IND granted for FAP targeting therapeutic in SOFIE partnership

DULLES, Va., Jan. 17, 2023 /PRNewswire/ -- SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, will be supporting, through companion diagnostic [⁶⁸Ga]FAPI-46 PET, Yantai LNC Biotechnology's recently FDA accepted clinical study. 

On Jan 6^th, 2023 Yantai LNC Biotechnology received FDA clearance to proceed with a Phase 1 clinical study of ¹⁷⁷Lu-LNC1004 injection, targeting fibroblast activation protein (FAP). The study accepted as part of the FDA IND review is a Phase I, open label study of the safety and dosimetry of a 4-dose regimen of escalating doses of ¹⁷⁷Lu-LNC1004 injection in adult patients with advanced FAP-positive solid tumors. As the companion diagnostic agent of ¹⁷⁷Lu-LNC1004 Injection, [⁶⁸Ga]FAPI-46 PET will be used to screen subjects and assess therapeutic effect. Yantai obtained access to [⁶⁸Ga]FAPI-46 through a letter of cross reference to SOFIE Biosciences' IND along with corresponding precursor and reference standard for use.

Prof. Xiaoyuan (Shawn) Chen, co-founder of Yantai LNC Biotechnology and editor-in-chief of the journal Theranostics, stated, "we appreciate the opportunity to work closely with SOFIE in pushing the long-acting FAPI formula ¹⁷⁷Lu-LNC1004 forward. Applying Evans blue derivatives to modify pharmacokinetics and pharmacodynamics is a platform technology Yantai LNC Biotechnology has successfully implemented to multiple radioligands such as FAP inhibitors."

Sherly Mosessian, Ph.D., SOFIE's Chief Scientific Officer, added, "as license holders of FAPI family of compounds for diagnostic and companion diagnostic use, we are excited to support this very promising study by having [⁶⁸Ga]FAPI-46 serve as a companion diagnostic tool for patient selection and treatment monitoring with ¹⁷⁷Lu-LNC1004. This highlights the power of theranostics in utilizing the same target, FAP, for imaging and treatment interventions."

The study is expected to enroll up to 24 subjects in advanced solid tumors that show high level of FAP expression detected by [⁶⁸Ga]FAPI-46 and will establish the recommended expansion phase dose with ¹⁷⁷Lu-LNC1004. Site feasibility and selection is complete and the study is expected to launch in Singapore Q2 2023.

Yantai LNC Biotechnology Singapore Pte. Ltd. is a wholly owned subsidiary of Yantai Dongcheng Pharmaceutical Group. As the unique innovative nuclear medicine development platform in Dongcheng Group, Yantai LNC Biotech is committed to radionuclide diagnosis and therapy innovation. For more information, contact  [email protected].

177Lu-LNC1004 is a fibroblast activation protein inhibitor (FAPI) modified with Evans blue (EB) and a metal chelator (DOTA), radiolabeled with beta-emitting radionuclide lutetium Lu-177. As a first-in-class drug the FAP-targeting probe will be used to treat adult patients with advanced FAP-positive solid tumors.

Fibroblast Activation Protein (FAP) is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Developed by the team at the Heidelberg University Hospital (UKHD), quinoline-based PET tracers that act as FAP inhibitors (FAPI) have shown encouraging results in pre-clinical and clinical studies.  SOFIE has licensed the rights for diagnostic and companion diagnostic use of FAPI family of compounds from Heidelberg University. [⁶⁸Ga]FAPI-46 is the lead gallium-68 and [¹⁸F]FAPI-74 is the lead fluorine-18 radiolabeled PET tracer of FAPI family of compounds. They have demonstrated favorable dosimetry, avidity, safety and biodistribution profile amenable for detection of FAP-expressing cells in patients with various cancers. Both products have active INDs for Phase 2 studies in cancers of the digestive system.

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  [email protected].

SOURCE SOFIE