Immunogenicity assessment for vidutolimod: a risk-driven approach for a simplified 1-tiered, singlicate anti-drug...

The bioanalytical strategy for a therapeutic should be driven by the overall immunogenicity risk of the molecule. Vidutolimod, a virus-like particle therapeutic, is being developed with a unique mechanism of action that requires the generation of a robust anti-drug antibody response to facilitate internalization and drive toll-like receptor immune activation. Consequently, the standard 3-tiered testing paradigm designed to detect very low levels of antibody may not be the best approach to generate clinically relevant data. The immunogenicity risk assessment performed for this virus-like particle led to the development of a simplified 1-tiered immunogenicity monitoring strategy where samples were tested in the titer assay in singlicate to determine both anti-drug antibody status and magnitude. This virus-like particle-based drug is an example of an alternative therapeutic modality where a thorough immunogenicity risk assessment was used to customize an immunogenicity testing strategy to meet the needs of the clinical program.