LBL-047 (DNTH212) is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function
Top-line results in healthy volunteers anticipated in 2H’26
Dianthus to provide update on indication prioritization in 1H’26
LBL-047 (DNTH212) has the potential to be a first-line biologic in multiple autoimmune disorders with patient-friendly S.C. self-administration and Q4W or less frequent dosing
Dec. 23, 2025 -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs”) (9887.HK), a clinical-stage biotechnology company focused on developing innovative therapies in oncology, autoimmune, and other severe diseases, and Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today 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.
This two-part, double-blind, randomized, placebo-controlled, dose-escalation (single ascending dose) Phase 1 trial is designed to evaluate the safety, tolerability and PK/PD of LBL-047 (DNTH212) in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B). The healthy volunteer part of the study is led by Professor Meng Xianmin at Shanghai Public Health Clinical Center, while the SLE part is led by Professors Ye Shuang and Chen Sheng at Renji Hospital, Shanghai Jiaotong University School of Medicine.
By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. LBL-047 (DNTH212) has the potential to be a first-line biologic with patient-friendly, S.C. self-administration and Q4W or less frequent dosing.
On October 16, 2025, Leads Biolabs entered into an exclusive global partnership with Dianthus, with the total potential deal value reaching up to $1 billion. Under the agreement, Dianthus licensed exclusive global rights from Leads Biolabs to research, develop, manufacture and commercialize LBL-047 outside Greater China, where it is known as DNTH212, jointly advancing its global development to maximize clinical and commercial potential. Dianthus expects to provide an update on prioritized indications for DNTH212 in the first half of 2026.
“We are pleased to announce the successful dosing of the first subject in our Phase 1 trial of LBL-047. By simultaneously targeting multiple pathways, LBL-047 is designed to address the limitations of single-target therapies. We look forward to advancing this program in collaboration with Dianthus Therapeutics to deliver potentially transformative options for patients worldwide,” said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs.
“Initiating this Phase 1 study is the first step to realizing the much anticipated by physicians outcome of targeting multiple pertinent dysfunctional pathways in several autoimmune indications,” said Dr. Simrat Randhawa, Head of Research & Development at Dianthus Therapeutics.
LBL-047 (DNTH212) is an investigational bifunctional fusion protein composed of a humanized anti-blood dendritic cell antigen 2 (BDCA2) antibody and an engineered transmembrane activator and CAML interactor (TACI) ectodomain. It is designed to selectively deplete pDCs to reduce type 1 interferon production, while simultaneously inhibiting B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) signaling pathways to suppress B-cell activation, differentiation, and antibody production. By targeting two key drivers of autoimmune disease pathogenesis, this differentiated approach has the potential to address multiple autoimmune indications. Additionally, LBL-047 (DNTH212) has also been optimized with Fc engineering to extend its half-life, offering the potential for a patient-friendly subcutaneous self-administration regimen with a dosing frequency of Q4W or less, supporting its potential as a first-line biologic therapy.
Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.
Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of innovative therapies to address unmet medical needs in oncology, autoimmune, and other severe diseases both in China and globally. As a front-runner in next-generation immuno-oncology treatments, the company has a differentiated pipeline of 14 innovative drug candidates, including six clinical-stage drug candidates, of which four lead products are among the top-tier clinically advanced candidates globally.
Leads Biolabs adopts a science-driven R&D approach and has successfully established comprehensive R&D capabilities spanning antibody discovery and engineering, in vivo and in vitro efficacy evaluation, as well as druggability assessment. The company has also developed multiple proprietary technology platforms, including LeadsBody platform (a CD3 T-cell engager platform), X-body platform (a 4-1BB engager platform), TOPiKinectics (ADC platform), which serve as the cornerstone for continued innovation and have been validated by the clinical outcomes of bispecific antibody portfolios.
Leads Biolabs has established integrated capabilities across early discovery, translational medicine, clinical development, CMC and business development. The innovative nature and competitive strengths of drug candidates, coupled with global perspectives, proactive strategy, and efficient clinical validation, have made the company an attractive partner for leading industry players and investment institutions.
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