AbolerIS Pharma Initiates First-in-Human Trial of Novel Anti-CD45RC Antibody for Rheumatoid Arthritis
核心洞察
AbolerIS Pharma (搜索) has dosed the first cohort in a Phase I trial of ABO21009 (搜索), a humanized anti-CD45RC (搜索) monoclonal antibody designed for rheumatoid arthritis (搜索) patients who haven't responded to existing treatments.
The antibody works through a multi-pronged mechanism that selectively depletes pathogenic CD45RC (搜索)-positive cells while sparing regulatory T cells, potentially offering a disease-modifying approach for autoimmune conditions.
Following the three-part adaptive design trial in the Netherlands, the company plans to expand development to other autoimmune indications including Sjögren's Disease (搜索), Graft-versus-Host Disease (搜索), and Inflammatory Bowel Disease (搜索).
AbolerIS Pharma (搜索) has initiated dosing in the first cohort of its Phase I clinical trial evaluating ABO21009 (搜索), a novel humanized anti-CD45RC (搜索) monoclonal antibody, for the treatment of rheumatoid arthritis (搜索) (RA). The study marks a significant milestone as ABO21009 becomes the first antibody of its class to enter clinical trials in Europe.
The first-in-human trial is being conducted in the Netherlands with an adaptive design that includes three distinct parts: single ascending dosing in healthy volunteers (Part I), single ascending dosing in RA patients (Part II), and multiple ascending dosing in RA patients (Part III). The study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO21009 (搜索).
Part I of the trial plans to enroll 24 subjects who will receive one of four single doses of the antibody, followed by a monitoring period of up to ten weeks. Patient enrollment and dosing are currently underway.
Novel Mechanism Targets Autoimmune Response
ABO21009 (搜索) represents a new approach to treating autoimmune and inflammatory diseases through its unique mechanism of action. The antibody selectively depletes CD45RC (搜索)-positive cells that actively drive the autoimmune response in rheumatoid arthritis (搜索). These cells are present across T-cell, B-cell, and NK-cell compartments of the adaptive immune system.
Importantly, the therapy spares regulatory T cells (Tregs), which can then suppress ongoing and future autoimmune activity. This dual approach—removing pathogenic cells while preserving regulatory function—could potentially enable long-lasting disease remission.
"AbolerIS is at the forefront of innovation in autoimmune and inflammatory diseases with our approach in targeting CD45RC (搜索) and we are thrilled to transition to a clinical-stage company," said Dr. Ann Meulemans, CEO of AbolerIS. "ABO21009 (搜索) is the first antibody of its class to enter clinical trials in Europe and we believe it has great potential as a disease-modifying treatment for RA due to its multi-pronged mechanism of action."
Addressing Unmet Needs in Rheumatoid Arthritis
The development of ABO21009 (搜索) addresses a significant unmet need for patients with rheumatoid arthritis (搜索) who have not responded adequately to current therapeutic options, including anti-TNF (搜索) treatments. Rheumatoid arthritis affects approximately 1% of the global population and can lead to joint destruction, disability, and reduced quality of life when inadequately controlled.
Professor Dirk Elewaut, MD and Chairman of AbolerIS's Scientific Advisory Board, emphasized the challenges in treating RA: "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. I am very excited to bring the first anti-CD45RC (搜索) agent to my patients, with the hope of providing long-term remission and improved quality of life."
CD45RC as a Novel Target
The CD45 protein is a transmembrane protein found on the surface of all nucleated hematopoietic cells and plays a crucial role in regulating signaling pathways that control various immune cell functions. The C domain of specific CD45 protein isoforms has emerged as a target of significant interest due to its unique role in modulating the immune system.
By targeting CD45RC (搜索) specifically, ABO21009 (搜索) aims to provide a more selective approach to immune modulation compared to broader immunosuppressive therapies, potentially offering improved safety and efficacy profiles.
Future Development Plans
AbolerIS Pharma (搜索), which is based in Belgium and France, has outlined ambitious plans for ABO21009 (搜索) beyond rheumatoid arthritis (搜索). Pending successful clinical proof-of-concept in RA, the company intends to expand development to other autoimmune conditions, including Sjögren's Disease (搜索), Graft-versus-Host Disease (搜索), Inflammatory Bowel Disease (搜索), and Autoimmune Polyendocrinopathy-Candidiasis-Ectodermal Dystrophy (搜索).
"This year we are focused on the determination of safety, target engagement and dose range finding in patients suffering from RA," Dr. Meulemans explained. The company's approach represents a potentially transformative strategy for addressing multiple autoimmune and inflammatory disorders with high unmet medical needs.
Dr. Ronald van Brempt, Chief Medical Officer of AbolerIS, added: "Rheumatoid arthritis (搜索) is a chronic, progressive autoimmune disease that significantly impacts patients' quality of life and physical health, and we believe that ABO21009 (搜索) has the potential to disrupt the field and bring innovation to patients."
The company is backed by a syndicate of experienced investors, including Criteria Bio Ventures, Sound Bioventures, Newton Biocapital, WE, Sambrinvest, SFPIM, and Sham Innovation Santé, supporting its mission to develop novel immunomodulatory therapies for patients with autoimmune and inflammatory diseases.