LEADS BIOLABS-B (09887): First systemic lupus erythematosus patient dosed in Part B of the Phase I study of LBL-047; novel BDCA2/TACI dual-target design enters patient clinical evaluation

LEADS BIOLABS-B (09887) announced that the first systemic lupus erythematosus (SLE) patient has been successfully dosed in Part B of the Phase I clinical study (LBL-047CN001) of LBL-047 (known as DNTH212 outside Greater China), a novel bispecific fusion protein independently developed by the Company targeting anti-blood dendritic cell antigen 2 (BDCA2) and transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI). This marks the first time LBL-047 has entered an autoimmune disease patient population. The molecule acts on both the innate and adaptive immune pathways, two clinically validated pathogenic pathways, and LBL-047's complementary and differentiated dual-target design is being directly validated in patients for the first time. The primary objective of Part B of the LBL-047CN001 study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic (PK/PD) characteristics, and preliminary clinical efficacy of LBL-047 in SLE patients, with Professor Ye Shuang and Professor Chen Sheng of Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine serving as principal investigators. Part A of the study is being conducted at Shanghai Public Health Clinical Center, with Professor Meng Xianmin serving as principal investigator; the cumulative safety and pharmacokinetic data in healthy subjects from this part support advancing the study to the SLE patient portion as designed in the protocol.