Jade Biosciences Inc.
09/30/2026 | Press release | Distributed by Public on 09/30/2026 05:14
Material Event (Form 8-K)
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Other Events. |
On September 30, 2026, Jade Biosciences, Inc. ("Jade") announced preclinical data characterizing JADE301, its anti-interferon beta ("IFN-ß") monoclonal antibody in development for dermatomyositis ("DM"), a rare, chronic and debilitating autoimmune disease characterized by painful inflammatory skin disease and progressive muscle weakness. JADE301 is a fully human IgG1 monoclonal antibody with a YTE modification designed to selectively and potently neutralize IFN-ß and inhibit downstream signaling implicated as a proximal driver in DM pathogenesis.
Summary of JADE301 Preclinical Data
High-affinity, selective and potent IFN-ß neutralization
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JADE301 demonstrated high-affinity binding to IFN-ß, with a KD of 11.3 pM, approximately 2.5-fold higher affinity than a dazukibart comparator, and no detectable binding to other interferon family proteins. |
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JADE301 potently inhibited downstream IFN-ß signaling. |
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In a human immune cell line, JADE301 inhibited induction of pSTAT with an IC50 of 13 pM, approximately 2.5-fold more potent than the dazukibart comparator. |
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Suppression of MX-1, a marker of IFN pathway activity relevant to DM, was demonstrated in human dermal fibroblasts, a disease-relevant skin cell type, and peripheral blood mononuclear cells; in human dermal fibroblasts, JADE301 inhibited MX-1 induction with an IC50 of 11 pM, approximately 8-fold more potent than the dazukibart comparator. |
Differentiated pharmacokinetic profile supports potential for infrequent subcutaneous dosing
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JADE301 demonstrated an approximately 30-day half-life following a 30 mg/kg intravenous dose in non-human primates ("NHPs"), approximately 3-fold longer than the dazukibart comparator. |
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Following subcutaneous ("SC") administration in NHPs, JADE301 demonstrated an approximately 25-day half-life. Translational modeling predicted human SC bioavailability of approximately 73%-75%, compared with a reported dazukibart SC bioavailability in humans of approximately 43%-44%, supporting the potential for convenient, infrequent SC dosing. |
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JADE301 concentrations in muscle were consistent with the typical range reported for monoclonal antibodies, approximately 1%-4% of serum concentrations, providing a translational framework to inform dose selection and exposure at a key site of active disease in DM. |
Favorable nonclinical tolerability profile
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In a GLP toxicology study in NHPs, subcutaneous JADE301 was administered every two weeks at doses of 0, 50, 100 and 200 mg/kg and was well tolerated at all dose levels evaluated. |
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There were no treatment-related adverse clinical observations or meaningful adverse findings on laboratory or other standard safety assessments. No treatment-related histopathology findings were observed. |
JADE301 Phase 1 Development
Jade expects to initiate a placebo-controlled, single ascending-dose Phase 1 trial evaluating subcutaneous JADE301 in 24 healthy volunteers in the fourth quarter of 2026, with interim data anticipated in the second half of 2027. The study is designed to assess safety and tolerability, and to characterize the pharmacokinetic and immunogenicity profile of JADE301.
Jade Biosciences Inc. published this content on September 30, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on September 30, 2026 at 11:14 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]