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Jade Biosciences Announces Interim Results of JADE101 Clinical Trial

Jade Biosciences announced interim results from its Phase 1 trial evaluating JADE101, an investigational anti-A Proliferation-Inducing Ligand, or APRIL, monoclonal antibody in development for the treatment of immunoglobulin A nephropathy. JADE101 is designed with ultra-high binding affinity to selectively block APRIL, a key driver of pathogenic IgA production in IgAN, a chronic autoimmune disease that frequently affects young adults and can lead to end-stage kidney disease over a patient's lifetime. These results will be presented in a focused oral session during the 63rd European Renal Association, or ERA, Congress, taking place in Glasgow, Scotland, from June 3-6. Mean IgA reductions reached approximately 70% from baseline and were sustained at 12 weeks at the 700 mg dose; this dose is anticipated to reflect the steady-state IgA responses in IgAN patients with the planned JADE101 dosing strategy. IgA-lowering effect observed to be deeper, faster, and more durable following a single dose of JADE101 than with first-generation anti-APRIL or dual APRIL/BAFF inhibitors. Greater than 70% IgA reductions simulated at steady-state with a single subcutaneous injection of 350 mg of JADE101 every 12 weeks following one 700 mg induction dose, which could support best-in-class clinical activity with a convenient dosing regimen of only four injections per year. IgA-lowering potency estimated to be approximately 379-fold higher than sibeprenlimab and approximately 26-fold higher than povetacicept. JADE101 achieved rapid, complete and durable suppression of fAPRIL, consistent with the femtomolar APRIL binding affinity of JADE101. Single subcutaneous doses of JADE101 up to 1,400 mg were well tolerated with an observed safety profile generally consistent with the anti-APRIL class. The most common treatment-emergent adverse events in the pooled safety analysis occurring in more than two participants were headache, upper respiratory tract infection, injection site erythema, oropharyngeal pain and pyrexia. There were no serious adverse events and no adverse events leading to study discontinuation. There were no cases of hypogammaglobulinemia, defined as IgG less than or equal to 3 g/L. JADE101 demonstrated dose-dependent increases in exposure across evaluated dose levels. Half-life at steady state for JADE101 was approximately 8.7-fold longer than reported for povetacicept and approximately 2.6-fold longer than reported for sibeprenlimab. Target-mediated drug disposition threshold with JADE101 is estimated to be approximately 2.5-fold lower than reported for sibeprenlimab. No apparent impact of anti-drug antibodies on PK or PD was observed. JUNIPER is an ongoing Phase 2 clinical trial evaluating JADE101 in participants with IgAN. The open-label trial is expected to enroll approximately 30 participants. Participants are expected to receive a 700 mg induction dose of JADE101 at treatment onset followed by maintenance doses of 350 mg starting at Week 4 and subsequently either every 8 weeks or every 12 weeks. Evaluating both dose intervals is intended to support accelerated Phase 3 initiation and satisfy global regulatory expectations for dose finding. The primary objectives of the trial are to evaluate the safety and tolerability of JADE101. Secondary and exploratory objectives include changes in 24-hour urine protein-to-creatinine ratio, including the proportion of participants achieving UPCR-24 levels below 0.5 g/day and 0.3 g/day, renal function as measured by estimated glomerular filtration rate, and hematuria resolution over time. Interim clinical data are anticipated in 2027. Jade plans to initiate a registrational Phase 3 clinical trial in the first half of 2027, pending FDA requirements.

Jade Biosciences Doses First Participant in JADE201 Phase 1 Trial

Jade Biosciences announced the first participant has been dosed in a first-in-human Phase 1 clinical trial of JADE201. JADE201 is an investigational, half-life extended, afucosylated monoclonal antibody targeting the B cell activating factor receptor designed to deplete B cells through a dual mechanism of action: enhanced antibody effector function and BAFF signal blockade. The company expects interim data in 2027.