Chugai Pharmaceutical, a member of the Roche Group, is a research-based company headquartered in Japan that leverages advanced antibody engineering technologies to drive innovative drug discovery.
In this presentation, we will introduce DONQ52, an investigational multispecific antibody being developed for celiac disease, currently conducting a Phase 2 clinical trial. DONQ52 is designed to selectively bind HLA-DQ2.5–gluten peptide complexes, thereby inhibiting gluten-specific T-cell activation, a key driver of celiac disease pathogenesis. This mechanism enables targeted intervention in the immune response to gluten without inducing systemic immunosuppression.
We will disclose, for the first time, the clinical results on the clinical development program for DONQ52. Following completion of Phase 1 single- and multiple-ascending-dose studies, a biological proof-of-concept (bPoC) trial is currently underway in patients with celiac disease using a controlled gluten challenge model. The study is designed to evaluate the biological activity of DONQ52 in the context of gluten exposure and to further characterize its clinical development potential.
Beyond the scientific and clinical updates, we will highlight Chugai’s holistic commitment to the celiac disease therapeutic area. We will share our overarching vision for delivering this innovative therapy to patients through active collaboration with Patient Advocacy Groups and key stakeholders, emphasizing our dedication to working hand-in-hand with the global celiac disease community.
Presented by Dr Daniel Leffler.
Daniel Leffler, MD, MS, AGAF is a gastroenterologist caring for patients with celiac disease and other gastrointestinal disorders and is a founding member of the Celiac Center at Beth Israel Deaconess Medical Center. He is an Associate Professor of Medicine at Harvard Medical School, has received multiple National Institute of Health, foundation and industry sponsored grants and has published over 200 articles in peer reviewed literature. Dr. Leffler served as the Global Clinical Lead for Celiac Disease at Takeda Pharmaceuticals from 2016 to 2025. He is now the Global Project Strategy Lead at Chugai Pharma and the Head of the Celiac Disease DONQ52 Program.
Invite only.
A Duodenal Pre Gluten-Challenge Interferon-γ/Antigen-Presentation State Predicts Susceptibility to Gluten-Induced Mucosal Injury in Celiac Disease - Aline Pesi
Using cryo-electron tomography and volume electron microscopy methods to localize active transglutaminase 2 and define the ultrastructure of dendritic cells and the small intestine - Krystal Brodsky
Less than half of patients newly positive for tissue transglutaminase antibodies undergo upper endoscopy for diagnostic confirmation: A population-based study from Alberta, Canada - James A King
JAK inhibition suppresses interferon driven epithelial stress pathways in celiac disease - Veera Räkköläinen
Serum proteomic profiling of celiac disease: Extending inflammatory signatures with the novel Protein XI multiplex platform - Jostein H. Ibsen
Global Preparedness of Celiac disease from the lens of dietitians: Are we ready for the future? - Suyasha Gupta
Tryptophan restores AhR signaling in celiac disease: A double-blinded randomized placebo-controlled exploratory study. - Utkarshini Kirtikar
Is prenatal exposure to per- and polyfluoroalkyl substances (PFAS) a risk factor for celiac disease? - Christina Elise Holm-Larsen
Functional Insights into Agathobacter rectalis Strain-Level Variation in Celiac Disease - Hanna Simpson
EVQ-001, a NanoDisc Antigen-Specific Immune Tolerance Therapy for Celiac Disease - Weston Daniel
In Vivo Evaluation of a Multi-Epitope Gliadin Peptide Construct as a Novel Drug Substance Candidate for Epicutaneous Immunotherapy (EPIT) in Celiac Disease - Tobias L Freitag
Safety and Efficacy of TAK-101: Results from a Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Phase 2 Trial in Patients with Celiac Disease on a Gluten-Free Diet - Jocelyn A Silvester
Clinical, histologic and safety outcomes of ZED1227 treatment in symptomatic celiac disease patients: results from the phase 2b CEC-004/CEL randomized clinical trial - Swee Lin Chen Yi Mei
Optimising Coeliac Disease Trials Through Participant-Centred Design: Motivators, Preferences and Gluten Challenge Acceptability - Amalia Marino
Study with Single Doses of VTP-1000, an Antigen-Specific Immunotherapy, Demonstrates Favorable Safety and Pharmacodynamic Responses in Adults with Confirmed Celiac Disease - Leon MD Hooftman
Real-World Functional, Economic, and Behavioral Burden of Acute Gluten Exposure in U.S. Adults with Celiac Disease: Insights from a Large National Cohort - Marilyn Geller
A New Mouse Model for Celiac Disease: Constitutive TG2 Activation Cooperates with Gluten and HLA-DQ2 to Induce Celiac-Like Enteropathy - Fu-Chen Yang