DONQ52 / Roche - LARVOL DELTA

LILY: Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Chugai Pharmaceutical | Active, not recruiting ➔ Completed

Biomarker • Trial completion • Celiac Disease • Immunology

LILY: Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Chugai Pharmaceutical | Trial completion date: May 2024 ➔ Jan 2025

Biomarker • Trial completion date • Celiac Disease • Immunology

Study of the safety, pharmacokinetics, immunogenicity, and biological effects of DONQ52 in celiac disease patients with gluten challenge (ANZCTR) - P1 | N=56 | Recruiting | Sponsor: Chugai Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2024

Enrollment open • Trial initiation date • Celiac Disease • Immunology • HLA-DQA1 • HLA-DQB1 • IFNG • IL2

LILY: Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients (clinicaltrials.gov) - P1 | N=56 | Active, not recruiting | Sponsor: Chugai Pharmaceutical | Recruiting ➔ Active, not recruiting

Biomarker • Enrollment closed • Celiac Disease • Immunology

A bispecific antibody targeting HLA-DQ2.5-gluten peptides potently blocks gluten-specific t cells induced by gluten ingestion in patients with celiac disease. (PubMed, Clin Immunol) - "DONQ52 can significantly block HLA-DQ2.5-restricted T cell responses to the most highly immunogenic gluten peptides in CeD. Our findings support in vitro data that DONQ52 displays selectivity and broad cross-reactivity against multiple gluten peptide:HLA-DQ2.5 complexes. This work provides proof-of-concept multi-specific antibody blockade has the potential to meaningfully inhibit pathogenic gluten-specific T-cell responses in CeD and supports ongoing therapeutic development."

Journal • Celiac Disease • Immunology • CD4

Study of the safety, pharmacokinetics, immunogenicity, and biological effects of DONQ52 in celiac disease patients with gluten challenge (ANZCTR) - P1 | N=56 | Not yet recruiting | Sponsor: Chugai Pharmaceutical Co., Ltd

New P1 trial • Celiac Disease • Immunology • HLA-DQA1 • HLA-DQB1 • IFNG • IL2

Characterizations of a neutralizing antibody broadly reactive to multiple gluten peptide:HLA-DQ2.5 complexes in the context of celiac disease. (PubMed, Nat Commun) - "In HLA-DQ2.5 transgenic mice, DONQ52 demonstrates favorable pharmacokinetics with high subcutaneous bioavailability, and blocks immunity to gluten while not affecting systemic immunity. Our results thus provide a rationale for clinical testing of DONQ52 in CeD."

Journal • Celiac Disease • Immunology • CD4

A BISPECIFIC ANTIBODY TARGETING HLA-DQ2.5-GLUTEN PEPTIDES POTENTLY BLOCKS GLUTEN-SPECIFIC T CELLS INDUCED BY GLUTEN INGESTION IN PATIENTS WITH CELIAC DISEASE (DDW 2023) - "DONQ52 is highly effective at blocking gluten-specific T cell responses to dominant wheat gluten epitopes. Studies to assess DONQ52 blockade of barley hordein and rye secalin-specific T cells induced by barley and rye challenge, respectively, are underway. Our findings support in vitro data that DONQ52 displays selectivity and broad cross-reactivity against HLA-DQ2.5/gluten peptides and provides proof-of-concept that such an approach has the potential to meaningfully inhibit pathogenic gluten-specific T cell responses in CeD."

Clinical • Celiac Disease • Immunology • CD4 • IFNG

LILY: Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Chugai Pharmaceutical | Not yet recruiting ➔ Recruiting

Biomarker • Enrollment open • Celiac Disease • Immunology

LILY: Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients (clinicaltrials.gov) - P1 | N=56 | Not yet recruiting | Sponsor: Chugai Pharmaceutical

Biomarker • New P1 trial • Celiac Disease • Immunology