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

Area of Science:

• Biopharmaceutical Development
• Immunology
• Data Science

Background:

• Predicting anti-drug antibodies (ADAs) against biotherapeutics is difficult, hindering immunogenicity risk assessment.
• Existing immunogenicity data are fragmented and inconsistently defined, impeding understanding of ADA formation drivers.

Purpose of the Study:

• To establish a centralized, structured resource for clinical immunogenicity data.
• To facilitate the prediction and mitigation of immunogenicity risk for biotherapeutics.

Main Methods:

• Developed the Immunogenicity Database Collaborative (IDC) and its public website.
• Curated and integrated therapeutic characteristics, amino acid sequences, and patient cohort data into the Immunogenicity Dataset (IDC DS V1).
• Collected 4,146 ADA-related datapoints from 727 clinical trials and 218 therapeutics.

Main Results:

• The IDC DS V1 provides a comprehensive dataset for analyzing ADA frequency and variability.
• Analysis identified key factors associated with immunogenicity risk.
• The dataset highlights trends and sources of variability in ADA formation across different clinical contexts.

Conclusions:

• The IDC provides a foundational resource for standardizing clinical immunogenicity data.
• This initiative supports improved immunogenicity risk assessment in the biopharmaceutical industry.
• An extensible data architecture is established for future community-driven expansion.