Phase II Pancreatic Cancer Study Cleared to Proceed by US FDA

SOFIE Biosciences has received clearance to proceed with its Fibroblast Activation Protein Inhibitor (FAPI) clinical trial after completing a 30-day IND review with the US FDA. The IND is for a Phase 2, multicenter, single blind, non-randomized study of ⁶⁸Ga-FAPI-46 PET for imaging patients with Pancreatic Ductal Adenocarcinoma (PDAC). This paves the way for SOFIE to pursue PDAC as an initial step for ⁸Ga-FAPI-46 clinical development in oncologic and non-oncologic indications. ⁶⁸Ga FAPI-46 is not currently approved in any jurisdiction including the United States and European Union.

SOFIE's President & CEO, Patrick Phelps stated, "This approval concludes a series of productive meetings with the Agency. We greatly appreciate their guidance and feedback throughout this process. Every month new publications come out from academia showing the excitement around FAP targeted radiopharmaceuticals, so this IND approval is timely."

Sherly Mosessian PhD, SOFIE's Vice President of Clinical and Regulatory Affairs added, "An active IND is a major milestone for SOFIE and the FAPI program. This IND and the Phase 2 trial will be the first key step in clinical development of ⁶⁸Ga-FAPI-46 in the United States, and we are excited to partner with our collaborators to expand the utilization of this IND in pursuing other trials and indications."

FAP is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Quinoline-based PET tracers that act as FAPI, developed by the team at the Heidelberg University Hospital and licensed exclusively by SOFIE, have shown encouraging results in pre-clinical and clinical studies. FAPI is an important diagnostic or therapeutic (theranostic) entity that can be deployed alone or in combination with other tumor-targeting therapies such as chemo, immunologic, radiation or cell-based therapies whose function may be otherwise blunted by the tumor stroma.

⁶⁸Ga -FAPI-46 is the Gallium-68 radiolabeled PET tracer consisting of FAPI-46 precursor small molecule critical drug intermediate consisting of a FAPI moiety conjugated with a DOTA chelator. This agent is currently optimized for production within SOFIE and its clinical trial partners and will be manufactured at its facilities as supply needs dictate.