Explore the Agenda
7:30 am Registration & Networking
8:25 am Chair’s Opening Remarks – “From Promise to Reality: Advancing Cell Therapies Beyond Oncology”
Demonstrating Clinical, Regulatory & Commercial Validation for Next-Generation Allogeneic Cell Therapies
9:00 am Deep B-Cell Depletion: Evolution From Early Proof-of-Concept To Registrational Trials
- How different companies in the field are playing to their strengths in choosing which indications to pursue in Phase III
- Using AlloNK as a case study, why Artiva opted to initiate a Phase III trial in rheumatoid arthritis based on the efficacy and safety data generated to date
- Lessons learned during clinical trials and from FDA interactions
9:30 am Highlighting Commercial Validation of Immune Reset Through Allogeneic Cell Therapy & Expanding Into Autoimmune Disease
- Examining the FDA approval of Orca-T and what this milestone signals for regulatory acceptance of next-generation allogeneic immune reset therapies
- Demonstrating how this transplant-replacement platform significantly reduces toxicity while preserving the curative potential of allogeneic hematopoietic stem cell transplantation
- Showcasing Orca-Q as the next-generation platform being advanced toward autoimmune disease, translating lessons from hematologic malignancies into severe autoimmune indications
10:00 am Morning Refreshments & Speed Networking
Preclinical Development & Translational Track
Spearheading In Vivo Cell Therapy Platforms Toward Clinical Reality
11:00 am In Vivo CD19 CAR-T Cell Engineering with Endless RNA (eRNA) & Pan-T Cell-Targeted Lipid Nanoparticles Drives Deep B-Cell Depletion & Immune Reset with Superior Dose Potency
- Discuss how eRNA achieves up to 240-fold greater CAR expression than mRNA in primary resting human T-cells, translating directly into approximately 2 logs greater depth of B-cell depletion in lymphoid tissues in vivo at matched dose levels
- Explore how Sail’s eRNA-TNP platform achieves greater than 99% B-cell depletion across all lymphoid compartments in two distinct humanized mouse models including lymph nodes where existing biologics fail and drives immune reset of the B-cell compartment, recapitulating the pharmacological signature of curative ex vivo CAR-T therapy
- Evaluate how in non-human primates, we establish for the first time that lymph node depletion is uniquely sensitive to drug potency relative to other lymphoid tissues, defining a potency threshold with direct implications for clinical candidate selection across the in vivo CAR-T field
11:30 am Advancing In Vivo DNA Delivery Platforms to Enable Durable & Controllable Immune Reset
- Evaluating DNA-based delivery approaches against RNA and viral systems to achieve more sustained yet controllable immune cell modification for autoimmune applications
- Exploring strategies to balance transient versus integrating expression to optimize durability while minimizing long-term safety concerns
- Leveraging complex cargo design including multi-target and dual CAR approaches to address immune reset alongside disease-specific drivers such as fibrosis
Clinical Development Track
Interpreting the Latest Clinical Data Across Autoimmune Indications
11:00 am Early-Phase Clinical Evaluation of GNTI-122, an Engineered Regulatory T-Cell Therapy, in Recent- Onset Type 1 Diabetes
- Evaluating early efficacy signals from proof-of-concept trials to guide development decisions
- Optimizing trial design and patient stratification to strengthen clinical proof-of-concept
- Integrating clinical insights with regulatory and operational strategies to accelerate progress
11:30 am Advancing Mesenchymal Stromal Cell Therapies for High Unmet Need Autoimmune Indications
- Demonstrating clinical value in steroid and JAK inhibitor refractory patients to position MSCs as a late-line option
- Showcasing validated potency assays to link cell quality with improved clinical outcomes
- Exploring allogeneic off-the-shelf MSC approaches to deliver broad immunosuppression with strong safety profiles
12:00 pm Lunch
Preclinical Development & Translational Track
Engineering Cell Therapies for Durable & Safe Immune Reset
1:30 pm Advancing Allogeneic CD19 Targeting Strategies to Enable Reliable Immune Reset in Autoimmune Disease
- Presenting preclinical data demonstrating B-cell targeting in SLE
- Exploring allogeneic off-the-shelf approaches to improve scalability
- Outlining strategies to translate preclinical findings into clinical development
2:00 pm Analyzing B-Cell Reset Data Across Multiple Autoimmune Indications
- Examining B-cell reset data across myositis, scleroderma, and limbus to uncover cross-indication insights for clinical application
- Highlighting the use of longitudinal clinical sample data to better understand immune reconstitution dynamics in patients
- Identifying how translational findings can inform clinical decision-making despite limited response data
Clinical Development Track
Comparing Clinical Performance Across Cell Therapy Modalities
1:30 pm Driving Treg Cell Therapy Innovation via T-Cell Targeting, Multi-Editing, and In Vivo Antigen Specific Tregs
- Overview of PolTREG and Immuthera clinical Treg modalities including “totality of T1D” approach
- T-cell targeting with the novel CD6/CTLA4 CAR-Treg
- In vivo antigen specific Tregs – clinically sourced tolerogenic peptides from 12 year sera samples of T1D patients
2:00 pm Highlighting Clinical Trial Results & Future Directions From the MiSLE Study in Lupus
- Presenting key findings from the MiSLE trial, equipping attendees with the latest efficacy and safety insights for MSC therapies in lupus
- Comparing MSC approaches with CAR-T modalities, enabling clearer understanding of relative risks and benefits to guide platform selection
- Outlining lessons learned and next-step strategies following trial readouts, supporting future clinical development and regulatory planning
2:30 pm Afternoon Refreshments & Poster Session
Scaling Manufacturing Capacity & Securing Investment for the Next Phase of Autoimmune Cell Therapy Growth
3:30 pm Exploring Preclinical & Translational Strategies to Advance Autoimmune Cell Therapy Toward Clinical Readiness
- Highlighting how emerging preclinical datasets and early PK insights can be leveraged to inform translational decision-making ahead of clinical readouts
- Addressing key challenges in bridging preclinical findings to human biology to improve confidence in safety and mechanism before entering later-stage trials
- Integrating translational learnings to guide clinical trial design strategy while managing expectations around early-stage data maturity
4:00 pm Audience Discussion: Deal-Making & Acquisition Drivers in the Next Wave of Cell Therapy
- Evaluating which cell therapy modalities and platforms are attracting investment and acquisition interest
- Assessing competitive positioning as multiple programs advance toward pivotal trials and regulatory submissions
- Understanding investor perspectives on autologous versus allogeneic versus in vivo approaches for long-term market viability