Conference Day Two

Thursday, March 27, 2025

7:30 am Check-In & Coffee

8:20 am Chair’s Opening Remarks

  • FABIEN DEPIS BIOTECH FOUNDER | INDEPENDENT TREG EXPERT & CONSULTANT, Independent Consultant

Cultivating Academic, Biotech & Pharma Collaborations to Revolutionize Treg Therapeutic Development

8:30 am Panel Discussion: Driving Industry Collaborations to Unlock New Therapeutic Opportunities

  • Miguel Forte Chief Executive Officer, Kiji Therapeutics
  • Julie Di Paolo Senior Director Immunology, Scientific Innovation Lead, Johnson & Johnson
  • FABIEN DEPIS BIOTECH FOUNDER | INDEPENDENT TREG EXPERT & CONSULTANT, Independent Consultant

Synopsis

  • Evaluating public and private partnerships between pharma and biotech companies institutions
  • Discussing ideal criteria for company collaborations and investment to improve discovery efficiency
  • Highlighting key strategies from successful collaborations to direct and refine future collaborative efforts

9:30 am Keynote Presentation: Leveraging Clinical Polyclonal Tregs for the Development of Modified & Engineered Tregs

  • Dan Shelly Chief Business Development Officer, PolTREG

Synopsis

  • Harnessing effective data from clinically derived polyclonal Tregs
  • Showcasing long-term clinical Type 1 Diabetes data
  • Utilizing polyclonal Tregs to shape the next generation of Treg therapies

10:00 am Morning Break & Networking

Treg Cell Therapy

Leveraging CAR-Tregs to Enhance Potency, Persistence & Safety

11:00 am Developing CAR-Treg Therapies to Enhance Clinical Efficacy

Synopsis

  • Discussing Treg engineering strategies to improve safety and efficacy
  • Revealing insights into the ongoing LIBERATE clinical trial
  • Exploring Treg stability and pharmacokinetics to enhance safety

11:30 am Designing CAR Tregs for Neurodegenerative Disease Therapy

Synopsis

  • Targeting disease sites in the CNS
  • Utilizing disease modifying molecules to improve therapeuticactivity
  • Harnessing CARs to improve Treg persistence in the CNS

Treg Modulators

Exploring IL-2 Fusion Proteins & Muteins as Treg Modulators

11:00 am Analyzing Natural Glycosylated PEG-IL2v with Treg Bias for ALS & Autoimmune Diseases

Synopsis

  • Designing the best IL-2v for chronic inflammatory diseases
  • CTM201 is the first long-acting PEG-IL2v without compromising its bioactivity
  • Examining the PK/PD and safety profiles of CTM201 in ALS patients

11:30 am Exploring CUE-401: A Novel TGF-β/ IL-2 Fusion Protein for the Induction & Expansion of FOXP3+ Regulatory T-Cells

Synopsis

  • TGF-β and IL-2 are two key signals for the induction of regulatory T-cell populations
  • CUE-401 is a novel TGF-β and IL-2 directed therapy that is being developed for the selective expansion of regulatory T-cells in vivo
  • Exploring the activity and mechanism of action of CUE-401

12:00 pm Lunch Break & Networking

Refining the Manufacturing Process for Successful Treg Cell Therapy Scalability

1:00 pm Elevating the Manufacturing Process to Identify & Produce Safe Cell Therapy Doses

Synopsis

Outlining methods and approaches for the development of a closed and automated manufacturing process for Tr1-based cell therapies

Detailing the operational and regulatory requirements for utilizing donor cell pooling as a technique to improve therapeutic outcomes

Improving the security and robustness of the manufacturing process to consistently produce the appropriate dose

1:30 pm Generating Potent, Stable & Off-the-Shelf Synthetic Tregs from CD4+ Tconv for the Treatment of Colitis & Beyond

Synopsis

  • Outlining the process of converting CD4 cells to synthetic Tregs (synTregs) via gene engineering
  • Highlighting the benefits of synTregs compared to tTregs as cellular therapy
  • Showcasing preclinical efficacy data from GvHD and colitis mouse models

2:00 pm Optimizing Treg Cell Expansion to Produce High-Quality Tregs

Synopsis

  • Exploring methods of Treg expansion to improve scalability
  • Identifying the ideal amount of Treg expansion to produce quality treatments
  • Assessing approaches to prevent differentiation during Treg expansion

Designing Enhanced Immunomodulators to Improve Therapeutic Outcomes

1:00 pm Exploring Strategies to Mitigate Immune Dysregulation Mediated by Foxp3 Deficiency

Synopsis

  • Targeting dysregulated signaling pathways in Foxp3-deficient Tregs
  • Metabolic reprogramming to harness fatal autoimmunity
  • Examining the role of IL2 signaling and Foxp1 in maintaining Foxp3-deficient Treg identity

1:30 pm The Poly-Pharmacology of S-4321, a Dual Cell -Bi- Directional PD-1 Agonist for the Treatment of Autoimmune & Inflammatory Diseases

Synopsis

  • Discussing the tole of inhibitory receptor in the maintenance of immune tolerance
  • Highlight ongoing research initiatives on dual cell bidirectional PD-1 agonist
  • Explore the intersection of Treg biology and PD-1 agonism

2:00 pm Clinical Evidence of Immune Tolerance Induction: Examples from Celiac Disease & Multiple Sclerosis

Synopsis

  • Exploring antigen targeting to effectively modulate a range of autoimmune diseases
  • Translating preclinical biology to clinical evidence: the role of regulatory T-cells in establishing immune tolerance
  • Unveiling clinical evidence of regulatory T-cell activity (including bystander/linked suppression)

2:30 pm Afternoon Break & Networking

Identifying the Appropriate Target Population & Selecting the Correct Disease Indications

3:00 pm Discussing Considerations when Determining Disease Indication

  • Paul Peloso Chief Medical Officer, COUR Pharmaceuticals

Synopsis

  • Exploring disease analysis methods to identify indications in which Tregs can be effectively utilized
  • Effectively unravelling complex mechanisms of action to find an appropriate disease indication
  • Identifying the ideal disease to be tackled by Treg cell therapies and Treg modulators

3:30 pm Determining the Right Patient Population to Improve Clinical Outcomes

Synopsis

  • Discussing methods to sufficiently analyze patient characteristics to identify populations that will benefit TRACT kidney transplant treatments
  • Identifying the right patient population when designing a clinical trial
  • Providing an update on kidney transplant phase II

4:00 pm Chair’s Closing Remarks

  • FABIEN DEPIS BIOTECH FOUNDER | INDEPENDENT TREG EXPERT & CONSULTANT, Independent Consultant

4:15 pm End of Treg-Directed Therapies Summit