Scientific Program Day Two
Thursday | June 12, 2025
과학 프로그램 2 일 차
科学议程第一天
カンファレンス ２日目
7:30 am Check In & Refreshments
Assessing How Novel Format & Payload Conjugates Can Deliver More Targeted & Safer Treatments to a Wider Patient Population
8:30 am Combining The Power of Protein Degraders With The Precision of Antibodies for Synergistic Potential Using Degrader-Antibody Conjugates (DACs)
Synopsis
- Delving into the mechanism and design of an antibody degrader conjugate, considering aspects like linker design for stability and efficient PROTAC release
- Evaluating safety, pharmacokinetic, pharmacodynamic and anti-tumor activity data
- Discussing the rationale for the chosen format and value proposition over traditional approaches
9:00 am Development of a Site Specific & Versatile Conjugation Approach Based on Bacterial Transglutaminase & the Diels-Alder Cycloaddition Reaction
Synopsis
- Explaining the versatility of maleimides that specifically conjugate to antibodies via cycloaddition reaction
- Exploring design and synthesis of diene-containing linkers for site-specific transglutaminase conjugation
- Evaluating in vitro and in vivo activity of the ADCs generated and assessing ADC stability
- Highlighting the importance of collaborations with CROs for discovering and developing novel linker and conjugation technologies
9:30 am Outlining How the Bi-XDC Technology Can Unlock New Opportunities for ADCs Through Tackling Difficult Targets
Synopsis
- Sharing the background of the Bi-XDC technology and its mode of action
- Leveraging bi-ligan synergies on multiple dimensions to drug the undruggable targets
- Updating current clinical progress and next steps for the Bi-XDC platform
10:00 am Versatile & Robust Chemical Site-Specific Conjugation Platform: AJICAP® Technology
Synopsis
- AJICAP® Conjugation: Examining how site-specific technologies are being employed in many of the next-generation ADCs due to the enhancement ofclinically relevant biological properties observed in various preclinical studies
- AJICAP® Linker: Demonstrating a novel hydrophilic linker technology that enables the versatile synthesis of homogenous DAR = 1, 2, 4, 8, and higher
- Showcasing Bispecific and Tri specific antibodies produced by fully chemical conjugation technology
10:30am Morning Break & Networking
Discovery Track
Selecting & Diversifying ADC Payloads for Overcoming Tumor Resistance, with Optimized Efficacy & Safety
11:30am Future of ADCs: Samjin’s Next-Generation Approach with Novel Payloads & Linkers
Synopsis
- Exploring immune-modulating ADC payloads
- Evaluating cancer metabolism-targeting ADC payloads and their clinical applications
- Thinking forward with Samjin's next-generation ADC development
12:00pm Panel Discussion: What is the Next Frontier Within ADC Payloads?
Synopsis
- What are the emerging trends in ADC payloads in APAC, the US and Europe?
- Exploring the most novel MOAs that are entering preclinical development and the value proposition of each compared to tubulin inhibitors and DNA damaging agents
- Considering the difference in physicochemical properties and PK profiles of next generation versus traditional ADC payloads
12:30pm Discovery of AT03-65, a Highly Selective Anti-CLDN6 ADC With a Proprietary Payload
Synopsis
- Overview of current and next generation of ADCs
- Discovery of AT03-65, a novel payload ADC using AxcynDOTTM technology
- Preclinical journey of AT03-65 and progression into the clinic
1:00pm Diving Deeper into the Next Wave of ADCs
Synopsis
- Breaking down the novel drug conjugate landscape
- Exploring emerging drug conjugate modalities and targets
- Understanding the trial landscape of novel drug conjugates
1:30pm Showcasing a Tri-Specific ADC with Novel Linker Technology for Solid Tumors
Preclinical & Clinical Development Track
Optimizing Clinical Development Strategies for ADCs to Demonstrate Early Efficacy & Inform Dosing Decisions
11:30am Outlining Tactice for Optimal Phase 1 Clinical Design from a Clinical Pharmacology Perspective
Synopsis
- Discussing considerations for early efficacy seeking studies
- Optimizing clinical trial design to streamline the first-in-human studies
- Questioning how to accelerate early clinical studies for quick progression in to and through early clinical development
12:00pm Roundtable Discussion: Utilizing Population Pharmacokinetic Analysis & Exposure-Response Analysis to Better Inform Dosing
Synopsis
- Enhancing characterization of doses prior to registration trials to maximize the efficacy and safety of oncology drugs
- Utilizing PopPK and quantitative medicine to determine optimal dose and dosing schedule for ADCs
- Navigating the regulatory guidance for dose optimization in ADCs and overcoming hurdles of a narrow therapeutic index
12:30pm Discovering & Translating Novel Target ADCs
Synopsis
- Outlining approaches to identifying new targets to differentiate your ADC pipeline and drive your ADC to first-in-class
- Discussing ROR-1 as a target, and the current unmet medical need for ROR-1 associated cancers
- Defining future considerations on X-X conjugation drugs
1:00pm Talk Details TBC
1:30pm Development and functional characterization of ELN28, a Novel soloMER Drug Conjugate (SDC) targeting TNFα and JAK enzymes in Immune Mediated Inflammatory Diseases
Synopsis
- Elasmogen has designed a first-in-class soloMER drug conjugate tailor-made for autoimmune and inflammatory diseases.
- This innovative treatment utilizes a super-potent, novel-acting multivalent anti-TNFα soloMER to site-deliver an anti-inflammatory JAK inhibitor payload, Tofacitinib.
- We will be presenting in vivo, ex vivo efficacy, PK and Biodistribution data.
CMC Track
Enhancing Analytical Methods & Validation Strategies to Support ADC Development & Approval
11:30am Process Characterization & Process Design of Bioconjugation Process
Synopsis
- General procedures and considerations in bioconjugation process characterization
- Tools in bioconjugation process characterization
- Process changes and comparability study
12:00pm Drug Linker Properties Impacting Hydrophobic Interaction Chromatography for Determining DAR
Synopsis
- Outlining how the drug-to-antibody ratio (DAR), which is one of the critical quality attributes (CQAs) for ADCs, is evaluated.
- Exploring which ADC properties impact hydrophobic interaction chromatography (HIC)
- Highlighting that the linker length of drug linkers is an important structural property for peak separation in HIC
12:30pm Utilizing Various Analytical Methods Across Different Clinical Phases
Synopsis
- Establishing a process for proving comparable analytical results across different clinical phases of an ADC
- Convincing the authorities on your drug substance specifications such as release specifications
- Showing how comprehensive characterization and bioassay strategies can help towards supporting a smoother pathway to clinical application
1:00pm Enzymatic Conjugation Technology & Application in ADC GMP Manufacturing
1:30pm Perspectives on Regulatory CMC Strategies for Drug-Linkers in Antibody Drug Conjugates
Synopsis
- Perspectives on major regulatory strategies are based on practical, scientific and risk-based from early development to registration.
- Approaches to regulatory starting material designation, controls and control strategies
- Navigating accelerated process validation, regulatory filing documentation, characterization, stability, post-approval changes and post-approval change management plans/comparability protocols
2:00pm Lunch
Overcoming Resistance With Next Generation ADCs to Reshape the Future of Oncology Care
3:00 pm Development of Site-Specific, High-DAR Dual-Payload ADCs
Synopsis
- Addressing the clinical challenge of acquired resistance to single-payload ADCs by delivering two different payloads simultaneously to tumors
- Utilizing an innovative cell-free platform to create novel antibody-drug conjugates
- Showcasing dual-payload ADC approaches with superior preclinical in vitro and in vivo efficacy
3:30 pm Awaiting Talk Details
4:00 pm Advantages of Clinical- Stage GlycoConnectTM Platform Technology – Successful Application for Multiple Targets & With Different Payload Classes
Synopsis
- GlycoConnectTM, HydraSpace® and toxSYN® technologies enable ADCs with best-in-class therapeutic index potential
- Updates on the rapidly advancing pipeline of GlycoConnectTM ADCs by partners
- Clinical development insights on the most advanced assets
4:30 pm Developing High-Efficacy, Stable Drug Bundle-Based ADCs with Optimized Dual Payload Combinations
Synopsis
- Dual Drug Bundles: Optimized dual-payload combinations are designed to enhance therapeutic efficacy and overcome resistance
- CHO-TEM ADC Technology: A one-step enzymatic process and mild conjugation conditions modify antibody glycans to introduce four azido groups, allowing the conjugation of four drug bundles—each containing two drugs from distinct categories
- High-Efficacy and Stable ADCs: Glycosite-specific conjugation of drug bundles enables the development of high-DAR ADCs with dual payloads, ensuring both efficacy and stability
5:00 pm Panel Discussion: Overcoming Challenges in Developing Dual-Payload ADCs for Enhanced Therapeutic Efficacy
Synopsis
- Exploring the potential advantages of dual-payload ADCs over conventional single-payload ADCs, particularly in overcoming secondary drug resistance
- Discussing strategies for selecting and optimizing payloads to achieve a balanced therapeutic profile, considering different mechanisms of action and toxicity profiles
- Highlighting preclinical data requirements to validate dual-payload ADCs, emphasizing the need for compelling evidence to support their clinical potential