7:50 am Registration & Morning Coffee
Paving the Path to Success With Next Generation Innovations
8:50 am Chair’s Opening Remarks
9:00 am Evolution of Anti-Rejection Strategies for Allogeneic Cell Therapy
9:30 am Next Generation Cancer Immunotherapy: CAR-CIK Manufacturing Process
Synopsis
- Made from allogeneic healthy donor cells
- No leukapheresis required
- No cell purification steps
- Non-viral gene transfer method
10:00 am Showcasing Safety & Clinical Activity of Next Generation Allogeneic Product to Overcome Patient Relapse
10:30 am Presentation by BioSharing Network
10:40 am Morning Refreshment Break & Tech Slam
Synopsis
Quickfire 10-minute presentations on innovative technologies in the space.
Pre-Clinical
Supercharging Solid Tumor Targeting for Broader Success
11:30 am Developing CAR-NK Therapies for Solid Tumors
Synopsis
- We are developing a “combination” CAR-NK therapy (integrating IL15 with anti-CD147 CAR-NK) that has shown a great promise in treating solid tumors in pre-clinical studies
- We have also developed a NK / CAR-NK cell expansion technology platform with great expansion efficiency and fidelity
12:30 pm Unlocking the Potential of Gamma Delta TCRs as a Safe and Effective Target Mechanism
Synopsis
- Using Gamma-Delta TCRs as a mechanism for allogeneic therapies to move into solid tumors
- Showcasing platform for discovery of true targets for solid tumors whilst developing T cell receptors for robust and specific T cell response against new targets
Translational
Conquering the Tumor Microenvironment to Drive Efficacy of Response
11:30 am Unlocking the Groundbreaking Potential of iNKT Cells for Allogeneic Cancer Therapy
Synopsis
- Arovella is developing its novel iNKT cell therapy platform to develop allogenic cell therapies to treat cancer.
- Arovella is initially targeting haematological malignancies with its lead product ALA-101. Through a strategic collaboration with Imugene, Arovella will use ALA-101 to target solid tumours.
- Arovella is also developing its DKK1- CARiNKT cells to target multiple myeloma and solid tumours
12:30 pm Full Landscape Overview of the Allogeneic Cell Therapy Space
Synopsis
- Assessing how allogeneic cell therapies align with the rest of the cell therapy landscape
- What does the existing allogeneic landscape consist of and how has it changed over recent years?
- Insights into potential trends and the potential future of allogeneic therapies for oncology
Manufacturing
Driving Automated Manufacturing Processes for Successful Commercialisation of Allogenic Therapies
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, single-use, 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.
12:30 pm Roundtable: Leveraging Automation to Minimizing Time & Cost of Batch Release
Synopsis
- Using robotics for process measurement, monitoring efficiency and quality of manufacturing processes
- Implementing automated filling devices for filling of product containers, inspection, labelling and getting products ready to be frozen.
- Integrating fast release methods with automatable technologies such as PCR and flow for sustainable execution and data processing
- Discussing gold standards in batch release for off-the-shelf therapies, and reducing lot-to-lot variability
Supply/Storage
Enhancing Cold-Chain Shipping & Storage to Deliver Truly Off-the-Shelf Products
11:30 am Innovating Sophisticated Digital Tools to Establish a Data Management/ Integration System Equipped to Handle Complex Allogeneic Products
Synopsis
- As next generation allogeneic products become more complex, how can we develop tools to manage more data and processing volumes?
- Digitalising the supply chain for greater control and tracking of raw material source, supply and quality
12:30 pm Knowledge Management with Flexible Platform Processes
Synopsis
- The complexity and diversity of Cell Therapy processes make them difficult to standardize.
- Utilizing a standard taxonomy with a phase-appropriate control strategy leverages previous knowledge and allows rapid implementation of new processes
1:00 pm Lunch Refreshment Break & Networking
Pre-Clinical
Pioneering the Next Innovations in Gene Engineering for Enhanced Efficacy of Response
2:00 pm SEAKERs: Targeted Cellular Micropharmacies that Generate Small- Molecule Drugs in situ
Synopsis
- SEAKER (Synthetic Enzyme Armed KillER) cells are CAR-T cells engineered to activate small-molecule prodrugs locally at tumor sites
- SEAKER platform is modular and can incorporate different engineered cells, antigen targets, and enzyme–prodrug combinations in vitro and in vivo proof-of- concept has been established for the SEAKER approach using two different enzyme–prodrug combinations
2:30 pm Roundtable: Developing an Advanced Engineering Strategy to Develop Novel Constructs with Increased Cell Persistence & Expansion
Synopsis
- Delving into the importance of cell performance and expansion to achieve success in the solid tumor setting
- Introducing cytokine support to enhance downstream signalling
- Discussing the balance between long lasting persistence versus the efficacy of the transient allogeneic product
Translational
Unveiling the Tools and Strategies to Maximize Efficiency in IND Filing
2:00 pm Discussing Early Phase Considerations in Preparation for IND Meetings
Synopsis
- Exploring what the ideal IND packages looks like in terms of necessary data etc
- How to prepare for and run a pre-IND meeting for complex allogeneic products
- Dissecting the ‘moving parts’ of an IND, such as manufacturing, viral vectors, cell sources, to line up timelines for parallel development
- Gaining and implementing feedback on trial design
2:30 pm Applying a Phase Appropriate Approach to the Development of Cell Therapeutics Processes and Analytical Methods
Synopsis
- Review how Phase Appropriate GMP applies to Cell Therapy Product Development
- Explore product development
- Explore Analytical Method Development
Manufacturing
Reviewing the Paradigm of Characterization & Strategical Viability Testing
2:00 pm Standards and Strategies for Establishing Fit-For-Purpose Analytical Methods for Cell Therapy Product Characterization
Synopsis
- Update on standards available/under development for cell characterization
- Public-Private partnerships for cell and gene therapy analytical method development
- Description of an approach to establish fit-for-purpose cell viability methods that are relevant to a cell manufacturing process
2:30 pm Characterizing Raw Starting Materials & Product for Quality, Safety & Efficacy
Supply/Storage
Revolutionizing Data Management & Process Integration
2:00 pm Cell Therapy Lab / Cell Pharmacy : The Resources Needed for the Onboarding of Cell Therapy Products
Synopsis
- The field currently
- Staff, Space, and the Challenge of New Products
- Standardization – Where do we begin?
2:30 pm Advancing Phase Appropriate Modifications Required for Allogeneic Products
Synopsis
- Maintaining reproducibility and consistency of cell products through end-to- end development
- Enabling bulk expansion and storage of allogeneic therapy, considering the conditions needed to keep cells viable
- Discussing the impact of different SOPs on the cold supply chain
3:00 pm Afternoon Refreshment Break & Networking
Ushering in the Next Wave of Universal Cell Therapy – Future Directions
3:30 pm B Cells as a Novel Off-The-Shelf Cell Therapy
Synopsis
- CRISPR/Cas gene editing results in high efficiency B cell engineering
- B cells can be differentiated into long lived plasma cells
- Plasma cells have naturally allogeneic properties that make them ideal for cell therapy
4:00 pm Development of iPSC-Derived Gamma Delta T Cell Therapies for Treatment of Liquid & Solid Tumors
Synopsis
- Harnessing the power of induced pluripotent stem cells (iPSCs) to develop novel allogeneic CAR-T cell therapies for cancer
- Multiplex engineering of iPSCs to develop allogeneic Gamma Delta T cells that can safely and effectively mediate anti-tumor immunity
- CAR design strategies that address disease-specific challenges
4:30 pm Developing Next-Generation Allogeneic Therapies for Solid Tumors Based on Gamma Delta T cells
Synopsis
- Discussing characteristics of gamma delta T cells as source for an allogeneic cell therapy approach
- Redirecting gamma delta T cells with TCRs against peptide-HLA targets to combat solid tumors
- Exploring next-gen strategies to potentiate anti-tumor activity