LEADS BIOLABS-B (09887) announced that the first patient has been successfully dosed in a Phase I clinical study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary clinical efficacy of LBL-047.
The Phase I trial is a randomized, double-blind, placebo-controlled, single-dose escalation study conducted in healthy adults and patients with systemic lupus erythematosus (SLE). It aims to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, and initial clinical effectiveness of LBL-047.
The healthy volunteer segment of the study 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.
LBL-047 is a bispecific fusion protein composed of a humanized anti-BDCA2 (blood dendritic cell antigen 2) antibody and a modified extracellular domain of TACI (transmembrane activator and CAML interactor). It selectively depletes plasmacytoid dendritic cells (pDCs) to reduce type 1 interferon production while inhibiting BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand) signaling pathways to block B-cell activation, differentiation, and antibody production.
This differentiated approach targets two key drivers of autoimmune disease pathogenesis, demonstrating potential for treating multiple autoimmune indications. Additionally, LBL-047 has been optimized through Fc region modification to extend its half-life.
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