ArticleFrontiers in immunology2026
Immunogenicity assessment for vidutolimod: a risk-driven approach for a simplified 1-tiered, singlicate anti-drug antibody testing strategy.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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.
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