Core Insights - Jade Biosciences, Inc. is focused on developing therapies for autoimmune diseases, with its lead candidate JADE101 targeting immunoglobulin A nephropathy (IgAN) [1][9] - JADE101 is an investigational anti-APRIL monoclonal antibody designed to inhibit APRIL, a key factor in IgAN progression, and is currently in a Phase 1 trial [2][8] Company Overview - Jade Biosciences is a clinical-stage biotechnology company that aims to address unmet needs in autoimmune diseases, with a pipeline that includes JADE201 and JADE-003 in preclinical development [9] - The company was established based on assets licensed from Paragon Therapeutics, an antibody discovery engine [9] Product Details - JADE101 is engineered for subcutaneous dosing and has shown a favorable pharmacokinetic and pharmacodynamic profile in non-human primates (NHPs), with a serum half-life of approximately 27 days [7] - Preclinical studies indicate that JADE101 effectively reduces immunoglobulin levels, including IgA and IgM by approximately 55–68% and 62–75% respectively, while maintaining a preserved vaccination response [5][6] Clinical Development - The ongoing Phase 1 trial is randomized, double-blind, and placebo-controlled, evaluating single ascending doses of JADE101 in healthy volunteers, with interim data expected in the first half of 2026 [2][8] - The trial aims to define optimal dosing intervals based on biomarker responses that correlate with clinical activity in IgAN patients [8][11] Safety and Efficacy - JADE101 has demonstrated a favorable safety profile in preclinical studies, with no off-target binding or significant adverse effects observed [5][6] - The pharmacokinetic and biomarker responses in healthy volunteers are expected to inform therapeutic responses in IgAN patients, linking APRIL suppression to reductions in total IgA and proteinuria [6][11]