Conference Day Two

7:45 am Check-in & Coffee

Accelerating the Road to Commercialization Through Clarity & Synchronization of Efforts

8:30 am Panel Discussion: Evaluating Safety & CMC Expectations between Different Cell Therapy Types & Autoimmune Indications

Synopsis

• Discussing the advantages and disadvantages of different cell therapy modalities when meeting CMC expectations

• Understanding safety parameters that need to be demonstrated and how those may differ in various autoimmune indications

• What are some of the standards that are set or need to be set for cell therapies to advance in the autoimmune space?

• What are some of the regulatory requirements that are unique in the autoimmune space as opposed to oncology which may be challenging?

9:00 am A Comprehensive Analysis of the Cell Therapy Landscape

Synopsis

• Reviewing the current landscape of cell therapies for autoimmune diseases

• Analysis of both the preclinical and clinical stage cell therapies in development

• A review of recent deals and emerging companies in the space

9:30 am Morning Refreshment Break & Networking

Preclinical Development

Unveiling Latest Preclinical Data on Novel Upcoming Cell Therapies for Autoimmune Disease

10:30 am Scientific Rationale for g-NK Cell Therapy in Autoimmune Disease

Synopsis

• G-NK cells are a naturally occurring subset of NK cells that are permanently epigenetically modified through priming in response to CMV

• g-NK cells have multiple MOA beyond B-cell depletion: the potential to treat much larger spectrum of autoimmune diseases including multiple sclerosis where T-cells play a larger role

• Clinical development plan includes mechanism driven biomarker program for biological POC in MS

NEW DATA

11:00 am Engineering Antigen Specific TCR Based Approaches for Precision B-cell Depletion

  • Maximilian Konig Director Cellular Therapy Program Autoimmunity, John Hopkins University School of Medicine

Synopsis

• Utilizing unique antigens for selective B-cell depletion as opposed to pan approaches.

• Preliminary research on selective T-cell depletion avoiding fratricide.

NEW DATA

Clinical Strategy

Clinical Showcase: Highlighting Efficacy of Cell Therapy Approaches in Autoimmune Disease

10:30 am CD19-directed CAR-T Cell Therapy Manufactured Using a Next-Generation Process, for Severe, Refractory Autoimmune Diseases

Synopsis

• Optimized autologous CAR-T construct

• Translational data for B-cell depletion and immune reset in autoimmune patients

11:00 am Mechanistic Insights of CABA-201 in Autoimmune Disease

  • Samik Basu Chief Scientific Officer, Cabaletta Bio

Synopsis

• Clinical safety and efficacy of CABA-201 across different autoimmune diseases

• Translational data highlighting the mechanism of action of CABA-201

NEW DATA

11:30 Lunch & Networking

1:00 pm Transforming Treg Biology Into Therapeutics for MS & T1D

Synopsis

• Discussing a platform that enables quick TCR discovery and plug and play manufacturing

• Highlighting autologous Treg therapies for tissue specific auto immune diseases such as progressive MS and T1D

1:30 pm Preliminary Data on Selective T-cell Depletion

Synopsis

• Developing CAR NKs for selective B and T-cell depletion.

• Demonstrating efficacy of this approach in mouse models of Lupus

2:00 pm Synthetic Tregs for Treatment of Colitis

  • Chris Rudulier Associate Director - Autoimmunity, Intellia Therapeutics

Synopsis

• Describe the synthetic Treg (synTreg) platform (Tregs produced from CD4 T-cells)

• Present efficacy data of synTregs in xeno-GvHD, mouse colitis, and humanized colitis models

NEW DATA

1:00 pm Development of CAR-Treg Therapies to Induce Immune Tolerance – Path to the Clinic

Synopsis

• Description of Quell Therapeutic’s platform to generate CAR-Treg products with enhanced safety and efficacy

• Analysis of the current outcomes from the clinical experience with CAR-Tregs in liver transplantation

NEW DATA

1:30 pm Long Term Follow-up of BCMA CD19 cCAR Therapy in Lupus

  • Greg Deener Chief Executive Officer, iCell Gene Therapeutics

Synopsis

• A complete humoral reset delivers long-term, medication-free complete remission

• Will present 2-5 year follow up in 12 lupus patients

NEW DATA

Maximizing Therapeutics Outcomes Through Effective Patient Management

2:00 pm Panel Discussion: Optimizing Patient Treatment Procedure for Best Outcomes

  • Maximilian Konig Director Cellular Therapy Program Autoimmunity, John Hopkins University School of Medicine
  • Jeffrey Jones Chief Medical Officer, Cullinan Therapeutics, Inc.
  • Greg Deener Chief Executive Officer, iCell Gene Therapeutics
  • David Porter Director - Cell Therapy & Transplant, Penn Medicine/ University of Pennsylvania

Synopsis

• Discussing regiments for patients such as ideal dosing, timing of certain procedures, and sample collection methods

• Evaluating the need for conditioning regiments such as lymphodepletion

• How long do patients need to be hospitalized?

2:30 Afternoon Break & Refreshments

  • Maximilian Konig Director Cellular Therapy Program Autoimmunity, John Hopkins University School of Medicine

Exploring the Potential of In Vivo Approaches as a Means to Meet Autoimmune Patient Demand

3:30 pm Using LNP RNA Delivery to Develop In Vivo CARs in Autoimmune Patients

  • Isin Dalkilic Senior Director, Drug Discovery, Orna Therapeutics

Synopsis

• Demonstrating B-cell depletion in humanized CD34 mouse models

• POC efficacy in Lupus patient blood samples

4:00 pm In Vivo Generation of CAR-T & NK cells Using an Engineered Lentiviral Vector

Synopsis

• Specific targeting of CD7 cells in vivo creates CAR-T and NK cells

• CD20 targeted for B-cell malignancies

• CD19 targeted for autoimmune applications

• Clinical entry Q424 for CD20 program

4:30 pm Insights into In Vivo CAR -Ts for Autoimmune Disease

  • Haig Aghajanian Co-Founder, Vice President & Head of Research, Capstan Therapeutics

Synopsis

• Sharing the latest learnings on efficacy of in vivo CAR-Ts

• Discussing the advantages of tLNP based delivery for mRNA encoded CARs

5:00 pm Close of Conference Day Two

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