Skip to main content
Premium Trial:

Request an Annual Quote

Sofie Biosciences Images First Gastrointestinal Cancer Patient in Phase II Radiopharmaceutical Trial

NEW YORK – Sofie Biosciences said on Friday that it has dosed and imaged the first gastrointestinal cancer patient in a Phase II trial of its radiopharmaceutical 18F-FAPI-74.

In the Phase II trial, Dulles, Virginia-based Sofie is assessing 18F-FAPI-74 as a diagnostic agent to identify fibroblast activation protein (FAP)-expressing liver, bile duct, gastric, pancreatic, and colorectal cancers. The study will include 120 patients, and Sofie's primary aim is to determine the imaging agent's positive predictive value in identifying FAP-positive lesions.

Separately, Sofie has been conducting a Phase II trial of a similar FAP-directed radiopharmaceutical as an imaging agent for FAP-expressing pancreatic cancers. However, that agent, 68Ga-FAPI-46, includes the radioactive isotope gallium-68 linked to the FAP inhibitor (FAPI) part of the drug, as opposed to fluorine-18, the radioactive isotope linked to the FAP-targeting imaging agent in 18F-FAPI-74.

"Fluorine-18 labeled FAPI opens up many possibilities in FAP targeting, and we are excited to be driving this product forward to unlock more of its potential," Sofie CSO Sherly Mosessian said in a statement. The company is focused on developing both diagnostic and therapeutic radiopharmaceuticals.