8:00am Workshop A
Tackling Antigen Selection & Understanding Immune Tolerance in Autoimmune Diseases
Synopsis
Join this interactive, discussion-based, deep-dive session to discuss the basic science of tolerance approaches for autoimmune disease therapeutics and navigate antigen selection across homogenous and heterogeneous diseases to hone therapeutic strategies.
- Putting B-cells in the spotlight to understand their role in inducing tolerance to an antigen
- B-cells vs T-cells? Assessing which to go after and target in tolerizing strategies
- Emphasizing mechanisms in immune tolerance and understanding the spread of immune tolerance to other antigens and the role of epitope spread
- Assessing with T-reg directed therapies, is being non-antigen specific enough? Honing antigen-specific t-regs
- Identifying multiple mechanisms and achieving immune tolerance; demonstrating preclinically and showing these mechanisms in in-human studies
- Assessing antigen selection for complex diseases to identify target antigens
- Tackling tolerance in complex heterogeneous disease settings rather than a well-defined population
- Evaluating going after well-defined antigens vs diseases with multiple antigens driving the disease
- Delving into bystander tolerance and exploring agnostic tolerance to deepen the understanding of antigen-specific tolerance mechanisms
- Exploring the Epstein Barr Virus as a viral antigen in MS to illuminate antigen discovery and tolerance understanding
- Mining big data for antigen correlations and to explore patient phenotypes to treat autoimmune diseases
10:30 am Morning Break
11:00am Workshop B
Building the Biomarker Toolbox for Practical Tolerance Strategies: Evaluating Biomarkers for Determinants of Efficacy, Patient Selection, & Durability
Synopsis
This session is your opportunity to assess your biomarker toolbox from early-stage, preclinical research and practically translate to clinical studies
- Exploring precision medicine to transform the treatment paradigm in autoimmunity
- Delving into the relationship between mechanistic and disease biomarkers
- Designing a biomarker program for clinical trials in antigen-specific tolerization
- Using multiple parameters to understand the mechanisms of tolerization
- Harnessing single-cell transcriptomic data for immune tolerance biomarkers
- Assessing the feasibility of cell assays to develop simpler assays that can be used in clinical phase multi-center studies
- Discussing both patient disease markers and mechanistic markers in tolerance studies, biomarkers of autoimmunity relevant to tolerance
- Assessing functional assays of tolerance
- Demonstrating bystander suppression via biomarkers
- Investing in biomarkers to accelerate biomarkers as a tolerance endpoint – discussing what will regulators accept
1:30 pm Lunch
14:30pm Workshop C
Translating Antigen-Specific Immune Tolerance Approaches to Mitigate Immunogenicity of Biologic Therapies
Synopsis
Dive into harnessing antigen-specific immune tolerance strategies and expertise to inhibit unwanted immune responses against protein and enzyme therapies, AAV gene therapies, and more. Capitalize on your antigen-specific autoimmune tolerance approaches and capture this opportunity at your fingertips.
- Understanding which cell populations become tolerized in drug-specific tolerance approaches Discussing pros and cons of applying antigen-specific immune tolerance technologies to anti-drug antibody responses vs treatment of autoimmune diseases
- Highlighting how anti-drug antibodies can compromise the safety and efficacy of biological drugs
- Identifying product opportunities for mitigating anti-drug antibody responses
- Delving into a case study of translating an antigen-specific immune tolerance technology from a preclinical idea to a successful end of Phase III
- Exploring the opportunity in gene therapy and how mitigation of immunogenicity can transform the field
- Evaluating potential combination therapy approaches to tackle the most difficult immunogenic proteins