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Development of a Neutralizing Anti-Drug Antibody Detection Assay Targeting the PD-1 Checkpoint Inhibitor, Nivolumab using a PD-1/PD-L1 Blockade Bioassay

Part # PS333


M-E Poupart¹, L. L. Walker¹, ZJ. Cheng², U. Herbrand³, S. Boridy¹, MS. Piché¹
¹Charles River Laboratories, 22022 Transcanadienne, Senneville, QC H9X 3R3. ²Promega Corporation, 2800 Woods Hollow Road, Madison, WI 53711. ³Charles River Laboratories, Max-Planck-Str. 15A, 40699 Erkrath, Germany.

The objective of this study was to develop a neutralizing anti-nivolumab antibody screening assay using the PD-1/PD-L1 Blockade Bioassay (Promega). This bioassay is primarily designed to measure the potency and stability of mAbs and other biologics known to inhibit the PD-1/PD-L1 interaction. Here we present the development of a functional cell-based NAb assay using the PD-1/PD-L1 Blockade Bioassay for the analysis of clinical serum samples. Results from the initial assessment of nivolumab activity for the NAb assay development were consistent with the previously developed potency assay, suggesting it is a highly reproducible cell-based format. Results for nivolumab activity for both the potency and NAb assay are presented, including critical NAb validation parameters: precision, selectivity, sensitivity and drug tolerance. Such optimized potency bioassays for checkpoint inhibitors have the potential to be developed into clinically relevant NAb assays with reduced variability and can be used to easily overcome common drawbacks associated with a cell-based format.

Printed in USA.