Journal of Immunology Research / 2016 / Article / Tab 6

Research Article

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

Table 6

Postbaseline ADA positive responses in cynomolgus monkey Study 1 as detected in the biotin-DIG ELISA and the plug-and-play assay. In Study 1, the biotin-DIG ELISA detected ADAs in two cynomolgus monkeys, one of them dosed with ADC A and the second one with mAb A. These two animals also had positive signals in the plug-and-play assay with good agreement between the ADA titer determined in the biotin-DIG ELISA and the relative ADA level by the ratios calculated in the plug-and-play assay (Figure 8). However, the plug-and-play assay detected ADA responses in animal 1 dosed with mAb A earlier (day 15) than the biotin-DIG ELISA. The plug-and-play assay identified positive responses in 3 additional monkeys, one dosed with mAb A and two dosed with ADC A.

MoleculeAnimalTime pointBiotin-DIG ELISAPlug-and-play assay
Screening result (positive/negative)AU or titerScreening result (positive/negative)AU or ratio

mAb A1BaselineNegative 0.054 AUNegative0.067 AU
D15Negative 0.067 AUPositive Ratio of 37.9
D44PositiveTiter of 3.99PositiveRatio of 42.9

mAb A2BaselineNegative0.057 AUNegative0.196 AU
D15Negative 0.065 AUPositiveRatio of 2.5
D44Negative 0.061 AUPositiveRatio of 12.3

ADC A3BaselineNegative 0.065 AUNegative0.117 AU
D15Negative 0.057 AUPositiveRatio of 1.5
D44Negative0.052 AUPositiveRatio of 1.3

ADC A4BaselineNegative 0.060 AUNegative0.149 AU
D15Negative0.053 AUNegative0.119 AU
D44PositiveTiter of 1.79PositiveRatio of 18.0

ADC A5BaselineNegative0.065 AUNegative0.128 AU
D15Negative0.052 AUNegative0.119 AU
D44Negative0.061 AUPositiveRatio of 3.5

ADAs = anti-drug antibodies; ADC = antibody-drug conjugate; AU = absorbance units; D = days after dosing or after baseline; mAb = monoclonal antibody; R = ratio.
Ratio = (postbaseline AU/baseline AU).

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