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.
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SOURCE Sofie Biosciences