#United States #Fort Myers #Pembrolizumab #Judy Wang #EDP1503

Innovative Study by Dr. Judy Wang Enhances Immunotherapy Outcomes

Florida Cancer Specialists & Research Institute has recently made headlines with a groundbreaking study led by Dr. Judy Wang, the Associate Director of Drug Development. This research focuses on an investigational treatment designed to enhance immunotherapy outcomes for patients battling advanced cancers by leveraging the gut microbiome. The study is documented in a manuscript detailing a Phase 1/2 trial that has provided promising insights into cancer treatment.

Overview of the Study

Conducted at various sites in the United States and Canada from 2018 to 2021, the study investigated the efficacy and safety of combining an oral bacterial supplement known as EDP1503 with pembrolizumab (commercially known as KEYTRUDA®). This trial targeted individuals diagnosed with advanced microsatellite-stable colorectal cancer, triple-negative breast cancer, and tumors that had previously relapsed after checkpoint inhibitor therapy.

Dr. Wang emphasizes the challenges immunotherapy can present, particularly for patients who either do not respond to treatment or experience diminishing effects over time. She explains that one significant factor influencing immunotherapy effectiveness is the gut microbiome, which plays a crucial role in the body’s immune responses.

Study Findings

The results of the study were released in the August 2025 issue of Investigational New Drugs. It indicated that EDP1503 was generally safe and well-tolerated both as a standalone treatment and in combination with pembrolizumab. Notably, the authors found that certain patients showed clinical benefits from this combined regimen. The study highlighted an anti-tumor activity that warrants additional large-scale prospective studies to validate these findings.

Dr. Wang stated, "While immune checkpoint inhibitors have helped many people with cancer, some patients don't respond or may stop responding over time. Factors such as the gut microbiome influence the efficacy of these treatments."

Navigating Challenges in Biotherapy Studies

One challenge noted in the findings is the ongoing difficulty in comparing various studies of live bacterial biotherapeutics. This variability arises from differences in bacterial strains, dosages, and treatment durations across studies. Despite these complexities, the research team remains optimistic about the future of oral bacterial supplementation in improving immunotherapy responses.

Commitment to Advances in Oncology

Dr. Manish R. Patel, Medical Director of Drug Development at FCS, remarked, "Every clinical trial deepens our understanding of cancer and paves the way for better treatments, improved patient care, and brighter outcomes for patients worldwide." This sentiment reflects the core mission of Florida Cancer Specialists, which has been advancing cancer treatment for over 40 years, primarily through its robust clinical research programs.

Ongoing Research and FCS’s Role

Florida Cancer Specialists & Research Institute partners with Sarah Cannon Research Institute, a prominent clinical research organization, to provide patients access to cutting-edge treatment options. Currently, FCS offers participation in over 150 clinical trials spread across its 29 clinics and three Drug Development Units located in Sarasota and Central Florida. This unique position allows patients access to many drugs that undergo clinical trials before receiving FDA approval, particularly in early-phase studies.

In conclusion, the advancement demonstrated by Dr. Judy Wang’s recent study not only propels the field of cancer immunotherapy forward but also provides hope for patients striving for improved outcomes against advanced cancers. As research continues, the collaboration between innovative treatment modalities like EDP1503 and established therapies such as pembrolizumab holds promise for revolutionizing oncology practices across the globe.