Claseprubart

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 Demonstrated superior inhibition of pDCs vs. litifilimab in vitro and superior Ig reductions vs. povetacicept in NHPs highlight the potential for improved clinical benefit in severe autoimmune diseases 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 IND cleared by FDA in September 2025 and expected to clear in China in Q4’25. Phase 1 study of DNTH212 expected to initiate in Q4’25 with top-line results in healthy volunteers in 2H’26 Pro forma estimated cash of ~$525 million; reaffirms runway into 2028 Investor conference call and webcast to be held today at 8:00 a.m. ET Oct. 16, 2025 -- 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 it has entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads” (9887.HK) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor. DNTH212 is an investigational, extended half-life 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. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. “We are excited to partner with Leads Biolabs and build upon our vision of becoming a leading autoimmune-focused biopharmaceutical company with the addition of DNTH212 to our pipeline,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Both claseprubart and DNTH212, with their validated mechanisms of action and patient friendly convenience of infrequent S.C. self-administration, have the potential to significantly improve the lives of patients suffering from a range of severe autoimmune disorders. We look forward to leveraging the pipeline-in-a-product potential of DNTH212.” pDCs are specialized immune cells that produce large amounts of Type 1 interferons (IFN- and IFN-). High levels of Type 1 interferon drive chronic inflammation and tissue damage, making Type 1 interferon inhibition a promising therapeutic strategy in multiple autoimmune diseases. DNTH212 demonstrated comparable IFNα inhibition and superior pDC depletion in-vitro compared to litifilimab, a late-stage clinically validated BDCA2 monoclonal antibody. BAFF/APRIL activation of B cells generate autoantibodies against tissues that trigger inflammation and tissue damage. Inhibiting BAFF/APRIL has been shown to be a clinically validated therapeutic strategy in numerous autoimmune diseases. DNTH212 demonstrated superior inhibition of immunoglobulins (i.e. IgM, IgA, and IgG) in non-human primates compared to povetacicept, a late-stage clinically validated BAFF/APRIL inhibitor. “The medical team is ready to exploit the full potential of this unique asset targeting both the innate and adaptive immune systems,” said Dr. Simrat Randhawa, Head of Research & Development of Dianthus Therapeutics. “Autoimmune experts have been asking for combination biologic approaches for years so we expect an enthusiastic reception from them as we roll out our target indications.” A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is expected to initiate by year end 2025, with top-line results in healthy volunteers expected in the second half of 2026. “We are pleased to partner with Dianthus, a leading biotechnology company with a proven track record of executing complex global clinical trials and delivering meaningful results for patients,” said Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs. “This collaboration reinforces our commitment to advancing highly innovative drug candidates into the clinic to address serious autoimmune conditions, while further diversifying our pipeline and positioning Leads Biolabs for long-term growth. Dianthus’ deep experience and expertise in this space will be invaluable as we work to bring LBL-047 to patients worldwide.” 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 developing innovative therapies for underserved medical needs in oncology, autoimmune, and other severe diseases in China and globally. A front-runner in next-generation immuno-oncology, the company has a pipeline of 14 drug candidates, including six clinical-stage programs, four of which are among the most advanced in their class. Leads Biolabs leverages proprietary platforms, including LeadsBody™ (CD3 T-cell engager) and X-body™ (4-1BB engager), along with integrated capabilities across discovery, translational medicine, clinical development, CMC, and business development. The innovative nature and competitive strengths of its drug candidates, combined with a proactive strategy, efficient clinical validation, and global perspective, position Leads Biolabs as a preferred partner for leading biopharmaceutical companies and venture capital investors. The content above comes from the network. if any infringement, please contact us to modify.