Dulles, VA – November 10, 2021 – SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has received clearance to proceed with its Fibroblast Activation Protein Inhibitor (FAPI) clinical trial after completing a 30-day IND review with the 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)[1].

The filing for the IND took place on October 8th and following the 30-day review by the FDA, it was deemed safe for SOFIE to proceed into Phase 2 trial implementation. This paves the way for SOFIE to pursue PDAC as an initial step for [68Ga]FAPI-46 clinical development in oncologic and non-oncologic indications.

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 Ph.D, 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.”

About 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, contact info@sofie.com.

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.

[1] [68Ga]-FAPI-46 is not currently approved in any jurisdiction including the United States and European Union.