China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study for its 177Lu-LNC1004 in advanced fibroblast activation protein (FAP)-positive solid tumors. This marks a significant step in the development of this innovative radiotherapeutic drug. Additionally, Dongcheng Pharma received a Study May Proceed Letter (SMP) in December 2022 from the FDA for its concomitant diagnostics 68Ga-FAPI-46, which will be used for patient screening, efficacy evaluation, and collection of relevant safety information.
Therapeutic Profile and Development
177Lu-LNC1004 is a radiotherapeutic drug targeting fibroblast activation protein (FAP), under development to treat FAP-positive advanced solid tumors. There is no similar product approved anywhere in the world, positioning 177Lu-LNC1004 as a potentially groundbreaking therapy. FAP, a type II transmembrane serine protease, is highly expressed in many epithelial tumor-associated fibroblasts (CAF), including those in gastric cancer, esophageal cancer, lung cancer, colorectal cancer, ovarian cancer, and others, but has no or low expression in normal tissues and benign tumor stroma.
The LNC1004 precursor can specifically bind to FAP on the surface of the CAF membrane, achieving precise tumor treatment by targeting the 177Lu radionuclide to solid tumors with positive FAP. Preclinical and clinical studies have demonstrated that 177Lu-LNC1004 can precisely and effectively kill solid tumor cells, such as those in gastric cancer, esophageal cancer, lung cancer, and thyroid cancer, showing significant therapeutic effects.
Future Outlook
The approval for the Phase I clinical study of 177Lu-LNC1004 underscores Yantai Dongcheng Pharmaceutical Group’s commitment to advancing innovative cancer therapies. With its unique targeting mechanism and demonstrated efficacy, 177Lu-LNC1004 has the potential to address significant unmet needs in the treatment of advanced solid tumors. Dongcheng Pharma’s ongoing efforts in clinical development highlight its dedication to improving patient outcomes in oncology.-Fineline Info & Tech
