Day One

• Updates from the ongoing DIAGNODE-3 phase 3 trial, (interim readout expected March, 2026)
• Review of pharmacodynamic effects of rhGAD65 treatment
• Evidence of disease-modifying benefit in Stage 3 Type 1 diabetes and strategy to guide next-phase development and future precision-medicine strategies

NEW DATA

• Explore in-depth clinical analyses of PBC including UK-PBC scoring, ALBI/GLOBE metrics, and emerging biomarkers to understand how tolerance influences disease prognosis
• Highlight responder outcomes, including responder-rate evaluation and respondercurve profiling following tolerance induction
• Delve into how these findings support translation into Myasthenia Gravis (MG), outlining clinical implications and future development strategy

• Integration of biology with clinical trial design to evaluate antigen-specific tolerance induction, drawing on Phase I and II experience across celiac disease
• Endpoint selection guided by both mechanistic and clinical relevance, including strategies for incorporating non-invasive biomarkers and disease-appropriate readouts
• Analytical methods used to assess antigen-specific responses and evolving approaches to improve sensitivity and reliability

• Exploring Aravax’s peptide-based immunotherapy that is designed to induce antigenspecific immune tolerance by precisely targeting T-cells
• Delving into the translational strategy that has led to late phase II clinical trials

NEW DATA

This informal session provides the perfect opportunity to connect with industry pioneers and key opinion leaders. Establish meaningful connections to build upon at the rest of the conference and gain exclusive first-hand insights into the latest research and developments driving progress in the space.

• What does true success look like in ASIT – single-dose cures, durable remission, or reduced treatment burden?
• How can the field align on shared clinical benchmarks as we move from preclinical to human data
• What lessons can be drawn from broader immunology approaches, such as B cell depletion, allergy learnings and tolerance induction?
• How do current clinical outcomes compare between targeted tolerance and broader immunoregulatory mechanisms?

• How do VCs and strategic partners assess differentiation among ASIT companies using nanoparticles, cell-based
• What development milestones -such as proof of infectious or bystander tolerance, early human safety signals, or scalable manufacturing – most strongly influence investment and partnership decisions?
• What do pharma see as the future challenges in the ASIT space?

• Explore how mRNA-encoded beta-cell autoantigens with immune modulators drive peripheral tolerance
• Delve into lipid nanoparticle delivery facilitating tolerogenic antigen presentation and Treg-aligned immunoreprogramming
• Discover the translational trajectory toward first-in-human studies in 2027, encompassing CMC scale-up, toxicology studies, and early regulatory engagement to validate safety, manufacturability, and indication expansion

• Translating discovery into the clinic by driving research from early discovery through preclinical validation, ensuring robust study design, regulatory alignment, and effective transition of lab findings into first-in-human studies
• Leveraging a tetramer-based assay to directly measure antigen-specific Treg populations, enabling precise proof-of-mechanism validation
• Establishing scalable GMP manufacturing processes that bridge scientific innovation and clinical application, ensuring efficient development of patient-ready therapeutics

• Cell therapy place in autoimmune disease, significance and cost appropriateness
• Examining both ex vivo and in vivo approaches, highlighting the trade-offs between customized manufacturing and off-the-shelf therapies
• Evaluating current GMP-level processes which remain largely manual, creating bottlenecks in speed, cost, and reproducibility
• Discussing automated technologies, such as advanced cell sorters and bioreactors, that could streamline manufacturing

• Navigating relevant endpoints, immune biomarkers, and proof-of-mechanism requirements unique to antigen-specific immune tolerance therapies
• Aligning with regulatory expectations and ensuring data supports both approval and reimbursement
• Planning for scalable adoption, pricing, and payer engagement to bring safe and effective ASIT therapies to patients efficiently