SOFIE Biosciences, a renowned US-based manufacturer of radiopharmaceuticals, is proud to announce its support of Yantai LNC Biotechnology’s recently FDA-approved clinical study – with the help of its cutting-edge companion diagnostic [68Ga]FAPI-46 PET.
Yantai LNC Biotechnology has just been granted FDA clearance to proceed with a Phase 1 clinical study of 177Lu-LNC1004 injection, targeting fibroblast activation protein (FAP). This study, which will assess 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, is an exciting step forward. As the companion diagnostic agent of 177Lu-LNC1004 Injection, [68Ga]FAPI-46 PET will be used to screen subjects and evaluate the therapeutic effect. Yantai has obtained permission to use [68Ga]FAPI-46 through a letter of cross reference to SOFIE Biosciences’ IND, with corresponding precursor and reference standard for use. This clinical study is an important milestone in the development of 177Lu-LNC1004 injection, and could potentially revolutionize the treatment of FAP-positive solid tumors.
We are delighted to collaborate with SOFIE in accelerating the development of the long-lasting FAPI formula 177Lu-LNC1004. Yantai LNC Biotechnology, the co-founder of which is Prof. Xiaoyuan (Shawn) Chen, editor-in-chief of the journal Theranostics, has been using Evans blue derivatives to modify the pharmacokinetics and pharmacodynamics of various radioligands, such as FAP inhibitors, with remarkable success.
Dr. Sherly Mosessian, Chief Scientific Officer of SOFIE, expressed her enthusiasm for the promising study, stating, “We are thrilled to provide our FAPI family of compounds as a companion diagnostic tool to select patients and monitor treatments with 177Lu-LNC1004. This highlights the incredible potential of theranostics in targeting the same molecule, FAP, for both imaging and therapeutic interventions.”
We are excited to announce the launch of a new clinical study in Singapore, expected in Q2 2023, to enroll up to 24 patients with advanced solid tumors that show a high level of FAP expression detected by [68Ga]FAPI-46. The study aims to establish the recommended expansion phase dose with 177Lu-LNC1004. Site feasibility and selection is complete, and we look forward to the results of this important research.
About Yantai LNC Biotechnology
Yantai LNC Biotechnology Singapore Pte. Ltd. is the only one of its kind – an innovative nuclear medicine development platform brought to you by Yantai Dongcheng Pharmaceutical Group. We are passionate about our mission – to revolutionize radionuclide diagnosis and therapy, helping to make the world a better place.
Introducing Lu-177-LNC1004, the revolutionary new fibroblast activation protein inhibitor modified with Evans blue and a metal chelator DOTA, and radiolabeled with beta-emitting lutetium Lu-177. This pioneering drug has been designed to treat adult patients with advanced FAP-positive solid tumors, offering a new ray of hope for those suffering from this condition.
Experience the latest innovation in cancer imaging! SOFIE has licensed the rights for the diagnostic and companion diagnostic use of the FAPI family of compounds, developed by the team at Heidelberg University Hospital (UKHD). With [68Ga]FAPI-46 and [18F]FAPI-74, the lead gallium-68 and fluorine-18 radiolabeled PET tracers, you can detect FAP-expressing cells in patients with various cancers with favorable dosimetry, avidity, safety and biodistribution profiles. Both compounds have received active INDs for Phase 2 studies in cancers of the digestive system, so don’t miss out on this revolutionary imaging experience!
At SOFIE, we are committed to revolutionizing patient care by developing and delivering innovative molecular diagnostics and theranostics. Our comprehensive radiopharmaceutical production and distribution network, along with our contract manufacturing services, provide us with the resources to pursue the promise of radiopharmaceuticals. Our advanced theranostic solutions are designed to improve patient outcomes through precision medicine.