Solving the Complexities of T Cell Engager Development: Pharmacology, PK, and Bioanalysis

T cell engagers (TCEs) are emerging as a powerful therapeutic modality in oncology, capable of redirecting immune cells to recognize and eliminate tumor targets with high precision. However, their complex structure and mechanism of action demand a rigorous understanding of pharmacology, safety, and translational biology. This webinar will explore pharmacological evaluation approaches for TCEs, including the use of diverse humanized preclinical models such as PBMC/HSC tumor xenografts (CDX/PDX) and knock-in systems that recapitulate the immune-tumor microenvironment. Attendees will also gain insights into predictive pharmacodynamic biomarker detection and mechanistic studies that can inform efficacy and safety optimization from discovery to development.

In parallel, this session will address the bioanalytical complexities inherent to TCE therapeutics. Experts will discuss critical considerations in pharmacokinetic (PK) profiling, immunogenicity assessment—including anti-drug antibody (ADA) and neutralizing antibody (NAb) evaluations—and biomarker analysis. Through case studies and practical examples, participants will learn how to overcome analytical complexities and generate robust and regulatory-ready datasets to support drug development.