Conference Day One
March 19, 2024

7:20 am Check-In & Coffee

Synopsis

Please join us on the third floor of the conference hotel to collect your badge and network with fellow attendees. Light snacks and coffee will be available

8:20 am Chair’s Opening Remarks

Delineating ‘Tolerance’ & Evaluating Biomarkers for Antigen-Specific Tolerance Approaches to Supercharge Autoimmune Tolerizing Strategies

8:30 am Key Factors Differentiating Tolerance vs Immunosuppression to Guide Development of Precise & Antigen-Specific Therapeutic Approaches

  • Laura Cooney Director of Biomarker Discovery Research for Autoimmunity, Immune Tolerance Network

Synopsis

  • Understanding the specificity of current tolerance approaches to benchmark against traditional immunosuppression, drawing upon tolerance definitions from the Immune
  • Tolerance Network’s clinical trials in autoimmunity, allergy, and transplant
  • Highlighting the role of antigen-specificity and bystander tolerance in therapeutic approaches
  • Leveraging insight from the Immune Tolerance Network’s current clinical trials to induce tolerance in autoimmune diseases including multiple sclerosis, systemic sclerosis, antiphospholipid syndrome, vitiligo, and type I diabetes

9:00 am Accelerating Immune Tolerance in Neurological Diseases: Neuromyelitis Optica Spectrum Disorder (NMOSD) as a Model of Progress

  • Michael Yeaman Professor of Medicine; Chief Molecular Medicine; Director Institute for Infection & Immunity, University of California

Synopsis

  • Proving and following the desired impact of tolerance on the immune system
  • Moving towards harmonization of clinical trial design and implementation in NMOSD
  • Specifying biomarkers of tolerigenesis in NMOSD and neurological diseases
  • Updating outcome measures of efficacy, durability, and patient quality of life

9:30 am The Landscape of Auto-Antigen-Specific Immune Tolerance Therapies for Autoimmune Diseases

Synopsis

  • Reviewing the landscape of auto-antigen specific immune tolerance therapies
  • Delving into what the field can expect for the road ahead

10:00 am Speed Networking

Synopsis

Put a face to a name – this session is the perfect opportunity to get face-to-face time with key opinion leaders, leading companies, and innovative researchers in the immune tolerance field. Establish meaningful connections to build upon for the rest of the conference and gain individual insight beyond the papers and press releases into the pioneering research and therapeutic development in the autoimmune field

10:45 am Morning Break

11:00 am Panel Discussion: Evaluating Antigen-Specific vs Antigen-Non-Specific Approaches: Assessing ‘Tolerance’ to Benchmark Tolerizing Strategies

  • Laura Cooney Director of Biomarker Discovery Research for Autoimmunity, Immune Tolerance Network
  • Aaron Winkler Research Fellow, Immune Tolerance Lead, Pfizer
  • Kevin White Director, Abbvie

Synopsis

  • Reviewing what we mean by ‘tolerance’ in autoimmune diseases to understand the end goal and refine biomarker, preclinical model, dosage, and delivery considerations
  • Discussing antigen-non-specific or antigen-agnostic approaches
  • Debating the possibilities of antigen-specific approaches for autoimmune diseases by looking cross-field to both allergy and transplant successes

Cultivating Biomarker Strategies in Immune Tolerance from Preclinical to Clinical Reality: Tolerance & Disease Specific Markers

11:45 am Renaissance of Interleukin-2 as a Sensitive Biomarker for Antigen-Driven Clinical Reactions & Monitoring Rare Antigen-Specific T cells in Blood

Synopsis

  • IL-2 shows as the most dynamic/consistent marker of CD4+ T cell activation in whole blood stimulated with gluten peptides
  • Administration of immunogenic gluten peptides or gluten causes acute symptoms in celiac disease within 2 hours, correlated in timing and magnitude with IL-2 elevations in plasma 
  • Whole blood IL-2 release assays for antigen-specific T cells are substantially more sensitive than ELISpot assays and appear to be as effective as flow cytometry-based assays using tetramers, potentially offering a monitoring tool for many T Cell mediated disease clinical trials, requiring only 12 ml of blood, low preparation time/complexity, and permitting storage/batch-testing of plasma

12:15 pm Decoding the Future: Leveraging Biomarkers in Antigen-Specific Immunotherapy for Type 1 Diabetes

Synopsis

  • Discussing immunological and genetic findings from clinical trials evaluating the antigenspecific immunotherapy Diamyd (rhGAD65/alum)
  • Highlighting the significance of HLA testing, exploring HLA haplotype frequencies and their relevance for personalized immunotherapy approaches and patient selection
  • Designing the Phase 3 trial DIAGNODE-3 from a biomarker perspective, including the collection of data for future potential personalization of the investigational therapy

12:45 pm Lunch

1:45 pm Informing Late-Stage Biomarker Strategies: Learnings from Early In-Human Studies to Inform Future Trial Design

Synopsis

  • Going from cell-based assays into symptoms or disease markers for tolerance studies
  • Delving into preclinical and clinical development for antigen specific autoimmune disease

Securing Effective Collaborations & Partnerships Across Biotechs, Pharma, & Research Groups to Supercharge Tolerance Strategies

2:15 pm Panel & Audience Discussion: Let’s Collaborate: Exploring What Big Pharma’s External Innovation & Partnership Directors Are Looking for in Antigen-Specific Tolerance Approaches

  • Saifur Rahman Director of Search and Evaluation Immunology, Sanofi
  • Benjamin Cohn Associate Director, - Strategy & Business Development, Bristol Myers Squibb

Synopsis

  • Starting at the beginning and working towards the clinic – what are the key points and factors that we look out for?
  • This is your opportunity to ask your burning questions and hear from the external innovators in this interactive and candid session set to accelerate your 2024 business goals

2:45 pm Afternoon Break & Poster Session

Synopsis

Connect with peers in a relaxed atmosphere and continue to forge new and existing relationships while exploring the latest antigen-specific immune tolerance approaches and research advancements

To submit a poster, please contact info@hansonwade.com

Focusing on Toxicity & Immune Safety Studies to Effectively Translate Efficacious Tolerance Approaches to the Clinic

3:45 pm Tackling Toxicity Studies & Moving Lead Candidates to the Clinic for Myasthenia Gravis

Synopsis

  • Highlighting the unique safety risks of the different antigen-specific approaches
  • Discussing the toxicity studies for lead candidates to accelerate to the clinic
  • Showcasing the data from toxicity studies in tolerance for autoimmune diseases
  • Divulging regulatory discussions to illuminate progressing the tolerance landscape and approaches forward

4:15 pm Roundtable Discussions: Learnings & Takeaways from Regulatory Bodies to Inform Future Directions

Synopsis

This session provides the opportunity for smaller groups to come together, share learnings, analyze, debate, and discuss the below topics and then feedback to the larger group and chair

Preclinical Models

Harnessing novel preclinical models in conjunction with established models of autoimmunity

Toxicity Studies

Assessing effective & efficient IND enabling studies

Biomarkers

Biomarkers that could be considered as an exploratory endpoint, validating biomarkers across preclinical and clinical studies

Establishing Immune Tolerance – What’s Next? Assessing Durability of Tolerance Approaches to Inform Frequency of Administration

4:45 pm Biomarkers of Efficacy & Durability of Therapeutic Immunomodulation in Autoimmune Diseases: From Preclinical Models to the Clinic

Synopsis

  • Use of mouse models of celiac disease and narcolepsy type I for testing efficacy of immunomodulatory compounds
  • Biomarkers of immunomodulation in preclinical models of autoimmune diseases, and their development as exploratory endpoints for clinical trials
  • Assessing durability in preclinical models, to explore persistence or repetitive loss of immune tolerance (once re-established by treatment)

5:15 pm Resetting the Immune System with TCR-engineered Autologous Tregs for Tissue Specific Tolerance Induction

Synopsis

  • Testing the therapeutic potential of TCR-engineered autoantigen specific Tregs to reset immune tolerance to treat progressive-MS or T1D
  • Defining drivers of tissue residency and durability of TCR-engineered Tregs
  • Measuring long lasting tolerance induction; considerations of clinical trial length

5:45 pm Chair’s Remarks