Quantitative Cell-Based Bioassays to Advance Individual and Combination Immune Checkpoint Immunotherapy

摘要

A major challenge in the development of antibody-based biologics drugs is access to quantitative and reproducible functional bioassays. Existing methods rely on primary cells and measurement of complex functional endpoints that are cumbersome, variable, and often fail to yield data quality required for drug development in a quality-controlled environment. We have developed a portfolio of functional cell-based reporter bioassays to measure the activity of biologics drugs designed to target immune checkpoint receptors including co-inhibitory (e.g., PD-1, CTLA-4, LAG-3) and c o-stimulatory (e.g., 4-1BB, GITR, OX40) receptors. These bioassays consist of stable cell lines that express luciferase under the precise control of receptor-mediated intracellular signals. Here we describe the application of MOA-based immune checkpoint co-inhibitory receptor bioassays for biologics drug discovery, development, potency and stability studies.