Potential New Drug for Pancreatic Cancer Imaging

A radiopharmaceutical targeting Fibroblast Activation Protein Inhibitor (FAPI) has been submitted to the US Food and Drug Administration (FDA) by SOFIE Biosciences as an Investigational New Drug (IND). The IND is for a Phase 2, Multicenter, Single Blind, Non-randomized Study of⁶⁸GaFAPI-46 PET for imaging patients with Pancreatic Ductal Adenocarcinoma (PDAC).⁶⁸GaFAPI-46 is not currently approved in any jurisdiction including the United States and European Union.

This filing continues the progress of SOFIE’s Global Academic Probe Network, allowing select institutions to participate with the company in generating clinically relevant diagnostic imaging data to support ongoing work in this critical oncologic indication, pancreatic cancer, and numerous other solid tumors and non-oncologic applications.

“A PET manufacturing network submitting an IND to the US FDA is a unique development, as well an inflection point for the company. Pancreatic Cancer is a formidable disease adversary that requires a meticulously designed theranostic program. As such, SOFIE is pleased to leverage its FAPI diagnostic compound, academic collaborations and radiopharmacy expertise in support of this endeavor and to ultimately save lives,” said Patrick Phelps, President and CEO of SOFIE.

“We are proud to build on the inventive work of Professor Haberkorn, Professor Giesel and the University Heidelberg team by taking this important next step in the progression of a FAPI tracer, towards FDA-approved clinical use,” added Trevor Subero, Senior Vice President of Business Development at SOFIE and lead of its FAPI advancement program.

Fibroblast Activation Protein (FAP) is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Quinoline-based PET tracers that act as FAP inhibitors (FAPI), developed by the team at the Heidelberg University Hospital (UKHD) 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.

⁶⁸GaFAPI-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.

As a measure of ensuring the continued progress with FAPI, the SOFIE leadership and its board view this important milestone as the first of several INDs for which FAPI is well suited and for which SOFIE will work with leading clinical experts that treat the appropriate indications and have a track record of successfully completing similar clinical trials.