Conference Day One
7:30 am Check-In, Coffee & Light Breakfast
New & Novel: Spotlights on Novel Targets Game-Changing Technologies
8:30 am Chair’s Opening Remarks
8:40 am Industry Leaders’ Fireside Chat: The Opportunity for Next-Gen
Synopsis
- Instilling the importance for innovative platforms and technologies to further enhance cell therapy efficacy
- Reviewing clinical advances of next generation programmes across solid tumours and autoimmunity
9:30 am Developing Ultraprecision T-Cell Receptor Bispecific Immunotherapies Using Generative AI
Synopsis
- Leveraging the power of our Generative AI platform and proprietary screening system to deliver optimal TCRs
- Engineering TCRs through generative AI to produce optimal clinical candidates
10:00 am Development of a First in Class CAR T-Cell Investigational Product for the Treatment of r/r AML
Synopsis
- Tackling on-target off-tumour toxicity in AML by targeting a unique, tumour associated antigen not expressed in healthy hematopoietic cells
- Designing a third generation CAR-T encompassing a highly specific scFv
- Developing a CAR-T investigational drug product demonstrating robust pre-clinical data in AML models
10:30 am Morning Refreshments & Speed Networking
Novel Platforms
Next Generation Engineering to Armour Cell Therapies to Boost Potency in Solid Tumours
11:30 am Modifying Gene Expression to Turbocharge Functionality of T-Cells
Synopsis
- Manipulating expression of various genes to augment cell activity
- Lowering gene expression to increase stemness and persistence
- Armouring cells to prevent antigen escape and therapeutic resistance
12:00 pm Unveiling Next-Generation CAR-Based Immunotherapies
Synopsis
- Harnessing optimised virus-free gene editing strategies for CAR T cells
- Refining clinical translation and the impact on their application
- Sharing insights into future directions to accelerate and amplify production to deliver CAR products with curative potential
12:30 pm Panel Discussion: Comparing Viral Vs Non-Viral Engineering Methods
Synopsis
- Reviewing engineering efficiencies of various methods to boost yield
- Assessing respective payloads of each system to identify cargo restrictions
- Exploring novel techniques including nanoparticle-based and electroporation to outline potential
Advanced Clinical Development
Boosting Clinical Efficacies through Trial Design & Strategy
11:30 am Designing a Basket Study to Measure Efficacies in Multiple Indications Simultaneously
Synopsis
- Distinguishing a solid tumour target with high expression across multiple indications
- Harnessing a basket study to mitigate against risk of failure
- Considerations when setting up a basket trial to facilitate approval and set-up
12:00 pm Operational Considerations for CAR-T Clinical Trials in Non-Oncologic Indications
Synopsis
- Holistic approach to leverage institutional experience across therapeutic areas at the site, the sponsor, and CRO
- Site capabilities and patient populations: hub-and-spoke options for patient selection and treatment
- Logistical support for autologous and allogeneic CAR-T designs: operational impact and patient considerations outside of oncology
12:30 pm Panel Discussion: Selecting the Right Indications to Ensure Successful Clinical Outcomes
Synopsis
- Reviewing how target selecting can inform clinical indication strategy
- Discussing potential data that could inform indication selection
- How can we balance proof of concept, commercialisation potential and clinical relevance?
Streamlined Manufacturing Processes
Improving Manufacturing Efficiency to Boost Scale, Drive Down Cost & Increase Accessibility
11:30 am Optimising TCR T-Cell Therapy Manufacturing in Preparation for Late-Stage Clinical Development
Synopsis
- IMA203 & IMA203CD8 are Immatics’ TCR-T product candidate(s) using a PRAME-specific TCR with or without a CD8 co-receptor
- Stepwise process development leading to increased manufacturing robustness and success rates
- Additional improvements have led to a significant reduction of vein-to-vein time
12:00 pm UpTempo (SM) CAR-T Cell Platform: a Flexible, Modular Process to Speed your Path to Patients
Synopsis
- Catalent’s fully closed GMP compliant CAR-T cell platform enables your cell therapy to reach the clinic and patients faster.
- Data-driven guidance to build a seamless, robust, modular workflow for both autologous and allogeneic cell therapies. Minimize risk without compromising on quality.
- With our advanced technologies and expertise in both autologous and allogeneic development and manufacturing, Catalent is your full-service CDMO partner for cell therapy. We offer flexible and transparent customer care
12:30 pm Panel Discussion: Boosting Efficiency of Production to Increase High Quality Product Yield
Synopsis
- Altering expansion conditions to optimise growth rates
- Promoting in vivo expansion to reduce manufacturing complexity
- Ensuring manufacturing processes are scalable to cater for trial progression
1:00 pm XOFLX™ Stable Technology: a Simplified High- Yielding LVV Manufacturing System that Lowers Costs & Improves Process Consistency
Synopsis
- WuXi Advanced Therapies is dedicated to supporting our cell therapy partners throughout their path to clinic and patient care
- Our innovative XOFLX™ (pronounced So-flex) stable technology was developed to meet the industry need for large quantities of high-quality lentiviral vectors (LVV) with demonstrated safety and efficacy
- By reducing or eliminating the requirement for plasmid input materials, our XOFLX™ technology cuts the cost of LVV production and improves process robustness
1:10 pm Lunch Break & Networking
Overcoming the TME to drive Durable Responses in Solid Tumour Indications
2:15 pm Boosting the Potency in Solid Tumours with Next Generation Toolbox-Engineered TCR-T Cells
Synopsis
- Helping TCR-T cells to cope with the hostile tumour microenvironment
- Improving performance of T-cells
- Reducing exhaustion to promote durability
2:45 pm T-Cell Expansion Using Chemically Defined Media & Recombinant Proteins in Dynamic Cultivation Conditions
Synopsis
- Key considerations when selecting raw materials for cell culture media development
- Supplementing cell and tissue culture media in chemically defined settings
- T-cell expansion in static and dynamic culture conditions
3:15 pm TCR-NK: A Novel Paradigm to Drive Durable Responses in Solid Cancers
Synopsis
- TCR based therapies have shown compelling tumour responses across various solid cancers; however, virtually all patients with advanced solid tumours showing initial response to treatment relapse
- Heterogeneity of target expression and / or loss of target have been clinically demonstrated to drive relapse in patients where cancers evade T cell recognition
- Arming NK cells with TCRs serves to provide an “off the shelf” therapeutic that can detect solid cancers with multiple mechanisms (TCR and NK receptors) offering the potential to combat tumour diversity that is limiting the treatment outcome of current therapies
3:45 pm Identification, Activation & Expansion of Target-Specific T-Cells
Synopsis
- Improved methods for identification of rare T-cells and complementary TCR sequences
- Artificial antigen presenting scaffold – new tool to evaluate activation and potency
- Expansion of MHC-peptide specific cells
Demonstrating Clinical Durability to Secure Long-Lasting Efficacy
2:15 pm Displaying Clinical Allogeneic Persistence to Increase Accessibility
Synopsis
- Preventing immune-rejection to maintain a durable off-the-shelf therapy response
- Cloaking therapies to mediate host immune evasion
- Optimising donor screening to select a high quality starting material
2:45 pm Engineering Macrophages for Cancer Immunotherapy: CAR-M & Beyond
Synopsis
- Reviewing clinical progress with CAR-M cell therapy
- Introducing a novel in vivo mRNA CAR-M platform
- Beyond CAR – other engineering strategies for cancer and immunology
3:15 pm Streamlining Lentiviral Vector Manufacturing for Cell Therapy Products: From Plasmids to Clinical Translation
Synopsis
Chimeric antigen receptor (CAR) T cell therapy is a promising new approach for treating certain cancers. However, manufacturing limitations around viral vector production have constrained widespread availability of this advanced immunotherapy. Lentiviral vectors are critical for efficient genetic modification of T cells to express CARs, but traditional production methods involving adherent cell cultures limit yields and scalability. Advances in suspension cell lines, culture media, bioreactor systems, and purification workflows have enabled significant improvements in lentiviral vector manufacturing. These process innovations allow for high-titer vector production at volumes relevant for commercialization of CAR T cell therapies. This talk will examine novel technologies and strategies for scalable lentiviral vector manufacturing. Improving the viral vector supply chain will accelerate development and delivery of potentially transformative CAR T cell immunotherapies to broad patient populations.
Key Learning Topics:
- Case Study from development of DMF-ready helper plasmids (LentiBone™) to GMP manufacturing
- Process development case to demonstrate scalability in both adherent and suspension setting
- Clinical Case Study on CAR Expression T-cell Transduction Efficiency for adherent and suspension
3:45 pm Track Closed
Next Generation Engineering to Shorten Manufacturing Processes to Improve Turnaround Time
2:15 pm Virus-Free Quantum Engine™ for Developing & Manufacturing Multiplexed Gene Therapy
Synopsis
- Addressing safety concerns and enhancing therapeutic potential of GCT using Quantum Engine™, a virus-free cell engineering technology
- Overcoming critical CAR-T challenges with qCART™, a Quantum Engine™ for multiplexed CAR-T development and manufacturing
- Making advanced virus-free multiplexed CAR-Ts more affordable and accessible by streamlining the process: from design to manufacturing
2:45 pm Multiplex Engineering & the Manufacture of High Purity Next Generation CAR-T Cells
Synopsis
- Creating non-alloreactive T-cells for development of off-the-shelf CAR-T cell products
- Multiplex and tuned engineering of allogeneic and hypoimmunogenic CAR-T cells
- Development of multimodal-engineered CAR-T cells for CD7-positive cancers
3:15 pm Utilising Advanced Genomic Engineering Methods to Streamline Engineered Cell Therapy Production
Synopsis
- Improving CAR and TCR transduction through novel non-viral editing techniques
- Leveraging CRISPR, nanoparticle or electroporation systems to simplify gene editing and decrease cost
- Incorporating non-viral engineering into established manufacturing processes to accelerate production
3:45 pm Hosting Partner Presentation
Synopsis
3:55 pm Afternoon Break
4:05 pm Final Formulation – Finia Live Demo (Terumo BCT booth)
Applying CAR-T Therapies to Treat Autoimmune Indications
4:30 pm Human Single Domain Antibodies From Transgenic Chickens Enable the Discovery of Next Generation Therapeutics
Synopsis
- OmniAb has a suite of animals with optimised immune repertoires on different scaffolds for sourcing novel therapeutic antibodies
- OmnidAb is a transgenic chicken producing human stabilised single domain antibodies (VHH), unlocking opportunities for use in CAR-T and other custom molecular formats
- Using NK engagers as an example, we highlight the breadth of possibilities for custom formats from OmnidAb and our other animal platforms
5:00 pm Employing CAR-T Cells to Elicit Durable Efficacies in Autoimmunity
Synopsis
- Selecting tissue-specific targets to prevent adverse effects and guarantee safety
- Engineering cells to facilitate long-term response
- Detecting surrogate biomarkers to measure cell activity in vivo
5:30 pm Panel Discussion: Pioneering the Opportunity for CAR-T Cells in Autoimmunity
Synopsis
- Brainstorming effective solutions to the unique challenges faced in autoimmune cell therapy development
- Evaluating potential indications for treatment to maximise clinical outcome
- Reviewing alternative safety considerations associated with non-life threatening disease
Advancing Companion Diagnostics to Reinvent Patient Selection & Clinical Outcomes
4:30 pm How Past Trial Data Unlocks Future Trial Success
Synopsis
- How AI and modelling can help you design trial protocols that help predict and mitigate key risks or patient safety events
- Understanding and selecting patient subpopulations most likely to positively respond to your therapy
- Using commonly collected lab markers from trial participants and benchmarking against past trial data to predict and mitigate severe adverse events
- How to leverage an external control arm to generate compelling evidence to guide internal, regulatory and market access decision points
5:00 pm Identifying Predictive Biomarkers to Stratify Responsive Patient Populations
Synopsis
- Utilising translational studies to identify trends in responders
- Uncovering biomarkers of response to indicate patient populations with low response rates
- Selecting patients for trial enrolment based on their predicted outcome to improve clinical outcomes
5:30 pm Developing Effective Methods to Monitor, Track & Assess T-Cell Efficacy In Vivo & In Vitro
Synopsis
- Engineering a tag into T-cells to assess and track function in patients
- Monitoring T-cell activity in vivo to uncover mechanism of action
- Harnessing engineered tags to detect surrogate biomarkers to imply clinical efficacy
Transforming Analytical Readiness to Simplify Product Release
4:30 pm The Evolution & Standardisation of Ancillary Materials for the Industrialisation & Democratisation of Cell-Based Immunotherapies
Synopsis
- How recombinant proteins in stable liquid formats lower the cost of goods
- What next next generation packaging solutions look like and how they streamline manufacturing and lower risk
- The need for standardisation of analytical tools, methods, and reports for redundant sourcing and global expansion
5:00 pm Round Table: Simplifying Analytical Testing to Streamline QC & Analytical Processes
Synopsis
Join this discussion-based session to gain an understanding of how your industry colleagues are tackling similar challenges. Engage in small group discussions and feed back to the full room to not only learn, but hear feedback on your internal processes.
- Determining notable and robust attributes that portray quality
- Defining product consistency to demonstrate batch-to-batch consistency
- Ensuring QC testing complies with varying standards
6:00 pm Chair’s Closing Remarks
6:05 pm Drinks Reception & Poster Session Hosted by ScaleReady
7:15 pm Close of Conference Day One
