Conference Day Two

See all agenda topics and sessions covered at our 2021 event.


7:30 am Online Networking Coffee

7:50 am Chair’s Opening Remarks

  • Lynne Murray Senior Vice President - Research & Development, MiroBio

Novel Approaches to Disrupting B & T Cell Collaborations

8:00 am Immune Homeostasis & How it Relates to B & T Cells in Autoimmune Disease

  • Mike Handley Chief Executive Officer & Board Member, Statera Biopharma


  • Statera’s immunomodulatory technology restores the balance between the cellular (Th1) and the humoral (Th2) immune systems
  • The Th2 lymphocytes target external pathogens like cytotoxic parasites, allergens, toxins through the activation of B cells and antibody production to effect to dendritic cells, which are natural activators of killer T cells, also known as cytotoxic T cells, or CD8+ T cells
  • Statera is developing therapies designed to elicit directly within patients a robust and durable response of antigen-specific killer T cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers

8:30 am T Cell Tolerance Induction Using Antigen-Encapsulating PLG Nanoparticles for Treatment of B Cell/Ab-Mediated Diseases

  • Stephen Miller Professor of Microbiology, Immunology , Northwestern University Feinberg School of Medicine


  • Sharing preclinical results in animal models of autoimmune disease and mechanisms of T cell tolerance using antigen-encapsulating
    biodegradable PLG nanoparticles
  • Reviewing results of Phase 1/2a clinical trial in celiac disease patients using gliadin encapsulating PLG nanoparticles
  • Summarizing preclinical results of tolerance induced by antigenencapsulating PLG nanoparticles in animal models of peanut and egg
    allergy and AAV-mediated gene therapy
  • Discussing the path forward – planned clinical studies examining antigen-encapsulating PLG nanoparticle tolerance in peanut allergy,
    gene/protein replacement therapy and type 1 diabetes

9:00 am Induction of Cytolytic Phenotype in Human & Mouse CD4+ T-Cells by MOG-Derived Imotopes™ & Validation of the Immunosuppressive Capacity in Mouse Models of Multiple Sclerosis


  • Imotopes™ are thioredox modified CD4+ T-cell epitopes with a unique mechanism of action, inducing cytolytic CD4+ T-cells with immunosuppressive capabilities
  • High quality MOG-derived Imotopes™ were generated for Multiple Sclerosis patients (HLA-DR B1) and mouse models (H2 IAb) for this autoimmune disease
  • MOG-derived imotopes™ were validated for the induction of cytolytic phenotype using CD4+ T-cells from Multiple Sclerosis patients and 2D2 T-cell receptor transgenic mice
  • Preclinical proof-of-concept studies on prophylactic- and therapeutic treatment with MOG-derived Imotope™ have been successfully completed, allowing translation to human clinical studies

9:30 am B & T Cell Therapeutic Approaches for Preventing & Treating Autoimmunity

10:00 am Panel Discussion: Use of Animal Models to Predict Efficacy in Autoimmune Disease


  • Utilizing translational models effectively for accurate research
  • Surrogate antibodies: opinions, drawbacks and optimization for beneficial efficacy predictions
  • Can we only analyze B or T cell biology in one model?
  • Is skipping animal models becoming increasingly viable? And what are the alternatives?

10:20 am
Morning Networking Break

Case Studies of Targeted Therapies for Specific Diseases

10:50 am Selective Targeting Of Autoimmune Disease-Associated HLA Haplotypes Via Small-Molecules


  • Suppressing antigen presentation via inhibition of autoantigen peptide binding to HLAs has been enabled via selective small-molecule inhibitors
  • Clinical trials in progress with T1D and HLA-DQ8-specific small-molecule inhibitors are expected to provide proof-of-concept of this drug discovery platform for HLA haplotype-associated conditions
  • Establishing key functional features in the selection of such HLA-specific small-molecule leads will guide the development of key assays required to generate optimal clinical candidates

11:20 am Preclinical & First-In-Human Pharmacology Of BTK Inhibitor BIIB091


  • A number of BTK inhibitors have been developed over the years, but strikingly not all have demonstrated the same level of efficacy in clinical trials even within the same indication, partly reflecting the complexity of the regulation of this kinase and that not all inhibitors are created equal
  • In this presentation, we will discuss some of the lessons learned from our preclinical and early clinical studies testing BIIB091, a potent, selective and reversible inhibitor of BTK

11:50 am BTK Inhibitor Evobrutinib: Translation of Preclinical Information into Clinical Data


The presentation will provide an overview of preclinical mode of action and pharmacodynamics studies of BTK inhibitor evobrutinib and how these translate into clinical relapsing multiple sclerosis studies.

12:20 pm
Online Networking Lunch

Targeting Epigenetic Mechanisms & Cytokines Which Drive B & T Cell Autoimmune Disease

1:00 pm The Versatility of JAK STATs & Therapeutic Impact in Various Autoimmune Diseases

  • Ana Correia Senior Global Clinical Research Scientist, Eli Lilly & Co.

1:30 pm Drugging Transcription: Selective Targeting of BD1 & BD2 of the BET Proteins in Cancer & Immunoinflammation

  • Inma Rioja Head of Immuno- Epigenetics and B cell Biology (Immunology Research Unit. GSK), GlaxoSmithKline


• Epigenetic modulators are providing the opportunity to characterise and understand immune responses in disease models.
• GSK has identified highly potent and selective small molecule inhibitors of the first (BD1) and second (BD2) bromodomains of the BET reader proteins
• BD1-selective inhibition phenocopies the effects of pan-BET inhibitors in cancer models and BD2-selective inhibitors are predominantly effective in models of inflammatory and autoimmune disease.

Autoantibodies & Clinical Targeting of Plasma Cells

2:00 pm Targeting FcRn for the Design of Therapeutics

  • Sally Ward Professor - Molecular Immunology & Director - Translational Immunology, University of Southampton


  • FcRn as a global regulator and transporter of IgG levels
  • FcRn antagonism to treat antibody-mediated autoimmunity
  • Targeting FcRn for the selective depletion of antigen-specific antibodies

2:30 pm FcRn-Guided Design of Protein Therapeutics with Favorable Properties

  • Jan Terje Andersen Prof. Biomedical Innovation & Group Leader, Department of Immunology , University of Oslo and Oslo University Hospital


  • IgG and albumin are the two most prevalent proteins in blood with a half-life of 3 weeks at average
  • FcRn is a key homeostatic regulator of IgG and albumin
  • In-depth insights into how FcRn binds and transports its ligands guide development of tailored FcRn-targeted molecules

3:00 pm Therapeutic Potential in Targeting the FcRn Receptor: Clinical Overview and Future Opportunities


  • FcRn is a promising therapeutic target because it has a vital role in prolonging the half-life of IgG blood levels
  • FcRn inhibitors are in clinical development for numerous autoantibodymediated diseases
  • FcRn effects may vary with physiological location and additional effects are still being discovered

3:30 pm Genome-Wide Mapping of Patient Autoantibody Targets to Understand and Predict Autoimmune Disease Pathogenesis and Progression

  • Thomas Tedder Alter Geller Professor for Research in Immunology Departments of Immunology & Pediatrics , Duke University Medical Center


  • All individuals make autoantibodies to a large and complex array of autoantigens regardless of health or disease
  • Autoantibodies target unique patterns of autoantigens that are unique to that individual7
  • Disease- and cohort-specific autoantibody specificities are found among disease cohorts that may provide new diagnostic, prognostic, or treatment-related markers for different phases of disease progression

4:00 pm Afternoon Break

Emerging Biomarkers: What Does Future of Detection Technologies Hold to Improve Patient Outlook for B & T Cell-Mediated Autoimmune Diseases?

4:20 pm Connecting Dots: Biomarker Studies Reveal B Cell – T Cell Interactions in Neuromyelitis Optica

  • Bob Axtell Associate Member Arthritis & Clinical Immunology Division, Oklahoma Medical Research Foundation


  • Neuromyelitis Optica Spectrum Disorder (NMOSD) is a neuro-autoimmune disease in which B cells and T cells play important roles in pathology
  • Our studies proteomic and transcriptomic data provide novel insights into how T cells and B cells interact in driving severe disability in NMOSD
  • These findings broaden our understanding of what biological pathways drive severe disease in NMOSD and provide potential markers for the clinical management of these patients

4:50 pm Panel Discussion: The Future of Combination Strategies in Autoimmune Disease

  • Ana Correia Senior Global Clinical Research Scientist, Eli Lilly & Co.
  • Vibha Jawa Executive Director, Bristol-Myers Squibb
  • Srini Ramanathan Senior Vice President, Research and Development Sciences and Site Head, Horizon Therapeutics
  • Jeffrey Bennett Gertrude Gilden Professor Departments of Neurology & Ophthalmology Programs in Neuroscience & Immunology, University of Colorado School Anschutz Medical Campus


  • With the increasing necessity for new therapeutics, comes the necessity for more research into combinatorial approaches
  • What are the potentials for overcoming resistances to established therapies?
  • Case studies: learnings from oncology and how to drive the autoimmunity field forward

Market Access Considerations After Drug Approval

5:10 pm Achieving Optimal Market Access and Pricing while Delivering Improved Patient Outcomes

  • Nate Murray Senior Director of Market Access, FINGERPOST


  • Developing a meaningful payer value proposition for a new autoimmune therapy
  • Achieveing targeted access/reimbursement levels
  • Ensuring a maximum level of reimbursement and access are gained at an optimal price while delivering improved patient outcomes

5:25 pm Chairs Closing Remarks & End of Conference