Day One

• Reviewing the Phase II/III clinical data across the most advanced antigen-specific programs to distinguish mechanism of action from execution and trial design, providing greater confidence in assessing which approaches are most likely to deliver meaningful clinical benefit
• Unpacking the dosing, timing, and site-selection decisions in the Phase III trial to highlight endpoints and spotlight what could be changed in hindsight
• Setting out the priorities for the next year of ASIT development based on direct latestage trial experience to focus the field’s collective effort on the antigen selection, patient stratification, and delivery choices most likely to succeed

• Presentation of cellular and molecular pathways regulating peripheral antigen-specific tolerance 
• Presenting alterations in antigen-specific T-cell phenotype and location in the therapeutic setting
• Presenting common measurable changes within blood between preclinical and clinical studies

• Deep profiling of autoreactive T-cells using multiomic single-cell profiling to support treatment efficacy, and demonstrate proof-of-concept, and allow for precise monitoring across clinical trials
• High-throughput analysis of autoreactive T-cells using multiparameter cytokine FLUOROSPOT assays, to enable broader screening of patient samples, and scalable monitoring of trial populations

Expand your network across the entire immune tolerance community and connect face-to-face with leading scientists, clinicians, and industry innovators. This is your chance to discover new perspectives beyond your specialty and build meaningful relationships that drive the next generation of immune tolerance breakthroughs. Each networking session will take place in the shared exhibition space across all three summits.

• Mapping a drug’s mechanism of action in detail, making it possible to anticipate how it will perform in the clinic before trial results arrive, and replacing a trial-and-error approach with one supported by evidence
• Precise biomarker panels built on a strong level of mechanistic detail, allowing trial teams to monitor a drug’s biological activity in real time, and confirm it is performing as expected well ahead of efficacy readouts
• Parvus’s peptide-MHC nanomedicine program which offers a study with safety, tolerability, and pharmacodynamic data showing how a well-designed biomarker strategy can demonstrate drug activity in humans

• Analyze biomarker data from landmark peanut-allergy trials (LEAP, IMPACT) to identify reliable predictors of sustained tolerance
• Assess the utility of monitoring circulating Th2a cells as a predictive biomarker for durable clinical tolerance
• Evaluate the relevance of shifts in protective versus pathogenic antibody levels (IgG4/ IgE ratios) as biomarkers of desensitization
• Differentiate the immune mechanisms driving transient desensitization versus durable tolerance in food allergy

This interactive Think Lab Roundtable will bring together attendees to exchange perspectives and identify practical strategies for improving durability assessment and regulatory alignment.

Think Lab Roundtable: Durable Immune Tolerance Therapies

Analyzing Long-Term Follow-Up Data & Distinguishing Durable Tolerogenic Signals from Therapies that May Require Redosing to Explore How Durability Data Could Shape Future Trial & Retreatment Design

• Reviewing the long-term follow-up data available across current antigen-specific approaches, to assess how consistently a tolerogenic effect is maintained beyond the initial treatment period
• Comparing single-dose and repeat-dosing strategies
• Considering how longer-term patient monitoring could shape expectations around retreatment to inform how future trials are designed to capture durability

Think Lab Roundtable: Aligning on FDA Guidance

Initiating Early FDA Engagement & Aligning on Endpoints Regulators Need to See to Reduce Late-Stage Surprises & Accelerate the Path to Market

• Learn how to initiate dialogue with the FDA during Phase I to align on Phase II and Phase III endpoints, ensuring you’re measuring what regulators need for approval
• Understand which clinical endpoints demonstrate disease modification versus symptomatic relief, and how to design trials that prove durable tolerance
• Discover why early-stage FDA engagement prevents costly late-stage surprises and accelerates the path to market

Review current levels of pharma and investor engagement with antigen-specific approaches to identify what would strengthen confidence in the space and positioning the field to attract deeper investment going forward.

• Understand what Big Pharma considers a commercially attractive indication and how they come to this decision to inform biotechs of what steps can support successful commercialization
• Discussing the type of data and evidence pharma and investors have indicated they want to see to clarify the gap between what is currently available and what may be expected, and explore how early-stage programs can prepare for this
• Considering how indication choice and commercial viability factor into investment decisions, to weigh biological rationale against practical, market-driven considerations, and inform how programs might frame their own value proposition

• Reviewing emerging evidence linking Epstein-Barr virus and other viral infections to autoimmune disease onset to understand their role in disease initiation and identify opportunities for earlier disease interception
• Examining how viral and self-antigens cross-react through molecular mimicry to reveal mechanisms driving autoimmunity and identify disease-relevant targets for antigen-specific therapies
• Evaluating whether viral exposure histories and cross-reactive immune signatures can identify at-risk individuals before clinical disease develops

Present your research, connect with peers, and continue building valuable relationships while exploring the latest advances in immune tolerance research.

This year, posters will be showcased in a joint networking session as part of World Immune Tolerance Week, bringing together attendees from the 10th Antigen-Specific Immune Tolerance Summit, 9th Treg-Directed Therapies Summit, and 2nd Immune Resetting: B-Cell Mediated & Beyond Summit. By presenting within the shared networking space, you’ll gain exposure to a broader audience spanning immunology, autoimmune disease, immune modulation, and tolerance restoration, creating opportunities to gather diverse perspectives and foster collaborations beyond antigen-specific approaches alone.

• Examining approaches that direct antigen-specific therapies toward a specific organ or tissue, such as the liver, to consider how this may concentrate the tolerogenic effect at the site where it matters most
• Comparing tissue-specific delivery against systemic administration to explore whether targeting a particular site could reduce activity elsewhere in the immune system to improve safety and tolerability while preserving therapeutic activity where it is needed
• Discussing how tissue-specific targeting might influence dosing frequency and route of administration to consider what this could mean for patient burden and trial design

• Examining why antigen-specific immune tolerance may need complementary therapies to succeed, to identify where monotherapy alone falls short, and set out where combination approaches could close that gap
• Reviewing which therapies can safely be combined with tolerance induction to distinguish combinations that support the tolerogenic effect from those that interfere with it and build a clearer picture of viable pairing options
• Exploring how depletion-based therapies and tolerance induction could work together, to consider how sequencing or timing might allow one to reinforce the other, and outline a possible framework for combination strategy design