Day Two

Wednesday 1st March 2023

8:25 am Chair’s Opening Remarks

8:30 am Panel Discussion: Focusing & Benchmarking the Antigen-Specific Immune Tolerance Space

Synopsis

  • What Do the Next 12 Months Look Like?
  • Exploring safety considerations: Is there risk of activating a counter-regulatory immune response?
  • Discussing the most promising therapeutics in the landscape – what readouts do we expect in 2023?
  • Where is the field with novel technologies, and what must we understand to move forward?

Exploring Effective Model Systems that Reflect the In-Human Condition to Bridge the Translational Gap

9:00 am Bridging the Transition Between Mouse Models to the Patient: Facilitating the Translational Stage from Preclinical to In-Human Studies

  • Bruna Barneda Director - Preclinical & Clinical Development, Ahead Therapeutics

Synopsis

  • Exploring in-vitro models with human cells and humanized mouse models
  • Developing a mechanistic understanding of how a human immune system responds in comparison to a mouse immune system

Investigating Clinical Endpoints & Determinants of Efficacy for Tolerance Induction Clinical Trial Design

9:30 am Visualizing Immune Tolerance Induction: Exploring Immune Tolerance Biomarkers for Celiac Disease

  • Glennda Smithson Senior Director - Head of Celiac Discovery & Biomarkers, Takeda

Synopsis

  • Looking at immune tolerance in people using multiple different techniques
  • How do visualize immune tolerance using biomarkers?
  • How far can you interpret the data as tolerance induction?

10:00 am Generating Mechanistic Proof-Of-Concept for Antigen-Specific Tolerization

Synopsis

  • Challenges in designing biomarker programs for clinical trials in cell therapy based tolerization
  • Dealing with the challenges of patient heterogeneity and responsiveness to therapy
  • Explaining the need for multiple parameters to understand the mechanisms of tolerization

10:30 am Morning Break

11:00 am Single Cell Transcriptomics of Antigen-Specific CD4 T-Cells to Identify Biomarkers of Imotope™ Treatment & Impact on Pathogenic CD4 T-Cells in Patients With Type 1 Diabetes

Synopsis

  • Highlighting the biomarker interim analyses of phase 2 IMPACT trial in type-diabetes
  • Using single cell transcriptomics to analyse antigen-specific CD4 cells

Honing the Understanding of Immune Tolerance to Illuminate Strategies for Successful Tolerization Therapeutics for Autoimmune Diseases

11:30 am Panel Discussion: Selecting an Antigen – Determining What Makes a ‘Good’ Antigen

  • Brendan Classon Executive Vice President - Research & Development, Parvus Therapeutics
  • Stephen Miller Professor Emeritus of Microbiology- Immunology, Northwestern University
  • Kristie Grebe Senior Vice President - Immunology & Translational Medicine, Anokion

Synopsis

  • What is the ideal profile of a good antigen?
  • What are the technical considerations?
  • Which antigens drive epitope heterogeneity in diseases?

12:10 pm Lunch & Networking

1:10 pm Mechanisms & Clinical Translation of Antigen-Encapsulating PLGA Nanoparticles for Tolerance Therapy of T Cell-Mediated Diseases

  • Stephen Miller Professor Emeritus of Microbiology- Immunology, Northwestern University

Synopsis

  • Ag-PLGA tolerance induction recapitulates how tolerance is induced in the hematopoietic compartment via uptake of apoptotic debris by scavenger receptors on splenic and liver APCs
  • Ag-PLGA tolerance requires activation of the cGAS/STING pathway
  • Ag-PLGA tolerance is dependent of induction of IL-10 producing Tregs
  • Ag-PLGA tolerance has been demonstrated to be effective in a phase 1/2a clinical trial in celiac disease

1:40 pm Roundtables: Exploring Different Approaches to Antigen-Specific Immune Tolerance: Attacking the Problem from Different Angles

Synopsis

This session will facilitate in-depth discussion between participants in an informal environment to explore different approaches to antigen-specific immune tolerance. Join a table and discuss your chosen topic then feedback to the chair and group

2:00 pm Using CAR-Treg Cells in the Setting of Refractory Systemic Lupus Erthematosus

  • Georg Schett Vice President - Research & Professor, Friedrich-Alexander-Universität Erlangen-Nürnberg

Synopsis

  • Developing CAR-Tregs in the experimental or pre-clinical setting for autoimmune disease

Engaging Tregs

Inducing Tolerance in Disease Remission or Disease Flare?

Combinational Approaches

Upstream Components

Targeting Different Areas of the Immune System to Enhance Tolerance

Inducing Tolerance to Biologics

2:30 pm Chair’s Closing Remarks