The immunogenicity database collaborative: a standardized, publicly available database for clinical immunogenicity...

Anti-drug antibodies (ADAs) against biotherapeutics remain difficult to predict, limiting efforts to assess and mitigate immunogenicity risk prior to clinical development. Existing immunogenicity data are fragmented across disparate sources and reported using inconsistent definitions, creating a major barrier to understanding the drivers of ADA formation. To address this challenge, we established the Immunogenicity Database Collaborative (IDC), launched its public website (https://www.immunogenicitydb.org), and developed the first release of the Immunogenicity Dataset (IDC DS V1), a structured clinical immunogenicity dataset integrating therapeutic characteristics, amino acid sequence information, and patient cohort-level clinical data curated from publicly available sources. The IDC DS V1 contains 4,146 ADA-related datapoints spanning 1,788 cohorts, 727 clinical trials, and 218 therapeutics. Analysis of the dataset highlights trends in ADA frequency, reveals important sources of variability across clinical contexts, and identifies key factors associated with immunogenicity risk. The IDC provides a foundational resource to standardize clinical immunogenicity data and support immunogenicity risk assessment across the biopharmaceutical industry. In addition to the current dataset release, it establishes an extensible data architecture and framework for future community-driven expansion into additional areas of immunogenicity research.