Conference Day One
Wednesday, February 26

7:00 am Registration & Coffee

7:50 am Chair’s Opening Remarks

  • José Carballido Executive Director – Translational Medicine & Preclinical Safety, Novartis

Examining Clinical Trials for Efficacy & Safety in Immune Tolerance Approaches for Autoimmune Disease

8:00 am Tolerogenic CNP-104 Treatment Regulates Th17 Cells Thereby Slowing PBC Progression and Liver Stiffness

  • Adam Elhofy Vice President - Research & Collaborations, COUR Pharmaceuticals

Synopsis

• Demonstrating efficacy across multiple immunological and clinical mechanisms

• Highlighting the potential of CNP-105 to be the first disease-modifying treatment for PBC

• Delving into the safety and tolerability data supporting ASIT clinical studies

8:30 am Updates on the Phase 3 Trial for an Antigen Specific Immune Tolerance Therapy for Type 1 Diabetes

  • Ulf Hannelius President & Chief Executive Officer, Diamyd Medical

Synopsis

• Discussing considerations for late-stage clinical trials for antigen-specific approached to treating TD1

• Acknowledging regulatory requirements for precision medicine approaches for autoimmune diseases

• Navigating the use of a surrogate endpoint for BLA submission of precision medicine approaches

9:00 am Clinical evidence of Immune Tolerance Induction: examples from Celiac Disease and Multiple Sclerosis

Synopsis

• Measuring immune tolerance through biomarkers in Celiac Disease

• Detection of antigen-specific tolerance to myelin-based autoantigens in MS; evaluation of bystander suppression and durability of responses

• Maximising patient safety in early clinical trials for inducing immune tolerance in the CNS

9:30 am Speed Networking

Synopsis

Put a face to a name – this session is the perfect opportunity to get face-to-face time with key opinion leaders, leading companies, and innovative researchers in the immune tolerance field. Establish meaningful connections to build upon for the rest of the conference and gain individual insight beyond the papers and press releases into the pioneering research and technique applications.

10:00 am Morning Refreshments

Successfully Translating Antigen-Specific Tolerance Inducing Therapies for Clinical Success

10:30 am Targeting Myasthenia Gravis with Antigen-Specific Immune Tolerance Approaches for a Durable, Disease Modifying Treatment

Synopsis

• Inducing immune tolerance in MG disease patients with a nanoparticle-based immune tolerizing therapy encapsulating gliadin proteins

• Delving into the design of clinical trials for efficacy – considering the interplay of accurate disease modeling and good standard of care with administering a tolerizing therapy

• Assessing the durability and necessary dosage to induce immune tolerance in the digestive system

11:00 am Navigating the Use of Cytokines to Induce Antigen-Specific Immune Tolerance

Synopsis

• Exploring the use of IL-2 as a specific marker for CD4+ Treg production and its role in assessing ASIT induction

• Understanding the broader cytokine landscape and assessing the advantages and disadvantages of using cytokines such as IL-10, TGF-β, and IFN-γ as biomarkers of immune tolerance

• Addressing the impact of epitope spreading and bystander suppression to explore how these phenomena can influence biomarker interpretation and clinical outcomes

11:30 am Session Researved for Revolo Bio

12:00 pm Panel Discussion: Redesigning Clinical Trials for Immune Tolerance Therapies: Enhancing Safety, Efficacy, and Regulatory Compliance

Synopsis

• Uncovering the limitations of autoimmune disease models in the context of the maturity of the autoimmune response in mice compared with humans

• Addressing the regulatory hurdles involved in using a biologic and a chemical component in ASIT therapies

• Looking at the potential for a changing paradigm in clinical development for precision medicine – focussing more on earlier human clinical studies to determine safety and efficacy rather than developing more sophisticated mouse models

12:30 pm Lunch & Networking

Benchmarking Biomarkers of Immune Tolerance to Inform Reliable Clinical Endpoints

1:30 pm Lessons Learnt from Type 1 Diabetes: Tolerance Mechanisms and Biomarkers

  • Lauren Higdon Director - Marker & Discovery Research, Immune Tolerance Network

Synopsis

• Identifying biomarkers of response to immunotherapy

• Discussing optimal biomarkers to establish durability of immune tolerance

• Considering how biomarkers relate to mechanism of immune tolerance

2:00 pm Measuring T-Regulatory Cells: Working Towards a Gold Standard for Assessing Immune Tolerance with Enhanced Accuracy

  • Dan Shelly Chief Business Development Officer, PolTREG

Synopsis

• Reviewing the strengths and limitations of existing approaches for quantifying CD4+ cells in the blood

• Discussing the potential for T-cells as valuable clinical biomarkers for monitoring immune tolerance and treatment response

• Exploring how T-cells can be used to assess immune reprogramming rather than suppression

2:30 pm Afternoon Refreshments & Poster Session

Synopsis

Immerse yourself in an engaging and informal session, join your peers in a relaxed atmosphere that encourages meaningful conversations and discussions. Explore a range of exciting poster presentations and showcase your own developments in the Antigen-Specific Immune Tolerance world. Don’t miss out on the chance to submit your own posters and get ready to connect, learn, and present. To submit your poster please contact info@hansonwade.com

Understanding Immune Tolerance in Relation to Viruses & Anti-Drug Antibodies to Inform Therapeutic Targeting

3:00 pm Reducing Anti-Drug Antibodies to Protein Therapeutics in an Antigen Specific Manner

Synopsis

• Generation of protein therapeutic from novel engineered bacterial strain

• Glyco-engineering of protein to improve PK, reduce immunogenicity, and target immune

cells

Forging Strategic Alliances Across Biotech, Pharma & Investors to Advance Commercial & Scientific Breakthroughs in Immune Tolerance

3:30 pm Panel Discussion & Q&A – Collaborating with Large Pharma and VCs: What are They Looking for & What to Expect?

Synopsis

• Hear from large pharma, venture capitalists, and experienced biotech leaders as they dive into the scientific and commercial factors of setting up a successful partnership to develop ASIT therapies

• Uncover the key end-to-end milestones that are evaluated when deciding on investment and partnership opportunities

• Ask your questions on what big pharma companies will be looking for next in their immunology and autoimmune portfolios

4:30 pm Chair’s Closing Remarks

  • José Carballido Executive Director – Translational Medicine & Preclinical Safety, Novartis

4:30 pm End of Conference Day One

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