Alignment with FDA obtained on study design to advance two Ph 3 trials in gastroesophageal cancers (FAPI-GO) and PDAC (FAPI-PRO), with [18F] FAPI-74
“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.”
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