7:00 am Registration & Coffee Room Networking
Driving Clinical Validation to Secure the Future of Allogeneic Products in the Cell Therapy Space
8:00 am Chair’s Opening Remarks
8:15 am Industry Leader’s Fireside Chat – Exploring the Past, Present & Future of Allogeneic Cell Therapies
Synopsis
An executive panel discussion from the industry leaders of the field to set the scene on the allogeneic cell therapy space. Ask your questions live to understand the expert’s thoughts on key topics including:
- The evolving shift in the cell therapy field from autologous to allogeneic
- Next generation and complex gene editing and the safety implciations/concerns
- Successfully moving into the clinic and the potential future for commercial development of off-the-shelf products
9:00 am Designing Diversified Approaches to Advancing Programs for Addressing Solid Tumors
Synopsis
- Overview of first-in-class learnings for gamma delta CAR-T cells
- Discuss considerations for enhancement and targeting CAR gamma-delta T cells in solid malignancies
- Reprogramming innate signaling capabilities to further engineer potency for gamma-delta T cells in solid tumors.
9:30 am Reframing the Inherent Donor Supply Chain Ecosystem to Support the Imminent Manufacturing Boom
Synopsis
- Is The Industry Ready to Deliver?
- Critical Aspects to Build a Reliable & Scalable Engaged Donor Community
- Why Stringent Donor Selection Criteria Yields Successful Programs
10:00 am Allogeneic Gamma-Delta T Cell Therapies – Advancing Clinical Data in Phase 1 & Navigating the Path to Solid Tumor Applications
Synopsis
- Overview of Gamma-delta T cells and their advantages in the Allogeneic setting
- Update on Allogeneic INB-100 clinical program, evaluating the safety, efficacy and patient response using gamma-delta T cells for Leukemia
- How to move beyond Leukemias and into solid tumors using Allogeneic Gamma-Delta T cell therapies, how to think about safety, durability and response
10:30 am Morning Refreshment Break & Structured Networking
Synopsis
As the allogeneic 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 three different tracks: Pre-clinical & Translation, Manufacturing and Supply/Storage
Pre-Clinical & Translation
Advancing Donor-Derived Approaches & Overcoming Graft Rejection for Greater Patient Outcomes
11:30 am Donor-Derived CAR-T Cell Therapy
Synopsis
- Allo-SCT is a curative treatment option for high-risk leukemias. However, pts who progress after allo-SCT have limited treatment options.
- One potential solution is to use their healthy donors’ T cells to make CAR-Ts. This approach not only enables pts who would otherwise be ineligible for CAR-T cell therapy, but may also provide healthier CAR-T cells for better clinical outcome
- We will share the scientific concepts and preliminary clinical data demonstrating clinical proof of concept of this approach
12:00 pm Critical Considerations Leveraging Successes in Allogeneic HSCT/BMT to Inform Scalable Launches of Emerging Allogeneic Cell Therapies
Synopsis
- Discuss key successes and challenges in the facilitation of the most widely used life saving allogeneic cell therapy, hematopoietic stem cell transplant (HSCT/BMT)
- Buildout of critical, reliable infrastructure for cell harvest and therapy delivery
- Expanding beyond centers of excellence to improve patient access
- Securing a reliable and ongoing source for allogeneic donor cells from a registry of 7M+ volunteer donors
- Building and enforcing standards to ensure equal outcomes
- Building and maintaining IT systems to support growth and expanded use cases
- Outline where key learnings from HSCT/BMT that may be applicable to emerging allogeneic therapies to enhance safety, efficacy, and scalability
12:30 pm Moving the Needle on Graft Rejection with Novel Strategies for T Cell Manipulation
Synopsis
- Exploring cell engineering to manipulate T-cells for elimination of the molecules responsible for rejection
- Discussing how to use gene editing to simultaneously prevent rejection and enhance the function of the allogeneic T cell.
- Incorporating new gene edits designed to avoid recognition by patient/host CD8+ T cells, CD4+ T cells and NK cells.
Manufacturing
Improving Scalability to Bring the True Promise of Allogeneic Products to Life
11:30 am Developing a New Generation of Manufacturing Tools to Meet the Needs of Allogeneic Products
Synopsis
- Our journey towards developing an automated, modular, singleuse, end to end allogeneic manufacturing platform.
- Combining our internal equipment characterization, PAT, process engineering and process science expertise with external partners to realize our vision.
12:00 pm Discussing the Difficulty In Scaling Early Development Process Into A Commercial Stage
Synopsis
- Cell therapy and biological complex process
- Scalability – aseptic process and operational challenges
- Cell therapy development – risk management, process optimization, cost and time control
- Commercial manufacturing and FDA concerns
12:30 pm Roundtable: How to Secure a Steady Donor Supply for a Scalable Allogeneic Product
Synopsis
- Discussing how to make truly off-the-shelf therapies a reality at large scale with a consistent supply of qualified donors
- Establishing multiple donor banks for generating a specific allogeneic product
- Exploring whether donor-derived approaches will need to be restricted to certain disease settings
Supply/Storage
Optimizing Cryopreservation to Revolutionize the Cold Supply Chain
11:30 am Optimizing Cryopreservation of Allogeneic Cell Products
Synopsis
- Outlining the fundamentals of cryobiology
- Considerations for addressing cryopreservation challenges for allogeneic products
- Exploring how to protect cells from cellular damage due to temperature changes
12:00 pm Ensuring Starting Material Availability & Consistency for Success in Development & Commercial Manufacturing of Allogeneic Cell Therapies
Synopsis
• Sourcing cells from a single, geographically broad network of donor collection sites to ensure donor base diversity, starting material flexibility, and supply
• How customization of collection parameters and donor selection criteria at early stage development can mitigate variability in research outcomes
• Discuss increasing challenges in scaling up cell sourcing during progression as donor selection criteria become more specific and more narrow
12:30 pm Enhancing Cryopreservation of NK Cells to Drive Development of Next Generation Products
Synopsis
- Exploring the basic biology and biochemistry of NK cryopreservation
- Overcoming intrinsic limitations of instrumentation equipment and reformulated cryo-solutions
- Discussing metabolic stabilization to improve cell viability
1:00 pm Lunch Refreshment Break
Pre-Clinical & Translation
Novel Platforms & Cell Types for Greater Safety & Efficacy of Response
2:00 pm Cutting Edge Platform Technology for Next Generation Allogeneic Products
Synopsis
- Enhancing cell performance with novel construct design
- Tackling the solid tumor setting for innovative cellular engineering
- Utilising new vectors and constructs for development of next generation products
- Understanding the genetic modifications required to go beyond targeted haematological indications
2:30 pm Next Generations Sequencing Product Suite for Cell Therapy Clinical Development
Synopsis
- HLA typing and pharmacokinetics monitoring are key elements in allogeneic cell therapy manufacturing and development;
- We will present a set of solutions for HLA typing, allogeneic cell product pharmacokinetic monitoring, and microchimerism testing for allogeneic hematopoietic stem cell transplant recipients;
- In particular, we will showcase AlloCell – a universal, NGSbased solution for quantifying and monitoring allogeneic cell therapy product levels in patients; AlloCell can be expected to maintain the same level of sensitivity and specificity across all allogeneic cell therapies and all modalities (T cell, NK cell, macrophage), without need for customization; this ready-to-use solution with end-to-end sample-to-results service allows our partners to rapidly generate PK data for both non-engineered and engineered therapies, with no need to disclose any of the confidential gene editing or genome engineering constructs.
3:00 pm Utilizing Gene Editing Technology to Minimize Ontarget, Off-tumor Toxicity Risk in AML
Synopsis
- Exploring the risks associated with immuno-therapy in AML
- Next-generation hematopoietic cell transplant
- Power of genome editing for precision of the drug and the safety of the patients
Manufacturing
Enhancing Efficiency of Delivery with Non-Viral Manufacturing
2:00 pm A Triple Play Allogeneic Manufacturing Platform
Synopsis
- Will demonstrate the benefit of the Luminary Allogeneic Mfg. Platform_
- PolyClonal Final Product
- Immune Cloaking
- Non-Viral Gene Engineering
2:30 pm Panel Discussion: Driving Non-Viral Delivery into the Spotlight for More Efficient Manufacturing
Synopsis
- Exploring the advantages of non-viral manufacturing over traditional delivery methods
- Discussing RNA and LNP as alternative methods for delivery genetic material to cells for greater cell viability
Supply/Storage
Rethinking Donor Cell Source & Selection for a Smoother Supply Chain
2:00 pm ADAPT-NK – An Off-the-Shelf Allogeneic NK Cell Therapy Using Select Superdonors
Synopsis
- Using cryopreserved donor material from preselected ‘superdonors’ we developed a novel GMPcompliant NK cell expansion protocol – ADAPT-NK
- Superdonors were identified through selection criteria based on NK cell phenotype, as harboring large adaptive NK cell subsets with single self-KIR expression
- Expanded ADAPT-NK cells show strong alloreactivity in a mouse model of AML as well as against primary AML blasts ex vivo
2:30 pm Considerations for Selecting Starting Material Provider for Developers of Allogeneic Cell and Gene Therapies
Synopsis
• Overview of Gift of Life Organization
• Gift of Life Biologics – A Full Service Partner Providing an Innovative Vertically Integrated Offering for Starting Material
• A Collaborative Approach – Supporting Developers from Research to Regulatory Approval and Commercialization
3:00 pm Panel Discussion: Battle of the Cell Source – Choosing the Best Starting Material for Your Product
Synopsis
- Examining the advantages and disadvantages of donor derived VS cordblood versus iPSCs as starting cell source
- How do you determine the cell source you want to begin with?
3:30 pm Tech Slam & Refreshment Break
Synopsis
Quickfire 10-minute presentations on innovative technologies in the space
Pre-Clinical & Translation
Advancing Safety with Innovations in Gene Editing
4:30 pm Panel Discussion: Overcoming Safety Fears to Build Complex Gene-Edited Therapies
Synopsis
- Comparing traditional gene editing strategies to CRISPR Cas9, Base editing etc
- How can we achieve a greater repertoire of gene edits in a safe manner?
- What are the downstream implications for manufacturing if you engage with complex gene editing?
- Exploring how to improve specificity of endo nucleases whilst balancing cargo size
5:00 pm Track Closed
Manufacturing
Utilizing Alternative Effector Cells for an Off-the-Shelf Approach
4:30 pm Applying Click Chemistry Concept to Allogeneic Cell Therapy: Utilizing Antibody-Cell Conjugation Technology against Solid Tumor
Synopsis
- Introducing the advantages of Antibody-Cell Conjugation technology in allogeneic cell therapy
- Providing preclinical evidence of antibody-conjugated gamma delta T cells against solid tumor
5:00 pm Armored HSC-derived CAR-iNKT Cells as a Differentiated Platform for Targeting Solid Tumors
Synopsis
- Discuss the engineering of hematopoietic stem cells to derive highly efficacious CAR- and iTCR expressing iNKT cells
- Establish a robust manufacturing process to provide differentiated allogeneic cell therapies for difficult-to-treat solid tumor indications
- Explore the muti-functional mechanisms of action of CAR-iNKT cells, including modification of immunosuppressive cells of the tumor microenvironment
Supply/Storage
Developing a Robust Supply Chain for Clinical and Commercial Needs
4:30 pm Roundtable: Challenges in Supply Chain of Cell Therapy Drug Product
Synopsis
- Managing the GMP facility and shipping vendors to prevent temperature excursions during storage and transport
- Managing limited Drug Product Supply based on small batch size production
- Global clinical site selection while involving the appropriate functional groups to ensure that all relevant factors are considered throughout the decision-making process
- Preparation of pharmacy manuals, as well as training of pharmacists and clinical dose administrators
- Strategic sourcing of critical GMP ancillary materials. How to mitigate risk, and ensure supply chain robustness