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8:50 am Chair’s Opening Remarks

Reviewing the State of Play of Antigen-Specific Immunotherapies

9:00 am SWOT Analysis-Style Panel Discussion – Topics to be Addressed:

  • David Wraith Founder & Chief Scientific Officer; Director, Institute of Immunology & Immunotherapy, Apitope; University of Birmingham
  • Bryan Vander Lugt Senior Scientist, Amgen
  • Jessica Grossman Chief Executive Officer, IgGenix, Inc


  • What have we learnt from recent industry developments?
  • What are the implications for R&D and the wider industry?
  • What are the strengths and differentiators of antigen-specific immunotherapies compared to other approaches?
  • What is the market opportunity and untapped clinical areas/unmet patient clinical need that holds most promise when it comes to antigen-specific immune tolerance inducing-therapies?
  • How have competing drug modalities reached late-stage clinical testing and what are the bottlenecks holding back the antigen-specific immune tolerance space back from clinical success?

Characterizing Driver Antigens of Disease & Mechanisms Underlying Immune Tolerance to Drive Antigen & Epitope Discovery

9:30 am Manipulation of TGF-β for Antigen-Specific Immunotherapy of Autoimmune Diseases

  • Wanjun Chen Senior Investigator & Chief, Mucosal Immunology Section, NIDCR, NIH


  • Explore how the development of antigen-specific T-cell therapy in animals with established autoimmunity to treat the disease is challenging and hopeful for therapy of patients with autoimmune diseases
  • By manipulation of apoptosis, phagocytosis and TGF-β production in vivo, we have successfully developed an approach to autoantigen-specific Tregs in mice with established autoimmune diseases
  • These in vivo generated antigen-specific Tregs potently suppress inflammation in the target organs, without compromising immunity to cancer and infection

10:00 am Inducing Tolerance to ApoB Epitopes to Curb Atherosclerosis

  • Klaus Ley Professor/Division Head - Center for Autoimmunity & Inflammation, La Jolla Institute for Immunology


  • Demonstrating that atherosclerosis is always accompanied by an autoimmune response to ApoB
  • Understand that ApoB contains hundreds of HLA-restricted T cell epitopes
  • Realizing that some ApoB epitopes are immunodominant

10:30 am Virtual Speed Networking & Break

11:30 am Strategies for Epitope-Based Tolerance-Inducing Immunotherapy

  • Remi J. Creusot Assistant Professor of Medical Sciences, Columbia University


  • Assess how soluble antigen arrays enhance the delivery and tolerogenicity of peptides
  • The way peptides are grafted onto macromolecules has a significant impact on the safety and efficacy of therapy
  • Learn how endotope constructs provide optimized and customizable solutions for epitope delivery via DNA- and mRNA-based vaccines

12:00 pm Understanding the Mechanism of Action of Imotopes™ at Molecular and Cellular Level


  • Demonstrating proximal T-cell receptor signalling upon cognate interaction with Imotopes™-pulsed antigen-presenting cells
  • Presenting single cell transcriptomics and proteomics of Imotope™-induced cytolytic CD4 T-cells Immunodeletion as a way to restore tolerance

12:29 pm
Discussing Collaborative Investment Opportunities for Industry & Academia to Engage in to Advance Immune Tolerance Drug Development Efforts

12:30 pm NIAID Funding Mechanisms for Immune Tolerance Research

  • Daniel Rotrosen Director, Division of Allergy, Immunology & Transplantation, National Institute of Allergy & Infectious Diseases of Allergy & Infectious Diseases


  • NIAID has a longstanding interest in immune tolerance spanning research on
    basic mechanisms through clinical trials
  • Overview of NIAID grant and contract mechanisms suitable for individuals and
    small companies
  • Opportunities for partnerships and collaborations

1:00 pm Lunch Networking Break

Leveraging Immune Biomarkers & Exploring Immune Tolerance in Diabetes

2:00 pm The Struggles with Immune Biomarkers and Pathologic Endotypes in Type 1 Diabetes

  • Matthias von Herrath Vice President & Senior Medical Officer, Global Chief Medical Officer, Novo Nordisk


  • Immune biomarkers exhibit substantial longitudinal variation in humans, they have so far failed to predict individual trajectories
  • Pathologically in the human pancreas there is little evidence for completely different endotypes/pathways comparing individuals
  • We have, to date, no reliable marker for antigenic tolerance that correlate reliably with clinical endpoints – learning across diseases will be needed

2:30 pm Requirement for Induced Tregs and Tr1 Cells or Regulation of Autoimmune Disease Using Antigen Encapsulating PLG Nanoparticles

  • Stephen D. Miller Judy Gugenheim Research Professor, Department of Microbiology- Immunology, Northwestern University Feinberg School of Medicine


  • Ag-encapsulating biodegradable PLG nanoparticles (Ag-PLG) induce activation of Tr1 and iTreg cells which are required for tolerance induction and maintenance and dependent on IL-10
  • Ag-PLG can be loaded with recombinant protein to target multiple CD4 and CD8 epitopes simultaneously
  • Ag-PLG therapy has been shown to be effective for inducing tolerance to gluten challenge in celiac disease patients in Phase 1/2a clinical trial

3:00 pm Afternoon Networking Break

3:30 pm Antigen-Specific Tolerance to Multiple Epitopes in T1D

  • Adam Elhofy Director of Immunology, COUR Pharmaceuticals


  • Discussing how antigen-specific tolerance to multiple proteins stops progression to overt diabetes in the NOD model
  • Tolerance induction by CNP-T1D included upregulation Tregs and TR1 cell populations, which resulted in inhibition of activation of diabetogenic epitopes not encapsulated within CNP
  • The CNP-T1D induced tolerance was durable to the end of the study and also
    prevented infiltration into the islets

4:00 pm Precision Medicine and Antigens – The Case of HLA and GADSpecific Immunotherapy in Type 1 Diabetes

  • Ulf Hannelius President & Chief Executive Officer, Diamyd Medical


  • Retrospective and prospective clinical data show that individuals carrying HLA variants associated with autoimmunity against GAD (glutamic acid decarboxylase) respond to GAD-specific immunotherapy, supporting the notion of precision medicine in Type 1 Diabetes
  • By prescreening for the presence of HLA DR3-DQ2, the HLA haplotype associated with GAD-specific autoimmunity, individuals that have a high likelihood of responding to GAD-specific immunotherapy can be selected for clinical trials
  • The importance of HLA for immunity and antigen presentation provides a rational platform to develop antigen-specific therapies for heterogeneous diseases

4:30 pm Chair’s Closing Remarks & End of Conference Day One