image: Breast imaging of one trial patient before (left image) and after (right image) six weeks of experimental immunotherapy. Note diminution of area of disease (dense white area on rightmost breast in each image) after treatment.
Credit: Kent State University/Moffitt Cancer Center
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,” Czerniecki said.
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.
About Gary Koski and Brian Czerniecki
Koski has been teaching at Kent State, an R1 top-tier research university, since 2010 and is a recipient of Kent State’s Distinguished Teaching Award. He earned his zoology pre-med degree from Kent State before getting a Ph.D. in immunology and infectious disease at Johns Hopkins University. After receiving his doctorate, he conducted research at the National Institutes of Health, University of Pennsylvania Medical School and Cleveland Clinic. He currently teaches Immunology and Principles of Infectious Disease and pursues research in the areas of immunology, cancer immunotherapy and dendritic cell biology.
For more information about Kent State’s Department of Biological Sciences, visit www.kent.edu/biology.
Czerniecki received his Bachelor of Science in Biochemistry from the University of Maine and his Doctor of Medicine from the University of Medicine and Dentistry of New Jersey (UMDNJ), Robert Wood Johnson Medical School, and his Ph.D. from UMDNJ-Robert Wood Johnson and Rutgers University. He completed his general surgical residency at Ohio State University and was Surgical Oncology Fellow at the National Cancer Institute prior to his position at the University of Pennsylvania, Philadelphia. While at the University of Pennsylvania, Dr. Czerniecki served as professor of surgery, Perelman School of Medicine; attending surgeon, Department of Surgery, Hospital of the University of Pennsylvania; and co-director of the Rena Rowan Breast Center–Recruitment and Center Expansion. His research interests focus on dendritic cell biology and interactions with T cells. He has developed dendritic cell vaccines for the treatment of cancer. He is known nationally for his contribution to the development of sentinel lymph node mapping, a procedure for determining the spread of cancer into lymph nodes that is less invasive than diagnostic surgery.
For more information about Czerniecki and Moffitt Cancer Center, visit www.moffitt.org/providers/brian-czerniecki/.
# # #
Photo Caption:
The top image is Gary Koski, Ph.D., professor (left) and Carissa Lepore, Ph.D., a lab team member and research scientist in the Department of Biological Sciences at Kent State University, in Koski's Cunningham Hall laboratory on the Kent Campus.
Media Contacts:
Jim Maxwell, JMAXWEL2@kent.edu, 330-672-8028
Emily Vincent, evincen2@kent.edu, 330-672-8595
Journal
JAMA Oncology
Method of Research
Randomized controlled/clinical trial
Subject of Research
People
Article Title
Alteration of the Tumor Microenvironment With Intratumoral Dendritic Cells Before Chemotherapy in ERBB2 Breast Cancer
Article Publication Date
5-Dec-2024
COI Statement
Dr Han reported nonfinancial support from Natera during the conduct of the study as well as grants from the US Department of Defense; research support from AbbVie, Arvinas, Pfizer, Zymeworks, Senhwa, Quantum Leap Health, Mersana, and Gilead; and personal fees from Onclive, Paradigm, Pfizer, and Arvinas outside the submitted work. Dr Mo reported grants from the National Cancer Institute and National Institutes of Health during the conduct of the study. Dr Soliman reported personal fees from AstraZeneca, Novartis, Eli Lilly, and Sermonix outside the submitted work. Dr Costa reported personal fees from AstraZeneca, Daiichi Sankyo, Pfizer, and Gilead Sciences outside the submitted work. Dr Lee reported grants from the US Department of Defense, consulting fees from Elucent, and advisory board service for Provepharm outside the submitted work. Dr Koski reported contract work for the CTL Corporation and a patent pending for dendritic cell production and activation methods for ImmunoRestoration outside the submitted work. Dr Czerniecki reported intellectual property with ImmunoRestoration and advisory board service for Merit during the conduct of the study as well as a patent for the development of syringe ready dendritic cells for cancer therapy pending outside the submitted work. No other disclosures were reported.