DNTH212 / Leads Biolabs, Dianthus Therap - LARVOL DELTA

A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Nanjing Leads Biolabs Co.,Ltd

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Nanjing Leads Biolabs Co., Ltd…announced the first subject has been successfully dosed in the Phase 1 clinical trial of LBL-047 (DNTH212), a potential first- and best-in-class anti-BDCA2/TACI bifunctional fusion protein developed by Leads Biolabs. (Dianthus Press Release) - "Top-line results in healthy volunteers anticipated in 2H’26; Dianthus to provide update on indication prioritization in 1H’26."

P1 data • Trial status • Systemic Lupus Erythematosus

…Nanjing Leads Biolabs…is pleased to announce that on November 25, 2025, the National Medical Products Administration of the People’s Republic of China (the 'NMPA') approved the Investigational New Drug (the 'IND') application of its self-developed drug candidate LBL-047 (HKEXnews) - "The approved clinical trial is a double-blind, randomized, placebo-controlled, dose-escalation Phase I study conducted in both healthy adults and patients with systemic lupus erythematosus (SLE)."

New P1 trial • Systemic Lupus Erythematosus

LBL-047, A First-In-Class Anti-BDCA2/TACI Fusion Protein, Inhibits the Function of Both pDCs and B cells [WITHDRAWN] (ACR Convergence 2025) - "Litifilimab, an anti-BDCA2 antibody, has demonstrated promising preliminary efficacy and excellent safety profile in patients with cutaneous lupus erythematosus...Targeting this pathway, two TACI based recombinant fusion proteins, such as Povetacicept and Telitacicept, have shown clinical benefits and favorable safety profile in autoimmune disease trials... LBL-047 has shown dual immunosuppressive effects, inhibiting simultaneously the function of pDCs and B cells both in vitro and in vivo. In addition, it has demonstrated excellent PK and PD profile, coupled with good safety profile and tolerability in cynomolgus monkeys. Taken together, these findings support the clinical development of LBL-047 and highlight its promise as a therapeutic candidate for autoimmune diseases."

Cutaneous Lupus Erythematosus • Immunology • Inflammatory Arthritis • Lupus • CD34 • IFNA1 • IL6 • TNFA

First-in-Class Potential! FDA Clears IND Application for LBL-047, an Anti-BDCA2/TACI Bispecific Fusion Protein Developed by Leads Biolabs (PRNewswire) - "LBL-047 is a bispecific fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain independently developed by Leads Biolabs....'LBL-047, our first autoimmune therapeutic candidate to enter the clinic, represents a major milestone in translating foundational immunology research into clinical development'."

IND • Immunology