Shanghai-based immuno-oncology therapeutics specialist Lyvgen Biopharma has announced the initiation of an open-label, multi-center, randomized Phase II clinical study to assess the efficacy and safety of its LVGN7409 in combination with docetaxel or nivolumab for the treatment of advanced/metastatic non-small cell lung cancer (NSCLC). The combination study is set to begin in the first half of 2023.
Drug Profile and Platform
LVGN7409 is a CD40-targeted agonistic monoclonal antibody (mAb) based on Lyvgen Bio’s xLinkAb platform. The drug features a unique structure and function that allows for a higher tolerable dosage and wider clinical application. Lyvgen was founded in 2016 by Dr. Jieyi Wang, a former oncology scientist with Amgen, and specializes in generating IgG agonists targeting co-stimulatory receptors with selectivity for the tumor microenvironment.
Clinical Progress
Lyvgen has three in-house developed monoclonal antibodies at the clinical stage. LVGN7409 has demonstrated safety and preliminary efficacy in a Phase I clinical study conducted in China and the United States. Additionally, LVGN6051, a 4-1BB agonistic mAb with preliminarily proven clinical safety and activity, is undergoing a Phase Ib/II clinical study in combination with pembrolizumab for advanced tumors in the US and a Phase II clinical study in combination with a small molecule vascular endothelial growth factor receptor inhibitor in China.-Fineline Info & Tech
