Journal of Immunology Research / 2016 / Article / Tab 5

Research Article

Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development

Table 5

Summary of immunogenicity data for cynomolgus monkey Studies 1 and 2 with the biotin-DIG ELISA and the plug-and-play assay. Samples from cynomolgus monkey studies with two ADCs and their corresponding mAbs were analyzed in the plug-and-play assay. The number of animals that developed anti-drug antibodies after exposure to the above molecules and the immunogenicity incidence obtained with this assay were compared to those previously obtained in the biotherapeutic-specific biotin-DIG ELISA. In Study 1, the plug-and-play assay detected the same positive responses as the biotin-DIG ELISA plus three additional animals with ADA positive responses. In Study 2, all the monkeys had positive responses with the biotin-DIG ELISA and the plug-and-play assay.

StudyMoleculePositive of totalImmunogenicity incidence

1mAb A1 of 42 of 425%50%
1ADC A1 of 43 of 425%75%
2mAb B3 of 33 of 3100%100%
2ADC B6 of 66 of 6100%100%

ADAs = anti-drug antibodies; ADC = antibody-drug conjugate; mAb = monoclonal antibody.

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