Conference Day One
Wednesday, April 2
7:30 am Check-In & Coffee Networking
8:30 am ACTengine IMA203 & IMA203CD8 TCR-T Cell Therapy Targeting PRAME in Solid Tumor Patients
Synopsis
• Phase 1b clinical data on IMA203 demonstrate deep and durable responses in heavily pretreated metastatic melanoma patients at RP2D
• Next-generation IMA203CD8 Phase 1a dose escalation data show enhanced pharmacology and potency per cell; to be evaluated for future in development in solid cancers with medium-level PRAME copy numbers
• SUPRAME, randomized-controlled Phase 3 trial to evaluate IMA203 in 2L+ metastatic melanoma patients, initiated in December 2024
8:55 am Chair’s Opening Remarks
Validating the Safety & Efficacy of TCR-Based Therapies in the Clinic
9:00 am T-Cell Therapies in the Real World
Synopsis
• Phase 1b clinical data on IMA203 demonstrate deep and durable responses in heavily pretreated metastatic melanoma patients at RP2D
• Next-generation IMA203CD8 Phase 1a dose escalation data show enhanced pharmacology and potency per cell; to be evaluated for future in development in solid cancers with medium-level PRAME copy numbers
• SUPRAME, randomized-controlled Phase 3 trial to evaluate IMA203 in 2L+ metastatic melanoma patients, initiated in December 2024
9:30 am Next Generation TIL: OBX-115 Engineered TIL Cell Therapy with Regulatable mbIL15
Synopsis
• OBX-115 is an engineered TIL cell therapy that leverages regulatable membrane-bound IL15 (mbIL15) to improve the expansion, persistence, safety, and efficacy of TIL cell therapy for patients with solid tumors
• Unlike IL2, mbIL15 promotes a predominant CD8+, memory, and “stem-like” progenitor phenotype, and does not increase immunosuppressive regulatory T-cells
• Clinically, we have observed a safety profile that is positively differentiated from nonengineered TIL cell therapy, which requires high-dose systemic IL2, as well as promising early efficacy and translational correlates
10:00 am Panel Discussion: Evaluating the Cell vs Bispecific Evolution to Elevate Their Respective Advantages
Synopsis
• Consolidating the clinical advances for both approaches while highlighting the next generation for each method
• Comparing clinical efficacy and safety data to highlight benefits and challenges of each modality
• Discussing how the impact of various targets and TCR enhancements may differ for each approach to determine priorities for future modification
• Reflecting on where each modality thrives and how they can learn from each other to further advance the TCR-based
therapy field
10:45 am Morning Refreshment Break & Speed Networking
Approaching Effective TCR Discovery & Optimization to Mediate Safe & Effective Targeting
11:45 am Showcasing a Cellular TCR Evolution Platform to Upscale TCRs for Clinical Deployment
Synopsis
• A novel platform to generate clinically actionable TCRs beyond the native TCR repertoire
• Utilizing synthetic biology to diversify TCR frameworks and functionally select variants in T-cell libraries
• Validating optimized TCR for allo-reactivity and cross-reactivity to demonstrate safety
12:15 pm Creating Robust Screens to Predict Cross-Reactivity & Off-Target Effects in Patients
Synopsis
• Analyzing TCR motifs to search the proteome and predict for potential off-target effects
• Determining the degree of similarity between TCR molecules and off-targets to ensure specificity for target antigen
• Minimizing cross-reactivity to allow for higher dose levels to increase the therapeutic window
12:45 pm Breaking Down Solid Tumor Barriers with a Novel Bispecific T-Cell Engager Against a Novel pHLA Target
Synopsis
• Leveraging the 3T-TRACE platform to screen TCR and TCR mimetic molecules for specific and off-target cross-reactivities
• Building highly specific and safe TCRs for shared targets to effectively treat solid tumors
1:15 pm Lunch Break and Networking
Synopsis
Private Lunch with Miltenyi
Reflecting on the Year & Turbocharging Future Success of the TCR Field
2:15 pm Industry Leaders’ Fireside Chat: A Commercial TCR-T & TCR Bispecific – What’s Next?
Synopsis
• Reflecting on the past: celebrating the first TCR-T commercial approval and its impact on the field, along with novel clinical data
• Determining the current state of play: discussing what challenges remain, the current funding environment and the priority for the field to outline present focus
• What’s next? Discussing the potential for allogeneic or in vivo approaches, scalable manufacturing and expansion to novel patient populations
Delivering to More Patient Populations by Expanding HLA Coverage
3:00 pm Targeting Novel Epitopes & HLA Molecules to Expand Patient Populations
Synopsis
• Utilizing innovative platforms and mass spectrometry to find novel epitopes presented by frequent HLAs
• Validating the best TCR-HLA target combinations for clinical success
• Choosing the right HLAs to expand coverage to minority patient populations
3:30 pm Cross-HLA Targeting of Synthetic Neoepitopes with T-Cell Engagers to Eradicate KRASG12C Inhibitor-Resistant Cancers
Synopsis
• Development of high-specificity and high-affinity T-cell engaging bispecific antibodies (HapImmune antibodies) targeting KRASG12C inhibitor-modified HLA peptides (haptenpeptides, “p*MHCs”)
• Direct detection of p*MHCs by mass spectrometry, detailed target characterization, and demonstrated in vitro/in vivo activity of HapImmune antibodies
• Demonstration of the molecular-basis for cross-HLA recognition, examples spanning alleles within and across HLA supertypes
4:00 pm Afternoon Break & Refreshments
Boosting Biomarker & Companion Diagnostics for TCR Therapies to Optimize Patient Selection & Accelerate Clinical Success
4:30 pm Leveraging Companion Diagnostics (CDx) to Distinguish Target Patient Populations
Synopsis
• Setting up your CDx tools early and evolving your CDx tools to cater to advancing clinical trials
• Understanding guidelines and retaining flexibility to adjust for changing diagnostics regulations
• Leveraging CDx to accelerate patient recruitment
5:00 pm Incorporating a Robust Tracking Method to Mediate Detection of TCRs In Vivo
Synopsis
• Tagging engineered TCR-T cells to enable precise tracking of TCR molecules
• Tracking cells in patients to support immune monitoring efforts
• Harnessing learnings from cell tracking to further advance discovery and translational efforts