Dulles, VA –May 12, 2023 – SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has dosed and imaged the first patient with [18F]FAPI-74 in its US Clinical Trial of flourine-18 labeled Fibroblast Activation Protein Inhibitor (FAPI). This study is a Phase 2, Multicenter, Non-randomized Study of [18F]FAPI-74 PET for imaging patients with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer (NCT05641896).

The clinical trial comes after the US FDA granted SOFIE an active IND in support of this study in November of 2022.  The study was launched at its first site in Boston under Principal Investigator, Shadi Esfahani, MD, MPH. Additional sites are in the process of activation and anticipated to begin recruitment in the coming weeks.

Sherly Mosessian, Ph.D., SOFIE’s Chief Scientific Officer, commented, “We are thrilled to see the launch of the study and imaging of the first patient in this prospective study. Tremendous promise exists in diagnostic and companion diagnostic use of FAPI family of compounds, especially in gastrointestinal cancers. Flourine-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.” The commitment to improving patient care through utilization of radiopharmaceuticals for imaging and therapy is a professional and personal mission of SOFIE’s. Frank Valla, SOFIE’s Director of Clinical Development and FAPI CMC lead, added, “The promise of FAP targeting in gastrointestinal cancers and the recognition of this important milestone for patient care brings great excitement to the field as well as sense of personal fulfillment after having lost my father to Colorectal Cancer in 2007.”

This study is the second SOFIE FAPI product in a clinical study. SOFIE is currently conducting a Phase 2 clinical study with the lead Galium-68 labelled FAPI product, [68Ga]FAPI-46, in Pancreatic Ductal Adenocarcinoma patients (NCT05262855).

About SOFIE

SOFIE’s vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value theranostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information, contact  info@sofie.com.

About FAPI

Fibroblast Activation Protein (FAP) is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Developed by the team at the Heidelberg University, quinoline-based PET tracers that act as FAP inhibitors (FAPI) have shown encouraging results in pre-clinical and clinical studies.  SOFIE has licensed the rights for diagnostic and companion diagnostic use of FAPI family of compounds from Heidelberg University.

About [18F]FAPI-74

[18F]FAPI-74 is the lead Fluorine-18 radiolabeled PET tracer of FAPI family of compounds. It has demonstrated favorable dosimetry, avidity, safety and biodistribution profile amenable for detection of FAP-expressing cells in patients with various cancers. This radioligand for imaging is currently optimized for production within SOFIE and its clinical trial partners.