SIM0709 / Simcere - LARVOL DELTA

DEVELOPMENT AND CHARACTERIZATION OF SIM0709, A NOVEL HALF-LIFE EXTENDED BI-SPECIFIC ANTIBODY SIMULTANEOUSLY TARGETING TL1A AND IL-23P19 FOR THE TREATMENT OF IBD AND BEYOND (UEGW 2025) - " SIM0709 simultaneously bound to both TL1A and IL-23 proteins with sub-nanomolar affinity and demonstrated superior functional activities under various functional assays on both TL1A and IL-23 axes compared to that of benchmark anti-TL1A mAb RG6631 and Guselkumab or its combination, respectively. Taken together, these data support the further development of SIM0709 as a potential FIC and BIC therapeutic agent for the treatment of IBD with expected first-in-human study in H1 2026."

Inflammatory Bowel Disease • CD4 • IFNG • IL12A • IL17A • IL18 • IL23A • IL2RA

Discovery and development of SIM0709 a novel bi-specific antibody targeting TL1A and IL23p19 for the treatment of IBD and beyond (IMMUNOLOGY 2025) - "In vitro, SIM0709 demonstrated superior functional activities under various functional assays on both TL1A and IL23 axes compared to that of benchmark anti-TL1A mAb RG6631 and Guselkumab, respectively. High solubility of SIM709 also supports patient-friendly formulation suitable for subcutaneous administration. Taken together, these data support the further development of SIM0709 as a potential FIC therapeutic agent for the treatment of IBD with expected first-in-human study in H1 2026.Keywords: Cells Monocytes/Macrophages T Cells; Diseases Autoimmunity; Molecules Antibodies; Tissues Mucosa"

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL23A

Preclinical data of four innovative autoimmune drugs from Innovent will be published in 2025AAI [Google translation] (Simcere Press Release) - "The 2025 Annual Meeting of the American Association of Immunologists (AAI) will be held in Honolulu, Hawaii, USA from May 3 to 7...SIM0709 is a new long-acting humanized bispecific antibody that can simultaneously target the above two pathways. In multiple in vitro and in vivo IBD animal experiments, it has shown superior functional and pharmacodynamic results to other anti-TL1A or anti-IL-23 monoclonal antibodies under development worldwide. Its synergistic effect is significant, even better than the combination of two monoclonal antibody molecules. The molecule has good drugability and is suitable for subcutaneous administration. It has shown an ultra-long half-life in PK experiments in crab-eating monkeys, which is expected to further reduce the frequency of administration and improve clinical compliance. The project is expected to enter human studies in the first half of 2026."

New trial • Preclinical • Inflammatory Bowel Disease