SOFIE Biosciences Prepares Launch of Two [18F]FAPI-74 Phase 3 Studies, following successful FDA engagement
Favorable End-of-Phase 2 meeting with U.S. FDA for [18F]FAPI-74 for GI cancers
Primary and secondary endpoints met
Alignment with FDA on study design to advance two Phase 3 Clinical trials in
gastroesophageal cancers (FAPI-GO) and PDAC (FAPI-PRO), with [18F]FAPI-74
DULLES, Va., Oct. 1, 2025 /PRNewswire/ -- SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, today announced the successful completion of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), supporting plans for both of its Phase 3 studies for [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP).
This meeting comes after a favorable Phase 2, multicenter, non-randomized study of [18F]FAPI-74 in patients with gastrointestinal cancers, which was comprised of patients with gastroesophageal cancers, cholangiocarcinoma, hepatocellular carcinoma, pancreatic cancer, and colorectal cancer (NCT05641896). The trial was activated May 2023 and conducted at six clinical sites (Massachusetts General Hospital, Memorial Sloan Kettering Cancer Center, BAMF Health, Northwell Health, UCLA Health, and Mayo Rochester), with the last patient imaged in January 2025. The primary objective was to evaluate the accuracy of [18F]FAPI-74 PET in detecting FAP-expressing cells from patient-collected tissues. Secondary objectives were to evaluate the safety profile and accuracy of [18F]FAPI-74 PET in detecting the presence of GI malignancies. The trial results demonstrated a 100% positive predictive value for the primary objective of detecting FAP-expressing cells, and a 94% positive predictive value in detecting the presence of disease in cancers of the GI tract.
"The successful FDA engagement brings us closer to making FAPI a reality for patients in areas of unmet need across multiple tumor types", said Sherly Mosessian, Ph.D., Chief Scientific Officer of SOFIE Biosciences. "Unlike conventional imaging and FDG PET, FAPI targets cancer-associated fibroblasts in the tumor microenvironment, giving us a key target for determination of disease. FAPI PET has tremendous potential in many oncologic and non-oncologic diseases. We are looking forward to focusing our initial efforts on the cancers of the GI tract, specifically gastroesophageal cancers and PDAC, where we see tremendous unmet need that can be successfully addressed with FAPI PET. We are excited to advance into Phase 3 and continue building the evidence that will establish FAPI PET/CT as a transformative tool in precision oncology."
Prof. Dr. Ken Herrmann, MBA, Chairman of SOFIE's Scientific Advisory Board and Chair of the Department of Nuclear Medicine at the Universitätsklinikum Essen and Section Editor of the Journal of Nuclear Medicine added, "The results of the phase 2 study are very encouraging and represent a very important milestone on bringing the first FAP directed tracer closer to approval. It is fantastic to see that [18F]FAPI-74 is now moving into a pivotal phase 3 study."
STUDY DESIGN AND NEXT STEPS
The EOP2 meeting focused on discussing SOFIE's Phase 2 data and resulted in alignment with the FDA on the two Phase 3 studies' design and endpoints. The first trial, FAPI-GO (FAPI in Gastroesophageal Oncology), will be a Phase 3, prospective, multicenter, open-label diagnostic accuracy trial designed to evaluate the performance of [18F]FAPI-74 PET in detecting metastatic disease in adults with Gastroesophageal Cancer. The second trial, to follow shortly after, FAPI-PRO (FAPI in Precision Imaging of Pancreatic Cancer), will be a Phase 3, prospective, multicenter, open-label diagnostic accuracy trial designed to evaluate the performance of [18F]FAPI-74 PET in detecting metastatic disease in adults with Pancreatic Ductal Adenocarcinoma.
ABOUT [18F]FAPI-74
[18F]FAPI-74 is the lead fluorine-18 radiolabeled PET tracer in the FAPI family of compounds. It has demonstrated favorable 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.
ABOUT FAPI
Fibroblast activation protein is highly expressed in cancer-associated fibroblasts across several tumor 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 tumor-targeting therapies such as chemo, immunology, radiation, or cell-based therapies whose function may be otherwise blunted by the tumor stroma.
ABOUT PANCREATIC AND GASTROESOPHAGEAL CANCERS
Pancreatic cancer is an aggressive disease with a high mortality rate and challenging patient management due to conventional diagnostic options that may miss established or developing metastatic disease. Surgical resection remains the only curative option for PDAC; however, only 15-20% of patients have resectable disease at the time of diagnosis. Therefore, accurate staging is critical to identify patients who may benefit from surgery and to avoid futile procedures in those with non-resectable metastatic or locoregional disease. Pancreatic cancer's nature is highlighted by 2025 estimates, where 67,440 new cases are expected to be diagnosed in the US, with an estimated 51,980 deaths from the disease.1 In 2022, worldwide statistics revealed 510,992 new cases with 467,409 deaths.2
Gastric and esophageal cancers are aggressive cancers with poor median survival rates. In 2025, it is estimated that there will be 30,300 new cases of stomach cancer, and an estimated 10,780 people will die of this disease.3 It is estimated that there will be 22,070 new cases and 16,250 people will die of esophageal cancer in the US in 2025.4 The overall median survival of a patient with gastric cancer at one year is approximately 50% and, for patients with esophageal cancer, the median overall survival is 45% at five years. In both cancer types, patients with distant metastases have a median overall survival of approximately four to six months. Despite the accuracy of current imaging technology, futile surgery is performed in between 5 to 20% of patients, and early recurrence at 6 to 12 months is seen in as many as 20% to 40% of patients. These data imply that current staging tools are not optimal for providing patients with the best care options.
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, please visit https://sofie.com/ or contact fapiprogram@sofie.com
SOFIE BIOSCIENCES Media Contact:
Janna Laton
Director of Product Launch – FAPI
janna.laton@sofie.com
[3] https://seer.cancer.gov/statfacts/html/stomach.html
[4] https://seer.cancer.gov/statfacts/html/esoph.html
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