Conference Day Two
7:30 am Morning Coffee & Light Breakfast
8:25 am Chair’s Opening Remarks
Breaking the Tumour Microenvironment Barrier: Showcasing CAR-TCR Success in Solid Tumours
8:30 am CAR-T Cells in Solid Tumours: Not Just a Dream
Synopsis
- Clinical development of a next generation autologous CAR-T with a co-stimulatory domain and suicide gene for improved efficacy and safety in patients
- Hear results from the Phase II trial in Neuroblastoma with over 60% remission rates with potential to reinvent solid tumour treatment
9:00 am Digital Transformation & Compliance for the Cell Therapy Industry
Synopsis
- How do you maintain operational integrity by minimising risk of errors?
- How can the transfer and changeover to manufacture different products be made faster?
- How can the technology transfer process be shortened for your product development pipeline?
9:30 am Clinical Activity of IMA203 TCR-T Targeting PRAME in Melanoma & Beyond
Synopsis
- Characterising cancer testis antigen PRAME as a target for TCR-based therapies
- Providing a clinical update on IMA203 TCR-T demonstrating a manageable tolerability profile as well as deep and durable responses in heavily pre-treated last-line melanoma patients
- Discussing clinical activity of 2nd generation TCR-T IMA203CD8 in solid cancer patients
10:00 am Revolutionising Cell Therapy: End-to-End Automated Manufacturing of Low-Seed CAR-T Cells
Synopsis
- Insights into the critical factors involved in the rapid technology transfer of an end-to-end manufacturing protocol to a contracted site
- Detailed investigation into the expansion of CAR-T cells on the Quantum Flex Cell Expansion System as part of the strategic collaboration between BioCentriq and Terumo Blood & Cell Technologies
- Presentation of technical results including cell expansion kinetics of CAR-T cells and deep phenotypic characterisation
10:30 am Morning Break & Networking
10:40 am Cell Expansion – Quantum Flex Demo (Terumo BCT booth)
Novel Platforms
Enhancing Novel Target Discovery to Increase Repertoire Across Oncology & Autoimmunity
11:30 am Developing a Robust Tumour-Specific Target Discovery Platform for Next-Generation Immunotherapies
Synopsis
- Utilising a high-throughput platform to screen disease tissues for novel target
- Determining which targets are best suited to CAR or TCR approaches
- Broadening repertoire of specific antigens to increase diversity of indication targeting
12:00 pm Detecting, Selecting & Validating a Novel Solid Tumour-Specific Target
Synopsis
- Determining the characteristics of a good target with high specificity
- Screening solid tumours for surface antigens with differential expression to normal tissue
- Harnessing validation methods to safeguard against off-target toxicities
12:40 pm Increasing the Fitness & Durability of T-Cell Therapies Using the Novel Small Molecule MITO-66 Targeting Mitochondrial Metabolism
Synopsis
- Overview of MPC Therapeutics’ approach to target the mitochondrial pyruvate carrier (MPC) to reprogramme CAR-T cell metabolism
- Pre-clinical data showing that MPC inhibition during manufacturing dramatically improves CAR-T cell efficacy and durability
- Opportunities to integrate MPC inhibition into a clinical manufacturing pipeline
12:40 pm Next-Gen Fully Human Heavy Chain Only Antibody (HCAb)-Based CAR-T Platform
Synopsis
- Introducing the world's first and clinically validated fully transgenic mouse platform for the generation of fully heavy chain-only antibodies (HCAbs).
- Showcasing HCAb as the ideal modality for CAR-based cell therapies, with lower immunogenicity and superior efficacy
- Establishing an innovative direct CAR-function-based HCAb screening platform
Advanced Clinical Development
Safeguarding Patient Access & Safety in the Clinic to Ensure Smooth Progression
11:30 am Round Table: Boosting Patient Access in a ‘Crowded’ Field to Facilitate Trial Recruitment
Synopsis
- Exploring methods to drive down cost-of-goods to improve patient accessibility
- Can we move to earlier lines of treatment to increase target population pool?
- Identifying educational needs and treatment priorities to expand patient engagement
12:00 pm Droplet Digital PCR, a Precise & Accurate Tool for CAR-T QC & Bioanalysis
Synopsis
- Droplet Digital PCR (ddPCR) is the most precise method to determine Vector Copy Numbers and Genome Editing Frequencies for CAR cells
- As well in QC as in bioanalysis, ddPCR allows great precision, accuracy and reproducibility, even in complex matrices. ddPCR's increased tolerance to inhibitors and its excellent sensitivity make it an excellent tool for safety testing, including for undesirable genome edits
- Fully validated kits for safety testing include Replication Competent Virus and Mycoplasma Detection kits
12:30 pm Armouring CAR-T Cells for Off-the-Shelf Therapeutics
Synopsis
- Utilising chRDNA genome-editing technology to engineer more precise genome edits
- Developing armouring strategies that improve antitumour response in allogeneic CAR-T cell therapies
- Reporting safety and efficacy dose escalation data from the ongoing CB-010 ANTLER Phase 1 trial
1:00 pm Track Closed
Streamlined Manufacturing Processes
Boosting Scalability while Maintaining Product Quality to Guarantee Batch-to-Batch Comparability
11:30 am Scalable & Stable Treg Products: From Bench to Bedside
Synopsis
- The path from laboratory to GMP-compliant site to produce clinical-stage Tregs
- Tregs physiology matters during manufacturing – why subset-specific features need to be taken into account in the clinic
- How to scale up? Autologous , allogeneic or both…
12:00 pm AKT Inhibition Generates Potent Polyfunctional Clinical Grade AUTO1 CAR-T Cells, Enhancing Function & Survival
Synopsis
- Incorporation of AKT inhibitor VIII (VIII) in the manufacture of AUTO1, a fast off-rate CD19 chimeric antigen receptor (CAR) with a 41BBz endodomain
- AUTO1 products manufactured with VIII show enhanced expansion, cytotoxicity and polyfunctionality in vitro accompanied by superior anti-tumour activity in vivo
- Manufacture with VIII can be scaled to cGMP on the semi-automated CliniMACS Prodigy platform
12:30 pm From BaseCamp to Summit: Elevating Your Partnership for Cell & Gene Therapies
Synopsis
- How an integrated ecosystem streamlines the path to clinic
- De-risking the development path with technology systems and expertise at every step
- Collaborating with industry leaders to enhance efficiencies and deepen our partnerships through shared innovation
12:40 pm Non-Viral Engineering of TCR-T for Product ScaleOut
Synopsis
- Understanding the extremely broad target space of TCR-T therapies
- Deploying product families to meet target and patient diversity
- Engineering TCR-T with non-viral methods enables agile deployment of product families
1:10 pm Lunch Break & Networking
Leveraging Innovative Platforms to Create Fast, Scalable & Cost-Effective CAR-T Therapies
2:15 pm Hypoxia-Sensing CAR-T Cells for Treating Solid Cancers
Synopsis
- Introducing ‘HypoxiCAR’ a CAR-T platform which responds to hypoxia, a characteristic of most solid cancers, to express CAR molecules selectively in the tumour microenvironment
- We demonstrate the HypoxiCAR platform to be a sensitive and dynamic safety switch
- We demonstrate that hypoxia-sensing CAR-T cells effectively avoid the toxicities associated with on-target off-tumour activation in healthy tissues while delivering anti-tumour efficacy in pre-clinical models
2:45 pm CAR ProTcell, Towards Well-Tolerated & Persistent Off-the-Shelf Allogeneic Immunotherapies
Synopsis
- Solving alloreactivity and persistence hurdles
- AI-backed off-the-shelf products biobanks
- Managing tumour escape with versatile universal Plug&Play technology
3:15 pm Optimising In Vivo Delivery to Enhance Engineering Specificity & Transduction Efficiency
Synopsis
- Ensuring precise targeting to achieve desired therapeutic effect
- Guaranteeing delivery specificity to minimise off-target implications
- Improving efficiency of transduction to increase CAR expression
Expanding Clinical Access by Pursuing Autoimmune & Solid Tumour Applications
2:15 pm Round Table: Boosting Patient Access in a ‘Crowded’ Field to Facilitate Trial Recruitment
Synopsis
- Exploring methods to drive down cost-of-goods to improve patient accessibility
- Can we move to earlier lines of treatment to increase target population pool?
- Discussing the pivot into autoimmune indications to facilitate trial set up and recruitment
- Identifying educational needs and treatment priorities to expand patient engagement
2:45 pm Developing Allogeneic Cell Therapies for B Cell-Driven Autoimmune Diseases
Synopsis
- Treating autoimmunity with CAR T-cell therapies with demonstrated clinical durability and safety with informed endpoints
- Guaranteeing therapy safety to comply with regulations for non-fatal disease
- Educating clinical immunologists about CAR T-cell application to ensure optimal clinical care
3:15 pm ITIL-306; TILs Modified with a Co-Stimulatory Antigen Receptor (CoStAR) Targeting FOLR1
Synopsis
- CoStAR enhances T-cell effector function and proliferation in an IL-2 independent manner
- CoStAR is not prone to on-target, off-tumour toxicity experienced with CARs
- Currently being evaluated in a phase 1a/1b clinical trial evaluating safety and feasibility; TIL-306-201
Innovations in Supply Chain to Improve Vein-to-Vein Efficiency while Expanding Capacity
2:15 pm Accelerate Time to Clinic for Advanced Therapies with a Platform Approach
Synopsis
- Considerations underpinning robust platform design tailored for the unique challenges of cell and gene therapies
- Exploration of key features and integrations to enhance process and production efficiency
- Recommendation for end-to-end offering for plasmid production, viral vector manufacturing, cell therapy processing, and in-process and release analytics
2:45 pm Leveraging the T-Charge Superscript Platform for Transformative Efficacy in Autoimmune Diseases
Synopsis
- YTB323, a rapid-manufactured CD19-CAR-T enhances in vivo CAR-T expansion while preserving T-cell stemness
- YTB323 has demonstrated favourable benefit-risk in lymphoma with potential for reduced vein-to-vein timelines
- Emerging clinical data from YTB323 in severe refractory SLE supports the use of T-charge superscript manufactured CD19-CAR-T in autoimmune diseases
3:15 pm Fireside Chat: Optimising Site & Supply Chain Coordination Throughout Scale Up & Scale Out to Ensure Commercial Readiness
Synopsis
- Analysing differing requirements of European territories to ensure regulatory compliance
- Effectively onboarding and training new sites to streamline trial expansion
- Navigating phase appropriate expansion to facilitate scale out
3:45 pm Afternoon Break & Networking
Harmonising the Global Regulatory Landscape & Streamlining the Road to Commercialisation
4:15 pm Opie Jones Foundation: Remembering the Reason Why
Synopsis
Opie's story
- Opie and his family's experience receiving a CAR-T therapy
- The creation of the Opie Jones Foundation: our objectives, initiatives, and information on how you can get involved
4:45 pm The Current & Evolving Regulations in the EU, Impact to the CAR-T Sector & Global Harmonization
Synopsis
- A brief review of the current definitions and legislative framework in the EU
- Current proposal/draft for future legislation in the EU
- Potential implications for ATMPs
- Impact to global harmonisation
5:15 pm A Landscape Overview of CAR & TCR Therapies
Synopsis
- Reviewing current trends in the CAR & TCR therapy landscape
- Looking to the future: solid tumour progress and novel non-oncology disease indications
- Utilising this database to accelerate development of your own cell therapy pipeline
5:45 pm Chair’s Closing Remarks & Close of Conference
