Explore the Agenda
7:30 am Check-In & Light Breakfast
8:25 am Chair’s Opening Remarks
Strengthening Preclinical Evidence to Improve Clinical Translation, De-Risk Development, & Increase the Likelihood of Clinical Success
8:30 am Utilizing Fc-Engager Proteins as a Targeted Therapy to Direct Suppression Precisely to the Antigen Driving Disease & Reduce Off-Target Immune Effects
- Presenting mechanistic mouse model and primary human cell data, and top-line safety signals to de-risk the path from preclinical proof of mechanism to patient outcomes for antigen-specific immune inhibition by LoopLab’s Fc-Engager proteins
- The lessons to be learned from the synergies and discrepancies between primary human cell data and humanized mouse models to clarify where these models diverge and improve the interpretation of preclinical data before advancing into the clinic
9:00 am Presenting Mechanistic Mouse Model Data & Top-Line Safety Signals to De-Risk the Path from Preclinical Proof of Mechanism to Patient Outcomes
- Presenting mechanism of action data from mouse models across COUR’s antigenspecific pipeline to show how their nanoparticle platform drives tolerance before a single patient is dosed, giving the field a reproducible template for validating mechanisms ahead of the clinic
- Pairing that mouse model functionality data with preclinical safety results to demonstrate that a blood-based biomarker readout can be functionally linked to disease-altering changes in the target tissue
- Setting out how this mechanistic and safety package informs indication and endpoint selection before trial design begins so the field can learn and avoid costly decisions
Selecting the Right Platform & Delivery Approach to Maximize Efficacy & Accelerate Clinical Development
9:30 am Evaluating PoITREG In Vivo Data to Advance Delivery System Technologies & Enhance Tolerance Induction
- Present on the ability to stimulate T-regulatory-cells and demonstrate that these stimulated Tregs can suppress T-effectors
- Ongoing findings from 86 patient serum samples collected over 12 years
- Update on preclinical data
- In vivo animal data related to a developing delivery system technology
10:00 am A Hydrophilic Nanoparticle mRNA-Based Platform Enabling Targeted Delivery & Inducing Immune Tolerance in Autoimmune Diseases
- Introduction to the NanoGalaxy hydrophilic nanoparticle (HNP) mRNA delivery platform
- HNP-mRNA biodistribution, immune cell engagement, and safety in mice and nonhuman primates
- Application of the HNP-mRNA platform to induce immune tolerance in autoimmune indications
10:30 am Morning Break & Networking
11:00 am An Anti-CD6 Monoclonal Antibody for the Treatment of Autoimmune Diseases
- Explore how selective immune modulation can control disease-driving responses while preserving protective immunity to improve therapeutic safety and long-term patient outcomes
- Assess strategies to induce immune tolerance while maintaining anti-tumor immunity, expanding the therapeutic potential of ASIT approaches across diseases
- Analyzing the distinctions in the molecular interactions between anti-CD6 and CD4+ versus CD8+ T-cells
Building Better Antigen-Specific Therapies Through Smarter Target Discovery & Selection
11:30 am Driving Robust Tolerance with Multi-Cargo Lipid Nanoparticles to Advance Safe, Targeted, & Durable Therapeutic Responses
- Explore the updates from our Intergrated Nanotherapeutics T1D preclinical program to understand the therapeutic potential of multi-cargo lipid nanoparticles in antigen- specific immune tolerance
- Demonstrate the translation of antigen selection from preclinical models to the clinic to support more effective and clinically relevant therapeutic design
12:00 pm Lunch & Networking Break
Defining the Optimal Window for Intervention to Maximize the Preventive Therapeutic Potential of Antigen-Specific Therapies
1:00 pm Roundtable Discussion: How Antigen-Specific Approaches can be Positioned as a Prophylactic Measure as Well as a Therapeutic Cure
- Which autoimmune diseases are best suited for the use of antigen-specific therapy once a patient has been diagnosed
- Debate whether the field should prioritize preventing disease in at-risk individuals (Stage 1-2) versus treating established disease (Stage 3)
- Understand why prophylactic clinical trials are challenging (slow enrollment, long duration, high costs) but may offer the best path to demonstrating tolerance efficacy
- Learn from teplizumab’s success as a preventive therapy that delays type 1 diabetes onset by two years
Applying Proven Tolerance Mechanisms to Advance Antigen-Specific Therapies & Unlock New Opportunities for Innovation
1:30 pm Developing an Antigen-Specific NanoDisc Platform for Immune Tolerance: From Platform Design to Clinical Translation in Celiac Disease
- Describe EVOQ Therapeutics’ NanoDisc platform for the antigen-specific induction of immune tolerance and the principles guiding antigen and formulation design
- EVOQ’s celiac disease program as a translational case study, highlighting the progression from preclinical development toward clinical evaluation and the opportunities celiac disease provides for assessing antigen-specific pharmacodynamic responses
- Discuss how a modular NanoDisc platform may be applied across autoimmune diseases in which disease-relevant antigens are known
2:00 pm Afternoon Break & Networking
2:30 pm Applying Insights from Allergy Immunotherapy to Accelerate the Development of More Effective & Patient-Friendly Antigen-Specific Tolerance Therapies
- Allero’s SOMIT platform translates learnings from Allergen Immunotherapy (AIT) to address requirements for next-generation antigen-specific immunotherapies in other immune-mediated disorders, including safety, efficacy, scalability, and patientfriendliness
- SOMIT is a non-invasive, scalable oral patch-based, first-in-class approach that leverages the tolerance gateway of the oral mucosa
- SOMIT has platform potential across a wide range of immune-mediated disorders where the triggering antigen is known e.g., allergies, autoimmune diseases, and anti-drug antibodies (ADA), with new developments underway on an mRNA-based approach
Honoring More Than 10 Years of Innovation in Antigen-Specific Immune Tolerance & Inspiring the Next Decade of Breakthroughs
3:00 pm 10 Years of the Antigen-Specific Immune Tolerance Summit Panel Discussion: Assessing this Year’s Presentations & Defining the Next Steps in Immune Tolerance Research for Clinical Success
- Evaluating the novel mechanistic insights from this year’s program
- Assessing the preclinical data shared and looking to the next year’s clinical therapeutic landscape
- Supercharging antigen-specific immune tolerance therapies to the clinic – what can the field do together to make the promise of the technology a reality?