Judy Wang, MD is Lead Author of Manuscript Detailing Investigational Treatment to Improve Immunotherapy Outcomes for Patients with Advanced Cancers

FORT MYERS, Fla., Sept. 25, 2025 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) Associate Director of Drug Development Judy Wang, MD is lead author of a phase 1/2 study manuscript detailing an investigational treatment regimen aimed at boosting patient response to immunotherapy by supporting the gut microbiome. The trial results, "Phase 1/2, open-label study of oral bacterial supplementation (EDP1503) plus pembrolizumab in participants with advanced or metastatic microsatellite-stable colorectal cancer, triple-negative breast cancer, and checkpoint inhibitor–relapsed tumors" are published in the August 2025 issue of Investigational New Drugs.

Dr. Wang noted, "While immune checkpoint inhibitors have helped many people with cancer, some patients don't respond or may stop responding over time. One reason this can happen is that the gut microbiome and other factors can affect how well the treatment works."

The study, conducted at sites in the U.S. and Canada between 2018 and 2021, investigated the safety, tolerability, and efficacy of combining an oral bacterial supplement (EDP1503) alone and in combination with pembrolizumab (KEYTRUDA®) in patients with advanced MSS colorectal cancer, triple negative breast cancer, and checkpoint inhibitor-relapsed tumors.

The authors concluded: "EDP1503 was considered generally safe and well tolerated as monotherapy and in combination with pembrolizumab, and it demonstrated clinical benefit as a combination regimen in a subset of subjects. Emerging anti-tumor activity warrants further large prospective studies."

Additionally, the authors noted: "Comparing studies of live bacterial biotherapeutics can be challenging because of the variability of bacterial strains tested, treatment dosage, and treatment duration… Regardless, ongoing studies are evaluating oral bacterial supplementation to improve immunotherapy response."

"Every clinical trial deepens our understanding of cancer and paves the way for better treatments, improved patient care, and brighter outcomes for patients worldwide," said Manish R. Patel, MD, FCS medical director of drug development.

This study was made available through a partnership with Sarah Cannon Research Institute, one of the world's leading clinical research organizations that helps bring innovative treatment options to FCS patients. FCS provides ongoing access to more than 150 clinical trials within 29 FCS clinics and three early-phase Drug Development Units (DDUs) located in Sarasota and Central Florida. In recent years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation, prior to approval, and many of these therapies began as Phase 1 or first-in-human clinical trials at FCS DDUs.

View the abstract: https://rdcu.be/eHBeH

https://ascopubs.org/journal/po 

About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)
For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program.

FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS.

Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes.

SOURCE Florida Cancer Specialists & Research Institute