7:45 am Registration & Morning Coffee
Driving Clinical Validation to Secure the Future of Allogeneic Products in the Cell Therapy Space
8:45 am Chair’s Opening Remarks
9:00 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
10:00 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
10:30 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
11:00 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 four different tracks: Pre-clinical, Translation, Manufacturing and Supply/Storage
Pre-Clinical
Novel Gene Engineering Strategies for Greater Safety & Efficacy of Response
12:00 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
12:30 pm Program Partner Presentation
1:00 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
Translational
Advancing Donor-Derived Approaches with Enhanced Screening & Selection
12:00 pm ADAPT-NK – an Off-the-Shelf Allogeneic NK Cell Therapy Using Select Superdonors
Synopsis
- Using cryopreserved donor material from pre-selected ‘superdonors’ we developed a novel GMP-compliant 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
12:30 pm Program Partner Presentation By Be The Match BioTherapies
1:00 pm 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
Manufacturing
Improving Scalability to Bring the True Promise of Allogeneic Products to Life
12:00 pm Development & Production Strategies to Enable Migration from Autologous CAR-T to Allogeneic Gamma/ Delta-T Cells
Synopsis
- Advantages of the gamma/delta-T cell chassis over CAR-T alpha/beta T-cells
- Native and CAR gamma/delta-T cell killing efficacy in multiple disease applications.
- Discussing the challenges of high-scale, high-quality gamma/delta-T cell production
12:30 pm Program Partner Presentation By Cardinal Health
1:00 pm Driving Scale Up from Academic Labs to Industry Settings for Successful Product Development
Synopsis
- Discussing industrialization of academic protocols/procedures
- Building scale down/scale up models of processes to run meaningful experiments that provide indications of how to run processes at larger scales
Supply/Storage
Optimizing Cryopreservation to Revolutionize the Cold Supply Chain
12:00 pm Optimizing Cryopreservation of Allogenic Cell Products
Synopsis
- Outlining the fundamentals of cryobiology
- Developing new cryopreservation protocols for T-Cell based products for faster shipping and storage whilst preserving cell quality
- Exploring how to package and protect cells from cellular damage of cryoprotectants/room temperature changes
12:30 pm Ensuring Starting Material Availability & Consistency for Success in Development & Commercial Manufacturing of Allogeneic Cell Therapies
1:00 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
1:30 pm Lunch Refreshment Break
Pre-Clinical
Advancing Safety of Gene-Edited Products to Pave the Path to Success
2:30 pm Utilizing Gene Editing Technology to Minimize On-target, 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
3:00 pm Program Partner Presentation
3:30 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
Translational
Overcoming Allogeneic Graft Rejection for Greater Patient Outcomes
2:30 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.
3:00 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, NGS-based 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.
3:30 pm Panel Discussion: Evading Identification by the Host Immune System to Prevent Immunological Rejection
Synopsis
- Exploring and comparing the different gene edits designed to overcome the major pathways of host versus graft rejection
- Discussing the regulatory issues and hurdles that appear when trying to make multiple modifications to overcome graft rejection
Manufacturing
Enhancing Efficiency of Delivery with Non-Viral Manufacturing
2:30 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
3:00 pm Program Partner Presentation
3:30 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
2:30 pm Roundtable: How to Secure a Steady Donor Supply for an 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 an early supply chain comprised of multiple donor banks for generating a specific allogeneic product
- Exploring whether donor-derived approaches will need to be restricted to certain disease settings
3:00 pm Program Partner Presentation By Gift of Life Biologics
3:30 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?
4:00 pm Tech Slam & Refreshment Break
Synopsis
Quickfire 10-minute presentations on innovative technologies in the space
Pre-Clinical
Utilizing Alternative Effector Cells for an Off-the-Shelf Approach
5:00 pm 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.
5:30 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-conjugate gamma delta T cells against solid tumor
Translational
Tackling Graft Versus Host Disease to Reduce Treatment-Related Mortality
5:00 pm Roundtable – Mitigating the Risk of GVHD Using Virus Specific T Cells
Synopsis
- Outline strategies to lower/remove the risk of graft-versus-host disease in patients who undergo allogeneic stem cell transplant
- Editing/removing CD8 alpha beta TCRs, to reduce activity of graft versus host disease
- Discussing potential of using virus specific T Cell as alternative approach
5:30 pm Modulating the Immune System with Novel Engineered Cell Therapies for Cardiovascular Applications
Manufacturing
Developing a Safe & Consistent Allogeneic Product for Commercial Readiness
5:00 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
5:30 pm WU-NK-101: Development of a Feeder Cell-free Memory NK Cell Therapy
Synopsis
- Stepwise development approach to meet clinical demands
- Ensuring product comparability during process optimization and scale up
- Planning for commercial readiness
Supply/Storage
Developing a Robust Supply Chain for Clinical and Commercial Needs
5:00 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