Scientific Program Day One | Wednesday, June 25
7:00 am Check-In & Coffee
7:50 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
8:00 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
8:30 am Xaluritamig, A STEAP1-Targeted Immune Therapy for The Treatment of Prostate Cancer
Synopsis
- Designing a T-cell engager that selectively targets STEAP1-high tumors
- Specificity and efficacy of AMG 509 in preclinical models
- A brief update on the clinical trials status of AMG 509
9:00 am Morning Break & Speed Networking
Translation to Clinic: Uncovering Appropriate Animal Models & Biomarkers for Immune Engagers to Replicate & Predict Immune System Function
10:00 am Translational PK/PD modeling strategies for human dose prediction of T Cell-Engaging Therapies in Oncology
Synopsis
- Implementing translational PK/PD modeling strategies for human dose prediction using pre-clinical (in vitro and in vivo) as well as clinical data
- Application of translational PK/PD models to guide the design of novel T cell engager molecules
10:30 am Accelerating TCE & TCRm Discovery with Diverse & Optimized CD3 Binders
Synopsis
- Diverse and optimized CD3 antibodies are critical to unlocking the full potential of TCE and TCRm therapies
- CD3 affinity, epitope, and signaling strength can be tuned to match the therapeutic application, enabling the development of safer, more effective therapeutics
11:00 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
11:30 am CROSSCHECK-101: Accelerating Phase 1 Development for a Novel T-cell Engager in Relapsed or Refractory Hematologic Malignancies
Synopsis
- Leveraging forward-thinking dose-finding strategies, including quantitative-systemspharmacology modeling to inform the starting dose
- Designing an innovative trial to expedite escalation while balancing optimal characterization of a recommended phase 2 dose and mitigation strategies for cytokine release syndrome
- Developing early clinical development strategies to maximize meaningful collection of safety and preliminary efficacy in a phase 1 setting
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 Engineering the Next Generation of T Cell Engagers: A Trispecific Platform Approach
Synopsis
- Validated bispecific discovery engine designed for manufacturability and clinical translation: The B-Body® bispecific antibody platform enables plug-and-play assembly and high-throughput screening of hundreds of bispecific constructs per week, supporting rapid optimization of affinity, specificity, and developability
- Introducing the T-Body™ trispecific platform: The T-Body™ platform enables efficient expression and purification of trispecific antibodies using a streamlined workflow for early functional testing. T-Body™ constructs maintain parental mAb binding and support rapid testing of diverse antibody combinations
- Enabling the next wave of immune engagers: The platform supports rational assembly of trispecific TCEs incorporating CD3 and other binding
2:00 pm Afternoon Break & Poster Session
2:45 pm A Tetravalent Bispecific T-Cell Engager with Optimized Efficacy & Safety Profile for Oncology & Autoimmune Indications
Synopsis
- Developing a tetravalent TCE platform FIT-Ig with reduced CRS
- Clinical validation of FIT-Ig based TCE for hematology and autoimmunity
- Optimizing a FIT-Ig based TCE for solid tumors
3:15 pm Targeted PD-1 Agonists as Localized Immune Suppressants Against Autoimmune Diseases
Synopsis
- Developing immunosuppressive bispecifics consisting of high affinity targeting domain fused to a PD-1 agonist to treat autoimmune diseases
- Inhibiting T cell activity by activating PD-1 pathway only when molecules are bound to
- target cells
- Delivering tissue-restricted T cell inhibition while avoiding systemic immunosuppression
Igniting the Immune Spark: Strategies to Improve Durability of Tumor Response to TCEs
3:45 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
4:15 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