Jade Biosciences Announces First Cohort Dosed in Phase 1 Healthy Volunteer Clinical Trial of JADE101, a Novel and Potentially Best-in-Class Anti-APRIL Monoclonal Antibody Being Evaluated for the Treatment of IgA Nephropathy
Jade Biosciences (NASDAQ:JBIO) has initiated dosing in its Phase 1 clinical trial of JADE101, a novel anti-APRIL monoclonal antibody targeting IgA nephropathy (IgAN). The trial marks a significant milestone in developing a potential best-in-class treatment for this autoimmune kidney disease.
The Phase 1 study is designed as a randomized, double-blind, placebo-controlled trial evaluating single ascending subcutaneous doses in healthy volunteers. The company expects to report interim data in H1 2026, which will help determine optimal dosing strategies for future IgAN patient studies.
JADE101 has demonstrated promising preclinical results, including femtomolar binding affinity to APRIL and sustained IgA reductions in non-human primates, suggesting potential for convenient eight-week or longer dosing intervals.
Jade Biosciences (NASDAQ:JBIO) ha iniziato la somministrazione nella sua sperimentazione clinica di Fase 1 di JADE101, un nuovo anticorpo monoclonale anti-APRIL volto al trattamento della nefropatia da IgA (IgAN). Lo studio rappresenta un traguardo importante nello sviluppo di una possibile terapia di riferimento per questa malattia autoimmune renale.
Lo studio di Fase 1 è uno studio randomizzato, in doppio cieco e controllato con placebo che valuta dosi sottocutanee singole ascendenti in volontari sani. L’azienda prevede di comunicare i dati provvisori nella prima metà del 2026, utili a definire le strategie di dosaggio ottimali per studi futuri nei pazienti con IgAN.
JADE101 ha mostrato risultati preclinici promettenti, compresa un’affinità di legame a livello femtomolare per APRIL e riduzioni sostenute delle IgA nei primati non umani, suggerendo la possibilità di intervalli di somministrazione comodi di otto settimane o più.
Jade Biosciences (NASDAQ:JBIO) ha comenzado la dosificación en su ensayo clínico de Fase 1 de JADE101, un nuevo anticuerpo monoclonal anti-APRIL dirigido a la nefropatía por IgA (IgAN). El ensayo supone un hito importante en el desarrollo de un posible tratamiento de referencia para esta enfermedad autoinmune renal.
El estudio de Fase 1 está diseñado como un ensayo aleatorizado, doble ciego y controlado con placebo que evalúa dosis subcutáneas ascendentes únicas en voluntarios sanos. La compañía espera presentar datos provisionales en la primera mitad de 2026, que ayudarán a determinar las estrategias de dosificación óptimas para futuros estudios en pacientes con IgAN.
JADE101 ha mostrado resultados preclínicos prometedores, incluida una afinidad de unión a APRIL a nivel femtomolar y reducciones sostenidas de IgA en primates no humanos, lo que sugiere la posibilidad de intervalos de dosificación cómodos de ocho semanas o más.
Jade Biosciences (NASDAQ:JBIO)가 IgA 신증(IgAN)을 표적으로 하는 새로운 항-APRIL 단일클론항체 JADE101의 1상 임상시험에서 투약을 시작했습니다. 이번 시험은 이 자가면역성 신장질환에 대한 잠재적 최고 수준 치료제 개발에 있어 중요한 이정표입니다.
1상 연구는 건강한 피험자를 대상으로 단회 상승 피하주사 용량을 평가하는 무작위배정, 이중맹검, 위약대조 시험으로 설계되었습니다. 회사는 향후 IgAN 환자 연구의 최적 투약 전략을 결정하는 데 도움이 될 중간 결과를 2026년 상반기에 보고할 계획입니다.
JADE101은 전임상에서 유망한 결과를 보였으며, APRIL에 대한 펨토몰 수준의 결합 친화력과 비인간 영장류에서의 지속적인 IgA 감소를 포함해 8주 또는 그 이상의 편리한 투약 간격 가능성을 시사합니다.
Jade Biosciences (NASDAQ:JBIO) a commencé les premières administrations dans son essai clinique de Phase 1 de JADE101, un nouvel anticorps monoclonal anti‑APRIL ciblant la néphropathie à IgA (IgAN). Cet essai constitue une étape importante dans le développement d’un traitement potentiellement de référence pour cette maladie rénale auto‑immune.
L’étude de Phase 1 est conçue comme un essai randomisé, en double aveugle et contrôlé par placebo évaluant des doses sous‑cutanées uniques ascendantes chez des volontaires sains. La société prévoit de publier des données intermédiaires au premier semestre 2026, qui permettront de définir les stratégies de dosage optimales pour de futurs essais chez des patients atteints d’IgAN.
JADE101 a montré des résultats précliniques prometteurs, notamment une affinité de liaison à APRIL au niveau femtomolaire et des réductions soutenues des IgA chez les primates non humains, suggérant la possibilité d’intervalles de dosage pratiques de huit semaines ou plus.
Jade Biosciences (NASDAQ:JBIO) hat mit der Dosierung in seiner Phase‑1‑Studie von JADE101 begonnen, einem neuartigen anti‑APRIL monoklonalen Antikörper, der auf IgA‑Nephropathie (IgAN) abzielt. Die Studie stellt einen wichtigen Meilenstein bei der Entwicklung einer potenziell erstklassigen Therapie für diese autoimmunbedingte Nierenerkrankung dar.
Die Phase‑1‑Studie ist als randomisierte, doppelblinde, placebokontrollierte Studie angelegt und untersucht einmalige aufsteigende subkutane Dosen bei gesunden Freiwilligen. Das Unternehmen erwartet, vorläufige Daten in H1 2026 zu berichten, die dabei helfen sollen, optimale Dosierungsstrategien für zukünftige IgAN‑Patientenstudien zu bestimmen.
JADE101 zeigte vielversprechende präklinische Ergebnisse, darunter eine femtomolare Bindungsaffinität an APRIL und anhaltende IgA‑Reduktionen bei nicht‑menschlichen Primaten, was auf mögliche komfortable Dosierungsintervalle von acht Wochen oder länger hinweist.
- Demonstrated ultra-high binding affinity in preclinical studies
- Potential for patient-friendly dosing schedule (every 8 weeks or longer)
- Strong preclinical data showing deep and prolonged IgA reductions
- Anti-APRIL class positioned to be foundational treatment for IgAN
- Long wait for interim data (H1 2026)
- Early-stage development (Phase 1) with no efficacy data yet
- Will require extensive testing in actual IgAN patients after healthy volunteer study
Insights
Jade reaches important clinical milestone with JADE101 for IgA nephropathy, positioned to potentially deliver best-in-class therapy with patient-friendly dosing.
Jade Biosciences has reached a significant clinical milestone by dosing the first cohort in their Phase 1 healthy volunteer trial for JADE101, their anti-APRIL monoclonal antibody targeting IgA Nephropathy (IgAN). This progression into clinical trials represents a crucial step in their drug development timeline.
The scientific rationale behind this program is compelling. APRIL inhibition has already demonstrated disease-modifying potential in IgAN patients in other clinical trials, validating the mechanism. What differentiates JADE101 is its ultra-high binding affinity at the femtomolar level and its pharmacokinetic profile that could enable subcutaneous dosing every eight weeks or longer - a significant convenience advantage for a chronic disease therapy.
This biomarker-rich Phase 1 study is particularly valuable as it will likely provide early indicators of JADE101's effect on APRIL inhibition and IgA levels, potentially derisking later-stage trials. With interim data expected in H1 2026, this study will inform critical decisions on dosing regimens for patient trials.
For context, IgAN is a serious autoimmune kidney disease that can progress to end-stage kidney disease, typically affecting younger adults who require lifelong treatment. The competitive landscape for anti-APRIL therapies in IgAN is developing, with several companies pursuing this approach, but Jade appears positioned to potentially offer the most convenient dosing schedule within this emerging drug class - a meaningful differentiator that could translate to better real-world adherence and outcomes.
- Selective APRIL inhibition has shown disease-modifying potential in IgAN patient clinical trials
- JADE101 has shown ultra-high binding affinity and a differentiated pharmacokinetic and pharmacodynamic profile preclinically, supporting the potential for patient-friendly subcutaneous dosing every eight weeks or longer
- Interim, biomarker-rich Phase 1 healthy volunteer data are expected in the first half of 2026, and are anticipated to define dose and dosing interval selection based on biomarker responses associated with optimal clinical activity in IgAN patients
SAN FRANCISCO and VANCOUVER, British Columbia, Sept. 02, 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 has dosed the first cohort of participants in a Phase 1 healthy volunteer trial of JADE101. JADE101 is the Company’s investigational monoclonal antibody designed to selectively inhibit the activity of A PRoliferation-Inducing Ligand (APRIL) in patients with immunoglobulin A nephropathy (IgAN). The Company expects interim Phase 1 clinical data in the first half of 2026.
“We believe the anti-APRIL class is poised to be the foundational treatment for patients with IgAN, an autoimmune kidney disease that leads to end-stage kidney disease over the lifetime of most patients,” said Andrew King, Ph.D., Chief Scientific Officer and Head of R&D at Jade Biosciences. “JADE101 has a differentiated preclinical profile, demonstrating femtomolar binding affinity to APRIL and deep and prolonged IgA reductions in non-human primates. These properties could lead to potentially capturing the full efficacy of the anti-APRIL mechanism and offering the most convenient dosing schedule in the class—an important consideration for a lifelong disease that typically affects otherwise healthy young adults. Our interim healthy volunteer data are expected to be highly informative, providing readouts on APRIL and IgA biomarkers, and are anticipated to define dose and dosing interval selection for later-stage IgAN patient studies.”
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study evaluating single ascending subcutaneous doses of JADE101 in healthy adult volunteers. The trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of JADE101. More information on the JADE101 Phase 1 trial is available on ClinicalTrials.gov.
About JADE101
JADE101 is a 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.
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 for the anti-APRIL class to become the foundational treatment for patients with IgAN, 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 JADE101; 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
FAQ
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