Preclinical & Translational

Chair: Rakesh Dixit, President & Chief Executive Officer, Bionavigen Oncology

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Assessing ADC Non-Clinical PK/PD to Characterise ADC Mechanism & Predict Clinical Activity

11.30 am A Translational Approach to ADC Evaluation: From In Vitro Organoids to Advanced In Vivo Models

• Exploring the assessment of ADC efficacy through single-mouse in vitro PDXO, MiniPDX, PDX, and clinical MiniPDX models
• Demonstrating how models bridge preclinical findings to clinical indications, offering insights into drug efficacy and resistance
• Highlighting the integration of diverse models to accelerate ADC development and guide decision-making in pharmaceutical R&D

Simon Jiang, Vice President, Biology & Head, Scientific Engagement, Lide Biotech

12.00 pm Exploring Preclinical Characterisation of pH Dependent AnticMET ADC MYTX-011 Designed for Enhanced Tumour Delivery

• Outlining rationale and engineering of MYTX-011, a cMET targeting ADC
• Assessing comprehensive preclinical in vitro and in vivo characterisation in various animal models
• Evaluating MYTX-011 PK data and safety in non-human primates

Nimish Gera, Vice President, Biologics, Mythic Therapeutics

12.30 pm Hacking the Tumour Matrix: Non-Invasive Extracellular Matrix (ECM) Biomarkers for ADC Drug Development

• Sharing how dysregulated ECM remodelling in cancer leads to the release of specific ECM turnover fragments into the bloodstream
• Discussing the doubling ADC response rates with PRO-C3: Harnessing non-Invasive ECM biomarkers for enhanced tumour drug delivery
• Outlining how specific ECM-derived cleavage products have the potential to predict ADC linker cleavage, and drug release within tumours

Nicholas Willumsen, Director & Head, Oncology, Nordic Bioscience

1.00 pm Lunch & Learn Sessions Presented by 

Invite only session

Diving into Translational Development of Novel ADC Linker-Payload Designs

2.00 pm Session Presented by

2.30 pm Evaluating Comprehensive Preclinical Development of IKS04: the First Anti-CA242 Ultra-Low DAR ADC Against Solid Tumours

• Introducing IKS04 ultra-low DAR approach co-dosed with antibodies
• Applying concepts of increased tumour penetration to highly potent PBDnprodrug payloads
• Reviewing the preclinical profile of IKS04 targeting GI solid tumours and highlighting future plans for clinical investigation

Jutta Deckert, Vice President, Research & Development, Iksuda Therapeutics

3.00 pm Broad-Spectrum Efficacy of
CEACAM6-Targeted ADC With BET
Protein Degrader

• Developing a novel ADC targeting CEACAM6 with BET protein degrader
• Demonstrating potent and broad spectrum efficacy in CRC, BC, and LC models
• Discussing combination therapy effects
with immune checkpoint inhibitors

Hiroyuki Kogai, Scientist, Eisai

Clinical Lessons

Chair: Gilles Gallant, Chief Development Officer, Mythic Therapeutics

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Breaking Down Emerging ADC Translational Profiles to Understand What Makes a Clinically Effective ADC

11.30 am Assessing Safety & Tolerability of MYTX-011, a cMET ADC in the Phase 1 KisMET-01 Study

• Reviewing the safety and tolerability of c-MET targeting agents focusing on c-MET ADCs
• Explaining MYTX-011 preclinical data and performance
• Describing the safety profile of MYTX-011 in a dose escalation first-in-human Phase 1 NSCLC study

Gilles Gallant, Chief Development Officer, Mythic Therapeutics

12.00 pm Applying Learnings From Clinical Development of SQ3370 to Optimise Development of Novel Tumour-Targeted Therapies

• Discussing safety and efficacy results from the phase 2 clinical programme of SQ3370
• Reviewing learnings from the clinical study and how they have informed design principles going forward
• Highlighting data from Shasqi’s lead asset targeting CEACAM5

Travis Biechele, Vice President, Research, Shasqi

12.30 pm PDL1V (PF-08046054): A First-in-Class PD-L1-Directed ADC with Promising Activity in 2L+ NSCLC

• PDL1V was engineered for enhanced potency through increased internalization and payload delivery
• PDL1V is efficacious across a broad range of PD-L1 expression & induces MMAE-mediated immune activation in vivo
• Interim results of a phase 1 Study of PDL1V in patients with PDL1-expressing solid tumours demonstrate promising activity in 2L+ NSCLC

Garrett Cornelison, Senior Principal Scientist, Pfizer

1.00 pm Lunch & Learn Sessions Presented by 

Invite only session

Showcasing & Contextualising Cutting-Edge ADC Clinical
Performance & Trial Design

2.00 pm CBP-1019, a Bispecific Small Molecular Conjugate From Preclinical to Clinical Development

• Showcasing a good example of translation from preclinical to clinical development
• Discussing how TRPV6-targeting conjugate is validated again in a clinical trial
• Displaying promising results in endometrial carcinoma

Guitao Wang, President, Research & Development, Coherent Biopharma

2.30 pm Cross Border Mindset as a Key Success Factor for Rapid & High-Quality Clinical Development of ADCs

• What is different in the development of an ADC as opposed to other molecules, and why does it matter?
• Evaluating cross-border mindset and partnerships as key tools to accelerate clinical development of ADCs
• Exploring case studies of ADC clinical development

Maria Dahl, Chief Operating Officer & Head, Europe, Innovent Biologics

3.00 pm Clinical Lessons Stream Closes

Process & Analytical Development

Chair: Paul Wolstenholme-Hogg, Vice President, Medicinal Chemistry, ADC Therapeutics

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Navigating Development & Validation of Biological Assays to Assess ADC Properties

11.30 am Detailing Bioassay Development & Applications in ADC Characterisation & Lot Release

• Exploring bioassays in place to support ongoing ADC development and characterisation
• Looking to the future – how much more can bioassays be used for ADC analysis?
• Explaining how bioassays fit into lot release and process

Uchechukwu Okorji-Obike, Senior Scientist, Bioassay Development, AstraZeneca

12.00 pm Intact Mass Analysis to Investigate In Vitro & In Vivo ADC Properties

• Leveraging hybrid immunocapture and HR-MS methods to assess ADC properties
• Investigating applications for in vivo DAR determination
• Investigating ADC stability characterisation

Federico Riccardi Sirtori, Director & Head, NBE-DMPK Innovative Bioanalytics, Merck KGaA

12.30 pm Antibody Drug Conjugates From a Bioanalytical Lab’s Perspective: LBA & LCMSMS Two Different Solutions for Similar Questions

• Unveiling the diverse and complex bioanalytical dataset needs for successful development of ADCs – the BA lab as a key partner
• Exploring approaches and types of data using LBA assays
• Explaining approaches and types of data using mass spectrometric assays

Daniel Schulz-Jander, Senior Director, Bioanalysis (Mass Spectrometry), QPS

1.00 pm Lunch & Learn Sessions Presented by 

Invite only session

Controlling ADC Process Through In-Depth Knowledge of Process Analytical Technologies

2.00 pm Residual Toxin Removal: Scale & Phase Appropriate Approaches & Challenges

• Using three model ADCs with variability in toxin-linker properties to explore residual toxin removal methods and their applicability across a set of key toxin classes
• Assessing challenges in residual toxin removal change from discovery to manufacturing
• Evaluating approaches to improving ADC quality with residual toxin removal

Alisdair Hearn, Senior Process Development Scientist, Sterling Pharma Solutions

2.30 pm Risk Evaluation of Nitrosamine Impurities in Drug-Linker Intermediates Used to Generate ADCs

• Providing a science-based, holistic approach to evaluating the risks of nitrosamine presence in drug-linker as intermediates towards ADC drug substances
• Demonstrating that chemically synthesised fragments of ADCs are
unlikely to lead to nitrosamine presence in the final drug product
• Proposing a simplified abbreviated workflow for quality risk management of nitrosamines in drug-linkers

Osama Chahrour, Principal Scientist, Chemical Development, AstraZeneca

3.00 pm Roundtable Discussion: Brainstorming Novel Conjugation Methods to Improve ADC Product Quality & Yield

• Discussing the challenges in achieving desired product quality and yield in ADC synthesis and conjugation
• Exploring the benefits of site-specific conjugation technologies in ADC process optimisation– what has been demonstrated to simplify process testing so far?
• Debating the top considerations from ADC process development impacting process robustness and product quality control

Manufacturing & Supply Chain

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Maintaining & Upgrading ADC Manufacturing Under Accelerated Clinical Timelines

11.30 am Accelerating HPAPI & ADC Manufacturing Process Optimization with Artificial Intelligence

• Leveraging AI to advance clinical and commercial manufacturing processes
• Presenting case studies that highlight AI predictions paired with experimental validation
• Introducing an innovative alternative to traditional empirical/heuristic PRD approaches

Rohtash Kumar, Senior Vice President, Development Operations & Chief Technology Officer, Veranova

12.00 pm Managing CMC Challenges & Capabilities Across Complex ADC Supply Chain

• Evaluating challenges and opportunities in ADC development and CMC
• Exploring CMC strategy across ADC components: drug-linker, mAbs, DS and DP
• Highlighting strategies for effective ADC manufacturing supply chain

Francois D’Hooge, Tech Management Lead, ADC Drug Substance, Daiichi Sankyo

Meike Roskamp, Director, Bioconjugation, Daiichi Sankyo

12.30 pm Session Presented by

1.00 pm Lunch & Learn Sessions Presented by 

Invite only session

Exploring ADC Best Practices & Strategy for Safe Manufacturing at Scale

2.00 pm Integrating Highly Potent Drug Safety Into ADC Development & Manufacturing

• Integrating HPAPI Occupational Health and Safety within ADC manufacturing projects – getting the strategic decisions right
• Exploring ADC component hazard assessments (occupational toxicology) and risk assessments across targeting moieties and payloads
• Covering API Containment and Control in all ADC working environments

Justin Mason-Home, Director, HPAPI Project Services Limited

2.30 pm Roundtable Discussion: Breaking Down the Top Opportunities to Overcome ADC Manufacturing & Supply Chain Bottlenecks

Join this closing roundtable session with leaders in the ADC CMC field to break down the key learnings from the two days of presentations and discussion. With your fellow speakers and attendees, discuss, debate and evaluate the opportunities and challenges in ADC manufacturing timelines, navigating supply with multiple outsourcing partners, technology transfer and scale-up, and more.

3.00 pm Manufacturing & Supply Chain Stream Closes