Bioanalytics – Biomolecular
End-to-End Hot Topic
The complexities of bi-specific platforms and T-cell redirection modalities far exceed that of mono-specific biotherapeutics. Due to the multi-cellular engagement requirement, due to the highly sensitive mechanism of action of these therapeutics, and depending on the tissue location of the target cells, receptor occupancy assessments may not be feasible at the desired site of action or at the sensitivity levels that can elicit pharmacological action. In addition, the assessment of bi-specific drug engagement with soluble (shed or alternatively spliced) targets could also impact the distribution of the bi-specific drug on the cellular receptor targets. Nonetheless, assessments of receptor occupancy to one or both cellular targets and, if applicable, the soluble target engagement of a bi-specific drug can be used to complement other available PK, PD, safety and efficacy assessments. This presentation is intended to provide examples of receptor occupancy (flow cytometry) and soluble target engagement (ligand binding assay) approaches for several T-cell redirector programs.