FCS Clinical Research Driving Progress to Cure Cancer

Clinical Trials Showcased at Global Gathering

Fort Myers, Fla., April 5, 2024 – Clinical research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) will be highlighted at the American Association for Cancer Research 2024 Annual Meeting in San Diego as scientists, clinicians and other health care professionals and stakeholders from all over the world gather to share the latest advances in cancer science and medicine.

“Finding cancer cures requires diligence and collaboration among the greatest minds in cancer research,” noted Lucio N. Gordan, MD, FCS President & Managing Physician. “Through our extensive and growing clinical trials research program, FCS is proud to be part of global efforts that are saving lives and enhancing the quality of life for patients and their families.”

FCS provides ongoing access to more than 160 clinical trials within 32 FCS clinics and three Drug Development Units (early-phase) across Florida, in Sarasota, Lake Mary and Lake Nona. 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.

FCS physician investigators will present findings during oral and poster sessions at the ACCR 2024 Annual Meeting.

FCS abstracts at AACR 2024 Annual Meeting: 068, 075, 132, 141, 156, 163, 291, 6552, 7172, 099, 077, 2565

FCS Director of Drug Development Manish Patel, MD, co-author of nine abstracts:

• Interim results of the ongoing phase 1-2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors
• Phase 1 trial evaluating AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer
• Phase I/IIa clinical trial (TranStar101) to evaluate the safety, tolerability and pharmacokinetics of OSEMITAMAB administered as monotherapy or in combination with nivolumab or standard of care in patients with locally advanced or metastatic solid tumors
• mRNA-4157 (V940) individualized neoantigen therapy (INT) + pembrolizumab (pembro) in advanced unresectable HPV- head & neck carcinoma (HNSCC): Clinical & translational analysis
• Phase I study evaluating AC676, an innovative BTK chimeric degrader, in patients with relapsed and refractory B-cell malignancies
• Phase 1 clinical trial of the farnesyl transferase inhibitor KO-2806 alone or as part of combination therapy for advanced solid tumors
• Phase 1/2, first-in-human study of DS-3939a in patients with advanced solid tumors: A new DXd ADC targeting TA-MUC1
• Intratumoral (ITu) delivery of mRNA-2752 encoding human OX40L/IL-23/IL-36γ in combination with durvalumab induces an immunostimulatory effect within the tumor microenvironment (TME) of patients with advanced solid tumors
• Pharmacokinetic/biomarker (PK/BMx) analysis of the toll-like receptor 7 and 8 (TLR7/8) agonist EIK1001 in phase 1 studies in participants (Pts) with solid tumors

FCS Associate Director of Drug Development Judy Wang, MD first author:

• NGM707 in combination with pembrolizumab in advanced or metastatic solid tumors: Preliminary results from dose escalation

FCS Scientific Director of Research and Associate Professor of Medicine, Wake Forest University School of Medicine Lowell Hart, MD, FACP, first author:

• Vitamin D deficiency and outcomes in prostate cancer patients-A real world database

Co-authors include FCS Trial Match Specialist and Medical Oncologist and Hematologist (retired) James Reeves Jr., MD, FCS Nurse Specialist Stacey Garofalo RN and members of the FCS Real-World Evidence Team, IT Director Data Science Derek Hall and Informatics Data Scientist Parth Kothiya.

FCS Director of Drug Development, Lake Nona DDU, Cesar Augusto Perez, MD, co-author:

• Open-label phase 1 study to investigate SGN-CEACAM5C in adults with advanced solid tumors

“Our clinical trials research contributes daily to the discovery of ground-breaking new drugs and therapies that are accelerating our understanding of cancer and transforming the standard of care,“ said FCS Director of Late-Phase Clinical Research Bradley Monk, MD.

Dr. Monk is co-author of a study conducted at HonorHealth University of Arizona College of Medicine and Creighton University School of Medicine prior to being named to his leadership position at FCS earlier this year, “Tumor microenvironment (TME) biomarkers of TIGIT and PD-L1 immune checkpoint blockade in cervical cancer: An exploratory biomarker analysis from SKYSCRAPER-04 (SKY04) study.”

Abstracts will be published in the AACR journal, Cancer Research, following the annual meeting. The American Association for Cancer Research (AACR), the first and largest cancer research organization dedicated to accelerating the conquest of cancer, represents 58,000 members residing in 141 countries.