Scientific Program Day One | Wednesday, June 25
7:30 am Check-In & Coffee
8:20 am Chair’s Opening Remarks
Building on the Success of CAR-T: Exploring the Clinical Approvals & Pathways for Cell Engagers for a More Patient & Health-System Friendly Approach
8:30 am Mapping the Past, Present & Future of Cell Engager Therapies
Synopsis
- Revisit the recent developments within the landscape of cell engagers with11 total approvals to date
- Understanding which mechanisms, scaffolds and targets have established themselves and which are just entering the space
- Reviewing future directions for cell engagers within demonstrating durable clinical responses and minimal toxicities
9:00 am Exploring how the Success Story of Tarlatamab has Changed the Face of T-Cell Engagers: Clinical Development & Learnings
Synopsis
- Tracing the clinical development of tarlatamab from preclinical rationale to recent trial outcomes in small cell lung cancer
- Evaluating efficacy, safety, and resistance mechanisms observed in clinical studies, with a focus on cytokine release syndrome and T-cell exhaustion
- Identifying key learnings from tarlatamab’s development to inform next-generation T-cell engagers, including target selection, dosing strategies, and combination approaches
9:30 am Morning Break & Speed Networking
Translation to Clinic: Uncovering Appropriate Animal Models & Biomarkers for Immune Engagers to Replicate & Predict Immune System Function
10:30 am Strategies for Rapid Definition of Clinical Dose for T Cell-Engaging Therapies in Oncology
Synopsis
- Implementing innovative dose-finding strategies, including model-informed drug development and adaptive trial designs, to accelerate dose selection for T-cell engages
- Optimizing the balance between efficacy and safety by leveraging pharmacokinetic/pharmacodynamic modeling, biomarkers, and real-time patient monitoring
- Refining dosing paradigms through insights from recent clinical trials, including step-up dosing, intra-patient escalation, and mitigation strategies for cytokine release syndrome
11:00 am Session Reserved for Alloy Therapeutics
11:30 am Unlocking the Therapeutic Potential for TCEs Through Dose Selection & CRS Management
Synopsis
- Summarizing pharmacological perspectives on key challenges in clinical development and presenting novel solutions through dose regimen selections, both in monotherapy and combination therapies
- Covering early clinical development strategies for dose finding, aiming to balance and optimize efficacy, acute safety, and chronic safety for favorable outcomes
12:00 pm Lunch & Networking
Navigating an Expanding Cell Engager Landscape: The Shift to Autoimmune Disease
1:00 pm Looking into the Differences in Approaching TCEs for Autoimmune vs Oncology Indications
Synopsis
- Comparing the mechanistic and translational differences in T-cell engager design for autoimmune diseases versus oncology, including target selection and immune activation thresholds
- Evaluating safety considerations, balancing immune activation and toxicity, and lessons learned from cytokine release syndrome management in both therapeutic areas
- Exploring emerging strategies to tailor T-cell engagers for autoimmune indications, including selective T-cell modulation, tissue-restricted targeting, and dose optimization
1:30 pm Roundtable Discussion: Novel Targets for Cell Engagers & Autoimmune Disease
Synopsis
- Identifying novel targets beyond CD3, including tissue-specific antigens and inhibitory receptors, to enhance precision and minimize off-target effects
- Exploring mechanisms to fine-tune T-cell engagement, such as conditional activation, dual-specificity designs, and regulatory T-cell recruitment
- Optimizing therapeutic strategies by leveraging insights from oncology, including biomarker-driven target selection and cytokine modulation approaches
2:15 pm Afternoon Break & Poster Session
3:15 pm From Antibody Engineering to Clinical Development in EMB-06 – A BCMA/ CD3 Targeting BiTE
Synopsis
- Exploring antibody engineering for EMB-06
- Delving into the shift from oncology to autoimmune indication – targeting both multiple myeloma and autoimmune diseases
- Looking into phase 1 trial results for EMB-06 and next steps
3:45 pm Exploring the Use of TCEs for Type 1 Diabetes – Preclinical Development for a HLA-A02 Targeting TCE
Synopsis
Session Details to Be Confirmed
Igniting the Immune Spark: Strategies to Improve Durability of Tumor Response to TCEs
4:15 pm Bispecific Antibody Combinations for Optimized Anti-Tumor Activity in Liquid & Solid Tumors
Synopsis
- Co-localizing “signal 1” (TCR) and “signal 2” (co-stimulation) within the tumor microenvironment to drive optimized anti-tumor responses
- Integrating signal 3 (cytokine support) for even deeper anti-tumor responses
- Preclinical and clinical data support rational combinations with biologics in patients
4:45 pm EVOLVE104: A First-In-Category T-Cell Engager with Integrated CD2 Costimulation Targets ULBP2/5/6-Expressing Solid Tumors
Synopsis
- The integration of CD2 costimulation and carefully affinity-tuned CD3 binding mediate improved potency and superior efficacy of EVOLVE104 over conventional bispecific and clinical comparators
- The preclinical data demonstrate safety, efficacy, and developability of EVOLVE104, and support the upcoming Phase I clinical study
- ULBP2/5/6 is a novel target which is enriched on squamous cell tumors and transitional urothelial cancer, positioning EVOLVE104 to address underserved patient populations with high unmet needs