*All times shown in EST

8:00 am
Registration & Coffee

8:45 am Chair’s Opening Remarks

  • Amy Rosenberg Senior Director of Immunology & Protein Therapeutics , EpiVax, Inc

Reviewing the Treg Landscape to Accelerate Effective Therapies to Large-Scale Investigations

9:00 am Uncovering the Promise of Treg Directed Therapies: The Current Developments & Key Players

Synopsis

  • Providing a comprehensive analysis of the Treg therapies landscape
  • Sharing insights into the rapidly evolving Treg pipeline, cell therapy, cytokine approaches and future trends
  • Revealing TRexBio’s unique approach to modulating tissue Tregs

9:30 am Expanding beyond IL-2: Developing a TNFR2 Agonist to Selectively Expand Stable Tregs

Synopsis

  • Explaining how TNRF2 agonist antibodies selectively targets the most immunosuppressive Tregs for expansion autoimmunity and inflammation
  • Understanding antibody structural design to optimize agonism in vivo – it is all about hexamers
  • Planning for large scale clinical trials to provide efficacy in patients

10:00 am
Morning Refreshments & Structured Networking

11:00 am Learning from Smaller Scale Studies to Plan Effectively for Phase 3 Trials, Using Learnings From ALS

  • Stanley H. Appel MD Chair & Scientific Advisory Board , Houston Methodist Research Institute / Coya Therapeutics

Synopsis

  • Utilizing biomarkers to characterize Treg response and impact on disease progression
  • Leveraging data to optimize dosage frequency and timing in treatment paradigm to have the most therapeutic impact
  • Presenting phase II trial data and discussing later stage trial development to optimize efficacy in large populations of ALS patients

11:30 am Expert Panel: Reviewing Learnings from IL-2 Clinical Trials to Fuel Further R&D & Advance Efficacious Treg Therapies to Patients

Synopsis

  • The potential for low-dose IL-2 and engineered IL-2 variants for the treatment of immune mediated diseases
  • Taking learnings from discontinued phase II trials to understand lack of efficacy
  • Glimpsing to next generation of IL-2 pathway therapies and the potential for synergy between IL-2 based therapies and cell based Treg therapies for the treatment of immune-mediated diseases

12:30 pm
Lunch & Networking

Cell-Based Approaches Track

Diving into the Engineering Approaches Accelerating Specific, Stable & Functional Treg Cells to The Clinic

1:30 pm Generating EngTregs to Overcome Key Challenges Associated with the Successful Application of Treg Therapeutics

Synopsis

  • Engineering abundant T cell populations with stabilized FOXP3 expression to create a scalable and stable Treg phenotype
  • Utilizing an inducible chimeric receptor to provide highly specific and tunable IL-2 signaling support
  • Providing tissue specificity and enhanced regulatory functions through antigen-specific CARs or TCRs

2:00 pm Advancing Treg Cell Therapy with 3 Engineered Genes for Improved Specificity, Stability & Safety

Synopsis

  • Explaining the science behind Quell’s approach to building a Treg cell therapy in autoimmunity, inflammation and transplant rejection
  • Reflecting on preclinical data to explain improved antigen specificity and stability model for generating efficacious and safe products
  • Glimpsing at clinical development of Quell’s Treg therapy, from Treg population isolation to expansion, clinical design and clinical outcomes to further understand the technology

Non Cell-Based Approaches Track

Enhancing Selective Treg Targeting to Avoid Effector T Cell Induction For Durable Responses

1:30 pm NKTR-358, a Modified IL-2 Pathway Agonist for Selective Expansion of Tregs in vivo

Synopsis

  • Discussing the design of NKTR-358 using polymer chemistry
  • Exploring NKTR-358’s mechanism of action and preclinical development
  • Presenting Clinical highlights demonstrating Treg specificity and an optimal pharmacology profile for the treatment of autoimmune diseases

2:00 pm Synergizing Activity of ImmTOR Tolerogenic Nanoparticles & an IL-2 Mutein to Expand Antigen- Specific Tregs

Synopsis

  • Co-administering antigens with ImmTOR nanoparticles encapsulating rapamycin to induce antigen-specific tolerance
  • Using ImmTOR combination with a fungal-derived uricase enzyme in Ph3 clinical trials in for the treatment of chronic refractory gout
  • Combining ImmTOR with an IL-2 mutein and antigen to induce massive expansion of antigen-specific Tregs in vivo

2:30 pm
Afternoon Refreshments & Poster Session

3:00 pm Expert Panel: What Does a Good Treg Cell Product Look Like?

Synopsis

  • Taking learnings from other cell therapy products to fuel Treg cell therapy development
  • Discussing the real challenges of developing a Treg cell product to overcome them
  • Understanding the role of IL-2 in Treg cell therapy development

3:30 pm Engineering Immunosuppressive T-Cell Receptor Fusion Construct Regulatory T cells (TRuC-Tregs)

Synopsis

  • Treating a broad range of multiple autoimmune mediated diseases with immunosuppressive TRuC-Tregs
  • Utilizing TRuC-Tregs to maintain the characteristic hypomethylation of the T-cell specific demethylated regions TSDR of the FOXP3 gene to maintain stability
  • Analyzing efficient protection of mice with TRuC-Tregs when compared to non-transduced polyclonal Treg TRuCs (NT Tregs) or vehicle controls and discussing plans for translation

4:00 pm De-Coding & Re-Wiring Tregs with CRISPR to Enable Next-Gen Treg Cellular Therapy

  • John Cho Director, Immunobiology, KSQ Therapeutics

Synopsis

  • Describing strategies employed by KSQ to identify novel regulators of human Tregs
  • Utilizing in vitro and in vivo systems to model human Treg stability and persistence
  • Engineering approaches to improve potency of Treg cellular therapy

Expanding Tregs with Maximal Stability To Maintain Phenotype & Function

3:00 pm Leveraging A Natural Differentiation Pathway of T Regulatory-1 (TR1) Cell to Fuel a Nanomedicine Approach to Treat Autoimmune Disease

Synopsis

  • Showing how T-follicular Helper (TFH) cells can serve as in vivo precursors of TR1 cells in humans and in mice
  • Describing complete differentiation of TR1 effector function, requiring the transcription factor Blimp-1 (Prdm1)
  • Presenting Navacims, a pMHC-II nanomedicine platform to induce TFH expansion and differentiation to immunomodulatory TR1 cells

3:30 pm Chemically Modifying IL-2 to Optimize Delivery to Tregs for Sustained Responses

Synopsis

  • Overview of PEGylated IL2v to enhance activation of Tregs with high specificity and maintain stability
  • Highlighting preclinical data to predict clinical efficacy of PEGylated IL2v
  • Overcoming the challenges to translate from preclinical models to humans

4:00 pm Agonizing Over Treg Expansion to Treat Human Disease: An Update on Our TNFRSF25-Agonist, PTX-35

Synopsis

  • Describing a clinical-stage Treg immunomodulator with utility in both oncology and auto/inflammation
  • Demonstrating preclinical efficacy in several indications including transplantation, autoimmunity, and metabolic diseases
  • Expanding plans for new indications & modalities – opportunities for partnerships

4:30 pm Chairs Closing Remarks & Close of Day One