7:30 am Check In & Networking
8:25 am Chair’s Opening Remarks
Unlocking the Future of TIL Therapies through Breakthrough Clinical Insights & Strategic Perspectives
8:30 am OBX-115 Engineered TIL Cell Therapy with Regulatable Membrane-Bound IL15: Initial Multicenter Clinical Trial Results in Advanced Melanoma
Synopsis
- OBX-115 TIL is engineered to express membrane-bound IL15 regulated by acetazolamide, abrogating the need for IL2
- OBX-115 is compatible with low-dose lymphodepletion and has a positively differentiated safety profile
- At RP2D, OBX-115 can induce deep and durable responses in patients with ICIresistant advanced melanoma
9:00 am Advancing TIL Trials: Strategic Approaches to Patient Recruitment and Operational Execution in TIL Therapy
Synopsis
- Operational lessons learned from supporting global TIL trials across diverse healthcare environments
- Strategies to enable cell therapy research naïve sites to participate in clinical studies
- How to expand recruitment by leveraging ex-US regions to improve speed, diversity, and site engagement
9:30 am Driving Innovation in TIL Therapy with a Pipeline Update from KSQ Therapeutics
Synopsis
- Showcasing recent clinical data on the efficacy and safety of KSQ Therapeutics’ engineered TIL therapies across multiple cancer types
- Exploring how gene-editing strategies are improving TIL function and persistence, with implications for more durable and effective patient outcomes
10:00 am Fireside Chat: Clinical Data & Reflections on the Current State of TIL Therapies in the Clinic
Synopsis
- Examining the latest clinical insights shaping TIL therapy to better understand the direction of innovation in the field
- Discussing real-world challenges and opportunities in TIL development to uncover practical strategies for accelerating progress
- Envisioning the future of TIL therapies through expert perspectives to inform more effective research and clinical decisions
10:30 am Morning Refreshments & Speed Networking
R&D Track
Engineering Next Generation TIL Therapies with Combination Strategies for Enhanced Clinical Outcomes
11:30 am Engineering Co-Stimulation-Independent T-Cells to Overcome Tumor Immunosuppression
Synopsis
- Introducing a gain-of-function gene that enhances T-Cell sensitivity to low antigen levels and bypasses CD28 costimulation
- Demonstrating resistance to PD-1 and CTLA-4 mediated suppression, improving efficacy in low-immunogenic tumors
- Exploring translational potential for TIL therapies beyond melanoma through strategic partnerships
12:00 pm Novel Approaches in Post-TIL Combination Therapy Development
Synopsis
- Reintroducing checkpoint inhibitors after TIL, assessing safety and early signs of efficacy
- Setting benchmarks for post-TIL trials using emerging realworld data
- Identifying patient populations who may benefit from follow-up therapies after early TIL use
12:30 pm Development of a Next-Generation Dual Knock-Out TIL Product GT300 with AaCas12bMax Nuclease
Synopsis
- GT300 is a CRISPR/AaCas12bMax engineered TIL product with KO of two key immunoregulatory targets that reverses TIL exhaustion and overcomes the harsh TME
- A safety assessment framework was developed aligning with FDA guidelines, incorporating orthogonal methodologies for off-target and chromosomal structural variation assessment
- Comparative analysis of SpCas9- versus AaCas12bMAXedited TIL products, including on-target efficiency, safety profiling, functional phenotyping, and mechanistic interrogation
CMC Track
Safely Optimizing TIL Expansion Using Pre-Treatment Insights & Engineering Advances
11:30 am CTMC: An integrated approach to TIL therapy development
Synopsis
- Integrated partnership model to accelerate the path to clinical proof of concept and seamlessly transition to commercialization
- Clinically validated TIL manufacturing platform adaptable to emerging product requirements
- Forming a Global Alliance to Democratize Cell Therapy Manufacturing and Expand Global Access to Transformative Treatments
12:00 pm OBX-115 Engineered TIL with Regulatable Membrane- Bound IL15: Translational Data from Patients with Advanced Melanoma
Synopsis
- OBX-115 is a highly differentiated TIL cell therapy with optimized characteristics for response and persistence
- This data confirms successful platform validation, supporting the proposed OBX-115 mechanism of action
- ACZ dose-driven regulatable mbIL15 expression on OBX-115 enables elimination of IL2 from the regimen and the potential for a safer, more effective TIL cell therapy
12:30 pm G-Rex Bioreactors: Principles and Practice for Commercialization of Cellular Therapies
Synopsis
- Principles of G-Rex Bioreactor Technology
- Scaling Cellular Therapy Manufacturing Using G-Rex
- Quality Control and Regulatory Aspects
- Commercialization challenges and strategies
1:00 pm Lunch
Speeding Up Turnaround Times for the Manufacturing of TIL Products to Decrease Patient Wait Times
2:00 pm Using the EPiC Platform to Accellerate Manufacturing of INV441
Synopsis
- Leveraging a closed system to enable rapid, same-day reinfusion of viable TIL products
- Adapting classical TIL expansion protocols with novel cytokine and chemokine mixes to enhance safety
- Implementing flexible source material processing to streamline clinical readiness for glioblastoma patients
2:30 pm Considerations for Patient/Donor Cell Characterization and Optimization Strategies
Synopsis
- The role of feeder cells in TIL production
- Cell characterization parameters relevant to TIL therapy
- Potential strategies to optimize TIL products
2:40 pm Accelerating TIL Manufacturing Turnaround & Improving Safety with the FAST-TIL Platform
Synopsis
- Presenting a manufacturing platform, achieving 13-19-day turnaround with a closed system to enhance safety and consistency
- Highlighting Phase I clinical results showing strong efficacy and a favorable safety profile, with reduced lymphodepletion and IL-2 dosing
- Exploring how streamlined CMC processes support rapid, scalable, and patient-friendly TIL therapy delivery
3:10 pm Afternoon Refreshments
Understanding Operational Challenges of Treating Patients from Managing Side Effects to Preparing Treatment Teams
3:30 pm Exploring TIL Therapies from the Patients’ Perspective
Synopsis
- Hearing firsthand accounts from someone who has undergone TIL therapy, including their expectations and lived experiences
- Discussing the emotional, physical, and logistical challenges faced by patients throughout the TIL treatment journey
- Emphasizing the importance of clear communication, education, and support systems in empowering patients during treatment
4:00 pm Scaling TIL Therapy: Clinical Lessons from the Front Lines
Synopsis
- Managing the operational and logistical hurdles of expanding TIL programs beyond early-phase trials
- Recognizing patient care complexities and toxicity management challenges in real-world settings
- Adapting institutional workflows and multidisciplinary coordination to support broader clinical adoption
4:30 pm Panel Discussion: Exploring Real-World Perspectives from Patients & Providers Driving Better TIL Outcomes
Synopsis
- Hearing directly from patients about their experiences with TIL therapy, including the challenges and successes they faced
- Gaining insights from healthcare providers on the practical aspects of administering TIL therapy and managing patient care
- Discussing collaborative solutions to improve patient outcomes and enhance the overall TIL therapy experience