8:00 am Morning Coffee
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
9:00 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
9:30 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
10:00 am Session Reserved for ScaleReady
10:30 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
12:30 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
Clinical Manufacturing & Development
Maximizing NK Expansion for a Robust & Effective Scale-Up of an Allogeneic Product
11:30 am 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
12:00 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
12:30 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
1:00 Lunch Break & Networking
Lengthening NK Cell Persistence for Prolonged Therapeutic Benefit
2:00 pm Developing Allogeneic Evasion to Reduce Host Attack
Synopsis
- Analyze the underlying causes of immune rejection in allogeneic NK cell therapies and their impact on treatment efficacy
- Explore engineering NK cells with host evasion mechanisms to avoid recognition and rejection
- Evaluate approaches to make cell surfaces “slippery” for enhanced NK persistence
2:30 pm Engineering NKs in Combination with Antibodies for Longer Lifespans & Prolonged Effect
Synopsis
- Discussing NK combination therapy for multiple myeloma
- Diving into NK therapy mechanisms in combination with monoclonal antibodies
Improving our Understanding of Clinical NK Performance for Best Patient Outcomes
2:00 pm Optimizing Patient Selection Through Advanced Stratification Algorithms to Ensure Clinical Benefit of NK Therapy
Synopsis
- Discover which biomarkers are most indicative of NK therapy efficacy and patient response
- Understand how to link specific biomarkers with clinical outcomes to better predict treatment success and patient prognosis
2:30 pm 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?
3:00 pm Afternoon Break & Networking
Exploring the Applications of NK Biology to Tackle Infectious Diseases
3:30 pm Leveraging an IL-15 Superagonist to Activate NK Cells Against HIV Infected T-Cells
Synopsis
- Sharing insights into mechanisms of NK cell activation to target HIV infected T-cells
- Discussing the “kick and kill” strategy when deploying a super agonist to activate dormant HIV infected cells to target them for elimination
4:00 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