Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the amount of tabalumab in the blood after it is given by two different injection methods - A traditional syringe or a spring loaded syringe for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.

开始日期2014-01-01

申办/合作机构

Eli Lilly & Co.

JPRN-jRCT2080222103

/ Unknown status临床3期

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE)

开始日期2013-06-10

申办/合作机构

Parexel International

PER-088-11

临床3期

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLED-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LY2127399 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (RA) WHO HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF-α INHIBITORS

开始日期2013-01-07

申办/合作机构

Eli Lilly & Co.

100 项与 Tabalumab 相关的临床结果

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100 项与 Tabalumab 相关的转化医学

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100 项与 Tabalumab 相关的专利（医药）

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项与 Tabalumab 相关的文献（医药）

2025-04-01·JOURNAL OF DERMATOLOGICAL SCIENCE

BAFF modulates T follicular helper cell differentiation through the BAFFR-PI3K/AKT-mTOR signaling pathway in bullous pemphigoid

Article

作者: Qiao, Hongjiang ; Li, Zhiguo ; Li, Xia ; Wang, Gang ; Shen, Shengxian ; Shao, Shuai ; Li, Liang ; Dang, Erle ; Miao, Haijun ; Li, Kang ; Fang, Hui

BACKGROUND:

Bullous pemphigoid (BP) is an autoimmune blistering disease primarily affecting older individuals. B-cell activating factor (BAFF), a member of the tumor necrosis factor superfamily, is crucial for B cell survival and T cell function. However, its role in the development of BP remains unclear.

OBJECTIVE:

To explore the BAFF expression and its specific role in the pathogenesis of BP.

METHODS:

BAFF levels in the serum, skin lesions, and blister fluid (BF) were measured using enzyme-linked immunosorbent assay, immunofluorescence, and flow cytometry. Naïve CD4⁺ T cells derived from healthy volunteers were cultured with BAFF to evaluate T cell activation, proliferation, and differentiation in vitro. A BP-like mouse model was constructed using BP180 immunization to analyze the therapeutic effects of anti-BAFF monoclonal antibody (mAb).

RESULTS:

BAFF levels were elevated in the serum, BF, and skin lesions of patients with BP, and the BAFF levels in the serum and BF were correlated with disease severity. Additionally, monocytes, neutrophils, and eosinophils were the likely sources of BAFF in the circulation and skin lesions of BP patients. In vitro, BAFF facilitated the activation and differentiation of naïve CD4⁺ T cells into T follicular helper cells (Tfh). Moreover, BAFF mediated Tfh differentiation via the BAFF receptor (BAFFR)-PI3K/AKT-mTOR pathway. Anti-BAFF mAb treatment reduced both the proportions of Tfh cells and autoantibody production in vivo.

CONCLUSION:

These findings suggested that BAFF mediated Tfh differentiation via the BAFFR-PI3K/AKT-mTOR pathway, highlighting its promise as a therapeutic target for the management of BP.

2025-02-01·Rheumatology (Oxford, England)

Improvement of high-density lipoprotein atheroprotective properties in patients with systemic lupus erythematosus after belimumab treatment

Article

作者: Sidiropoulos, Prodromos ; Constantoulakis, Pantelis ; Bertsias, George ; Gkolfinopoulou, Christina ; Ruhanen, Hanna ; Käkelä, Reijo ; Christopoulou, Georgia ; Bournazos, Stavros ; Holopainen, Minna ; Chroni, Angeliki ; Dedemadi, Anastasia-Georgia ; Nikoleri, Dimitra ; Nikoloudaki, Myrto

Abstract:

Objective:

Chronic inflammatory diseases, like Systemic Lupus Erythematosus (SLE), carry an increased risk for atherosclerosis and cardiovascular events, accompanied by impairment of atheroprotective properties of high-density lipoprotein (HDL). In SLE, serum B cell-activating factor (BAFF), a cytokine implicated in disease progression, has been correlated with subclinical atherosclerosis. We investigated the impact of treatment with belimumab -an anti-BAFF monoclonal antibody- on HDL atheroprotective properties and composition in SLE patients.

Methods:

Serum samples were collected from 35 SLE patients with active disease despite conventional therapy, before and after 6-month add-on treatment with belimumab, and 26 matched healthy individuals. We measured cholesterol efflux and antioxidant capacities, paraoxonase-1 (PON1) activity, serum amyloid A1 (SAA1), myeloperoxidase (MPO) and lipid peroxidation product levels of HDL. LC-MS/MS was performed to analyse the HDL lipidome.

Results:

Following treatment with belimumab, cholesterol efflux and antioxidant capacities of HDL were significantly increased in SLE patients and restored to levels of control subjects. HDL-associated PON1 activity was also increased, whereas lipid peroxidation products were decreased following treatment. HDL cholesterol efflux and antioxidant capacities correlated negatively with the disease activity. Changes were noted in the HDL lipidome of SLE patients following belimumab treatment, as well as between SLE patients and healthy individuals, and specific changes in lipid species correlated with functional parameters of HDL.

Conclusions:

HDL of SLE patients with active disease displays impaired atheroprotective properties accompanied by distinct lipidomic signatures compared with controls. Belimumab treatment may improve the HDL atheroprotective properties and modify the HDL lipidomic signature in SLE patients, thus potentially mitigating atherosclerosis development.

2024-04-01·International immunopharmacology

The role of BAFF and BAFF-R inhibitors in the treatment of immune thrombocytopenia; a focused review

Review

作者: Najar Nobari, Minou ; Lotfi, Zahra ; Heidari, Nazila ; Ghane, Yekta ; Jaffary, Fariba ; Heidari, Amirhossein ; Nilforoushzadeh, Mohammad Ali ; Najar Nobari, Niloufar

Immune thrombocytopenia (ITP) is an autoimmune-driven disease characterized by increased destruction and impaired platelet production resulting in an enhanced risk of bleeding. Immunosuppressant agents are the most common treatment strategies for ITP. Despite their efficacy, these medications often cause unpredictable side effects. Recent investigations revealed that patients with ITP exhibit elevated B-cell activating factor (BAFF) levels in both their spleens and serum. Belimumab, a BAFF inhibitor, illustrated a promising therapeutic avenue for managing ITP by interfering with BAFF activity and long-lived plasma cell production. Both clinical and experimental studies have yielded positive outcomes when combining rituximab with an anti-BAFF monoclonal antibody in treating ITP. In addition, ianalumab, a monoclonal antibody with a dual mechanism that targets BAFF-R and deletes peripheral BAFF-R⁺ B cells, is currently being used for ITP treatment [NCT05885555]. The upcoming results from novel BAFF inhibitors, such as ianalumab, could offer clinicians an additional therapeutic option for treating ITP.

项与 Tabalumab 相关的新闻（医药）

2026-01-05

·GlobeNewswire-Health Care

Jade Biosciences Outlines Key 2026 Objectives and Strategy to Advance Pipeline of Potentially Best-in-Class Monoclonal Antibodies Across Multiple Autoimmune Diseases Ahead of the 44th Annual J.P. Morgan Healthcare Conference

JADE101 Phase 1 healthy volunteer trial ongoing; biomarker-rich interim data expected in the first half of 2026 Phase 2 clinical trial of JADE101 in patients with IgA nephropathy expected to begin mid-2026; preliminary data anticipated in 2027JADE201, a half-life extended afucosylated anti-BAFF receptor antibody, expected to advance into first-in-human study in rheumatoid arthritis patients in the second quarter of 2026; interim data anticipated in 2027Third development candidate, JADE301, nominated; currently in preclinical development; Phase 1 clinical trial expected to commence in the first half of 2027Approximately $336 million of cash, cash equivalents, and investments as of December 31st, 2025 expected to provide runway into the first half of 2028 Company to present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026, at 11:15 a.m. PT SAN FRANCISCO and VANCOUVER, British Columbia, Jan. 05, 2026 (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 its 2026 strategic priorities, including anticipated milestones ahead of the 44th Annual J.P. Morgan Healthcare Conference, taking place January 12–15, 2026, in San Francisco, California. “2026 is expected to be another year of rapid growth for Jade as we advance our pipeline across multiple clinical trials and transition toward late-stage development for our lead candidate, JADE101” said Tom Frohlich, Chief Executive Officer of Jade Biosciences. “With interim Phase 1 data and Phase 2 initiation anticipated for JADE101 in IgA nephropathy, the planned Phase 1 start of our anti-BAFF-R program, JADE201, and continued investment in discovery-stage antibody innovation, we are executing on a focused strategy to build a next-generation autoimmune company. Our programs are designed to deliver deeper, more durable efficacy with a lower treatment burden for patients. Backed by a strong balance sheet with runway expected to last into the first half of 2028, we enter the year poised to deliver meaningful benefit to patients, have impactful clinical catalysts, and drive long-term growth and value creation.” Key Program Updates JADE101: Novel Anti-APRIL Monoclonal Antibody in Development for IgAN JADE101 is an investigational, fully human monoclonal antibody designed to selectively inhibit A Proliferation-Inducing Ligand (APRIL), a key driver of pathogenic IgA production in patients with IgA nephropathy (IgAN), a progressive autoimmune kidney disease that can lead to kidney failure. Currently in Phase 1 testing in healthy volunteers, JADE101 has demonstrated ultra-high binding affinity in preclinical studies and is engineered for half-life extension, aiming to combine the disease-modifying efficacy of the anti-APRIL mechanism through a long dosing interval with patient-friendly subcutaneous dosing. Its favorable and differentiated preclinical safety, pharmacokinetic and pharmacodynamic profile in non-human primates supports the potential for infrequent dosing and a best-in-class therapeutic profile. Jade is developing JADE101 with the goal of transforming the treatment paradigm for IgAN and other autoimmune diseases. The company believes selective anti-APRIL therapies are poised to become foundational treatments in IgAN, potentially moving to frontline therapy by delivering disease-modifying efficacy, including durable reductions in pathogenic IgA and proteinuria and stabilization of kidney function, without unnecessary immune suppression. Key upcoming anticipated JADE101 milestones: Phase 1 interim results from the ongoing healthy volunteer study expected in the first half of 2026 are anticipated to define dose and dose interval selection for Phase 2 and Phase 3 IgAN patient studies.Jade expects to initiate a Phase 2 clinical trial in patients with IgAN mid-2026, with preliminary data anticipated in 2027. JADE201: Half-Life Extended, Afucosylated Anti-BAFF Receptor Monoclonal Antibody in Development for Autoimmune Diseases JADE201 is a half-life extended, enhanced effector function monoclonal antibody targeting the B-cell activating factor receptor (BAFF-R). JADE201 is designed to build on the differentiated dual mechanism of prior anti-BAFF-R antibodies to deplete B cells, while addressing limitations such as short half-life through the incorporation of half-life extension technology, with the goal of prolonging receptor coverage and enabling less frequent subcutaneous dosing. This approach has the potential to deliver deeper and more durable B-cell depletion than existing therapies, translating into enhanced efficacy and reduced treatment burden for patients. Key upcoming anticipated JADE201 milestones: A first-in-human study initially evaluating JADE201 in patients with rheumatoid arthritis is expected to begin in the second quarter of 2026, with interim data anticipated in 2027. The randomized, placebo-controlled, single ascending dose trial will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics, incorporating biomarker-rich endpoints such as BAFF-R occupancy, soluble BAFF levels, and B-cell subpopulation profiling.With its differentiated mechanism and engineering, JADE201 has broad potential across a range of autoimmune diseases validated by BAFF-R biology. Broader Autoimmune Pipeline Key pipeline milestones: Nominated development candidate, JADE301, an undisclosed antibody program. JADE301 is currently in preclinical testing and is expected to enter first-in-human study in the first half of 2027.Further details on JADE301 are expected to be disclosed in the second half of 2026. Financial Update Jade expects to report that its cash, cash equivalents and investments as of December 31, 2025 were approximately $336 million, which is expected to fund operations into the first half of 2028. Jade has not yet completed its quarter- or year-end financial close process for the period ended December 31, 2025. This estimate of the Company’s cash, cash equivalents and investments as of December 31, 2025 is preliminary, has not been audited and is subject to change upon completion of the company’s financial statement closing procedures and the completion of the audit of the 2025 financial statements. Additional information and disclosure would be required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2025. The Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to this preliminary result and, accordingly, does not express an opinion or any other form of assurance about it. J.P. Morgan Healthcare Conference Presentation Jade to present a company overview and 2026 outlook at the 44th Annual J.P. Morgan Healthcare Conference on Thursday, January 15, 2026, at 11:15 a.m. PT. A live audio webcast of the presentation and a replay will be available on the Company’s website at JadeBiosciences.com. Members of the Jade management team will host one-on-one investor meetings during the conference. 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 JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody program, 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, Jade’s ability to achieve the expected benefits or opportunities with respect to JADE101, JADE201 and JADE301; the expected timelines for interim data from the Phase 1 clinical trial of JADE101, initiation of the Phase 2 clinical trial of JADE101 and the Phase 1 clinical trials of JADE201 and JADE301, and the availability of data from such trials; plans for future clinical trials; the potential for anti-APRIL therapies to become foundational treatments or frontline therapy for IgAN; the potential of Jade’s product candidates to become best-in-class therapies; their potential therapeutic uses, efficacy, durability, safety profiles, and dosing; and the expectation that Jade’s runway will extend into the first half of 2028. 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, the planned trials of JADE101, JADE201 and JADE301, and any other clinical trials may be delayed or may not demonstrate desirable efficacy; adverse events and safety signals may occur; 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 Jade’s dependence on third-party vendors for the development, manufacture and supply of its product candidates; Jade may use its capital resources sooner than expected; 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 September 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 ShahMedia@JadeBiosciences.comIR@JadeBiosciences.com908-447-6134

临床1期临床2期

2025-10-28

·恺佧生物

APRIL、BAFF：经典靶点再焕生机

2025年10月17日，天广实生物宣布其APRIL靶向单抗MIL116向NMPA提交临床试验申请，拟开发用于治疗IgA肾病（IgAN），这标志着MIL116正式加入了该靶点的竞争行列，成为继Sibeprenlimab和Zigakibart之后又一款备受行业关注的APRIL靶向药。这些在研疗法共同聚焦于APRIL这一关键信号通路，旨在通过精准干预B细胞分化及抗体的产生，为IgA肾病等自身免疫性疾病提供新的治疗选择。APRIL属于肿瘤坏死因子（TNF）家族，与其同家族的BAFF类似，他们在免疫系统中密切相关，尤其在B细胞功能调控中具有核心地位，两者因在调节体液免疫和抗体生成的关键作用而成为重要的药物靶点。经典靶点APRIL、BAFF APRIL即A Proliferation-Inducing Ligand，也称TNFSF13，是一种关键B细胞存活因子，核心功能是促进成熟B细胞的存活并分化为浆细胞，并刺激这些浆细胞大量生产抗体。APRIL对维持生发中心B细胞及长寿命浆细胞的存活至关重要，这直接影响长效体液免疫。 BAFF即B cell activating factor，也称BLyS（B Lymphocyte Stimulator）、TNFSF13B、CD257，核心功能是作为B细胞的生存信号，主导了成熟B细胞的筛选、存活与稳态维持。与APRIL更侧重于终末分化阶段不同，BAFF的作用更上游，它决定了过渡期B细胞能否成功进入外周B细胞库，并维持成熟B细胞亚群的存活。APRIL和BAFF及其相关信号通路共同构成B细胞功能调控的关键网络。 APRIL和BAFF均是同型三聚体II型蛋白，经蛋白水解酶切割后可产生可溶形式，这些可溶形式被检测为同源或异源三聚体分子，另外BAFF在某些条件下也以更复杂的20-三聚体组装体的形式存在。BAFF的主要受体是BAFFR，其次是TACI（transmembrane activator and CAML interactor，也称TNFRSF13B）。APRIL的主要受体是BCMA，其次是TACI，而不结合BAFFR。APRIL还可与硫酸肝素蛋白聚糖（HSPG）的多糖侧链结合，但不影响APRIL与BCMA和TACI的相互作用。 BAFF和APRIL与受体BAFF-R、BCMA、TACI间的相互作用[1] 作为B细胞存活的核心开关，BAFF和APRIL的异常表达可能破坏免疫耐受，促进癌症发展。当过度激活时，会放任病态B细胞存活，产生攻击自身的抗体。因此，和APRIL、BAFF有关的适应症集中在B细胞相关自身免疫疾病，包括系统性红斑狼疮（SLE）、重症肌无力（MG）、IgA肾病（IgAN）、狼疮肾炎（LN）、类风湿性关节炎（RA）、原发性干燥综合征、视神经脊髓炎谱系疾病等。除了自免疾病，APRIL-BAFF系统在血液癌症、感染、移植、过敏和免疫缺陷中也发挥重要作用。目前，针对自免的靶向BAFF-APRIL通路的药物有： APRIL单靶点抑制剂 APRIL是半乳糖缺陷型IgA1（Gd-IgA1）产生的关键驱动因子，而Gd-IgA1是IgAN的核心致病因子，APRIL通过激活B细胞分化和浆细胞存活，促进这种致病性IgA的产生，因此靶向APRIL的药物大多针对IgAN。代表药物： 1. Sibeprenlimab Otsuka的Sibeprenlimab（即Visterra、VIS649）是首个单靶点针对APRIL的人源化IgG2单克隆抗体，也是目前临床进展最快的APRIL靶向药。在3期VISIONARY研究中，与安慰剂相比，Sibeprenlimab在治疗9个月后实现了具有统计学意义和临床意义的蛋白尿降低（uPCR-24h＜51.2%，P<0.0001），且安全性良好。2025年3月31日，Otsuka已向FDA提交BLA申请并获得了优先审查资格，另外也于2025年9月2日在中国提交了上市申请，有望成为APRIL的第一个破局者。 Sibeprenlimab 3期数据披露[2] 2. Zigakibart Novartis的Zigakibart（BION-1301）是一种人源化IgG4单克隆抗体。在一项100周的长期研究显示，Zigakibart可显著降低Gd-IgA1水平、减少血尿发生频率、大幅降低蛋白尿，并在整个观察期间稳定患者的肾功能。在第100周，蛋白尿较基线下降了60%，超过一半的患者达到<500mg/24小时，31%达到<300mg/24小时，同时各亚组的eGFR保持稳定。Zigakibart目前已处于3期国际多中心研究。 3. MIL116 上文提及的MIL116（即CLYM116）是一款长效型APRIL单抗抑制剂，采用Fc区长效化改造和pH依赖性清除的双重策略，不仅可阻断APRIL和受体的结合，还可降低其体内的循环水平。2025年1月10日，天广实生物近9亿美元授权Climb Bio使用MIL116的相关专利和专有技术，并授权其在大中华区以外的全球范围内开发、生产和销售的权利。 MIL116（CLYM116）设计原理[3] BAFF单靶点抑制剂代表药物有： 1. Belimumab Belimumab（也即Benlysta, HGS1006, GSK1550188）由HGS开发并与GSK合作完成临床与商业化的IgG1型单抗，也是首个靶向BAFF的治疗性单抗。3期临床（BLISS-52、BLISS-76）证实可降低系统性红斑狼疮活动度，2011年获FDA批准上市。随后GSK于2012年收购HGS，并扩展至肾炎、支气管疾病、血小板减少症等更多适应症。 2. Tabalumab Tabalumab（LY2127399）由Eli Lilly开发的一款全人IgG1型单抗，3期临床试验主要在SLE患者中进行，初期的试验显示其安全性较好，但在关键的疗效终点上未能显著改善SLE患者的疾病活动性（如SLEDAI评分）或减少临床症状，最终止步于3期。值得注意的是，Blimumab和Tabalumab都设计为可以结合膜结合型的BAFF[4][5]。以Belimumab为例，Belimumab与膜结合型BAFF的首次结合可能较为容易，但不足以抑制BAFF的生物活性，只有在抗体的第二臂与膜结合型的BAFF结合后，才会发生真正的抑制，这个过程依赖于BAFF近膜端的Stalk区。研究发现，如果敲除Stalk，BAFF位置将会过于靠近细胞膜，那么作为大分子抗体的Belimumab在到达其第二个结合位点的过程可能会因空间阻碍而受阻，难以完成对BAFF的有效抑制，说明了抗体空间构型和抗原表位适配的重要性。 Belimumab与膜结合型BAFF结合的假设模型[4] 双靶点BAFF/APRIL抑制剂通过同时阻断BAFF和APRIL信号，全面抑制B细胞和浆细胞活化，适用于系统性自身免疫病及抗体介导的肾病。代表药物： 1. Telitacicept Telitacicept（泰它西普）是荣昌生物开发的一种TACI和Fc的融合蛋白，能同时结合可溶形式和膜结合形式的BAFF和APRIL，阻止它们与B细胞膜受体TACI、BCMA、BAFF-R之间的相互作用，不仅可防止B细胞继续成熟，也可阻断成熟B细胞向产生抗体的浆细胞转化，有效减少致病性抗体的产生。 Telitacicept的结构[6] 2021年3月9日，Telitacicept获NMPA附条件上市批准，成为全球首款治疗系统性红斑狼疮的双靶点生物制剂。2023年11月由附条件批准转为完全批准。2024年7月获批用于类风湿关节炎治疗。2025年5月27日，NMPA又批准其新适应症上市，即与常规治疗药物联合用于治疗抗乙酰胆碱受体抗体阳性的成人全身型重症肌无力患者。三种适应症的获批验证了Telitacicept在自免领域的地位。 2. Atacicept Atacicept（阿赛西普）由Vera Therapeutics研发，一项针对IgAN的ORIGIN 3期临床显示，与安慰剂组相比，接受Atacicept治疗的患者在第36周时，蛋白尿水平降低了42%（p<0.0001），这一结果具有统计学意义和临床相关性[7]。Vera计划在2025年第四季度提交生物制品许可申请（BLA），申请加速审批。 3. Povetacicept Povetacicept（也称为ALPN-303、Pove、波维塔西普）是Vertex Pharmaceuticals开发的工程化TACI-Fc变体，对BAFF和APRIL的亲和力显著提升。一项RUBY-3的2期临床结果显示，Povetacicept 80mg治疗24周后，蛋白尿降低52.6%，同时Gd-IgA1显著降低，且耐受性良好，大多数不良事件为低级别[8]。另外相比Telitacicept和Atacicept的每周皮下一次给药，Povetacicept延长至每月1次，提高了依从性，目前处于3期临床。2025年1月10日，再鼎医药和Vertex达成独家合作和许可协议，获得Povetacicept在大中华区和新加坡的开发和商业化权益。 4. CS2013 CS2013是基石药业于2025年7月3日首次披露的针对BAFF和APRIL的双特异性抗体药，临床前研究显示其可触发高效协同效应，同时较融合蛋白类药物具备更优的药代动力学特性，例如较长的半衰期、潜在更长的给药间隔、支持皮下给药等。拟开发适应症包括SLE、RA、IgAN等多种B细胞相关自身免疫性疾病。目前处于临床前候选化合物确认阶段，并计划于2025年下半年启动IND准备工作。无论是单靶还是双靶抑制剂，均体现了对APRIL和BAFF相关通路复杂性日益深入的了解，靶点的选择取决于疾病的具体驱动机制和患者的耐受性。一般来讲，如果免疫异常主要由单一靶点（如BAFF或APRIL）驱动，且需要较为精准的治疗，选择单靶抑制剂更合适；如果免疫异常较为复杂，涉及BAFF和APRIL共同作用，且患者能耐受较高的免疫抑制，双靶抑制剂可能会提供更强的疗效。恺佧生物BAFF-APRIL相关通路蛋白系列产品自免疾病患者基数庞大且日益年轻化，传统治疗无法阻止器官不可逆损伤（如肾衰竭、肌无力），创新药可显著降低致残或致死率并减少激素依赖，临床与经济价值重大。为满足自免疾病药物的开发需求，恺佧生物供应高质量APRIL、BAFF及其受体等相关通路蛋白，涵盖活性三聚体、BAFF Stalk区等不同形式和不同Domain产品，所有产品均采用哺乳动物细胞表达，且生物学活性经过严格验证，适应于动物免疫、抗体筛选及亲和力分析等不同的使用场景。数据举例： Immobilized Human APRIL Trimer, His Tag at 0.1 μg/ml (100 μl/well) on the plate. Dose response curve for Human BCMA, hFc Tag with the EC50 of 0.9 ng/ml determined by ELISA (QC Test). Loaded Human TACI, hFc Tag on ProA-Biosensor can bind Human APRIL Trimer, His-Flag Tag with an affinity constant of 0.76 nM as determined in BLI assay (QC Test). Immobilized Human BAFF Trimer, His Tag at 2 μg/ml (100 μl/well) on the plate. Dose response curve for Human TACI, hFc Tag with the EC50 of 3.5 ng/ml determined by ELISA (QC test). Loaded Biotinylated Human BAFFR, His-Avi Tag on Streptavidin-Biosensor can bind Human BAFF Trimer, His-Flag Tag with an affinity constant of 0.20 nM as determined in BLI assay (QC test). 产品列表：货号名称 APRIL： APR-HM110 Human APRIL Trimer, His-Flag tag APR-HM110-UL Human APRIL Trimer, Ultra Low Endotoxin, His-Flag tag APR-HM410B Biotinylated Human APRIL Trimer, His-Avi-Flag tag APR-CM410 Cynomolgus APRIL Trimer, His-Avi-Flag tag APR-CM410-UL Cynomolgus APRIL Trimer, Ultra Low Endotoxin, His-Avi-Flag tag APR-CM410B Biotinylated Cynomolgus APRIL Trimer, His-Avi-Flag tag APR-CM410B-UL Biotinylated Cynomolgus APRIL Trimer, Ultra Low Endotoxin, His-Avi-Flag tag APR-MM113 Mouse APRIL, His-Flag tag APR-MM113-UL Mouse APRIL, Ultra Low Endotoxin, His-Flag tag APR-MM110 Mouse APRIL, hFc tag BAFF： BAF-HM13D Human BAFF (68-133), His tag BAF-HM23D Human BAFF (68-133), hFc tag BAF-HM214 Human BAFF, monomeric hFc tag BAF-HM4AFB Biotinylated Human BAFF, His-Avi tag BAF-HM112 Human BAFF Trimer, His-Flag tag BAF-HM213 Human BAFF Trimer, Monomeric hFc-Flag tag BAF-HM213-UL Human BAFF Trimer, Ultra Low Endotoxin, Monomeric hFc-Flag tag BAF-CM412 Cynomolgus BAFF Trimer, His-Avi tag BAF-CM412B Biotinylated Cynomolgus BAFF Trimer, His-Avi-Flag tag BAF-MM301 Mouse BAFF, mFc tag BAFFR： BAF-HM10R Human BAFFR, His tag BAF-HM40RB Biotinylated Human BAFFR, His-Avi tag BAF-HM201 Human BAFFR, hFc tag BAF-CM10R Cynomolgus/Rhesus macaque BAFFR, His tag BAF-CM20R Cynomolgus/Rhesus macaque BAFFR, hFc tag BAF-MM10R Mouse BAFFR, His tag BAF-MM20R Mouse BAFFR, hFc tag BCMA： BCM-HM107 Human BCMA, His tag BCM-HM117B Biotinylated Human BCMA, His-Avi tag BCM-HM117F FITC-labeled Human BCMA, His-Avi tag BCM-HM1D2 Human BCMA (P33S), His tag BCM-HM1D3 Human BCMA (P34del), His tag BCM-HM1D4 Human BCMA (R27P), His tag BCM-HM1D1 Human BCMA (S30del), His tag BCM-HM417 Human BCMA Trimer, His-Avi tag BCM-HM417B Biotinylated Human BCMA Trimer, His-Avi tag BCM-HM417P PE-labeled Human BCMA Trimer, His-Avi tag BCM-HM217 Human BCMA, hFc tag BCM-HM217-UL Human BCMA, Ultra Low Endotoxin, hFc tag BCM-CM117 Cynomolgus/Rhesus macaque BCMA, His tag BCM-CM217 Cynomolgus/Rhesus macaque BCMA, hFc tag BCM-MM417 Mouse BCMA, His-Avi tag BCM-MM417B Biotinylated Mouse BCMA, His-Avi tag BCM-MM217 Mouse BCMA, hFc tag TACI： TAC-HM213 Human TACI, hFc tag 点击货号查看产品详情，更多产品欢迎查询官网：https://www.kactusbio.cn/ 参考资料（上下滑动查看）： [1] Transmembrane Activator and CAML Interactor (TACI): Another Potential Target for Immunotherapy of Multiple Myeloma? doi: 10.3390/cancers12041045 [2] https://www.otsuka-us.com [3] https://climbbio.com [4] Inhibition of Membrane-Bound BAFF by the Anti-BAFF Antibody Belimumab. Front Immunol. 2018 Nov 20:9:2698. doi: 10.3389/fimmu.2018.02698. [5] Generation and characterization of tabalumab, a human monoclonal antibody that neutralizes both soluble and membrane-bound B-cell activating factor. J Inflamm Res. 2014 Aug 20:7:121-31. doi: 10.2147/JIR.S67751. [6] Telitacicept, a novel humanized, recombinant TACI-Fc fusion protein, for the treatment of systemic lupus erythematosus. doi: 10.1358/dot.2022.58.1.3352743. [7] https://ir.veratx.com [8] Updated results from the RUBY-3 study of povetacicept, an enhanced dual BAFF/APRIL antagonist, in autoantibody-associated glomerulonephritis. Nephrology Dialysis Transplantation, Volume 39, Issue Supplement_1, May 2024, gfae069-0431-1342, doi.org: 10.1093/ndt/gfae069.431 [9] The BAFF/APRIL system: Emerging functions beyond B cell biology and autoimmunity. doi: 10.1016/j.cytogfr.2013.04.003. [10] The BAFF-APRIL System in Cancer. doi: 10.3390/cancers15061791. [11] B-cell activating factor in the pathophysiology of multiple myeloma: A target for therapy? doi: 10.1038/bcj.2015.3. KACTUS 400-614-0008 www.kactusbio.cn support@kactusbio.com

临床结果临床1期引进/卖出

2025-05-21

·PipelineReview

Zura Bio Launches Global Phase 2 TibuSHIELD Study to Evaluate Tibulizumab in Adults with Hidradenitis Suppurativa

HENDERSON, NV, USA I May 20, 2025 I Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio” or the “Company”), a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases with unmet needs, today announced the launch of TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS. “Hidradenitis suppurativa remains a difficult condition to manage, with many patients experiencing persistent disease activity despite currently available treatments,” said Alexa B. Kimball, MD, MPH, Professor of Dermatology at Harvard Medical School, and President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. “Studying tibulizumab represents an important opportunity to evaluate an investigational therapy designed to target multiple aspects of the inflammatory process in HS. We look forward to investigating this approach for individuals living with this challenging disease.” TibuSHIELD is designed to enroll approximately 180 adults with moderate to severe HS across the United States, Canada, and Europe. The study will evaluate tibulizumab over a 28-week period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, with an optional OLE. Topline results for the primary efficacy endpoint at Week 16 are expected in the third quarter of 2026. “The initiation of TibuSHIELD marks a key milestone in our mission to advance potentially differentiated therapies for patients with severe inflammatory diseases, ” said Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. “Tibulizumab’s dual mechanism of action, targeting both BAFF and IL-17A, offers a novel approach for the potential treatment of hidradenitis suppurativa. We remain committed to advancing clinical development with investigators, clinical sites, and the HS community.” The launch of this HS study follows the December 2024 initiation of TibuSURE, a global Phase 2 study evaluating tibulizumab in adults with systemic sclerosis. Tibulizumab remains an investigational product and has not been approved by any regulatory authority. Its safety and efficacy have not yet been established. ABOUT TibuSHIELD TibuSHIELD is a global, Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, and efficacy of tibulizumab in approximately 180 adults with moderate to severe HS. Participants are randomized 1:1:1 to receive two different doses of tibulizumab or placebo. The study includes a 16-week efficacy assessment period followed by a 12-week safety follow-up and an optional OLE. The primary endpoint of the study is the percent change from baseline in total abscess and nodule (AN) count at Week 16. Secondary endpoints include the proportion of participants achieving HiSCR50 or HiSCR75, defined as at least a 50% or 75% reduction in AN count without an increase in abscesses or draining fistulas at Week 16. Key safety assessments include the assessment of tolerability, and monitoring for adverse events. ABOUT HIDRADENITIS SUPPURATIVA Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic, progressive, and debilitating inflammatory skin disease affecting approximately 1% of the global population. HS primarily involves follicular occlusion, rupture, and secondary inflammation of hair follicles, leading to painful nodules, abscesses, sinus tracts (also referred to as draining tunnels), and scarring. Lesions typically occur in areas where skin rubs together, such as the armpits, groin, and under the breasts. HS is associated with several comorbidities, including inflammatory arthropathies, metabolic syndrome, increased cardiovascular risk, inflammatory disorders, lymphedema, squamous cell carcinoma, and depression. The chronic pain, visible scarring, and disease burden contribute significantly to physical disability, stigmatization, unemployment, and reduced quality of life. Currently, there is no cure for HS. Despite its relatively high prevalence and disease burden, treatment options remain limited, and many patients fail to achieve adequate disease control. ABOUT TIBULIZUMAB Tibulizumab is an investigational, humanized, tetravalent dual-antagonist antibody engineered by fusing Taltz® (ixekizumab) and tabalumab to bind to and neutralize both IL-17A and BAFF. It is currently being evaluated in two Phase 2 clinical studies in adults with systemic sclerosis and hidradenitis suppurativa. Prior to in-licensing, Phase 1/1b studies were conducted in patients with Sjögren’s syndrome and rheumatoid arthritis. Tibulizumab is an investigational compound and has not been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. ABOUT ZURA BIO Zura Bio is a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases with unmet needs. The Company’s pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients. Zura Bio’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two separate Phase 2 clinical studies in adults, including TibuSURE for systemic sclerosis and TibuSHIELD for hidradenitis suppurativa. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions. For more information, please visit www.zurabio.com . SOURCE: Zura Bio

临床2期免疫疗法

100 项与 Tabalumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10083	Tabalumab	-	DB11657

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	临床3期	美国	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	日本	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	阿根廷	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	澳大利亚	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	巴西	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	保加利亚	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	哥伦比亚	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	克罗地亚	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	匈牙利	Eli Lilly & Co.	2010-12-01
类风湿关节炎	临床3期	印度	Eli Lilly & Co.	2010-12-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01556438 (CTgov)	临床1期	复发性多发性骨髓瘤	16	Tabalumab+Bortezomib IV+Dexamethasone	遞糧窪顧夢網淵顧衊選(衊憲膚製觸憲淵築壓夢) = 艱醖觸餘築夢壓餘廠製鹹艱鹽觸範選製膚繭廠 (鑰鏇顧齋簾艱蓋願積夢, 10.7) 更多	-	2019-03-20
NCT00308282 (CTgov)	临床2期	类风湿关节炎	136	Placebo (Placebo)	觸構淵艱鑰簾淵簾鑰夢 = 積醖膚夢壓鏇選鏇鑰窪鬱襯鹹襯膚鏇膚壓夢齋 (糧鑰鏇鹹廠繭築繭窪憲, 獵鹽窪鏇廠簾艱獵獵築 ~ 鏇範膚範餘製蓋築廠廠) 更多	-	2019-03-18
				LY2127399 (30 mg LY2127399)	觸構淵艱鑰簾淵簾鑰夢 = 網艱艱鹹鹽衊網鹽範艱鬱襯鹹襯膚鏇膚壓夢齋 (糧鑰鏇鹹廠繭築繭窪憲, 齋選壓遞廠選鏇餘齋鑰 ~ 繭醖鏇網衊襯膚夢醖餘) 更多
NCT01253291 (CTgov)	临床1期	类风湿关节炎	26	Placebo+LY2127399 (Placebo/LY2127399 120 mg Q4W)	襯蓋獵選糧齋簾廠齋襯 = 糧積網遞憲鬱積鏇醖繭鏇衊壓窪窪積餘廠鹽獵 (醖觸遞遞淵窪壓鏇製餘, 餘糧願構糧鬱鏇願願構 ~ 選壓築鹹襯壓窪鬱憲艱) 更多	-	2019-03-01
				LY2127399 (LY2127399 30 mg Q4W/120 mg Q4W)	襯蓋獵選糧齋簾廠齋襯 = 鹽鬱鬱簾簾遞醖顧網築鏇衊壓窪窪積餘廠鹽獵 (醖觸遞遞淵窪壓鏇製餘, 積鏇鏇顧鑰鑰衊顧構遞 ~ 鹹窪膚鹹鹹淵繭繭選膚) 更多
NCT01253226 (CTgov)	临床1期	类风湿关节炎	32	Tabalumab (30 mg Tabalumab Q4W)	觸顧膚簾願壓繭膚鬱糧 = 鑰選鹽築膚鬱壓憲夢醖鑰糧蓋遞鑰獵壓範構餘 (繭網淵廠觸積餘艱製夢, 簾餘壓糧願顧鹽製艱獵 ~ 選鬱壓鑰壓築蓋鹽鏇鑰) 更多	-	2018-10-23
				Tabalumab (60 mg Tabalumab Q4W)	觸顧膚簾願壓繭膚鬱糧 = 獵衊獵襯鬱鹽壓觸醖襯鑰糧蓋遞鑰獵壓範構餘 (繭網淵廠觸積餘艱製夢, 淵餘淵積積獵廠鬱鹹窪 ~ 繭蓋夢製壓憲範糧壓觸) 更多
NCT01602224 (CTgov)	临床2期	多发性骨髓瘤	220	Tabalumab+Bortezomib+Dexamethasone (300 mg Tabalumab+Dexamethasone+Bortezomib)	遞糧艱顧鬱獵壓齋獵鹽(窪鹽齋積鏇網齋齋範繭) = 糧艱構夢網廠餘顧淵艱廠願獵憲鹽積簾衊選簾 (淵艱夢製齋醖鹹壓觸鏇, 鑰淵襯蓋網選願壓選鑰 ~ 網網遞網衊廠鑰鬱獵簾) 更多	-	2018-08-15
				Placebo+Bortezomib+Dexamethasone (Placebo Comparator: Placebo + Dexamethasone + Bortezomib)	遞糧艱顧鬱獵壓齋獵鹽(窪鹽齋積鏇網齋齋範繭) = 廠憲艱觸選艱簾夢窪觸廠願獵憲鹽積簾衊選簾 (淵艱夢製齋醖鹹壓觸鏇, 積簾衊製艱蓋壓鑰構簾 ~ 獵遞憲餘鏇遞範襯鹹構) 更多
NCT01205438 (ILLUMINATE-2, CTgov)	临床3期	系统性红斑狼疮	1,124	LY2127399 (LY2127399 Every 2 Weeks)	遞衊築範壓鬱鹹鏇獵繭 = 繭網築觸網糧衊製繭淵窪鏇衊鏇獵憲鹹構廠鹹 (夢遞餘蓋獵築築鏇簾鏇, 餘鬱網餘鹹觸築顧衊遞 ~ 遞築遞齋膚艱簾構餘壓) 更多	-	2018-06-19
				Placebo every 4 weeks+LY2127399 (LY2127399 Every 4 Weeks)	遞衊築範壓鬱鹹鏇獵繭 = 糧淵糧廠襯鏇鑰繭顧襯窪鏇衊鏇獵憲鹹構廠鹹 (夢遞餘蓋獵築築鏇簾鏇, 鬱積繭積築獵壓網鏇窪 ~ 選鏇觸製簾觸網衊選鹽) 更多
NCT01488708 (Illuminate-X, CTgov)	临床3期	系统性红斑狼疮	1,518	Placebo+LY2127399 (LY 2127399 Q2W)	鏇鹹製鹽遞簾鏇繭範衊 = 遞獵膚糧憲蓋糧衊艱齋鏇鏇廠餘衊夢夢膚築壓 (簾艱壓糧蓋鏇選構築夢, 艱鏇繭築願醖窪齋鹽網 ~ 網鹹積蓋鏇範艱網衊糧)	-	2018-05-17
				Placebo+LY2127399 (LY2127399 Q4W)	鏇鹹製鹽遞簾鏇繭範衊 = 築壓觸範鹹鹹淵醖觸遞鏇鏇廠餘衊夢夢膚築壓 (簾艱壓糧蓋鏇選構築夢, 膚鹽憲簾襯窪繭製夢糧 ~ 範顧製構醖範範膚觸鹽)
NCT01200290 (CTgov)	临床2期	终末期肾脏病	18	LY2127399	鏇夢遞鑰鑰鹹選壓製夢(衊艱積鹽築繭網製窪襯) = 夢廠鏇願壓壓廠淵築顧範簾簾顧醖築鏇觸製膚 (艱鑰餘範鏇構憲簾選壓, 2.664) 更多	-	2018-05-14
NCT01676701 (CTgov)	临床3期	类风湿关节炎	8	Tabalumab (Tabalumab Auto-Injector (Treatment Period))	築築獵築繭齋鹹範獵築(壓願艱顧鏇獵衊齋廠淵) = 鬱鹽淵襯願淵鑰範鹽鏇壓鬱齋範簾蓋夢鏇繭鏇 (願觸鹹廠鏇淵簾鏇齋製, 憲製鑰窪築構鏇積鹽窪 ~ 壓觸選廠鬱艱製夢鬱糧) 更多	-	2018-04-26
				Tabalumab (Tabalumab Auto-Injector (Post Treatment Follow-Up Period))	築築獵築繭齋鹹範獵築(壓願艱顧鏇獵衊齋廠淵) = 夢衊憲壓鹽窪選襯構淵壓鬱齋範簾蓋夢鏇繭鏇 (願觸鹹廠鏇淵簾鏇齋製, 膚窪築鹽網襯選選鹽鏇 ~ 壓顧鑰齋觸觸製膚網窪) 更多
NCT01576549 (CTgov)	临床2期	类风湿关节炎	2	LY2127399 (LY2127399 - Treatment Period)	淵製築範觸艱憲築選艱(廠憲網餘鑰觸膚獵糧願) = 構壓繭選糧憲範獵鏇鹹餘淵鹽範鏇觸積膚糧醖 (襯蓋獵繭膚願餘觸窪繭, 鑰蓋範構構鬱築願網範 ~ 觸鹽廠網淵壓壓範廠構) 更多	-	2018-04-26
				LY2127399 (LY2127399 - Follow-up Period)	淵製築範觸艱憲築選艱(廠憲網餘鑰觸膚獵糧願) = 積齋衊鹹網鏇窪壓鬱糧餘淵鹽範鏇觸積膚糧醖 (襯蓋獵繭膚願餘觸窪繭, 鏇艱蓋鹹憲糧範淵糧鹹 ~ 餘選淵簾獵顧鬱廠襯襯) 更多