AbolerIS制药公司宣布，其新型抗CD45RC抗体ABO21009用于类风湿性关节炎的1期研究中，第一组已开始给药-动脉网

AbolerIS Pharma Announces First Cohort Dosed in Phase 1 Study of ABO21009, a Novel Anti-CD45RC Antibody, for Rheumatoid Arthritis

CISION 等信源发布 2025-05-07 15:00

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-Company is advancing a new class of immunomodulators for autoimmune and inflammatory disorders with high unmet medical need-

-公司正在推进一类用于自身免疫和炎症性疾病的新免疫调节剂，满足高度未满足的医疗需求-

ABO21009's unique mechanism of action depletes pathogenic T and B cells, induces expansion of Tregs for lasting efficacy, and preserves overall immunity-

ABO21009的独特作用机制可耗竭致病性T细胞和B细胞，诱导Tregs扩增以实现持久疗效，并保持整体免疫力。

GOSSELIES,

戈塞莱，

Belgium

比利时

and NANTES,

和南特，

France

法国

，

May 7, 2025

2025年5月7日

/PRNewswire/ -- AbolerIS Pharma ('AbolerIS'), a clinical-stage biopharmaceutical company committed to improving the lives of people suffering from autoimmune and inflammatory diseases, announced today that the first cohort of participants has been dosed with ABO21009, a humanized anti-CD45RC monoclonal antibody, in a first-in-human Phase 1 study for the treatment of Rheumatoid Arthritis (RA). ABO21009 was designed to address the unmet medical need for patients with RA who have not responded well to currently available therapeutic options, including anti-TNF therapeutics..

/PRNewswire/ -- 致力于改善自身免疫和炎症疾病患者生活的临床阶段生物制药公司AbolerIS Pharma（“AbolerIS”）今日宣布，在一项针对类风湿关节炎（RA）治疗的首次人体1期研究中，第一组参与者已被给予ABO21009，一种人源化抗CD45RC单克隆抗体。ABO21009旨在满足那些对现有治疗选择（包括抗TNF疗法）反应不佳的RA患者的未满足医疗需求。

'AbolerIS is at the forefront of innovation in autoimmune and inflammatory diseases with our approach in targeting CD45RC and we are thrilled to transition to a clinical-stage company,' said Dr.

“AbolerIS在针对CD45RC的自身免疫和炎症性疾病创新方面处于前沿，我们很高兴能转型为一家临床阶段的公司，”博士表示。

Ann Meulemans

安·梅勒曼斯

, Ph.D., CEO of AbolerIS. 'ABO21009 is the first antibody of its class to enter clinical trials in

，哲学博士，AbolerIS首席执行官。'ABO21009是其同类中第一个进入临床试验的抗体，

Europe

欧洲

and we believe it has great potential as a disease-modifying treatment for RA due to its multi-pronged mechanism of action. This year we are focused on the determination of safety, target engagement and dose range finding in patients suffering from RA. Pending clinical proof-of-concept in RA with ABO21009, we'll advance ABO21009 in the clinic for additional indications like Sjögren`s Disease, Graft-versus-Host Disease, Inflammatory Bowel Disease, and Autoimmune Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy as we continue to grow our company.'.

并且我们相信，由于其多管齐下的作用机制，它作为类风湿关节炎（RA）的疾病修饰治疗具有巨大的潜力。今年，我们将专注于确定RA患者中的安全性、靶点结合和剂量范围。在等待ABO21009在类风湿关节炎中的临床概念验证的同时，我们将继续在临床上推进ABO21009用于其他适应症，如干燥综合症、移植物抗宿主病、炎症性肠病和自身免疫性多内分泌病-念珠菌病-外胚层营养不良，同时我们继续发展我们的公司。

The Phase 1 study is a first-in-human, adaptive design, randomized, single-blind, placebo-controlled dose escalation study with single ascending dosing in healthy volunteers (part I), single ascending dosing in patients with RA (part II) and multiple ascending dosing in patients with RA (part III) to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ABO21009. In part I, 24 patients are planned to be enrolled who will receive one of four single doses of ABO21009 and will be followed up for up to 10 weeks; the Phase 1 study has been initiated in .

第一阶段研究是一项首次人体试验，采用适应性设计、随机、单盲、安慰剂对照的剂量递增研究，包括在健康志愿者中进行单次递增剂量（第一部分）、在类风湿关节炎（RA）患者中进行单次递增剂量（第二部分）以及在RA患者中进行多次递增剂量（第三部分），以评估ABO21009的安全性、耐受性、药代动力学和药效学。在第一部分中，计划招募24名患者，他们将接受四种单剂量之一的ABO21009，并随访长达10周；第一阶段研究已在开始。

the Netherlands

荷兰

, and is currently enrolling and dosing participants.

，目前正在招募和给参与者用药。

Studies have shown that the C domain of specific CD45 protein isoforms is a target of significant global interest given its unique role in modulating the immune system. The CD45 protein is a transmembrane protein found on the surface of all nucleated hematopoietic cells, and is involved in the regulation of signaling pathways that control various immune cell functions..

研究表明，特定CD45蛋白异构体的C结构域因其在调节免疫系统中的独特作用而成为全球关注的重要目标。CD45蛋白是一种跨膜蛋白，存在于所有有核造血细胞的表面，参与调控控制各种免疫细胞功能的信号通路。

'Despite the recent progress in the management of RA, it remains one of the most difficult to treat autoimmune disorders, as many patients do not respond to the currently available therapies or they experience unwanted side effects,' added Prof.

“尽管RA的管理近期有所进展，但它仍然是最难治疗的自身免疫性疾病之一，因为许多患者对目前可用的疗法没有反应，或者他们经历了不良的副作用，”教授补充道。

Dirk Elewaut

德克·埃勒沃特

, MD and Chairman of the SAB AbolerIS. 'I am very excited to bring the first anti-CD45RC agent to my patients, with the hope of providing long-term remission and improved quality of life.'

医学博士，SAB AbolerIS主席。 “我非常兴奋能为我的患者带来首个抗CD45RC药物，希望它能带来长期缓解并提高生活质量。”

More information about the ABO21009 clinical trial can be found at

有关ABO21009临床试验的更多信息可以在

AbolerIS EU Clinical Trials

阿博勒里斯欧盟临床试验

。

'Rheumatoid arthritis is a chronic, progressive autoimmune disease that significantly impacts patients' quality of life and physical health, and we believe that ABO21009 has the potential to disrupt the field and bring innovation to patients,' commented Ronald van Brempt, MD, Chief Medical Officer of AbolerIS. 'Further, I am very proud of our team who have executed well to open the Phase 1 study so quickly in .

“类风湿性关节炎是一种慢性、进行性的自身免疫疾病，显著影响患者的生活质量和身体健康，我们相信ABO21009有潜力颠覆这一领域，并为患者带来创新。” AbolerIS首席医学官Ronald van Brempt博士评论道，“此外，我为我们团队感到非常自豪，他们执行出色，使一期研究能够如此迅速地展开。”

Europe

欧洲

, and we look forward to expanding the study into additional indications.'

“并且我们期待将研究扩展到更多的适应症。”

About ABO21009

关于ABO21009

ABO21009 is the Company's lead monoclonal antibody program stemming from its novel immunomodulatory approach to treating autoimmune and inflammatory diseases. ABO21009 is effective through a multi-pronged mechanism of action, selectively depleting CD45RC-positive cells that are actively sustaining the autoimmune response in Rheumatoid Arthritis.

ABO21009 是公司领先的一种单克隆抗体项目，源于其治疗自身免疫和炎症性疾病的新型免疫调节方法。ABO21009 通过多管齐下的作用机制发挥作用，选择性地清除在类风湿性关节炎中积极维持自身免疫反应的 CD45RC 阳性细胞。

These CD45RC-positive cells are present in the T-, B-, and NK-cell compartments of the adaptive immune system. By selectively depleting these cells, the cells driving the autoimmune disease are taken out of the immune cell population..

这些CD45RC阳性细胞存在于适应性免疫系统的T细胞、B细胞和NK细胞区室中。通过选择性地消耗这些细胞，引发自身免疫疾病的细胞被从免疫细胞群体中移除。

ABO21009 also spares regulatory T cells, which can unleash their full potential and suppress ongoing and future autoimmune activity in the adaptive immune system. Treatment with ABO21009 may enable a long-lasting and durable remission in RA, which will improve the patient experience and lessen the burden of side effects from currently available therapeutic options.

ABO21009 还能保留调节性 T 细胞，充分发挥其潜力，抑制适应性免疫系统中正在进行和未来的自身免疫活动。使用 ABO21009 治疗可能使 RA（类风湿关节炎）实现持久而稳定的缓解，这将改善患者的体验，并减轻当前可用治疗方案带来的副作用负担。

In .

在。

May 2025

2025年5月

, AbolerIS began patient dosing under an authorized Clinical Trial Application (CTA) for a first-in-human Phase 1 study of ABO21009 in RA. Pending clinical proof-of-concept in RA, the Company intends to broaden its development into other autoimmune diseases.

AbolerIS 已根据授权的临床试验申请（CTA）开始对 ABO21009 在类风湿关节炎（RA）中进行首次人体 I 期研究的患者给药。在等待 RA 的临床概念验证的同时，公司计划将其开发扩展到其他自身免疫性疾病。

About AbolerIS Pharma

关于AbolerIS制药公司

AbolerIS Pharma is a clinical-stage biopharmaceutical company committed to improving the lives of patients suffering from autoimmune and inflammatory diseases. The Company is advancing potentially best-in-class and first-in-class immunomodulatory antibodies that target CD45RC, a key regulator of the immune system.

AbolerIS制药是一家处于临床阶段的生物制药公司，致力于改善自身免疫和炎症疾病患者的生活。该公司正在推进针对CD45RC的潜在同类最佳和首创免疫调节抗体，CD45RC是免疫系统的关键调节因子。

AbolerIS' lead program, ABO21009, is designed to demonstrate broad efficacy in multiple autoimmune and inflammatory disorders with large unmet medical needs including rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and organ transplantation..

AbolerIS的主导项目ABO21009旨在展示其在多种自身免疫和炎症性疾病中的广泛疗效，这些疾病存在巨大的未满足医疗需求，包括类风湿关节炎（RA）、炎症性肠病（IBD）和器官移植。

At AbolerIS, we envision a future where patients can enjoy long-term remission and improved quality of life through therapies that are effective and safe. The Company is based in Gosselies,

在AbolerIS，我们设想了一个未来，患者可以通过有效且安全的疗法享受长期缓解和生活质量的提高。公司位于戈塞利。

Belgium

比利时

and Nantes,

和南特，

France

法国

, and is backed by a syndicate of experienced investors, which includes Criteria Bio Ventures, Sound Bioventures, Newton Biocapital, WE, Sambrinvest, SFPIM and Sham Innovation Santé.

，并由一组经验丰富的投资者组成的财团支持，其中包括Criteria Bio Ventures、Sound Bioventures、Newton Biocapital、WE、Sambrinvest、SFPIM和Sham Innovation Santé。

For more information, please visit

欲了解更多信息，请访问

www.aboleris-pharma.com

or follow us on

或关注我们

领英

to learn more about our transformative approach to immunotherapies.

了解更多关于我们对免疫疗法的变革性方法。

Company Contact:

公司联系人：

Dr.