LEADS BIOLABS-B(09887): LBL-047 medication for the first subject in Phase I trial.

LEADS BIOLABS-B (09887) announces that the first subject of Phase I clinical study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary clinical efficacy of LBL-047 has successfully received treatment. This Phase I study is a randomized, double-blind, placebo-controlled, single-dose escalation trial conducted in healthy adults and patients with systemic lupus erythematosus (SLE), aiming to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary clinical efficacy of LBL-047. The healthy volunteer part of the study is led by Professor Meng Xianmin from the Shanghai Public Health Clinical Center, while the SLE part is led by Professor Ye Shuang and Professor Chen Sheng from the Renji Hospital, Shanghai Jiaotong University School of Medicine. LBL-047 is a bispecific fusion protein composed of humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and modified transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) extracellular domain, which selectively depletes pDC to reduce type I interferon production, and inhibits the B cell activating factor (BAFF) and proliferation inducing ligand (APRIL) signaling pathways to block B cell activation, differentiation and antibody production. This differentiated approach targets the two major drivers of autoimmune disease pathogenesis, with the potential to treat multiple autoimmune conditions. In addition, LBL-047 has been optimized through Fc region modification to prolong half-life.