7:30 am Check In & Networking
8:50 am Chair’s Opening Remarks
Reframing Tumor Immunity & Resistance to Unlock the Full Potential of TIL Therapy
9:00 am Understanding the Art & Science of TIL Therapy by Reframing Immunity & Resistance
Synopsis
- Reframing tumor immunity with a new model: I before E: inflammation, inception, initiation, followed by immune editing with elimination, equilibrium, and escape
- Introducing pre- and post-TIL strategies to enhance the number and quality of TIL and overcome resistance
- Emphasizing the bespoke nature of TIL as a scientific advantage, and a strength
9:30 am A Real-World Approach to the Early Identification of TIL Patient Candidates
Synopsis
- Fast-tracking TIL for patients unlikely to benefit from checkpoint inhibitors
- Minimizing immune exhaustion from prolonged immunotherapy exposure
- Enhancing referral networks to reach patients beyond major treatment centers
10:00 am Morning Refreshments & Poster Session
R&D Track
Improving TIL Therapy Specificity Using Next-Gen Approaches to Improve Targeting & Therapeutic Impact
11:00 am A Novel Approach to Generate Tumor-Targeting T-Cells for Solid Tumors
Synopsis
- Leveraging GEMs to identify and enrich neoantigen-specific TILs via engineered APCs
- Enhancing TIL metabolic fitness using GEMs to boost persistence, trafficking, and function
- Applying antigen and GEM-based strategies to improve TIL quality and overcome tumor resistance
11:30 am Enhancing TIL Selection to Improve Specificity & Functionality
Synopsis
- Enriching highly tumor-reactive CD8+ TILs by selecting CD39/ CD103 double-positive cells
- Expanding exhausted TILs into billions while retaining tumor killing functionality
- Demonstrating long-term persistence, trafficking, and efficacy in IL-2-supported clinical models
CMC Track
Optimizing Cell Banking Pathways to Retain High Quality TIL with Improved Efficacy
11:00 am Translational & Regulatory Insights from Academic TIL Development
Synopsis
- Dissecting TIL product composition through definition of antigen specificity and TCR repertoire profiling
- Understanding translational data requirements to align with learnings from EMA interactions
- Bridging GMP manufacturing and clinical application in melanoma in a transition from academic to commercial setting
11:30 am Advancing Potency Assays for TIL Therapies to Prevent Clinical Holds & Streamline Route to Patients
Synopsis
- Comparing the development of potency assays for CAR-Ts, TCR-Ts, ex vivo T-cell therapies and TILs, highlighting the unique challenges faced by personalized T-cell therapies like TILs
- Exploring the complexities of developing potency assays for TIL therapies, including surrogate assays and GMP-ready validation
- Discussing the difficulties in validating potency assays that accurately target the mechanism of action of TILs
12:30 pm Lunch
Identifying Novel Biomarkers & Innovating in Translation Studies to Optimize the Route to the Clinic
2:00 pm Advancing GT201 by Enhancing TIL Persistence, Demonstrating Clinical Activity & Uncovering Biomarker Insights
Synopsis
- Showcasing product design, mechanism of action, and preclinical data demonstrating enhanced TIL persistence and tumor cytotoxicity with reduced IL-2 dependency
- Demonstrating safety and preliminary efficacy data from approximately 10 solid tumor patients, including at least one complete response and multiple partial responses
- Deep diving into analyses leveraging single-cell profiling of longitudinal patient samples with TCR tracking to optimize manufacturing process and guide biomarker discovery
2:30 pm Refining TIL Therapy through Selective Expansion & Genetic Engineering
Synopsis
- Isolating tumor-reactive TIL using phenotypic markers to enhance therapeutic specificity
- Engineering selected TIL with viral constructs to boost potency and persistence
- Expanding enriched TIL populations in optimized culture conditions to improve product quality
3:00 pm Afternoon Refreshments & Networking
Advancing Global Regulatory Strategies & Clinical Adoption for TIL Therapies
3:30 pm Enhancing Regulatory Frameworks & Data Translatability for TIL Therapies
Synopsis
- Presenting clinical updates from the BST-02 liver cancer program, including Phase I data from China
- Sharing regulatory experiences with both the FDA and the Chinese NMPA, including simultaneous IND filings and designations
- Exploring how regulators assess and accept clinical trial data generated outside their regions for global approvals
4:00 pm Understanding Global Approvals & Implementation of TIL Therapies
Synopsis
- Highlighting the process of implementing TIL therapies within publicly funded healthcare systems through health technology assessments
- Comparing regulatory approval pathways across countries to inform trial design and global strategy
- Addressing the role of academic institutions in sustaining TIL research amid industry and funding instability
4:30 pm Panel Discussion: Navigating Regulatory Insights for Global Clinical Adoption of TIL Therapies
Synopsis
- Examining the spectrum of regulatory flexibility from IND filing to BLA submission and its impact on TIL therapies
- Highlighting the differences in regulatory approaches in China and other regions, and their implications for clinical trials and patient access
- Assessing the feasibility of expanding TIL therapies beyond North America to increase patient accessibility