8:20 am Chair’s Opening Remarks
Evaluating Delivery Technologies & Novel Approaches to Propel Tolerizing Approaches to Clinical Reality
8:30 am Engineering Treg Approaches to Promote Immune Tolerance in Autoimmune Disease
Synopsis
- Using CAR-Treg cell therapy approaches for autoimmune diseases including rheumatoid arthritis
- Translational data supporting 7101 CAR Treg as a therapeutic approach
- Demonstrating proof-of-mechanism for the immune tolerance strategy
9:00 am Exploring the Use of mRNA-LNP for Antigen-Specific Immune Tolerance
Synopsis
- Focusing on the mRNA and LNP to identify an optimal drug product for inducing antigen-specific tolerance
- Highlighting the influence of the antigen on T-cell fate outcomes
- Interrogating what target product profile may be achievable
9:30 am Harnessing a Multi-Cargo LNP Technology to Enable Antigen Specific Immune Tolerance
Synopsis
- Outlining a multi-cargo LNP approach that enables mRNA-LNPs for immune tolerance
- Showcasing proof-of-concept in preclinical type 1 diabetes models
- Investigating the immunological mechanisms induced by multi-cargo LNPs
10:00 am Morning Break
10:45 am Delivering Biologics Directly to the Gut: The ActoBio Delivery Technology for Antigen-Specific Tolerance in Type I Diabetes & Celiac Disease
Synopsis
- Boosting antigen-specific T-Regs to rebalance the immune system
- Highlighting the phase I study results
11:15 am Roundtable Discussion: Delving into Delivery & Technology Approaches to Evaluate the Strengths & Weaknesses & Accelerate Immune Tolerance Approaches to Patients
Synopsis
The roundtable leaders will set the context for the session, then attendees will choose a table of one of the below, participants will
Lipid Nanoparticles (LNP)
CAR-Treg
Peptide Approaches
Combination Approaches
RNA Approaches
Other Delivery Approaches
Using In Vivo & In Vitro Models to Effectively Highlight Tolerance Induction & Translate to the Clinic
12:00 pm Inducing Immune Tolerance with Glycan-Containing NSAAs: In Vivo & In Vitro Assays to Validate Efficacy
Synopsis
- Understanding current approaches to treating autoimmune disease and attenuating immunogenicity of therapeutics broadly suppress the immune system
- Tolerizing patients to specific antigens is a holy-grail challenge that can displace systemic immunosuppression
- Illuminating the in vivo and in vitro assays used to validate efficacy for the immune tolerance approach
- Highlighting GROBio’s ProGly approach to immunotolerization enables reversal of autoimmune disease and elimination of anti-drug antibodies without systemic immunosuppression
12:30 pm Lunch
1:30 pm Introducing Genetic Tolerance Through HLA Gene Editing: Evaluating the Preclinical Data & Regulatory Feedback
Synopsis
- Identifying antigen-specific HLA gene-editing targets with bioinformatics and novel assays
- Editing the HLA gene without immunosuppression or rejection
- Reviewing the preclinical data and FDA feedback for Rheumagen’s lead indication of treatment-resistant rheumatoid arthritis
2:00 pm Illuminating Preclinical Translation of a Nanoparticle-Based Active Antigen-Specific Immune Tolerance Platform
Synopsis
- Discussing the nanoparticle pMHC-delivered tolerance approach
- Using humanized mouse models to translate to the clinic
Exploring Tissue Specific Tolerance Approaches in Antigen-Specific Strategies
2:30 pm Tackling Tissue Specificity: The Translational Journey from Antigen Selection to Clinical Proof-of-Concept
Synopsis
- Selecting the antigen of choice for delivery/presentation with MHCII
- Highlighting data showing tissue specificity, bystander effect, disease modification, and persistence
- Discussing plans for clinical proof-of-concept for direct measurement of endogenously expanded Treg cells
Assessing Future Directions for Approaches: Delving into Drug Tolerance & Combination Strategies for Immune Tolerance
3:00 pm Panel & Audience Discussion: Supercharging Antigen-Specific Approaches to Autoimmune Disease Patients: Evaluating the Next Steps to Move Forward as a Field
Synopsis
- Selecting antigens – what makes a ‘good’ antigen?
- Assessing preclinical models – what should we move towards for regulatory buy-in?
- Creating a biomarker toolbox – what biomarkers could be a tolerance endpoint?
- Honing clinical study design – what are key considerations for tolerance?