Core Viewpoint - The announcement from Valiant Biopharma-B (09887) highlights the successful administration of the first subject in the Phase I clinical trial of LBL-047, focusing on its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy [1] Group 1: Clinical Trial Details - The Phase I study is a randomized, double-blind, placebo-controlled, single ascending dose trial conducted in healthy adults and patients with systemic lupus erythematosus (SLE) [1] - The healthy volunteer segment is led by Professor Meng Xianmin from Shanghai Public Health Clinical Center, while the SLE segment is overseen by Professors Ye Shuang and Chen Sheng from Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine [1] Group 2: Drug Mechanism and Potential - LBL-047 is a bispecific fusion protein composed of a humanized anti-BDCA2 antibody and a modified transmembrane activator and calcium-modulating cyclophilin ligand (TACI) extracellular domain [1] - The drug selectively eliminates plasmacytoid dendritic cells (pDC) to reduce type I interferon production and inhibits the B-cell activating factor (BAFF) and proliferation-inducing ligand (APRIL) signaling pathways, thereby blocking B-cell activation, differentiation, and antibody production [1] - This differentiated approach targets two major driving factors of autoimmune disease pathogenesis, indicating potential for treating various autoimmune indications [1] - LBL-047 has also been optimized to extend its half-life through Fc region modification [1]
维立志博-B：LBL-047于I期试验的首例受试者用药