Explore the Agenda

8:30 am Check in & Light Breakfast

Workshop A

9:30 am Engineering Autoimmune T-Cell Engager Constructs to Maximize Targeted Cell Depletion While Minimizing Cytokine Release

Senior Manager of Clinical Pharmacology, Gilead Sciences

T-cell engagers have demonstrated remarkable potency in oncology, but in autoimmune diseases they aim to achieve sufficient target-cell killing without triggering cytokine release profiles that are unacceptable in chronic outpatient populations. This technical workshop will explore the molecular architecture, construct design, and developability considerations that underpin next generation autoimmune TCEs by:

  • Evaluating CD3 tuning as a molecular design strategy rather than a clinical mitigation tool, examining how affinity modulation, epitope selection, valency, and spatial geometry influence T-cell activation thresholds
  • Identifying the structural determinants of efficacy-versus-cytokine separation, to understand construct formats that may uncouple cytotoxic activity from systemic T-cell hyperactivation
  • Optimizing engager architecture for autoimmune applications, exploring how binder orientation, domain arrangement, linker design, avidity effects, and target-antigen biology influence immune synapse formation, pharmacology, and safety outcomes

12:30 pm Lunch

Workshop B

1:30 pm Building Predictive Development Strategies for Autoimmune T-Cell Engagers, From Ex Vivo Models to Clinical Trial Execution, for Optimized Patient Outcomes

Director of Cell & Gene Therapy, Novartis AG

T-cell engager programs are advancing toward the clinic, but developers face an important challenge in demonstrating efficacy and safety in a therapeutic class where traditional preclinical models often fail to predict human responses. Unlike oncology, where tumor killing can be readily measured, autoimmune TCEs must balance selective immune-cell depletion, cytokine control, and long-term disease modification in heterogeneous patient populations. This workshop will explore innovative approaches to generating more predictive translational data and overcoming bottlenecks in both preclinical and clinical development by:

  • Advancing ex vivo and human-derived testing platforms to improve clinical predictability, exploring the use of patient-derived samples, diseased tissue models, organoid systems, and immune-cell co-culture assays to evaluate pharmacodynamic activity in settings that better reflect autoimmune biology
  • Establishing translational frameworks for assessing efficacy and safety before firstin-human studies, examining which biomarkers, functional assays, and immunemonitoring approaches are most predictive of clinical outcomes
  • Innovating patient recruitment and trial design for emerging autoimmune TCE programs, exploring approaches to identify appropriate patient subsets, leverage biomarker-driven enrolment strategies, and recruit patients with specific immunecell signatures most likely to benefit from targeted depletion therapies

4:30 pm End of Pre-Conference Workshop Day