Conference Day Two
Thursday, May 23, 2024
8:00 am Registration & Refreshments
8:55 am Chair’s Opening Remarks
9:00 am Navigating the Complexities of Disease Indication Selection for Treg Therapies
Synopsis
- Acknowledging the unique challenges faced by smaller biotech companies in making strategic decisions when selecting particular disease indications
- Discussing the implications of disease indication selection on the success of Treg therapies and how this may impact development decisions
- Offering strategic considerations and decision-making frameworks for smaller biotech’s to capitalize on market opportunity
9:30 am Revolutionizing TNFR2 Agonism for Autoimmunity & CNS Diseases: Creation of High Potency Antibodies with Tiny Concentrations
Synopsis
- The design of agonistic antibodies to surface receptors of the TNF family have been challenging to make and dose correctly in human clinical trials
- Our group has focused on single cell surface hexagonal networks to form the tight clustering for potent intracellular signaling, such as for TNFR2 agonism instead of bridging ADCC mechanisms
- TNFR2 agonist antibodies with high potency and validity across broad dose responses demonstrate the validity of single cell hexagonal clustering
10:00 am Morning Refreshments & Speed Networking
Cell-Based Approaches
Exploring the Next Steps for Cell-Based Therapies to Address Regulatory Concerns
11:00 am Roundtable Discussion: Unlocking the Full Potential of Treg Cells: Beyond Therapeutic Frontiers
Synopsis
- As Treg therapies continue to demonstrate their efficacy in autoimmune and inflammatory conditions, this session explores the broader landscape of opportunities that Treg cells can provide for diverse therapeutic applications
- Delve into the untapped potential of Tregs and discuss how their success can be leveraged to shape the future of immunotherapy
- Explore avenues for expanding the scope of Treg applications, addressing challenges, and envisioning new possibilities that Tregs can yield across various therapeutic domains
11:30 am A look at the Current Treg Landscape for Autoimmune Diseases & Recent Deals and Emerging Companies
Synopsis
- Reviewing the current landscape of Treg cell therapies for autoimmune disease
- Discussing the future of Treg cell therapies in autoimmune disease
- A review of the recent deals and emerging companies in the Treg space
Spearheading the Development of Novel Strategies for Targeted Delivery to Meet the Need for Continued Innovation
12:00 pm The Future of Small Molecule In Vivo Activated Cell Therapy: Modulation of Tregs in the Body
Synopsis
- AZD1656 is a specific activator of glucokinase; but not hexokinase (the latter is used by T effector lymphocytes for migration)
- A randomised blinded placebo-controlled trial of this drug in diabetic patients with Covid 19 significantly decreased death and time in hospital in the treated group. This trial was undertaken by the speaker and his team. New immunology data from this human study will be presented
- This approach will be tested in several autoimmune diseases
Non-Cell Based Approaches
Unravelling Clinical Insights into Non-Cell Based Approaches Utilizing Novel Modalities for Enhanced Tolerance in Treg Function
11:00 am Applying a Novel CD8 Treg Directed Therapeutic Approach to the Clinic
Synopsis
- Discussing the significance of regulatory CD8 T cells in autoimmune disease
- Discussing the therapeutic potential of modulating CD8 Treg for the treatment of autoimmune disease
- Advancing the CD8 Treg modulator MTX-101 targeting inhibitory KIR as autoimmune checkpoint into the clinic for the treatment of autoimmune disease
11:30 am Inhibitory Receptor Targeting & Modulation of Treg Biology
Synopsis
- Introducing inhibitor receptors (IRs) and their role in health and diseases
- Outlining the potential of inhibitory receptors in modulating Treg biology
- Discussing mechanisms by which targeting IRs can be used to restore tolerance
Exploring Combination Approaches to Treg Therapies to Elevate Therapeutic Efficacy
12:00 pm Targeted Approaches to Balance Treg Function in Inflammation & Cancer
Synopsis
- Pharmacological intervention to precisely and selectively modulate regulatory T (Treg) cell function is required to restore immune system homeostasis in autoimmune disease and cancer
- Egle Therapeutics’ platform harnesses the selectivity of modified cytokines (muteins) combined with antibody-mediated Treg targeting
- Preclinical studies highlight how Egle’s multifunctional immunocytokines display novel and unanticipated mechanisms of action, resulting in high in vivo selectivity for disease-specific Tregs
12:30 pm Lunch Break & Networking
Cell-Based Approaches
1:30 pm Emerging Approaches to Monitoring CAR Tregs in Patients for the Age of Clinical Translation
Synopsis
- Approaches to monitoring CAR Tregs in the clinic through correlative studies, with CD19-CAR therapy for cancer as an example
- Monitoring phenotype and TSDR methylation to assess stability of CAR Tregs in patients
- Lineage tracing to link the source of ‘unstable’ CAR Tregs to pre-existing impurities or loss of Treg identity
2:00 pm Development of CAR-Treg therapies to modulate immune responses in transplantation and autoimmunity
Synopsis
Session details TBC
Non-Cell Based Approaches
1:30 pm CSL as a Target for Inducing Immune Tolerance by Modulating Treg Cells & Application in Autoimmune Diseases
Synopsis
- CSL as a target for inducing immune tolerance by modulating Treg cells and application in autoimmune diseases
- Small molecule (CB-401/CB-433) mediated inhibition of CSL causes an expansion of Treg cells • CB-401/CB-433 induced Tregs maintain their suppressive characteristics
- Orally active CB-401/CB-433 alleviate autoimmune disease by re-establishing immune tolerance
2:00 pm Rezpegaldesleukin, a Regulatory T-Cell Selective IL-2 Conjugate: Lessons Learned From Preclinical Design to Clinical Evaluation in Inflammatory Skin Diseases Including Atopic Dermatitis
Synopsis
- Use of the appropriate design elements and experimental models for generation and preclinical evaluation
- Using clinical development approaches to address target engagement and assess PK/PD principles
- Using clinical studies to identify the correlation between the MOA and the indication
2:30 pm Afternoon Refreshments
Guaranteeing Success for Strategic Milestones from Start to End: IND Preparation to Clinical Insights in Treg Therapies
3:00 pm Failure of Singular Approaches to Induce Tolerance: Practical Applications to Boost Treg Function
Synopsis
- The need for a multi-faceted approach to enhance Treg therapeutic induction or restoration of immune tolerance
- Analysing limitations and failures of approaches in achieving immune tolerance in autoimmunity and allergy
- The potential for synergies between different therapeutic modalities in enhancing Treg efficacy
3:30 pm Roundtable Discussion: Building a Strategic Roadmap to Prepare for IND & Advance to Clinical Phases
Synopsis
- Preparing for Investigational New Drug (IND) applications and transitioning to clinical phases
- Emphasizing the importance of strategic planning to ensure successful progression through clinical development
- Detailing the essential components required for a successful IND application
- Highlighting regulatory expectations and common pitfalls in the IND submission process
4:00 pm IL-2 Containing Nanoparticles Induce Tregs & TGF-β-producing NK Cell
Synopsis
- The tolerogenic effect of IL-2 on Tregs is TGF-β dependent
- TGF-β producing NK cells are essential for Treg maintenance
- The NPs induce TGF-β locally so that encapsulation of TGF-β is not needed