
Jade Biosciences Presents New Data Demonstrating a Favorable Preclinical Safety Profile of JADE101 and a Translational Analysis of APRIL‑Mediated Biomarker Responses at the American Society of Nephrology Kidney Week 2025
•By ADMIN
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Jade Biosciences, Inc. (Nasdaq: JBIO), a clinical‑stage biotech focused on autoimmune disease therapies, unveiled fresh data showcasing its investigational anti‑APRIL monoclonal antibody, JADE101, during the American Society of Nephrology (ASN) Kidney Week 2025. The company presented two posters detailing: (1) a strong preclinical safety profile in non‑human primates (NHPs) and (2) translational biomarker modelling linking APRIL inhibition to IgA reductions and meaningful clinical signals.
In the safety studies, JADE101 was well‑tolerated at all doses including the NOAEL, showed no off‑target binding across >6,000 human proteins, and little impact on immune‑cell populations or inflammation markers. Serum IgA and IgM dropped ~55‑68 % and ~62‑75 % respectively, with IgG down ~35‑48 % — all reversible post‑treatment. Notably, vaccinated NHPs still mounted antibody responses despite treatment.
In the translational biomarker work, APRIL binding affinity correlated with IgA lowering in both NHPs and humans (r = 0.93 for IgA reduction; r = 0.96 for Gd‑IgA1 versus total IgA). Further, the magnitude of early IgA reduction in patients with IgA Nephropathy (IgAN) strongly associated with later proteinuria reduction (r = 0.89). These findings suggest healthy‑volunteer pharmacokinetics and biomarker responses may reliably guide dosing for IgAN trials.
Jade anticipates interim Phase 1 data in the first half of 2026 that will inform dose and interval selection ahead of patient trials. The differentiated profile of JADE101 — including potential for convenient subcutaneous dosing and minimal broad immunosuppression — positions it as a potential best‑in‑class therapy for IgAN.
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