Spatial Multi Omics

by Andrew Brown, PhD Antibody-drug conjugates have moved from concept to a proven therapeutic class. With more than 15 FDA-approved ADCs and a pipeline of over 100 candidates in active clinical development, ADCs represent one of the fastest-growing segments of the oncology pipeline. The momentum is driven by a simple but powerful idea: deliver cytotoxic payloads directly to tumor cells while sparing healthy tissue. The clinical impact is already reshaping how we think about target expression. The approval of trastuzumab deruxtecan (Enhertu®) for HER2-low breast cancer demonstrated that a patient population previously considered HER2-negative could respond to ADC therapy when target expression was characterized with greater sensitivity. It was a turning point: the biology hadn’t changed, but the precision of measurement had. In practical terms, building a successful ADC is complex. These are multi-component therapies where the antibody, linker, payload, and their metabolites all contribute independently to safety, efficacy, and pharmacokinetics. Recognizing this complexity, the FDA issued its first dedicated guidance on clinical pharmacology considerations for ADCs in March 2024, providing developers with a structured framework for evaluating these therapies throughout clinical development. For biomarker and translational science teams, this guidance has significant implications. It raises the bar on how […]