Mike Liao
Vice President of Clinical Pharmacology Third Arc Bio
Seminars
As autoimmune T-cell engagers rapidly advance into clinical development, one of the field’s greatest challenges remains the ability to accurately predict clinical efficacy, durability, and safety before large-scale patient studies. Traditional preclinical models often fail to capture the complexity of autoimmune disease biology, creating urgent demand for more predictive translational tools, mechanistic biomarkers, and early human readouts that can de-risk development and accelerate patient benefit. This interactive session will discuss how the industry can improve translational predictability and shorten the path from discovery to clinical success by:
- Building more predictive translational models for autoimmune T-cell engagers, evaluating how advanced in vitro systems, humanized models, patient-derived assays, and mechanistic immune profiling can better predict efficacy, cytokine release syndrome risk, tissue depletion, and long-term immune reconstitution.
- Identifying the biomarkers that matter most for early clinical decision-making, discussing how pharmacodynamic biomarkers, cytokine signatures, immune-cell depletion kinetics, tissue-level readouts, and translational immune-monitoring strategies can support dose optimization, patient selection, and earlier validation of therapeutic activity
- Integrating early human data to accelerate development and reduce clinical risk, exploring how first-in-human studies, adaptive trial designs, and translational datasets can be leveraged to refine therapeutic hypotheses, improve safety management, and establish clearer pathways toward durable patient benefit and regulatory success
As the first generation of autoimmune T-cell engagers advances through clinical development, the field is beginning to generate critical insights into safety management, depth of immune-cell depletion, patient selection, and long-term disease control. The key challenge now is determining which clinical learnings will truly differentiate successful therapies. Join clinical leaders, translational scientists, and developers of leading autoimmune T-cell engager programs as they discuss how emerging clinical evidence is reshaping drug design and development strategies by:
- Defining the clinical benchmarks for success, evaluating what early efficacy, safety, cytokine release syndrome, and durability data reveal about the therapeutic potential of T-cell engagers across different autoimmune diseases and patient populations
- Understanding the drivers of durable immune reset, exploring how depth of depletion and target biology, contribute to longterm remission, and identifying the biomarkers needed to predict sustained clinical benefit
- Translating clinical learnings into next-generation molecule design, discussing how insights from first-wave programs are informing improvements in target selection, construct engineering, dosing strategies, administration routes, and patient monitoring to enhance efficacy while minimizing treatment burden and safety risks
- Evaluating how clinical pharmacology insights from advanced CD3 bispecific programs can inform first-in-human study design, dose escalation strategies, cytokine release syndrome mitigation, and therapeutic window optimization in autoimmune disease settings
- Integrating pharmacokinetic, pharmacodynamic, and biomarker-driven approaches to better predict immune-cell depletion, target engagement, and early efficacy signals, enabling more informed and efficient clinical development decisions
- Leveraging translational and early human data from late-stage T-cell engager programs to refine patient selection, dosing paradigms, and safety monitoring frameworks that support accelerated development and improved patient outcomes
