7:00 am Check-in & Coffee
8:15 am Chair’s Opening Remarks
Diving into Challenges & Successes in the Autoimmune Space to Direct Future Outcomes
8:30 am Industry Leader’s Fireside Chat: Exploring Present Advancements & Challenges in the Cell Therapies for Autoimmune Disease Space
Synopsis
An interactive panel discussion from the industry leaders to set the scene on the autoimmune space. Ask your questions live to understand the expert’s thoughts on key topics including:
• How has this rapidly evolving space advanced this year?
• Discussing the latest findings and what this means for the cell therapy for autoimmune field
• What are some new challenges that have come up that we previously haven’t faced?
9:30 am Case Study: Perspectives on Bringing Cell Therapies to the Autoimmune Space: From Concept to Clinic
Synopsis
- Unique considerations for patients with autoimmune disease relative to the historical oncology setting of cell therapy
- Sharing the journey of bringing cell therapy to the autoimmune field from concept through phase 2 trials
- Perspective on opportunities and key open questions to drive impact in this space
10:00 am Morning Break & Speed Networking
Synopsis
As the autoimmune community is reunited, this valuable session will ensure you can reconnect with your peers in the room to make new and lasting connections. Also, don’t forget to enjoy some refreshments before we split off into the two different tracks: Preclinical Development, & Clinical Strategy
Preclinical Development
Track Chair – Marko Radic, Professor, University of Tennessee
Track Chair – Marko Radic, Professor, University of Tennessee
Selecting Effective Preclinical Models for Accurate Recapitulation of Disease
11:00 am A New & Advanced Fully Humanized Mouse Model that Mounts Mature & Neutralizing Antibody Responses & Develop Lupus
Synopsis
• Developing a new and advanced fully humanized THX Lupus mice with a full human immune system
• Discussing the use of estradiol to condition and promote the maturation of immune cells
• Discussing estradiol activity in differentiating immune cell elements and potentiating the immune response
NEW DATA
11:30 am Roundtable Discussion: Key Considerations When Selecting the Most Appropriate Preclinical Models
Synopsis
• Evaluating different models such as acute inflammatory, experimental autoimmune encephalomyelitis (EAE), nod scid gamma mice and more
• What are the priorities in animal model requirements for different cell therapy types?
• What do the most appropriate animal models look like among different indications?
Clinical Strategy
Track Chair – Greg Deener, Chief Executive Officer, iCell Gene Therapeutics
Track Chair – Greg Deener, Chief Executive Officer, iCell Gene Therapeutics
Advancing Understanding of Cell Therapies & Autoimmune Disease to Accelerate Development
11:00 am How Our Knowledge of Neuroinflammatory Pathophysiology Informs Understanding Potential Benefits of Cell Therapies
Synopsis
• Discussing mechanistic insights into neuroinflammatory diseases such as multiple sclerosis
• Evaluating which neuroinflammatory patients are most amenable to which cell therapies based on disease understanding
11:30 am
Panel Discussion: Uniting Industry & Academia to Accelerate Cell Therapy Development for Autoimmune Disease
Moderator – Greg Deener, Chief Executive Officer, iCell Gene Therapeutics
Synopsis
• How can we foster increased partnerships between industry and academic/clinical institutions to strengthen our understanding of current autoimmune indications?
• How do we build on the established experiences where academic clinical trials provided early POC for cell therapy in AID to attract investment and clinical development and commercialization of cell therapies in the autoimmune space?
12.00 Lunch Break & Networking
Novel Approaches to Engineering Cell Therapies for Increased Efficacy in Autoimmune Indications
1:00 pm Engineered Tregs to Designed to Overcome Therapeutic Bottlenecks for Achieving Therapeutic Benefit in Type 1 Diabetes
Synopsis
• Discussing the advantages of GNT-122, including a targeted, stable phenotype with a chemically inducible signaling complex (CISC) to overcome the IL-2 scarce environment in T1D
• Highlighting the importance of Tregs in regulating acute inflammatory responses
1:30 pm Engineered Stem Cell Derived NKT & Gamma Delta T-cell Therapies: Scalable Products with Enhanced Safety for Autoimmune Diseases
Synopsis
• Highlighting strong efficacy and depth of B-cell depletion, comparable to CAR-T cells in preclinical models
• Discussing modifications of NKT and gamma delta T-cells for reduced risk of adverse events such as CRS and ICANS
• Elucidating key market advantages of NKT cells, such as scalable manufacturing and off-the-shelf availability
2:00 pm Next Generation of Dual Antigen IDR-CAR-T cells for Autoimmune Diseases
Synopsis
• Discussing increased potency, sensitivity and complete immune reset of dual antigen targeting IDR-CAR-T cells
• Proof of concept data for SLE and other autoantibodymediated autoimmune indications targeting B and T-cells
• Development of best-in-class next generation of immune cell depleting CAR-T cells and tissue or organ system modulating CAR-Tregs
NEW DATA
1:00 pm Uncovering Translational Biomarkers for Disease Monitoring & Mechanistic Insights of Drugs
Synopsis
• Key translational biomarkers for indications such as LN and MS for enhanced disease monitoring and therapeutic activity
• Leveraging translational biomarkers to provide early insights in clinical trials
• How does the application of cell therapies alter the biomarker approach in these diseases? And where do they overlap to provide historical benchmarking?
Discovering Novel Antigens to Expand Beyond CD19 & into Unmet Indications
1:30 pm Looking Beyond CD19 Antigens for Selective Depletion
Synopsis
• Exploring antigens such as BCMA, BAFF, CD20, and CD90 to improve the targeting of B-cells
• Can we combine targeting of different antigens for more therapy efficacy?
2:00 pm CD19/CD3 Bispecific T-cell Engagers as an Alternative for Safer B-Cell Depletion
Synopsis
• Discussing clinical results of starting dose efficacy in B-cell lymphoma demonstrating B-cell depletion
• Highlighting the application of T-cell engagers to SLE and other autoimmune indications
2:30 Afternoon Break & Poster Session
Understanding Long Term Responses & Relapses by Uncovering Cell Therapy Biology in Autoimmune Disease
3:30 pm Insights into Mechanisms & Prolonged Effects of Cell Therapies in Systemic Lupus Erythematosus
Synopsis
• Diving into our current knowledge of cell therapy mechanisms in autoimmune disease to understand the long-term effects
• Is lasting efficacy desirable when treating autoimmune disease?
• Manipulating metabolism of Tregs to understand their effect in humanized mouse models of Lupus
NEW DATA
4:00 pm Identification of Fully Human HCAbs Targeting CD19 for Cell Therapy using the NonaCarFxTM Platform
Synopsis
- Nona’s proprietary, clinically validated fully human heavy chain-only antibodies (HCAbs)
- Superior efficacy of HCAb-based CAR-T (NonaCARTM)
- Discovery of CD19-specific HCAbs using the NonaCarFxTM platform
4:30 pm Understanding Efficacy & Longevity of CAR-Ts in Autoimmune Disease
Synopsis
• Discussing the process of trogocytosis in CAR-Ts and its effects on T-cell exhaustion
• Using mouse models of lupus for increased understanding of CAR-T mechanisms
NEW DATA
5:00 pm Closing Remarks
5:10 pm Close of Conference Day One
