Drug testing: translating a novel immunotherapeutic from bench to bedside
Drug development is a time-consuming and expensive process that often fails to translate new, exciting scientific findings into safe and effective clinical therapies. In this chapter, we outline strategies for preclinical drug testing studies, using as an example a cancer-targeted, immunotherapeutic, bispecific antibody. These studies have in part led to the initiation of a Phase I clinical trial (NCT04903795). We provide an overview of drug design and optimization strategies and include example approaches to in vitro and in vivo evaluation. We also discuss the evaluation of toxicology, dosing strategies, and manufacturing, all factors critical to the drug testing process and successful clinical translation of a novel therapeutic. We conclude with a discussion of potential sources for funding and considerations for successful partnerships.
