期刊
EXPERT OPINION ON BIOLOGICAL THERAPY
卷 22, 期 1, 页码 87-94出版社
TAYLOR & FRANCIS LTD
DOI: 10.1080/14712598.2021.1944098
关键词
Flow cytometry; receptor occupancy; clinical trial; immuno-oncology
资金
- Champions Oncology
This article discusses the importance of developing, optimizing, and validating a robust Receptor Occupancy Assay (ROA) to improve dose selection, pharmacology monitoring, and safety in clinical settings. The design of an ROA may be challenging and can lead to exaggerated pharmacology if not accurately developed, optimized, and validated. Improvements in understanding epitopes, binding, affinities, and pharmacological effects may lead to better antibody drug targeting and receptor evaluation.
Introduction: Immunotherapies are focused on strategies that alter immune responses, using antibodies that binds to receptors on different immune cell subsets and either activate or suppress their functions depending on the immune response being targeted. Hence, the necessity of developing assays that assess the functional and biological effect of a therapeutic on its target. When incorporated into high-parameter flow cytometry panels, receptor occupancy assay can simultaneously evaluate receptor expression and drug occupancy on defined cell subsets, which can provide information related to functional effects, and safety. Areas covered: This review focuses on the importance of developing, optimizing, and validating a robust Receptor Occupancy Assay (ROA) to improve dose selection, pharmacology monitoring and safety mainly in clinical settings. Expert opinion: The designing of an ROA can be challenging and can lead to exaggerated pharmacology if not accurately developed, optimized, and validated. However, improvements in our understanding of epitopes, binding, affinities, and pharmacological effects may lead to improved antibody drug targeting and receptor evaluation.
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