Debaters
Affirmative:
Negative:
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.
PREDICTORS OF PROGRESSION TO VILLOUS ATROPHY IN CHILDREN WITH TYPE 1 DIABETES AND POTENTIAL CELIAC DISEASE - Raghav Lal
Reframing Celiac Disease Diagnostics in an Emerging Therapeutics Era - Christopher Cao
A Continuous Composite Endpoint Methodology Improves Clinical Trial Efficiency for Celiac Disease - Jack A. Syage
Feasibility and Diagnostic Performance of a Needle-Free Salivary ADAP Assay for Coeliac Disease Screening - Cynthia Kanagasundaram
Role of gut epithelial-cell derived transglutaminase 2 in the formation of celiac disease autoantibodies - Fleur du Pre
Coeliac disease autoimmunity and coeliac disease in the Environmental Determinants of Islet Autoimmunity pregnancy-to-childhood cohort study of Australian children at risk of type 1 diabetes - Rebecca Thomson
Early-Life Screening for Celiac Disease in Genetically At-risk Children: the BABYSCREEN Study - Laura Kivelä
Prevalence of Celiac disease in second generation south Indian migrants’ parallels that of native North Indians: A community-based epidemiological study - Samagra Agarwal
Prenatal and early life vitamin A intake is not associated with the risk of celiac disease: The Norwegian Mother, Father, and Child cohort study - Elin HÅRD AF SEGERSTAD
Does Early-Life Greenspace Shape Celiac Disease Risk? Evidence From a Swedish Birth Cohort - Nan Du
Long-term gluten exposure without villous atrophy in adults with coeliac disease - Luca LE Elli
The Recipe for Retention: Dietitian-Led Gluten-Free Diet Education as a Stronger Predictor of Pediatric Celiac Follow-Up Than Location, Insurance, or Comorbidities - Sadie Nagle
Gluten-induced disruption of intestinal neuronal signalling affects the brain and is reversible by transglutaminase inhibition in coeliac disease - Aline Pesi
Panelists:
Abstract Speakers:
Dress to impress and celebrate with us under the stunning glass ceiling of the NGV! The Gala Dinner promises an evening of elegance, laughter, and inspiration — complete with great food, entertainment, and the perfect backdrop for connection and celebration.
The evening will also include the prestigious Celiac Disease Foundation Award Presentation — a highlight of the conference calendar. Do not miss the social highlight of the conference!
* This is a ticketed event, please indicate your Gala Dinner attendance when registering. Ticket inclusions: 3-course meal.