3rd Novel Conjugates Day

Chair: Kevin Hamblett, Senior Director, ADC
Biology, Pfizer

ADC design innovation is booming with conjugates comprising non-traditional payloads and targeting moieties beyond antibodies. This not only expands the mechanisms of action and multi-target capability but also opens the door to applications beyond oncology. Join this seminar day to discover non-cytotoxic payloads across DACs and AOCs, bispecific ADC design and rationale, dual payload and high DAR ADCs, and bioconjugate applications in neurological diseases

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Assessing the New Frontier of ADC Payloads: How Do They Compare to the Tried & Tested Classics?

09.30 am Diving Deeper into the Next Wave of ADCs

• Breaking down the novel drug conjugate landscape
• Exploring emerging drug conjugate modalities
and targets
• Understanding the trial landscape of novel drug conjugates

Yu-Shin Hsu, Research Analyst, Beacon by Hanson Wade

10.00 am Targeted PROTAC Delivery: Principles of Crafting PROTAC-ADCs & Self-Assembling PROxAb Shuttles

• Summarising the current technological status of Degrader-ADCs, emphasising the challenges in their generation
• Introducing the PROxAb Shuttle technology, which has the potential to expedite Degrader-ADC discovery
• Presenting data showcasing the practical application of the PROxAb Shuttle in vivo

Marcel Rieker, Team Leader, PROxAb Shuttle, Merck KGaA

10.30 am Exploring Delivery of BET Protein Degrader to Pancreatic Cancer & Microenvironment via CEACAM6-Targeted Degrader-Antibody Conjugate

• Discovering a novel payload effective on PDAC, BET protein degrader
• Exploring a novel degrader-antibody conjugate (DAC) targeting CEACAM6
• Showcasing anti-cancer efficacy and microenvironment modulation in PDAC models

Shuntaro Tsukamoto, Scientist, Eisai

11.00 am Morning Break & Networking

Investigating Applications of ADCs & Conjugated Therapies in Indications Beyond Oncology

11.30 am Bioconjugates in Neuroscience: Developing & Delivering Antibody-Oligonucleotide Conjugates Using BrainshuttleTM Technology

• Leveraging transferrin brain shuttle technology to deliver antibody oligonucleotide conjugates to the brain
• Applying learnings from ADC conjugation and linker knowledge to inform bioconjugate design and biophysical properties
• Outlining opportunities and challenges of applying antibody oligonucleotide conjugates in neuroscience

Kerstin Hofer, Matrix & Science Lead, Roche

12.00 pm Showcasing Enhanced Tumour Penetration & Activity of Antibody Fragment Conjugates Using Novel Site-Specific Conjugation

• Introducing novel site-specific conjugation technology allowing one-step conjugation and simplification of in process testing
• Applying one-step conjugation to antibody variable region to develop fragment-drug conjugates
• Assessing increased tumour penetration and activity properties of fragment conjugates against HER2 and EGFR/cMET

NingNing Ma, Professor, Shenyang Pharmaceutical University

12.30 pm Lunch & Networking

Two is Better Than One: Investigating Dual Target & Dual Payload ADC Design

1.30 pm Showcasing Target Rationale & Payload Selection Across Bispecific & Dual Payload ADC Development

• Outlining current challenges facing ADCs and opportunities for innovative design
• Explaining target and format rationale selection in bispecific ADC development
• Exploring payload selection and conjugation strategies for dual payload ADCs

Ming-Tain Lai, Chief Scientific Officer, OBI Pharma

2.00 pm ABL206 & ABL209: Bispecific ADC as Next Generation of ADC May Overcome Current Clinical Limitations

• Investigating synergistic cancer-killing effect by targeting two different targets on cancer cells
• Outlining recent discovery research of bispecific ADC
• Contrasting advantages and challenges of bispecific ADC development against traditional ADC design

Jinwon Jung, Senior Director, Protein Engineering,ABL Bio

2.30 pm Afternoon Break & Networking

2nd Toxicity Day

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

Despite ADCs’ groundbreaking progress in oncology treatments; understanding, predicting and mitigating toxicity remains the great
translational challenge stopping them from reaching patients faster. Don’t miss this seminar day to identify the mechanisms of on- and off-target toxicity, leverage in vitro and in vivo models to predict ADC clinical safety, and understand the toxicity profiles of ADC with novel linker payloads and targets

Download the Full Event Guide for full details

Characterising On & Off Target Toxicity to Develop Mitigation Strategies in the Clinic

9.30 am Demonstrating Importance & Explaining Best Methods to Understand ADC Toxicity Mechanisms

• Breaking down challenges in not fully understanding ADC toxicity mechanisms
• Exploring the use of in vitro models to understand ADC lung and liver toxicity mechanism characterisation
• What are the factors preventing the wider use of in vitro models in ADC toxicity studies?

Rakesh Dixit, President & Chief Executive Officer, Bionavigen Oncology

10.00 am Exploring the Correlation Between Toxicity & Linker Technologies for Topo1 Class ADCs

• Outlining a holistic review of early toxicity data associated with 2nd and 3rd generation linkers for Topo1 class ADCs
• Exploring novel drug conjugate classes and target disease indications
• Laying out Topo1 class ADC growth trend by geography

Callum Angus, Senior Market Analyst, Hanson Wade Intelligence

10.30 am Antibody-Drug Conjugates in Ovarian Cancer: Pioneering a New Era in Targeted Therapy

• A variety of therapeutic targets with high expression in ovarian cancer, combined with different payloads, is currently being evaluated to bring a wide range of opportunities to patients
• The therapeutic index (benefit/adverse effects) appears promising, positioning ADCs as a potential new standard of care in different settings of the disease
• Large efforts have been made to establish mitigation and prevention strategies to manage potential toxicity

David Garcia Illescas, Medical Oncologist, Gynaecological Cancer Programme, University Hospital Vall d’Hebron

11.00 am Morning Break & Networking

Contrasting Toxicity & Tolerability Profiles With Novel ADC Linker- Payloads & Targets

11.30 am Exploring Discovery & Preclinical Investigation of a Novel ADC Targeting Gastrointestinal Cancer

• Exploiting novel and underexplored targets to deliver potential first-in-class ADCs for gastrointestinal cancers
• Understanding and managing the challenges and safety profile of on-target toxicities of GI targets
• Widening the ADC therapeutic window by matching target biology with the linker-payload design

Martin Steegmaier, Chief Scientific Officer, SOTIO Biotech

12.00 pm Using Patient-Derived Organoids to Prioritise ADC Clinical Development & Derisk Early Toxicities

• Exploring how HUB Organoid Technology allows for the development of patient-derived organoids relevant with high fidelity to the original tumour
• Discussing how HUB Organoids can be used to derisk the preclinical development of ADC, prioritise indications, uncover off-target toxicities, and complement your biomarker strategy
• Assessing how the next frontier for Organoids in ADC will see mode of action studies being performed to optimize clinical candidates and prioritise patient selection

Eider Valle-Encinas, Scientific Business Development Manager, HUB Organoids

12.30 pm Lunch & Networking

Leveraging Non-Clinical Studies to Best
Predict ADC Toxicities

1.30 pm From Bench to Bedside: Translating Safe Toxicity Profiles of Amanitin-Based ADCs to Clinical Applications

• Addressing how the preclinical toxicity profile of HDP-101 can predict clinical safety outcomes
• Comparing the toxicity profile of amanitin-based ADCs across preclinical models and patients
• Exploring strategies to refine the pharmacokinetics and treatment regimens of amanitin-based ADCs

Sarah-Jane Neuberth, Group Leader In Vivo Biology,Heidelberg Pharma

2.00 pm Assessing Non-Clinical Safety Profile of M9140 & the Putative Mechanism Behind ILD

• The therapeutic window of ADCS remains challenging due to safety issues such as ILD observed with specific deruxtecan-based ADCs
• The current safety data of M9140 from NHP models are discussed with special focus on the absence or presence of ILD with other antibody camptothecin-conjugates, for which a hypothetical pathogenic mechanism is postulated
• M9140 is in clinical phase 1b/2 currently to investigate treatment of solid tumours overexpressing CEACAM5

Willem Sloot, Associate Director, Non-Clinical Drug Safety, Merck KGaA

2.30 pm Afternoon Break & Networking

3rd ADCs in Combination Day

Chair: Sharsti Sandall, Senior Director, Research, ADC Programs, Pfizer

As the number of ADC combination therapies rapidly grows, smartly selecting the combination partner is critical for success. The right decision will help your ADC overcome resistance and best position it to reshape the standard of oncology care. Attend this seminar day
for a breakdown of clinical stage ADCimmunotherapy performance, understand the rationale for selecting effective combination partners, and explore ADCs in sequence to counter resistance mechanisms

Download the Full Event Guide for full details

Evaluating Clinical Stage ADCImmunotherapy
Combinations & Performance

9.30 am Breaking Down Clinical Combination Therapy Data of Belantamab Mafodotin in Treatment of Relapsed or Refractory Multiple Myeloma

• Laying out the foundation to believe in combinations with Blenrep in Multiple Myeloma: BCMA target, MOA for Blenrep, and data from previous clinical trials
• Assessing results from DREAMM7 and DREAMM8 study in Multiple Myeloma

Joanna Opalinska, Senior Director, Clinical Development, GSK

10.00 am Translational Learnings From Enhertu in HER2-Positive & HER2-Low Breast Cancer & Beyond: Providing Context for ADC Combinations

• Contextualising Enhertu translational data from DestinyBreast-03 and DestinyBreast-04 trials and beyond
• Overlapping and distinct mechanisms relating to Enhertu activity for HER2-low vs. HER2-positive breast cancer
• Translational rationale in the design of ADC combinations

Aislyn Boran, Senior Director, Translational Strategy, Daiichi Sankyo

10.30 am Cancer Immunotherapy Combined With ADCs: Exploiting Novel & Rational Combinations

• Combining cancer immunotherapy with ADCs: Independent action versus synergy
• Cancer immunotherapy combined with ADCs: Combinations based on efficacy response
• Does adding in chemotherapy provide additional benefit to cancer immunotherapy combined with ADC’s?

Michael Chisamore, Executive Medical Director (Distinguished Scientist), Oncology Clinical Research, Early Development, MSD

11.00 am Morning Break & Networking

Delving Into ADC Immunotherapy Rationale & Mechanism – What Makes an Effective Pairing?

11:30 am Investigating ADC Biomarkers to Optimise
Clinical Trials & Evaluate ADC-Immunotherapy
Combinations

• Exploring genomic biomarkers to inform ADC patient selection and precision oncology clinical development
• Leveraging real world data to investigate genomic signatures and retrospectively identify enriched patient populations
• Understanding biomarkers to identify synergy in ADC-immunotherapy combinations

Alireza Tafazzol, Senior Scientist II, Oncology Bioinformatics, AbbVie

12:00 pm Laying Out Preclinical Investigation to Validate the Rationale for ADC-Immunotherapy Combinations

• Contextualising the landscape and future perspectives of ADC-immunotherapy combinations
• Assessing preclinical combination thesis: what are the best agents to combine with ADCs?
• Breaking down preclinical investigation and use of models to understand ADC-immunotherapy mechanism and rationale

Irena Adkins, Director, Pharmacology, SOTIO Biotech

12.30 pm Lunch & Networking

Exploring Benefits of Sequential ADC Combinations to Tackle Patient Resistance

1:30 pm Rational Selection of Antibody-Drug Conjugates for Tumours Expressing Multiple Receptors

• Outlining how as more ADCs are clinically approved, patients eligible for 2 or more ADCs will become more frequent, leading to decisions on treatment selection
• Discussing how average expression levels of the targets are important, but how antigen heterogeneity can also play a role
• Showcasing a rational framework for predicting the efficacy of ADCs against different targets in the same tumour to guide preclinical and clinical studies

Greg Thurber, Associate Professor & Chair, Graduate Education, University of Michigan

2:00 pm Roundtable Discussion: What Are the Benefits & Limitations of ADC Combinations?

• Discussing and debating the potential of dual payloads and ADC therapy sequences to help combat ADC patient resistance
• What are the lessons learnt from ongoing clinical stage ADC combination trials?
• Evaluating the best strategic approaches to select ADC combination partners with rationale and evidence-based decision-making

Sharsti Sandall, Executive Director, Oncology Research, Pfizer

2.30 pm Afternoon Break & Networking

1st Regulatory CMC Day

Chair: Colm Reddington, Senior Director, Global Regulatory CMC, AstraZeneca

As ADCs globally advance quickly towards regulatory submissions; understanding the necessary specifications, dossier filing data, and evolving regulatory attitudes is vital for successful approval and commercialisation. Join this redesigned seminar day to tackle ADC modality-specific challenges, streamline impurity control strategy, and discuss the important areas for ongoing industry regulator communication

Download the Full Event Guide for full details

Tackling ADC Regulatory CMC Strategy as Intermediates Between Biologic & Small Molecules

9.30 am Understanding High-Level Regulatory Guidance for Linker-Payload, Monoclonal Antibody & Conjugate Control Strategy

• Introducing global regulatory attitudes and guidance for ADC component and conjugate control strategy
• Approaching ADC regulatory CMC strategy as a biologic-small molecule intermediate
• Highlighting experiences, challenges and lessons learnt in ADC control strategy development

Colm Reddington, Senior Director, Global Regulatory CMC, AstraZeneca

10.00 am Exploring Scientific Understanding & Analytical Control Strategy of ADC Heterogeneity

• Exploring how ADCs are composed of both small molecule and large molecule components and need additional points of analytical control and intensified characterisation
• Outlining heterogeneities of ADCs including charge, size, post-translational modification variants, and DAR distribution originating from the mAb, drug-linker and the conjugation process
• Discussing the inherent heterogeneity of ADC and the analytical control strategy

Daisy Sun, Principal Scientist, Cell-Based Sciences, MSD

10.30 am Achieving a Shorter ADC Time-to-Clinic Through Early CMC Planning & Stakeholder Alignment

• Designing a multipronged strategy based on risk analysis and contingency planning to streamline the development of an ADC program
• Exploring how early alignment of technical, regulatory, and supply chain factors can support parallel executions, expedite studies and open accelerated options, saving months in time-to-clinic
• Outlining how the methodic and dynamic alignment of internal and external stakeholders and factors is key in the execution of a streamlined CMC strategy

Sonia Appel, Founder & Principal Consultant,Alismere

11.00 am Morning Break & Networking

Contextualising ADC Regulatory CMC Attitudes & Debating Important Areas for Future Guidance

11.30 am Audience Activity Session: Discussing Challenges & Opportunities With Existing ADC Regulatory CMC Legislation & Data Submissions

Maintaining constructive bi-directional communication between sponsors and regulators is crucial for successful ADC approval and commercialisation as a unique and emerging modality.

Join individual table discussions moderated by ADC regulatory CMC leaders with prepared discussion points surrounding the opportunities and setbacks of global regulatory guidance. Make sure you come with your thoughts and questions prepared!

Discussion highlights include:
• Evaluating the challenges of preparing for ADC regulatory submissions under accelerated timelines with limited manufacturing experience
• Comparing and contrasting the ADC regulatory CMC across global health authorities
• Debating the sponsor perspective – what are the top areas to prioritise for future industry-regulator interactions

Hayley Jackman, Director, CMC Regulatory Affairs, AstraZeneca

12.30 pm Lunch & Networking

Ensuring Internal & External Alignment to Streamline ADC Regulatory CMC Strategy Execution

1.30 pm Perspectives on Regulatory CMC Strategies for Drug-Linkers in Antibody-Drug Conjugates

• Sharing IQ consortium proposals for regulatory considerations on drug-linker in ADC development, aiming to align drug linker development and regulatory expectations
• Discussing perspectives on major regulatory strategies from practical, scientific and risk-based investigation from early development to registration
• Addressing approaches to regulatory starting material designation, controls and control strategies, accelerated process validation, regulatory filing documentation, characterisation, and stability

Llorente Bonaga, Senior Director, Global Regulatory Affairs & Clinical Safety, CMC, MSD

2.00 pm Roundtable Discussion: What are the Key Opportunities for Success & Improvement in ADC Regulatory CMC?

Join this closing roundtable session with leaders in ADC regulatory CMC field to break down the key learnings from the seminar day. With your fellow speakers and attendees, discuss, debate and evaluate the opportunities and challenges in ADC regulatory CMC guidance, analytical control strategy, creating development packages, and more.

Colm Reddington, Senior Director, Global Regulatory CMC, AstraZeneca

2.30 pm Afternoon Break & Networking