Sofie to launch FAPI-PET phase II trial

AuntMinnie.com staff writers

Dec 1, 2022

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Sofie Biosciences has received Investigational New Drug (IND) clearance for a phase II clinical study of its investigational fibroblast activation protein inhibitor (FAPI) radiotracer in patients with gastrointestinal cancer.

The company will test F-18 FAPI-74 specifically in patients with gastric cancer, cholangiocarcinoma, hepatocellular carcinoma, pancreatic cancer, and colorectal cancer. The radiotracer is designed to bind to fibroblast activation protein (FAP), which is highly expressed across several tumor entities and has shown encouraging results in pre-clinical and clinical studies, Sophie said.

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Examples in two patients. (Top) Abnormal leukocyte accumulation was observed in the right 1st to 5th toes, with the radioactive lesions extending to the bone, indicating osteomyelitis (left panel, MIP image; right panel, axial SPECT/CT). Two spherical VOIs were drawn on diabetic foot infections (DFIs) and the highest SUVmax was 4.2 (higher than the cutoff of 1.1) Despite intensive treatment, the infection progressed, leading to the patient undergoing right below knee amputation 43 days after SPECT/CT. (Bottom) Mild focal abnormal leukocyte accumulation was detected in the right 3rd and 4th toes. The lesions were in contact with the bone, which raised a suspicion of osteomyelitis (left panel, MIP image; right panel, axial SPECT/CT). A circular VOI was drawn on DFIs and the SUVmax was 1.0 (lower than the cutoff of 1.1). After 10 weeks of antibiotic treatment, the infection was successfully resolved, and the foot was preserved. Image and caption courtesy of Scientific Reports.

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F-18 FDG and Ga-68 FAPI-46 images of a 51-year-old woman with adenocarcinoma with lepidic growth pattern in right upper lobe. (A) Maximum-intensity-projection PET images. The lesion had F-18 FDG uptake below blood pool level but was strongly Ga-68 FAPI-46-positive. CT-guided biopsy led to pathologic diagnosis of adenocarcinoma, and the patient was treated by stereotactic body radiation therapy because of functional inoperability. Image courtesy of the Journal of Nuclear Medicine.

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Predictions and Grad-CAMs of ViT-based models on sample PET/CT, PET, and CT test images from the “positive” class. ViT was fine-tuned using training data for each modality. The bounding boxes depicted in the figure indicate malignant lesions. The top row of the Grad-CAMs shows important areas for “positive” predictions, and the bottom row shows areas for “negative” predictions. Image courtesy of Scientific Reports.

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