*All times shown in EST

8:15 am Online Registration & Virtual Coffee

8:45 am Chair’s Opening Remarks

  • Matthew Seavey Executive Director of Special Projects, Pelican Therapeutics (subsidiary of Heat Biologics)

9:00 am Treg-based Therapies to Induce Immune Tolerance in Transplantation & Autoimmunity

Synopsis

  • Lessons learned from Treg-directed therapies in liver transplantation (polyclonal Tregs vs low dose IL-2 therapy)
  • Engineered Tregs for the modulation of antigen-specific responses
  • Quell Therapeutics strategy to enhance Treg therapies

9:30 am Engineered Tregs as a Therapeutic Modality

  • Adel Nada Co-Founder, President, CEO , GentiBio

Synopsis

  • Scalable technology to generate robust phenotype of engineered Tregs is critically needed to address many autoimmune and antiinflammatory disorders
  • TCR and CAR antigen specific Tregs enable optimal efficacy and safety
    of engineered Tregs

10:00 am Virtual Speed Networking & Morning Break

11:00 am Panel Discussion: Exploring Key Questions to Advance Understanding of Treg Behaviour

  • Emilio Flano Executive Director, Head of Immunology Discovery , Merck & Co
  • Tom Wickham CSO , Gentibio
  • Matthew Seavey Executive Director of Special Projects, Pelican Therapeutics (subsidiary of Heat Biologics)
  • Jo Viney Co-Founder, President & CSO , Pandion Therapeutics

Synopsis

  • Highlighting the importance of exploring the relevant mechanisms of action to further understanding of Treg cell biology and behaviour
  • Exploring the importance of the origin of the Treg cells and viability of the starting material
  • What are the different small molecules or antibodies we can use to target T regs for enhanced immune tolerance?

Driving Knowledge of Treg Cell Biology to Supercharge Development of Treg Directed Therapies

11:30 am Antigen Specificity of Tumor Infiltrating Tregs

Synopsis

  • Expansion of Tregs is seen in various human cancers and therapies directed at ablating them show efficacy.
  • Use of scRNAseq with paired TCR seq used to identify Treg TCRs that are enriched in the tumor microenvironment.
  • Multiple approaches were then used to identify the antigen specificity of tumor infiltrating Tregs.

12:00 pm TNFR2 Agonism for Expansion of Stable and Potent Human Tregs

  • Denise Faustman Director of Immunobiology MGH; Associate Professor , Harvard Medical School

12:30 pm Corelates of Biological & Clinical Response to Low-dose Interleukin-2 in Patients with Systemic Lupus Erythematosus: Results from a Phase-II Proof of Concept Trial

Synopsis

  • Outline of LUPIL-2, a Phase II Proof of Concept study evaluating ILT-101 in moderate to severe SLE patients
  • Chronic SC administration of ILT-101 is well tolerated
  • ILT-101 treatment clinically improves moderate to severe SLE patients
  • Clinical improvement correlates with Treg stimulation
  • Early Treg activation predicts clinical outcome

1:00 pm Bringing Next Generation Solutions to the Treg Therapies

Synopsis

  • Standardizing Biologic/Specific Activity measurements for a consistent and robust production
  • Bringing liquid IL-2 and other cGMP cytokines in functionally closed systems for ex vivo applications
  • Prioritizing safety and consistency with virus inactivated human-blood derived products
  • Increasing transparency and regulatory support with eCTD-format Master Files

1:10 pm Lunch & Networking

2:30 pm Hearing insights on a Clinical Program for IL2 Treg Directed Therapy

3:00 pm PT101, an IL-2 Mutein for Selectively Activating & Expanding Treg

  • Jo Viney Co-Founder, President & CSO , Pandion Therapeutics

Synopsis

  • Discovery of PT101, an IL-2 mutein
  • Selective activation and expansion of Tregs
  • Translation of model systems to human studies

3:30 pm A Revolutionary Approach to Resetting the Immune System for Long-Term Disease Remission

Synopsis

• Revolo Biotherapeutics is advancing revolutionary approaches to reset
the immune system and achieve long term disease remission
• ‘1805 is a protein that in a phase 2 clinical trial, showed disease
remission in Rheumatoid Arthritis after a single dose and has
applicability in a wide range of autoimmune diseases
• ‘1104 is a peptide derived from mTB Chaperonin 60.1, with data showing
suppression of allergic response and regulation of a key inflammatory
protein

4:00 pm A Novel TNFRSF25-Agonist for Regulatory T-cell Expansion

  • Matthew Seavey Executive Director of Special Projects, Pelican Therapeutics (subsidiary of Heat Biologics)

Synopsis

• TNFRSF25-engagment by PTX-35 can expand regulatory T-cells in
vivo and reduce disease severity in several animal models of GVHD &
inflammatory disease
• Favorable safety profile in monkeys; target engagement confirms Treg
expansion
• Plans for new indications & modalities – opportunities for partnerships
• Global program status update

4:30 pm Treg Cell Therapy in Hematopoietic Stem Cell Transplantation to Reduce Graft-Versus-Host Disease & Improve Engraftment

  • Everett Meyer Assistant Professor , Stanford University School of Medicine

Synopsis

  • Phase 2 trial results with Treg engineered donor grafts show reduced acute and chronic graft versus host disease (GVHD) incidence compared to standard of care.
  • Treg cells appear to improve donor bone marrow engraftment in preclinical studies which is being tested clinically in a phase 1 trial in the setting combined kidney and hematopoietic stem cell transplantation.
  • Preclinical strategies to improve Treg cell function show promise in GVHD prevention, GVHD treatment and in inducing immune tolerance in combined organ and hematopoietic stem cell transplantation studies.

5:00 pm Chair’s Closing Remarks & Close of Day 1

  • Matthew Seavey Executive Director of Special Projects, Pelican Therapeutics (subsidiary of Heat Biologics)