Scientific Program Day One
Wednesday | June 11, 2025
과학 프로그램 1 일 차
科学议程第一天
カンファレンス １日目
7:00 am Check In & Refreshments
7:45 am Chair’s Opening Remarks
Showcasing Latest Game-Changing Data From the ADC World to Reshape the Oncology Landscape
8:00 am MYTX-011, a cMET-Targeting Antibody-Drug Conjugate (ADC), In Patients with Advanced NSCLC: Dose Escalation Results In The Phase 1 Kismet-01 Study
Synopsis
- Examining the safety and tolerability of MYTX-011 in patients with advanced NSCLC
- Evaluating the PK of MYTX-011 in patients with advanced NSCLC
- Analyzing the preliminary efficacy of MYTX-011 in patients with advanced NSCLC
8:30 am Strategies in Early-Stage ADC Discovery for Design of Successful Lead Candidates for Clinical Development
Synopsis
- Designing ADCs for successful clinical development
- Using Thiobridge® conjugation and linker technology to build ADCs with payload diversity
- Modelling complex cell environments in vitro to ensure optimal ADC lead selection – a case study
9:00 am Dato-DXd: Translating Mechanism of Action into Clinical Benefit for Patients with Breast & Lung Cancer
Synopsis
- Overview of Dato-DXd mechanism of action and the DXd ADC platform
- Dato-DXd in breast cancer: TB01 registrational dataset and overview of the pivotal trial program in TNBC
- Dato-DXd in NSCLC: Efficacy/safety of Dato-DXd in EGFRm NSCLC supporting filing and overview of the pivotal trial program in NSCLC
9:30am Morning Break & Speed Networking
Discovery Track
Discovering & Validating New ADC Targets for Unlocking New Therapeutic Potential
11:00am Novel Cancer Targets for ADC Drug Development to Treat Advanced GI Tumors
Synopsis
- Outlining strategies for target identification and selection for gastrointestinal cancers
- Analyzing the use of biomarkers in translational medicine to accelerate clinical study design
- Discussing how to streamline IND-enabling studies when working with novel targets
11:30am Expanding ADC Therapeutic Index Through Site-Specific Bioconjugation & Tumor Selective Payload Release & Activation
Synopsis
- LCB’s site-specific ConjuAllTM platform enables discrete DAR ADCs with circulation stable bioconjugation
- LCB’s proprietary betaglucuronidase technology enables unprecedented preclinical therapeutic indexes through tumor selective release and activation of payload
- Early clinical safety and efficacy across payload classes validate the LCB platform
- Speaker TBC, LigaChem Biosciences
12:00pm Cell Surface Antibody Display System Using DT40 Cells for the Engineering of ADC-Suitable Antibodies
Synopsis
- The ADLib KI-AMP system is a cell surface displayed antibody library system that enables affinity engineering
- The example of affinity modulation for the discovery of ADCsuitable antibodies will be presented
- Chiome’s anti-CDCP1 antibody showed high potential as an ADC
Discovering & Designing Dual-Payload ADCs to Harness a Two-Pronged Attack to Tumor Cells
1:30pm Expanding ADC Therapeutic Potential: Dual-Payload ADCs & Co-Nectar Platform
Synopsis
• The trends and advantages of dual-payload ADCs
• Dual-payload ADC generated from Co-Nectar Platform
• Examples of various dual-payload ADCs in HoneyBear
Discovering & Designing Dual-Payload ADCs to Harness a Two-Pronged Attack to Tumor Cells
2:00pm Panel Discussion: Reviewing In-Vitro, In Vivo & In Silico Modelling Methods for Validating New ADC Targets
Synopsis
- Navigating the different approaches for modeling key parameters such as tumor penetration kinetics
- Utilizing clinically relevant models such as mouse andPDX to validate a target in the context of treatment-resistant mutations
- Discussing the relevance of these models in clinical settings
2:30pm Pushing the Envelope: Exploring the Next Generation of Antibody-Drug Conjugates
Synopsis
- Understanding the next generation of ADCs, containing payloads of different modalities
- Uncovering novel bispecific antibody targets that are being developed
- Understanding why these designs are important for maximizing ADCs with a broader therapeutic index
Preclinical & Development Track
Showcasing Pioneering ADC Clinical Development in 2025
11:00am An Introductory Review of the Development of Daiichi Sankyo’s ADC Portfolio
Synopsis
- Overview of the DXd ADC technology platform
- Latest updates on the clinical development of the DXd ADC programs
- Introduction of the clinical development of DS-9606 using a modified PBD payload
11:30am Roundtable Discussion: Bench to Bedside & Back – Assessing the Benefits of a Reverse Translational Approach When Minimizing ADC Toxicities
Synopsis
- Transferring from human studies to animal studies to obtain a deeper understanding of how different ADCs are distributed across healthy tissues
- Understanding potential biomarkers for predicting toxicities which present in humans and connecting these insights back to the pre-clinical stage.
- Navigating the concept of translating back and mechanistically blocking the toxicity In Vitro
12:00pm Overcoming Tumor Resistance With Amanitin-Based ADCs – Insights From the Clinic
Synopsis
- Discussing the trends and advantages of dual-payload ADCs to combat resistance
- Overviewing dual-payload ADCs generated from the co-Nectar platform
- Sharing HoneyBear Biosciences portfolio of dual-payload ADCs, and future plans
12:30pm Lunch
Bridging the Translational Gap in ADCs by Leveraging Preclinical Modeling & Biomarkers
1:30pm Innovative ADC Development: Preclinical Insights on Efficacy & Safety for an Emerging Target
Synopsis
- Identifying and developing competitive and underexplored emerging targets with tailored antibodies for ADCs
- Optimizing ADC platforms and selecting the most predictive preclinical models
- Evaluating safety profiles to determine clinical development value and patient benefits
2:00pm Panel Discussion: Translating Preclinical Models to Clinical Success for ADC Development
Synopsis
- Addressing the disconnect between in vitro and in vivo results and their impact on ADC clinical validation
- Evaluating the use of PDX and other animal models to demonstrate efficacy and safety
- Highlighting strategies to strengthen the predictive value of preclinical studies and improve clinical translation
2:30pm Evaluating Efficacy & Safety of Dual-Payload ADCs in Preclinical Models to Establish Their Value Over SinglePayload Alternatives
Synopsis
- Discussing the unique challenges of demonstrating efficacy for dual-payload ADCs compared to single-payload ADCs, which often achieve complete regression in preclinical studies
- Exploring experimental designs to assess the added therapeutic potential of dual-payload ADCs in tumor models
- Identifying the approach to accurately predicting ADME properties of dual-payload ADCs
CMC Track
Advancing ADC Conjugation Approaches for Enhanced Homogeneity & Optimal Drug Substance Quality
11:00am Assessing Lysine vs. Cysteine Conjugation Method for Achieving Enhanced Homogeneity of the Drug Substance in ADCs
Synopsis
- Comparing the individual challenges of lysine and cysteine stochastic conjugation and how it affects attributes of the ADC
- Site-specific vs. stochastic conjugation strategies to achieve controlled drug-to-antibody ratios (DAR)
- Examining the distinct process development requirements for each conjugation approach to ensure optimal outcomes
11:30am Roundtable Discussion: Comparing Enzymatic Conjugation & Chemical Conjugation from a CMC Perspective
Synopsis
- What are the pros of using enzymatic conjugation compared to chemical?
- Utilizing enzymatic conjugation to achieve a more homogenous DAR ratio
- What are the crucial CMC considerations for enzymatic conjugation?
12:00pm Navigating Regulatory Challenges to Address ADC CMC Change Hurdles for BLA/NDA Approval
Synopsis
- Gaining insights into regulatory frameworks and strategies for submission timelines to support efficient manufacturing during the clinical phase and preparation for BLA/NDA submission
- Setting comparability study acceptance criteria for site transfer and scale-up during clinical phase
- Leveraging CMC lessons learned from global case studies to adapt to regulatory compliance for setting product release specifications and process validations
Developing & Maintaining ADC CMC Capability at High Scale Production
1:30pm Shaping Best Practices for ADC Process Validation & Comparability
Synopsis
- Exploring industry approaches to process validation and comparability for ADCs, including key attributes for drug-linker and drug substance release specifications
- Discussing challenges in demonstrating comparability for ADCs with drug-linkers from different sources and strategies to meet regulatory expectations
- Sharing experiences from global ADC programs to identify best practices for ensuring process consistency and regulatory alignment
2:00pm Panel Discussion: Strategizing Control, Filing & Post Approval Changes for ADCs
Synopsis
- Examining real-world approaches to impurity control, comparability, and process validation throughout ADC development
- Discussing strategies for evaluating small molecule impurity clearance and establishing robust purge factor calculations
- Comparing IND and BLA filing approaches and regulatory expectations across different regions, with insights from industry experts and the IQ Consortium
2:30pm Unlocking the Potential: ADC Cutting Edge Analytical Development Strategies
Synopsis
- • Mass spectrometry (MS) offers high selectivity and specificity for the comprehensive structural characterization of antibodies and ADCs
- Among the MS-tool box, advantages of native and Ion Mobility MS, Collision Induced Unfolding (CIU) and Cyclic CIU, multiplexed Top and Middle-Down MS, multiple fragmentation techniques and Capillary Electrophoresis hyphenated to MS (CE-MS) will be discussed
- Multiple Attributes Method (MAM) based on High Resolution MS data for identification and quantitation of Critical Quality Attributes (CQAs) in one single analysis for mAbs and ADCs
3:00pm Afternoon Break & Poster Presentation Session
Clinically Validating Novel Biomarkers for Improved Patient Selection with ADC Drug-Diagnostic Co-Development
4:00 pm Our History to Serve the Innovators: A Step Ahead Against the Challenges of the Bioconjugates
Synopsis
- Discover the elements of a sustainable business model
- Learn about expertise, technology and service integration
- Discuss capacity shortage challenges and their implications for the future
4:30 pm Computational Pathology to Guide Patient Selection for ADCs: Discovery of a Novel TROP2 NMR Biomarker for Predicting Clinical Outcomes
Synopsis
- Computational pathology for revolutionizing the development and delivery of accurate biomarker, tailored to the drug’s mechanism of action
- Development of Quantitative Continuous Scoring (QCS) – an AI-based solution that allows interrogation of complex target and tumor biology
- Utilizing the novel computational pathology-based TROP2 NMR biomarker to predict clinical outcomes for Dato-DXd in NSCLC
5:00 pm Empowering Successful Bioconjugation Manufacturing with Process Technology Innovation
Synopsis
- Assessing the challenges in ADC and bioconjugates manufacturing
- Demonstrating XDC’s powerful process platform and technology innovation
- Exploring case studies on site specific conjugation process and manufacturing
5:30 pm Companion Diagnostic Strategies to Accelerate ADC Development: A Case Study on Teliso-V Companion Diagnostics’ Role in ADC Development & Drug Approval
Synopsis
- Outlining the role of companion diagnostics in ADC development and approval
- Sharing a case-study on Teliso V, an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression
- Assessing a CDX bridging strategy and early planning for RxDx co-approval