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Clovis Oncology Begins Study of FAP-2286 Targeted Imaging Agent, Radionuclide Therapy

NEW YORK – Clovis Oncology on Wednesday said that the University of Alabama at Birmingham's O'Neal Comprehensive Cancer Center will serve as the first clinical site for a Phase I/II trial of FAP-2286, its FAP-targeting imaging agent and radionuclide therapy.

In the Phase I portion of the LuMIERE study, which is now enrolling patients at the cancer center, researchers will investigate the safety of the therapeutic agent and identify the recommended Phase II dose and schedule. In the Phase II portion, Clovis will explore the activity of the FAP-2286 treatment in patients with different types of cancer.

FAP is expressed in cancer-associated fibroblasts that exist in the tumor microenvironment but occur infrequently on normal tissues, thus making it a good target for an imaging agent and a therapeutic. FAP-2286 labeled with gallium-68 will be the imaging agent that identifies patients with FAP-positive tumors for the LuMIERE trial. Subsequently, patients with FAP-positive tumors will receive the therapeutic agent labeled with lutetium-177.

"Given FAP is highly expressed in many of the hardest-to-treat solid tumors, we look forward to exploring the potential of FAP-2286 to treat patients with cancer as our first entry into this emerging field of targeted radiotherapy," Clovis CEO Patrick Mahaffy said in a statement. "The O'Neal Comprehensive Cancer Center and each of the clinical trial sites expected to open for enrollment in the near future bring tremendous nuclear medicine and medical oncology expertise as well as passion for the program."

FAP is expressed in more than 90 percent of breast, lung, colorectal, and pancreatic cancers. In preclinical models, FAP-2286 labeled with lutetium-177 selectively targeted FAP-positive cancer-associated fibroblasts and tumor cells and delivered a beta particle-emitting radioisotope, causing DNA damage and cell death.