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.
|Study||Molecule||Positive of total||Immunogenicity incidence|
|1||mAb A||1 of 4||2 of 4||25%||50%|
|1||ADC A||1 of 4||3 of 4||25%||75%|
|2||mAb B||3 of 3||3 of 3||100%||100%|
|2||ADC B||6 of 6||6 of 6||100%||100%|
|ADAs = anti-drug antibodies; ADC = antibody-drug conjugate; mAb = monoclonal antibody.|