Conference Day Two
Wednesday March 5, 2025
7:45 am Morning Coffee
8:25 am Chair’s Opening Remarks
Accelerating NK Therapy Development Through Clarity of Standards & Regulatory Expectations
8:30 am Panel Discussion: Defining NK Manufacturing Standards for Consistent Product Quality & Synchronized Efforts
Synopsis
- Examine key regulatory requirements and compliance issues for NK cell manufacturing, ensuring adherence to industry standards
- Explore strategies to synchronize manufacturing processes to maintain consistent product quality and performance
- Discuss key performance indicators and benchmarks for evaluating NK cell manufacturing quality and process improvements
9:30 am Case Study: Key Considerations for Developing a Combination Product
Synopsis
- Discussing the development of g-NK cell therapy with antibody combinations for NHL and AML
- Understanding how to navigate regulations and patient treatment procedures with multiple treatment regiments
- Highlighting positive clinical data reinforcing the rationale behind a combination approach
10:00 am Discussing Approaches when Developing an NK Product Potency Assay to Ensure Compliance
Synopsis
- Explore how potency is defined for NK cell therapies, including the critical factors that influence their therapeutic effectiveness
- Discuss best practices for designing robust and reproducible potency assays, including selection of appropriate biological endpoints and assay methodologies
- Identify and discuss common challenges in developing NK product potency assays, including troubleshooting and optimizing assay performance
10:30 am Half a Trillion Cells, One Simple Solution: Scalable Cell Therapy Manufacturing – Without the Automation Trap
Synopsis
- More Cells, Less Chaos – How to manufacture 500 billion NK cells in 20 days without unnecessary complexity
- Lean, Scalable, Affordable – The secret to high-throughput cell therapy production with a small footprint and low cost
- Invest in Simplicity – Why streamlined manufacturing isn’t just better for patients—it’s the key to profitability and faster IND approvals
- Break the Cost Barrier – How a G-Rex-powered approach eliminates inefficiencies, slashes costs, and unlocks commercial success
11:00 am Morning Break & Networking
Preclinical Development
Ensuring Proper Localization of NK Cells for On- Target Efficacy
11:30 am Leveraging Image-Guided Delivery of NKs to Tumor Targets
Synopsis
- Learn about cutting-edge approaches to circumvent NK localization hurdles by directly delivering them to tumor sites
- Delve into radiological approaches to deliver NK therapies to the appropriate site
12:00 pm Developing CAR-NKs for Increased Accuracy of Targeting
Synopsis
- Discuss strategies for designing effective CAR constructs, including the selection of target antigens, costimulatory domains, and optimizing CAR expression in NK cells
- Identify common challenges in developing CAR-NK therapies, such as CAR construct stability, NK cell expansion, and persistence
Clinical Manufacturing & Development
Maximizing NK Expansion for a Robust & Effective Scale-Up of an Allogeneic Product
11:30 am Panel Discussion: Evaluating Clinical Potential of Different NK Subtypes
Synopsis
- Discuss how different NK subtypes perform against various cancer types and disease models
- How do different NK phenotypes influence therapeutic outcomes?
- Is it best to have a homogenous or heterogenous NK product?
12:00 pm Streamlining Access to CAR NK Clinical Manufacturing
Synopsis
- Key capabilities and infrastructure necessary to support clinical manufacturing of allogeneic CAR NK cell therapies
- The importance of a flexible manufacturing partner to support early phase cell therapy trials
- Pathways to reduce manufacturing cost to enable commercial supply for broader patient access
12:10 pm Improving the Metabolic Fitness of NK Cells via the Manufacturing Process
Synopsis
- Leveraging a feeder cell-based process to maximize potency and antitumor efficacy of expanded donor-derived NK cells
- Understanding key aspects of the process that contribute to enhanced metabolic fitness of cells
12:40pm Lunch Break & Networking
1:30 pm Chimeric ILT-Receptor (CIR™) Technology Effectively Targets HLA-G+ Hematologic & Solid Tumors for Fit-for- Purpose Activation of NK Cells
Synopsis
- Diving on how CIR™NK cells with fit-for-purpose activation can efficiently and persistently target cancer cells across multiple tumors
- Understanding in vivo performance and functional activity of CIR™NK cells in leukemia and solid tumors
Improving Resistance of NKs to the Tumor Microenvironment to Target Solid Tumors
2:00 pm Discussing Strategies to Target & Overcome the Tumor Microenvironment
Synopsis
- Understanding HLA-G and HLA-E mechanisms employed by tumors to suppress NK cells
- Discussing armoring approaches like receptor modifications and expression of membrane bound cytokines
2:30 pm Revolutionizing Cell Therapy Through Novel CAR Designs to Boost NK & Cellular Therapy Persistence
Synopsis
- Highlighting a completely novel approach to design CAR constructs for enhanced persistence of cell therapy
- Sharing the efficacy of this platform in solid tumors
1:30 pm Maximizing NK Cell Viability & Cytotoxicity Through Novel Expansion Technology
Synopsis
• Leveraging the apexNK™ platform for high purity affordable NK expansion, without the need for sorting or feeder cells
• Highlighting preliminary efficacy of NK cells expanded this way to target lymphomas and solid tumors
• Successfully creating targeted apexNK™ cells utilizing a non-viral ACC™ chemical conjugation technology, specifically designed for blood NK cells
Improving our Understanding of Clinical NK Performance for Best Patient Outcomes
2:00 pm Developing a Functional Cure for Hep B HIV Infection via NK Cells & its Applications to Hepatocellular Carcinoma
Synopsis
• Harnessing an optimized platform for expansion of adaptive memory like NK cells and demonstrating how this platform can be modified to develop immunosuppressive environment resistant NK cells
• Showcasing preliminary efficacy against virus infected targets and hep G2 cell lines
• Discussing pathways of NK dysregulation in hepatitis B infections
2:30 pm Optimizing Yield & Function of Cytokine-Induced Memory Like (CIML) NK Cells
Synopsis
- Application of feeder cell technology to expand NK cells pre or post CIML programming
- Demonstrating feeder cell-based process leads to >700-fold greater yield of functionally superior CIML NK cells compared to published CIML method