NEW YORK – Sofie Biosciences on Tuesday said its diagnostic imaging agent, [68Ga]FAPI-46 PET, will be incorporated into a Phase I clinical trial of Yantai LNC Biotechnology's radiopharmaceutical 177Lu-LNC1004 injection for patients with advanced fibroblast activation protein (FAP)-positive solid cancers.
Sofie's imaging agent and Yantai's therapeutic both target FAP expression on solid tumor cells. Accordingly, Sofie's [68Ga]FAPI-46 PET will be used as a companion diagnostic to screen patients for high FAP expression before enrolling in Yantai's trial.
The news of Yantai's clinical trial, which is expected to enroll up to 24 patients starting in Q2 2023 in Singapore, comes after the US Food and Drug Administration cleared the firm's investigational new drug application last week. The trial is designed to evaluate the safety and dosimetry of 177Lu-LNC1004. [68Ga]FAPI-46 PET will be used to screen patients for trial eligibility and evaluate the therapeutic effect of 177Lu-LNC1004.
Separately, Dulles, Virginia-based Sofie is also evaluating [68Ga]FAPI-46 PET, including a fluorine-labeled version of the agent, 18F-FAPI-74, in clinical trials involving pancreatic and gastrointestinal cancer patients, respectively.