8:00 am Coffee & Registration

8:55 am Chair’s Opening Remarks

CLINICAL TRIAL CASE STUDIES
Hear updates on the most advanced clinical programs to discover how the application of Treg directed therapies are being successfully utilized in the clinic

9:00 am 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

9:30 am Adoptive Therapy with Allogeneic, Cord Blood Regulatory T Cells for Treatment of Inflammatory Bone Marrow Disorders & GVHD

Synopsis

  • What is different about cord blood regulatory T cells?
  • Phase I/ II data of using allogeneic cord blood regulatory T cells for the prevention of GVHD
  • Phase I data of using allogeneic cord blood regulatory T cells for the treatment of inflammatory bone marrow disorders

10:00 am Regulation of Treg Expansion by the IL-2 Mutein, PT101

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

Synopsis

  • Discussing the importance of Treg selectivity
  • Exploring dosing strategies
  • Translation of model systems to human studies

10:30 am Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the brightest minds working to advance Treg therapies. Benchmark against the industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond.

11:00 am Morning Refreshments

11:30 am The Challenges of Manufacturing & Distributing Advanced Therapies: From Small Scale to Licensing Studies

Synopsis

  • Translating early research into first in man clinical trials
  • Challenges of manufacturing Treg therapies utilizing closed system flow sorting
  • Consider the next steps for scale up to pivotal studies and market authorization
  • Logistics of delivering ATMPs on a global scale

12:00 pm 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

12:30 pm Treg Cell Therapy in Hematopoietic Stem Cell Transplantation

  • Everett Meyer Assistant Professor, Stanford University School of Medicine

Synopsis

  • Review ongoing clinical trial with Treg graft engineering to prevent graft versus host disease and promote healthy immune reconstitution
  • Review the use of Tregs to promote hematopoietic stem cell engraftment
  • Present preclinical data in the use of genetically modified Treg in hematopoietic stem cell transplantation

1:00 pm Lunch & Networking

2:00 pm Engineered T Regulatory Cell Products to Treat Neurodegenerative Diseases

Synopsis

  • AZTherapies is developing off-the-shelf CAR-T regulatory cell therapies (CAR-Treg) to treat high profile neurodegenerative diseases (NDD) including Alzheimer’s and Parkinson’s as well as rare diseases such as Amyotrophic lateral sclerosis (ALS).
  • Inflammation is now recognized as the common thread running through all NDD, that results in neuronal death and disease
  • Our CAR-Treg platform targets brain glial cells to shut down inflammation and prevent neuronal death
  • Our platform technology will result in off-the-shelf products, without the need for genome editing, for use in any NDD patient
  • We will present the pre-clinical validation of our first CAR-Treg product to treat NDD

2:30 pm TX200: CAR-Treg Cell Therapy for Renal Transplantation

  • Céline Dumont Senior Director, Pharmacology, Preclinical & Safety, Sangamo Therapeutics

Synopsis

  • TX200 is an autologous HLA-A2 specific CAR-Treg cell therapy in development for the prevention of immune-mediated rejection in HLA-A2-mistmatched renal transplantation
  • Preclinical work is promising and shows specificity and selectivity of CAR-Tregs to their target as well as suppressive activity in GvHD and skin transplantation models The STEADFAST study is a multicenter, open-label, single ascending dose, doseranging Phase 1/2 study. Sangamo plans to run this study in Europe, with first site openings planned in 2020

3:00 pm Antigen Specific Treg Cell Therapy Using TCRs, CARs & BAR’s to Treat Autoinflammatory & Allergic Diseases

Synopsis

  • Preclinical proof of concept in Autoinflammatory and Allergic Disease models
  • Research scale Treg cell therapy manufacturing
  • Treg cell therapy candidate selection and translational studies to select clinical indications and IND enabling toxicology and GMP manufacturing

3:30 pm Afternoon Refreshments & Poster Session

Synopsis

The learning and networking continue at the Poster Session, an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new, beneficial relationships. You will have the opportunity to present and review presentations displaying new data from Treg directed therapy development.

4:30 pm Panel Discussion: Exploring the Various Treg Directed Approaches

Synopsis

  • Highlighting the impoartance of furthering the understanding of Treg cell biology including exploring the relevant mechanisms of action
  • Addressing how to improve and expand Treg cell manufacturing and engineering
  • How can clincal outcomes regulatory T cell therapies be improved?

5:30 pm Chair’s Closing Remarks