation and donations from the Pennies in Action organization, which has raised approximately $7 million over the last decade to support this innovative cancer research. This unique funding model allows patients to directly contribute to advancements in treatments that may benefit them and others in the future.