| Source: Jade Biosciences
- Presentations to highlight JADE101’s preclinical safety profile and translational framework guiding its clinical development in IgA nephropathy
- JADE101 is an investigational, potentially best-in-class disease-modifying anti-APRIL monoclonal antibody, with a Phase 1 healthy volunteer study underway
SAN FRANCISCO and VANCOUVER, British Columbia, Oct. 17, 2025 (GLOBE NEWSWIRE) — Jade Biosciences, Inc. (“the Company” or “Jade”), (Nasdaq: JBIO), a clinical-stage biotechnology company focused on developing best-in-class therapies for autoimmune diseases, today announced that it will present new preclinical safety and translational data for JADE101, its lead investigational candidate for immunoglobulin A nephropathy (IgAN), during two poster sessions at the American Society of Nephrology (ASN) Kidney Week 2025, taking place November 5–9 in Houston, Texas.
JADE101 is designed to selectively inhibit A PRoliferation-Inducing Ligand (APRIL) in patients with IgAN, an autoimmune disease that leads to end-stage kidney disease over the lifetime of most patients. The therapy is engineered with properties intended to achieve the full efficacy of APRIL pathway inhibition with patient-friendly subcutaneous dosing, based on its differentiated preclinical pharmacokinetic and pharmacodynamic profile in non-human primates. JADE101 is currently being evaluated in a Phase 1 healthy volunteer clinical trial, with interim data expected in the first half of 2026.
ASN Kidney Week 2025 Poster Presentation Details
Title: Nonclinical Safety Profile of JADE101, a Half-Life Extended Fully Human Monoclonal Antibody Targeting APRIL for the Treatment of IgAN
Presenter: Ashley McCord, Jade Biosciences
Poster Board #: SA-PO0255
Date, Time: November 8, 2025 from 10:00 AM to 12:00 PM CT
Title: Translational Framework to Predict Clinical Responses to APRIL Blockade for Development of JADE101, an Anti-APRIL Monoclonal Antibody in IgAN
Presenter: Brandon Gufford, Jade Biosciences
Poster Board #: SA-PO0272
Date, Time: November 8, 2025 from 10:00 AM to 12:00 PM CT
About JADE101
JADE101 is a novel, fully human monoclonal antibody that selectively blocks APRIL with ultra-high binding affinity and is engineered for half-life extension. Preclinical studies demonstrated potent, sustained IgA suppression after a single dose in non-human primates, with a serum half-life of approximately 27 days. JADE101 was designed to avoid formation of high molecular weight immune complexes, with the goal of supporting predictable pharmacokinetics and reduced immunogenicity risk. Its differentiated pharmacokinetic and pharmacodynamic profile supports the potential for infrequent and convenient subcutaneous dosing, an important consideration for a condition often diagnosed in young adulthood and potentially requiring life-long treatment.
A Phase 1 randomized, double-blind, placebo-controlled clinical trial evaluating single ascending subcutaneous doses of JADE101 in healthy adult volunteers is ongoing. The Company expects data from the Phase 1 trial to define dose and dosing interval selection for later-stage studies, based on biomarker responses associated with optimal clinical activity in IgAN patients. More information on the JADE101 Phase 1 trial is available on ClinicalTrials.gov.
About Jade Biosciences, Inc.
Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune diseases. Jade’s lead candidate, JADE101, targets the cytokine APRIL, and is currently being evaluated in a Phase 1 clinical trial for the treatment of immunoglobulin A nephropathy. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE-003, both currently in preclinical development. Jade was launched based on assets licensed from Paragon Therapeutics, an antibody discovery engine founded by Fairmount. For more information, visit JadeBiosciences.com and follow the Company on LinkedIn.
Forward-Looking Statements
Certain statements in this communication, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Jade’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, the expected timeline for interim data from the Phase 1 clinical trial of JADE101, plans for future clinical trials, the potential of JADE101 to be disease-modifying, the potential of JADE101 and Jade’s other product candidates to become best-in-class therapies and their potential therapeutic uses, efficacy, dosing, safety and market opportunities. The words “opportunity,” “potential,” “milestones,” “pipeline,” “can,” “goal,” “strategy,” “target,” “anticipate,” “achieve,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “possible,” “project,” “should,” “will,” “would” and similar expressions (including the negatives of these terms or variations of them) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Jade will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Jade’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the Phase 1 clinical trial of JADE101 and any future clinical trials may be delayed or may not demonstrate desirable safety and/or efficacy; Jade may experience unanticipated costs, difficulties or delays in the product development process; Jade’s product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; enrollment or regulatory challenges; risks associated with dependence on third-parties for the development, manufacture and supply of Jade’s product candidates; and the other risks, uncertainties and factors more fully described in Jade’s most recent filings with the Securities and Exchange Commission (including the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025). Should one or more of these risks or uncertainties materialize, or should any of Jade’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You should not place undue reliance on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Jade does not undertake or accept any duty to release publicly any updates or revisions to any forward-looking statements. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Jade.
Jade Biosciences Contact
Priyanka Shah
Media@JadeBiosciences.com
IR@JadeBiosciences.com
908-447-6134
