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Sofie Biosciences to Begin Trial of Fluorine-Labeled PET Diagnostic Imaging Agent for GI Cancers

NEW YORK – Sofie Biosciences on Tuesday said it will begin evaluating its radiopharmaceutical 18F-FAPI-74 in a Phase II clinical trial as a diagnostic PET imaging agent for gastrointestinal cancers.

The US Food and Drug Administration cleared Sofie's investigational new drug application for 18F-FAPI-74, allowing the Dulles, Virginia-based firm to begin a non-randomized clinical trial involving patients with gastric, bile duct, liver, pancreatic, and colorectal cancers.

While the new trial is designed to evaluate the fluorine-18-labeled PET imaging agent, Sofie has already been conducting a Phase II clinical trial of a similar fibroblast activation protein inhibitor (FAPI) with a gallium-68 label. The aim of that trial is to evaluate the sensitivity of 68Ga-FAPI-46 in detecting pancreatic cancer patients whose tumors express FAP. According to a statement from Sofie CSO Sherly Mosessian, the firm wants to develop a fluorine-18-labeled version of its imaging agent in addition to the gallium-68-labeled version, because the former has a longer half-life.

"Fluorine-18 FAPI with the longer half-life will open up many opportunities in diagnostic and companion diagnostic utility of FAP targeting," Mosessian said.

Clovis Oncology is another company exploring a radionuclide therapy and imaging agent, called FAP-2286, as a treatment strategy for FAP-positive tumors. The company is using a targeting peptide labeled with gallium-68 in clinical trials as the imaging agent for identifying patients with FAP-positive tumors, but recently announced a deal with Evergreen Theragnostics to expand the FAP-2286 program and assess the radionuclide with another radioactive isotope, actinium-225.