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Flow cytometry and receptor occupancy in immune-oncology
Alessandra Audia1, Gregory Bannish1, Rachel Bunting1
1Champions Oncology, Biomarker Services Solution, Hackensack, New Jersey, USA.
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.
Insights
Developing a robust Receptor Occupancy Assay (ROA) is crucial for accurately assessing immunotherapies. This assay helps optimize drug dosing, monitor pharmacology, and ensure safety in clinical settings.
Area of Science:
- Immunology
- Pharmacology
- Biotechnology
Background:
- Immunotherapies leverage antibodies to modulate immune cell functions by targeting specific receptors.
- Assessing the functional and biological impact of therapeutics on their targets is essential.
- High-parameter flow cytometry enables simultaneous evaluation of receptor expression and drug occupancy.
Purpose of the Study:
- To highlight the critical need for developing, optimizing, and validating Receptor Occupancy Assays (ROA).
- To emphasize the role of ROA in improving dose selection, pharmacology monitoring, and safety assessments.
- To discuss the application of ROA primarily within clinical settings.
Main Methods:
- Review of existing literature and methodologies for Receptor Occupancy Assays.
- Focus on the integration of ROA within high-parameter flow cytometry panels.
- Discussion on the challenges and considerations in assay design, optimization, and validation.
Main Results:
- Receptor Occupancy Assays provide critical data on drug effects on target receptors.
- ROA can simultaneously assess receptor expression and drug binding on specific immune cell subsets.
- Accurate ROA is vital for understanding functional effects and potential safety concerns.
Conclusions:
- Designing a robust ROA presents challenges and can lead to inaccurate pharmacology if not properly executed.
- Improvements in understanding epitopes, binding kinetics, and affinities enhance antibody drug targeting.
- Validated ROAs are key to precise receptor evaluation and effective immunotherapy development.
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