March 2020
London

 

Day One
Tuesday 5th March 2019

Day Two
Wednesday 6th March 2019

08.00
Chair’s Opening Remarks

  • Alain Beck Senior Director, Biologics CMC and developability, Pierre Fabre Laboratories

08.10
Riding the ADC Rollercoaster: In-Depth Review of Current ADC Field, as well as Insights on Hotspots of Innovation

  • Alain Beck Senior Director, Biologics CMC and developability, Pierre Fabre Laboratories

Synopsis

• Reviewing the last 12 months of ADC research; lessons learned and current priorities for drug developers in ADC research
• Discuss strategies to select the best target antigens, as well as suitable cytotoxic drugs; the design of optimised linkers; the discovery of biorthogonal conjugation chemistries and cytotoxic issues
• Increasing homogeneity and stability through selection and engineering of antibodies for site-specific drug conjugation
• Exploring novel payload chemistries with differentiated mechanisms of action

08.40
Preclinical Development of a RAGE ADC for Gynaecological Cancers

  • Deyarina Gonzalez Associate Professor of Molecular Medicine , Swansea University Medical School

Synopsis

• Focus on gynaecological cancers
• Preclinical testing on patient derived 3D models
• Clinical pipeline, exploring new targets in silico analysis

09.10
Keynote: Lessons Learned from the Successful & Failed ADCs in Cancer Treatment: Moving Forward & Creating the Best Magic Bullets

  • Rakesh Dixit Vice President & Global Head, Biologics, MedImmune

Synopsis

• Maximising the therapeutic index of ADCs has proven challenging because of the complexity of the molecules. This Keynote will review lessons learned from both clinically successful and unsuccessful ADCs
• Addressing the challenges which are preventing the development of magic bullets
• Learning novel approaches and technologies to move ADC forward

09.40
Speed Networking

Synopsis

This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the ADC field and establish meaningful business relationships.

10.30
Morning Refreshments

Discovering New Era Payloads with Differentiated Mechanisms of Action

11.00 Exploring Novel Lower Potency PBD Payloads

  • Next generation PBD payloads
  • Warhead optimisation
  •  Exploring the effect of N10 Capping group

Philip Howard, Chief Scientific Officer, Spirogen

11.30 Tunable Drug Conjugates - Redefining Drug Conjugate Therapies for the Treatment of Cancer

  • TDCs utilize a modular set of ligands, linkers and payloads with aligned characteristics to enable both rapid payload release in the tumor and rapid systemic clearance with the goal of significant improvements in Therapeutic Index
  • TDCs employ proprietary pH-sensitive SiLinkers and Payload Cassette technology, as well as  Conditionally Activated Payloads (CAPs) whose features align with the design characteristics of TDCs
  • We have validated core components of the platform in a comprehensive Folate Receptor alpha targeted program

Jutta Wanner, Chief Scientific Officer, BlinkBio

12.00 Targeting uPARAP in Sarcoma with ADCs Carrying a Site-Specific PBD Payload

  • The physiological function and structure of uPARAP
  • Expression pattern of uPARAP allows highly specific targeting using ADCs in several cancer forms
  • Production and humanisation of anti-uPARAP antibodies, and optimisation of anti-uPARAP based ADCs and their effect on cancer cells

Andreas Hald, Research Associate, Copenhagen University Hospital

Solving the Mystery: ADC Internalisation & Trafficking

11.00 Minimising Off Target Toxicity of ADCs

  • Mechanisms of off-target toxicity of ADCs
  • Approaches to minimise off-target toxicities
  • Innovative models to assist preclinical safety evaluation

Hong Wang, Associate Director & Senior Scientist, Development Toxicology, Genentech

11.30 Quantitative Evaluation & Critical Analysis of ADC Bystander Effect

  • This presentation will provide quantitative perspective on in vitro and in vivo bystander effect of ADCs
  • It will highlight how one can optimize dosing regimen to maximise the bystander effect of ADCs
  • The presentation will also demonstrate how an ADC with the bystander effect behaves differently when it comes to antibody coadministration strategy to overcome the binding-site barrier for ADCs

Dhaval Shah, Assistant Professor, Department, Pharmaceutical Sciences, State University of New York at Buffalo

12.00 Absolute Quantification of mAbs & ADCs: Forget Amino Acid Analysis & Shift to the New Gold Standard

  • Limitations of AAA in terms of precision, accuracy and throughput
  • Development of an innovative method based on sulfur quantification by ICP-MS/MS
  • Presentation of validation data that confirm the unparalleled performance of the ICP-MS/MS method
  • Application to ADCs

Arnaud Delobel, Director, Research & Development, Quality Assistance

Reviewing Strategies & Technologies to Minimise ADC Manufacturing Costs

11.00 Strategy for a smooth transfer and scale-up at a CDMO

• Analytical optimisation
• Services and methods
• Analytical development
• ADCs characterisation

Melanie Derde, Head, Analytical, Bioconjugation, Novasep

11.30 Scale-up Synthesis of the PBD Drug-Linker Tesirine

  • How challenges arising during the 34 steps synthesis of tesirine were overcome
  • Why investing in a robust supply chain is key to a successful delivery
  • Remaining challenges and opportunities
  • How these synthetic and supply chains improvements can be translated to the delivery of future payloads

Arnaud Tiberghien, Scientist, Medicinal Chemistry, Spirogen

12.00 Conjugation & Fill Finish: How to Secure the Supply Chain of ADCs

• Overview of the supply chain
• Driving a clinical product to the BLA
• Setting a robust commercial supply

Giorgio Salciarini, Technical Business Development Manager, BSP Pharmaceuticals

12.30
Lunch & Networking

12.30
Lunch Seminar: Fast, Easy and Accurate DAR Measurement using SCIEX X500B QTOF System and BioPharmaView™ Software

Synopsis

Fast, Easy and Accurate DAR Measurement using SCIEX X500B QTOF System and BioPharmaView™ Software
• High resolution molecular weight (MW) determination
• Fast and detailed report generation
• Easy to operate X500B Mass Spectrometer

SCIEX Biotransform Solution featuring MetabolitePilotTM 2.0 Software
• Comprehensive Drug metabolism and processing workflow for small molecule, peptides and ADCs
• Dedicated ADC processing workflow and structural assignment that performs targeted searching for all components of the ADC: payload, linker and antibody
• Integrated correlation function allows comparison of metabolism across multiple samples for time course studies or inter-species comparison, using both MS and analog data.

 

Register here

Sharing Innovations in Linker Chemistry

14.00 Tubulis® – A novel Platform for Next-Gen ADC Development

  •  ADCs are fascinating multi-component drugs consisting of a biological entity and a chemical small molecule entity
  • However, despite great potential to enable targeted chemotherapy, ADCs struggle to translate to the clinics
  • Tubulis® aims to provide a novel platform solution to catalyze successful ADC development

Jonas Helma, Project Leader, Biology, Ludwig

14.30 Novel Immune-Stimmulatory ADCs (iADCs) for Effective Targeting of Solid Tumours

  • Exploring site-specific conjugates with ultra-potent anthracycline toxins
  • Discovering immune-oncology function of NBE’s iADCs
  • Reviewing Preclinical validation of a ROR1 targeting iADC

Ulf Grawunder, Chief Executive Officer, NBE Therapeutics

15.00 Original Rebridging Technology Giving Access to Optimised ADCs Exemplified In HER2+ Model

  • Synthesis and characterisation of McSAF’s conjugates
  • Evaluation in a HER2+ model
  • Optimised ADC compared favourably to Kadcyla®

Camille Martin, External R&D Director, McSAF

Sharing Preclinical Lessons Learned to Confidently Translate into the Clinic

14.00 Practical Aspects of Applying Preclinical Data to Clinical Biomarker Planning

  • Discussing types of preclinical work that can inform development planning
  • A focus on immunohistochemistry assay development/threshold setting
  • Practical applications of preclinical data to plan for clinical development

Rebecca Mosher, Executive Director, Translational Medicine, Mersana Therapeutics

14.30 Clinical & Non-clinical Translational of Dose-limiting Toxicities Associated with DNA Damaging Conjugates

  • Clinical landscape of DNA damaging conjugates
  • Review of preclinical translation for major dose-limiting toxicities associated with DNA damaging
  • Mylotarg case example – preclinical model for hepatic Veno-Occlusive Disease (VOD) and thrombocytopenia

Hadi Falahatpisheh, Research Fellow, AbbVie-Stemcentrx

15.00 Panel: Designing Preclinical Studies that Signal Future Clinical Trends

  • Assessing how we can alter the design of our studies to predict
    trends
  • How this can be used to enhance translation into the clinic
  •  How the technology can be used to ‘fill the gaps’

Steven Coats, Rebecca Mosher, Hadi Falahatpisheh

Unravelling the Complexity of ADC Manufacturing: Global Supply Chains

14.00 Platforming Antibody Drug Conjugate Process Development & Manufacturing Using Single Use Technologies

  • Single-use manufacturing technologies allow companies to quickly bring cGMP manufacturing capability online with less capital investment.
  • Here we describe a robust and scalable platform for ADC process development and manufacturing that uses single-use technologies to accelerate development timelines and increase manufacturing predictability while decreasing scale up risks.
  • In addition, chemical compatibility of the materials described in the platform to solvents typically used in ADC process will be discussed.

Ian Schwartz, Technology Consultant, Bioconjugation, Sartorius Stedim

Unravelling the Complexity of ADC Manufacturing: Global Supply Chains

14.30 Key CMC Considerations for Robust ADC Process Development & to Effectively Manage the CMC Supply Chain

  • Delving into the unique technical challenges ADCs create which require careful CMC considerations
  • Discussing insights on how to develop transferrable ADC processes
  • Sharing experiences on how to confidently manage the complexity in ADC supply chains

Eric Lacoste, Head, Bio-Organic, Chemistry Team, Sanofi

15.00 Working with a CMO in the ADC field – From Selection & Technology Transfer to Scale-up and GMP Manufacture

  • Typical challenges faced by companies searching for a CMO. What to consider when comparing options available on the market.
  • Process knowledge transfer to your chosen CMO. Common pitfalls and how to avoid them.
  • Managing all the moving pieces to bring your ADC to the clinic. What does developing an ADC have in common with a small molecule process and what is unique?
  • Models of typical conjugation processes will be included to illustrate the topics being presented.

Scott Miller, Senior Scientific Advisor, CARBOGEN AMCIS

Mitigating Toxicities to Maximise the Therapeutic Index of ADCs

15.30
Afternoon Refreshments & Networking

16.00
7 Minute Short-Fire Poster Presentation Talks

Synopsis

Capturing the scientific highlights of the World ADC London Poster Session. The Short-Fire Presentation talks will put the spotlight on exceptional posters. Scientific Posters to be Presented:

Streptavidin-Biotin conjugation as rapid and cost-effective platform to screen antibodies and payloads for ADC development Ricarda Melina Hoffmann, King’s College London

Straightforward Site-Specific Payload Attachment to Native Antibodies without Antibody Engineering

Philipp Spycher, Paul Scherrer Institute

Simple, Efficient Production of Homogeneous, Site-Specific ADCs With Transglutaminase

Jared Spidel, Eisai Inc

16.30
Development of a Novel Chemical Site-Specific ADC Conjugation Platform with Enhanced Therapeutic Window

Synopsis

  • One of the difficulties often encountered during the chemical modification of native non-engineered antibodies is the lack of selectivity that can be dialed in toward a specific residue.
  • We describe a new platform for the site-selective conjugation of antibodies through the use of a novel class of IgG Fc-affinity peptide reagents to install payload-compatible linkers to well-defined amino acid residues.
  • The activity of these resulting DAR2 ADCs will be reviewed and assessed compared to the state-of-the-art.

 

17.00
Preclinical Pharmacokinetics & Pharmacodynamics of DCLL9718A: an Antibody Drug Conjugate for the Treatment of Acute Myeloid Leukaemia

Synopsis

• Explore the development of a novel ADC – DCLL9718A is an antibody-drug conjugate that targets C-type lectin-like molecule-1 (CLL-1)
• Reviewing data the characterisation of the in vitro and in vivo stability, the pharmacokinetics (PK) and pharmacodynamics (PD) of DCLL9718A and MCLL0517A in rodents and cynomolgus monkeys
• Discussing key PK analytes to measure to deepen understanding of ADC in vivo behaviour

17.30
Chair’s Closing Remarks

  • Alain Beck Senior Director, Biologics CMC and developability, Pierre Fabre Laboratories

17.40
Scientific Poster Session

Synopsis

After the formal presentations have finished, the learning and networking carries on. The Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. During this session over 25 scientific posters will be presented from novel linker designs to validation of site specific conjugation technologies and more informative in vivo models.