Conference Day Two
March 20, 2024

Day One

Full Event Guide

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

  • Mark Eisner Chief Medical Officer, Sonoma Biotherapeutics

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

  • Heather Denroche Co-Founder & Director - Preclinical Development, Integrated Nanotherapeutics Inc.

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

  • Dan Mandell Chief Executive Officer & Co-Founder, GRO Biosciences

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

  • Brian Freed Co-Founder & Chief Scientific Officer, RheumaGen

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

  • Jack Ragheb Senior Vice President - Translational Sciences & Medicine, NexImmune Inc

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

  • Leonard L. Dragone Chief Medical Officer, Abata Therapeutics
  • Glennda Smithson Director - Scientific & Translational Biomarker Research, Takeda Pharmaceutical Co. Ltd.
  • Michael Yeaman Professor of Medicine, Chief of the Division of Molecular Medicine & Director of the Institute for Infection & Immunity, University of California
  • Kristie Grebe Chief Scientific Officer, Anokion Inc.
  • Joseph Podojil Director - Immunology, Cour Pharmaceutical Development Company

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?

3:30 pm Chair’s Closing Remarks

DAY ONE
EVENT GUIDE