SOFIE Submits Investigational New Drug Application to US FDA for Pancreatic Cancer Imaging

DULLES, Va., Oct. 12, 2021 /PRNewswire/ -- SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, achieves a major milestone with the filing of an IND application to the FDA for a radiopharmaceutical targeting Fibroblast Activation Protein Inhibitor (FAPI). 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).¹

This filing, which continues the progress of SOFIE's Global Academic Probe Network, allows 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. 

SOFIE's President & CEO, Patrick Phelps stated, "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." 

Trevor Subero, SOFIE's Senior Vice President of Business Development, and lead of its FAPI advancement program added, "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." 

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. 

About SOFIE Biosciences Inc. (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 [email protected].

About Pancreatic Cancer
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. Pancreatic cancer's aggressive nature is highlighted by 2021 estimates where 60,430 new cases are expected to be diagnosed in the US with an estimated 48,220 deaths from the disease². In 2020 worldwide statistics revealed 495,773 new cases with 466,003 deaths³. At present, there is no screening or early detection test for pancreatic cancer that has been shown to reduce mortality from the disease.

About FAPI
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. 

About [⁶⁸Ga]FAPI-46
[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.

SOURCE Sofie Biosciences

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