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SOFIE Biosciences, an established US manufacturer and developer of radiopharmaceuticals, announced that the first patient has been dosed in the second of its two phase 3 clinical trials evaluating 18F-FAPI-74, a fluorine-18 labelled radiopharmaceutical targeting Fibroblast Activation Protein (FAP), as a novel diagnostic for patients with pancreatic ductal adenocarcinoma.
To improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With our robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value radiopharmaceutical intellectual property, we are poised to deliver on the promise of radiopharmaceuticals.
"Dosing the first patient in our FAPI-PRO trial is a major step forward in the evaluation of FAPI as an oncological diagnostic tool," said Philipp Czernin, chief business officer, SOFIE Biosciences. "We undergo this trial encouraged by the results of our phase 2 and independent academic investigator-initiated studies supporting 18F-FAPI-74's potential role in staging accuracy, which is especially needed for pancreatic cancer."
"The potential sensitivity of 18F-FAPI-74 PET makes its availability to stage patients with newly diagnosed pancreatic ductal adenocarcinoma attractive to patients and clinicians alike. The whole team, including surgeons and oncologists, are enthusiastic about using 18F-FAPI-74 PET to help select the best initial treatments," said Dr. Gary Ulaner, James & Pamela Muzzy Endowed Chair in Molecular Imaging and Therapy, Hoag Family Cancer Institute, and Professor of Radiology and Cancer Biology, University of Southern California.
The FAPI-PRO (FAPI in Precision Imaging of Pancreatic Cancer) trial is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of 18F-FAPI-74 PET/CT in the detection of metastatic disease in adults with Pancreatic Ductal Adenocarcinoma. The study is planned for 18 sites with an estimated enrollment of 200 subjects over a 24-month period.
The primary study endpoints are sensitivity and specificity for detection of distant metastatic disease (M1).
The partner Phase 3 study, FAPI-GO (FAPI in Gastroesophageal Oncology), which began November 2025, is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of FAPI-74 PET/CT in the detection of metastatic disease in adults with gastroesophageal cancers. The first patient in FAPI-GO was dosed on December 26, 2025.
FAPI-74 is the lead fluorine-18 radiolabeled PET tracer in the FAPI family of compounds. It has demonstrated favourable dosimetry, avidity, safety, and a biodistribution profile amenable to 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.
Fibroblast activation protein is highly expressed in cancer-associated fibroblasts across several tumour entities. Quinoline-based PET tracers that act as FAP inhibitors (FAPI), developed by the team at Heidelberg University Hospital (UKHD), have shown encouraging results in pre-clinical and clinical studies. FAPI is an important diagnostic or therapeutic entity that can be deployed alone or in combination with other tumour-targeting therapies such as chemo, immunology, radiation, or cell-based therapies whose function may be otherwise blunted by the tumour stroma.
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.
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