Dulles, VA – November 29, 2022 – SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has received Investigational New Drug (IND) clearance to proceed with clinical study of [18F]FAPI-74, its lead fluorine-18 labelled Fibroblast Activation Protein Inhibitor (FAPI) product. The study accepted as part of the FDA IND review is for a Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in patients with Gastrointestinal Cancers. The cancer types included as part of this study are: gastric cancer, cholangiocarcinoma, hepatocellular carcinoma, pancreatic cancer and colorectal cancer.
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). The filing for the [18F]FAPI-74 IND expands SOFIE’s product portfolio and provides opportunities for FAP targeted diagnostics using both Gallium-68 and Fluorine-18 lead products. “Our team at Heidelberg are very proud of this fluorine-18 FAPI milestone”, stated Professor Uwe Haberkorn, whose team led the discovery and development of FAPI theranostics.
Sherly Mosessian, Ph.D, SOFIE’s Chief Scientific Officer, added, “Fluorine-18 FAPI with the longer half-life will open up many opportunities in diagnostic and companion diagnostic utility of FAP targeting. We are excited to demonstrate the performance of [18F]FAPI-74 in this Phase 2 study for a major area of unmet need in gastrointestinal cancers.”
In addition to the existing and upcoming sponsored trials, SOFIE engages with academic and industry partners through the FAPI global outreach program to expand access for investigational use of FAPI products. The [18F]FAPI-74 granted IND will further advance these efforts.
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 firstname.lastname@example.org.
Fibroblast Activation Protein (FAP) is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Developed by the team at the Heidelberg University Hospital (UKHD), 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.
[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.