Dianthus Therapeutics Announces Exclusive License Agreement with Leads Biolabs for DNTH212, a First and Potentially Best-In-Class, Phase 1 Ready Bifunctional BDCA2 & BAFF/APRIL Inhibitor for Severe Autoimmune Diseases

Core Insights - DNTH212 is a bifunctional fusion protein designed to target plasmacytoid dendritic cell (pDC) BDCA2, reducing Type 1 interferon production while inhibiting BAFF/APRIL to suppress B cell function, indicating its potential as a first-line biologic for severe autoimmune diseases [1][2][3] - The drug has shown superior inhibition of pDCs compared to litifilimab and superior immunoglobulin reductions compared to povetacicept in non-human primates, suggesting improved clinical benefits [1][4] - Dianthus Therapeutics has entered an exclusive licensing agreement with Nanjing Leads Biolabs for DNTH212, which is being developed in China as LBL-047, with a total potential payment of up to $1 billion [1][7] Company Overview - Dianthus Therapeutics is a clinical-stage biotechnology company focused on developing next-generation therapies for severe autoimmune diseases, with a strong pipeline including DNTH212 [10] - The company has an estimated pro forma cash balance of approximately $525 million, ensuring a cash runway into 2028 for ongoing development [8] Development Timeline - The IND for DNTH212 was cleared by the FDA in September 2025, with a Phase 1 study expected to begin in Q4 2025 and top-line results anticipated in the second half of 2026 [1][5] - The Phase 1 study will consist of two parts: one involving healthy volunteers and the other involving patients with systemic lupus erythematosus [5] Collaboration Details - The licensing agreement includes an upfront payment of $30 million and potential milestone payments totaling up to $962 million, along with tiered royalties on net sales outside Greater China [7]