Conference Day One
7:00am | Registration Open & Coffee Networking
8:20 am Chair’s Opening Remarks
8:30 am Industry Leaders Fireside Chat: The Promises & Challenges of “Next-Gen” CAR & TCR Therapies
Synopsis
• What learnings can we take from already approved therapies, in the wave of next-generation development?
• Where does the field need to go? Will next-generation CAR and TCR therapies have success in hard-to-treat cancers (i.e. solid tumours)?
• How will we overcome key challenges that are currently limiting clinical progression (i.e. tumour microenvironment)?
9:30 am Novartis’ Cell & Gene Therapy Journey
Synopsis
- Session details to be announced
10:00am | Morning Break & Speed Networking
Synopsis
As the CAR-TCR community reunites in London, this session will provide valuable networking time with your peers, enabling you to forge new and lasting connections.
Novel
Platforms
Platforms
Leveraging Innovative Technology to Enhance Cell Function & Improve Therapeutic Efficacy
11:00 am Leveraging the Nexus of the Immune System with Gamma-Delta CAR-T Cells
Synopsis
• Updating the industry on IN8bio’s work sharing brand new exciting data
• More details to be revealed soon
11:30 am The Use of PBMC Humanized Mice for Characterizing CAR T Efficacy, Cytokine Release Related Toxicity & Expansion
Synopsis
- Presenting both autologous and allogeneic CAR T data
- Evaluating individual PBMC donors with response to therapy, showing the translational relevance of the model system
- Discussing cytokine response to therapy in low and high tumor burden
12:00 pm New BOXR Genes: Enhancing Immune Cell Function in Solid Tumours
Synopsis
• Leveraging the BOXR platform to generate gene targets that enhance T-cell performance in solid tumour models
• Combining BOXR-discovered GOT2 transgene, a critical enzyme involved in cellular metabolism, with CAR-T technology targeting GPC3-expressing tumours in SOTIO’s first clinical candidate, BOXR1030
• Utilising data from GOT2 and additional BOXR transgenes with additional targets to validate a platform approach to T-cell engineering
12:30 pm Panel Discussion: Considering the Best Ways to Enhance Cell Function
Synopsis
• What next innovation is the most promising to improve cell function?
• Is it armouring, logic gates, adaptor molecules or other?
• Which mechanisms can we implement to reduce treatment-induced toxicities?
Advanced Clinical Developments
Exploring Cell Therapy Products in the Clinic for Hard-to-Treat Indications
11:00 am Revealing Phase 1/2 Data for an Off-the-Shelf CAR-T Therapy Treating T-ALL/LBL
Synopsis
- Sharing developments in Wugen’s WU-CART-007 programme, an allogeneic, fractricide resistant CAR-T cell for the treatment of CD7 hematological malignancies
- Sharing promising clinical data from dose escalation studies, with no GvHD and only minor CRS seen
- Discussing future plans
11:30 am Regulatory Strategy for Approaching Decentralised Clinical Trial & Decentralised Clinical Material Manufacturing
Synopsis
- Reviewing the benefits and challenges of decentralised CAR-T production for a decentralised clinical trial
- Exploring compliance with GMP and GMO requirements in decentralised production
- Reaching the patient faster with decentralised production and centralised batch release
12:00 pm Developing Allogeneic CAR-T Therapy for Relapsed or Refractory T-Cell Malignancies
Synopsis
• Developing donor-derived CD7-targeting allogeneic CAR-T cells to treat CD7+ malignancies
• Implementing genetic modifications to generate high potency cells that resist fratricide, GvHD and allogeneic rejection
• Demonstrating encouraging safety and efficacy profiles in phase I clinical trial
12:30 pm Panel Discussion: Leveraging Clinical Results to Drive Investment in Your Product
Synopsis
• What are the biggest challenges that the development of next-generation cell therapies face?
• How do we overcome these challenges?
• What clinical outcomes are the most important to drive investment?
Streamlined Manufacturing Processes
Reducing Production Timelines to Improve Speed to Patient
11:00 am Reducing Production Timelines in a Commercial Cell Therapy Manufacturing Facility
Synopsis
• Reducing manufacturing timelines to increase speed to patient
• Establishing new capabilities to improve manufacturing efficiency
11:30 am GMP-Compliant Manufacturing of TRUCKs: CAR T Cells Targeting GD2 and Releasing Inducible IL-18
Synopsis
- Developing next-generation CAR-T cells secreting immunomodulatory cytokines upon CAR signalling, known as TRUCKs
- Demonstrating that manufacturing of IL-18 TRUCKs targeting GD2 in a closed and automated system is feasible
- Generating a functional T-cell product of high quality
12:00 pm Roundtable Session: Blue Sky Thinking – Could CAR-TCR Therapies Be Manufactured in One Day?
Synopsis
• How can we reduce the time from blood extraction to modified cell re-infusion?
• What can we do to improve cell quality?
• How can we reduce the cost and time associate with manufacture to allow for greater access?
12:30 pm Panel Discussion: Working with Vendors & Discussing the Rationale Behind the Decision of Build vs Buy
Synopsis
• What do you look for when working with a vendor?
• How do you manage the tech transfer process to a vendor successfully?
• When should building rather than buying be considered?
1:00 pm Lunch Break & Networking
Developing Cellular Therapies with Improved Tumour Targeting with Novel Targets
2:00 pm Adaptor CAR-T Cell Targeting of NKG2D Ligand-Expressing Solid Tumours
Synopsis
• Engineering an adaptor CAR that recognises NKG2D ligands
• Achieving compelling anti-tumour activity across a range of immortalised and patient derived xenograft tumour models
• Superior trafficking of CAR-T cells to tumour deposits can be used to potentiate both efficacy and safety of this approach
2:30 pm Key Considerations When Choosing Recombinant Proteins for Cell & Gene Therapy Applications
Synopsis
- Exploring the role interleukins (ILs) play in the regulation of adaptive cellular response
- Reviewing critical factors when selecting a supplier for your recombinant proteins
- Developing recombinant growth factors and cytokines for cell-based therapies
- Achieving optimal results through a scientifically-driven selection of products
- Explaining why a close partnership with your supplier can accelerate the development process to therapy
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3:00 pm Dark Antigens as a Novel Source of Immunotherapy Antigens
Synopsis
• Introducing the EDAPT pipeline for discovery of novel, Dark Antigens
• Validating high quality, tumour-specific antigens for immunotherapy
• Advancing multiple therapeutic modalities of application with an internal focus on TCR-directed therapies
3:30 pm Identifying Tumour-Specific HLA-Associated Peptides & Generating TCR-Mimetic Antibody-Based CAR-T Cell Therapies
Synopsis
• Outlining a proteogenomic/immunopeptidomic platform for the identification of tumour-specific HLA-associated peptides from patient tumours
• Reviewing immunisation and screening strategies to generate HLA/peptide-binding TCR-mimetic antibodies with high affinities and specificities
• Optimising TCR-mimetic antibody-based CAR design for maximal anti-tumour potency and benchmarking to TCR-based cell therapies
Implementing Innovative Mechanisms to Enhance Potency, Persistence & Durability
2:00 pm Exploring Current Opportunities & Future Horizons for Gamma-Delta T-Cell Platforms & Pipeline
Synopsis
• Reviewing first-in-class development milestones for gamma-delta CAR-T cells
• Discussing areas of further innovation for leveraging, enhancing, and targeting gamma-delta T-cells
• Reprogramming innate signaling capabilities to augment potency for gamma-delta T-cells
2:30 pm Opportunities to Optimize CAR-TCR Clinical Trial Execution
Synopsis
- Improving CAR-TCR protocols to ease operational execution – site and patient centricity approach
- Exploring innovative approaches to specific CAR-TCR clinical trial challenges – standalone screening protocol, study expansion globally and long-term follow up solution
- Understanding solid tumor patient selection and the need for access to comprehensive genomic and immune profiling
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3:00 pm Pioneering Novel T-Cell Reprogramming Technologies Designed to Overcome Barriers to Successful Cell Therapies for Solid Tumours
Synopsis
• Building a multi-modal pre-clinical and clinical pipeline across several indications with high unmet needs for patients with solid tumours
• Addressing the apical barriers of T-cell exhaustion and lack of durable stemness that limit anti-tumour functions and sustained responses
• Revealing in vitro and in vivo data that supports improved durability and reduced T-cell exhaustion
3:30 pm The CALM Trial: Evaluating Safety & Antileukaemic Activity
Synopsis
• Sharing results from a phase 1, dose-escalation trial for a first-in-class allogeneic genome-edited anti-CD19 CAR-T cell therapy
• Demonstrating a manageable safety profiel and evidence of antileukaemic activity in heavily pre-treated patients with relapsed or refractory B-cell ALL
• Overcoming challenges limiting efficacy including potency, persistence and durability
Optimising Cell Quality Throughout the Manufacturing Process
2:00 pm Ensuring Product Quality During Manufacturing & Continued Process Improvements
Synopsis
• Process is the product: process robustness and consistency dictate product quality
• Implementing an effective control strategy is critical to ensuring product quality through different stages of clinical development
• Designing systematic comparability studies based on product Critical Quality Attributes (CQA) facilitates implementation of inevitable early-stage process improvements
2:30 pm Programme Partner Reserved
3:00 pm Developing a New Synthetic Platform for Efficient Ex Vivo CAR-T Cell Generation
Synopsis
• Exploring why a new platform is needed and the challenges this platform will overcome
• Implementing a process to generate more efficient CAR-T cells
• Maintaining product quality while improving manufacturing speed and efficiency
3:30 pm Improving Cell Quality & Enhancing Therapeutic Efficacy with CellPryme-M
Synopsis
• Utilising the CellPryme-M technology to produce superior cells during the cell manufacturing process
• Producing cells that are less prone to exhaustion, enable longer duration of cancer killing activity, and are capable of improved tumour trafficking and penetrance compared to the current generation of CAR-T cells
• Enhancing performance in highly aggressive solid cancer models
4:00 pm Afternoon Break & Tech Slam
Synopsis
Implement Novel Engineering Platforms to Alter the Expression of Multiple Genes
5:00 pm Reviewing Cell Multiplexing with the miCAR Platform
Synopsis
• Leveraging multiplex engineering for the development of efficient, safe, and effective allogeneic cell therapies
• Enabling simultaneous silencing of 6 genes and expression of a CAR/TCR in a single transduction step,
with Antion’s miCAR platform
• Yielding massive efficiencies, safety, and CoGs savings in allogeneic cell therapies
5:30 pm Programme Partner Reserved
6:00 pm Leveraging Multiplex TALEN Gene-Editing for the Next Generation of CAR-T Therapies for Solid Tumours
Synopsis
• Leveraging multiplexed TALEN gene-editing to expand the success of allogeneic CAR-T therapies from
hematological malignancies to solid tumours
• Utilising TALEN® to perform targeted genome modifications to programme optimal immune scenarios into therapeutic cells
• Improving potency without increasing toxicity to maintain patient safety
Enhancing Efficacy in the Clinic with Alternative Immunomodulation Strategies
5:00 pm Combining CAR-T Therapies with an Oncolytic Virus to Improve Therapeutic Response
Synopsis
• Combining CAR-T therapy with the administration of oncolytic virus intravenously
• Potentiating CAR-T cell efficacy against solid tumour models of melanoma and glioma
• Stimulating the native TCR to give rise to enhanced proliferation, CAR-directed anti-tumour function and distinct memory phenotypes which are readily re-activated by virus administration
5:30 pm Programme Partner Reserved
6:00 pm A Landscape Overview of CAR & TCR Therapies
Synopsis
• Reviewing current trends in the CAR & TCR therapy clinical landscape
• Looking to the future: next-generation engineering strategies to enhance cell function and tolerability (armouring, multiplex editing, suicide genes)
• Utilising this database to accelerate the clinical development of your own cell therapy pipeline
Tackling the Bottlenecks When Utilising Viral Vectors
5:00 pm Developing Safe, Selective & Efficient Delivery Vectors for In Vivo Generation of Cell & Gene Therapies
Synopsis
• Overcoming the challenges posed by current vectors which have limited the use of cell and gene therapies to ex vivo manufacturing processes
• Developing a new way of manufacturing therapies in vivo at an affordable cost
• Building a platform which could allow us to use our technology for oncology, autoimmune and infectious diseases
5:30 pm Programme Partner Reserved
6:00 pm Addressing the Bottlenecks of Viral Vectors in CAR-T Cell Therapy Manufacturing
Synopsis
• Reviewing key bottlenecks with the viral vector supply chain
• Resolving the bottlenecks by being self-reliant and manufacturing in-house
• Sharing data from analytical assays for LVV product release
6:30 pm Chair’s Closing Remarks & End of Conference Day One
6:45 pm CAR-TCR Europe Cell-ebrations
Synopsis
Join your peers for drinks, nibbles, entertainment & more!