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Day One

Tuesday, 3rd March, 2020

8:30 am Chair’s Opening Remarks

  • Alain Beck Senior Director, Biologics CMC & developability, Pierre Fabre

8:40 am Is There Method in the Madness? What Have we Learnt from the Last Decade of ADCs

  • Alain Beck Senior Director, Biologics CMC & developability, Pierre Fabre

Synopsis

  • Review the lessons from successes and failures
  • Assess 1st, 2nd, 3rd and next-generation ADCs
  • Discuss ADCs to watch in 2020/2021

9:10 am Impact of Drug Load & DAR of an ADC on Binding & Potency

Synopsis

  • Identification of sites of conjugation on a cysteine-based ADC
  • Impact of drug load and DAR on binding and in vitro and in vivo potency
  • Understanding of the structure-function relationship of drug load and DAR

9:40 am Sacituzumab Govitecan – A Clinical Development Update Across Multiple Indications

Synopsis

  •  A brief introduction on the unique background of SG
  • Clinical update on metastatic TNBC
  • Clinical update on HR+ metastatic Breast Cancer
  •  Clinical update on metastatic Urothelial Cancer

10:10 am 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.

11:00 am Morning Refreshments

Discovery Chemistry Stream

Discovery Biology Stream

Translational Steam

CMC Stream

Let’s Focus on the New, Novel Format Payloads & Looking Outside the Payload Box

Developing More Targeted & Stable ADCs with Next Generation Engineered Antibodies

Focusing on the Relationship of Half Life & Clearance Rates with Efficacy & Safety, to Gain Better Modelling & Improved Prediction

Securing Your Robust ADC Supply Chain & Conjugation Techniques

12.00 NAMPT & Eg5 Inhibitors – Two Novel Payload Classes for Antibody drug Conjugates

  • Exploring insights into discovery of two novel payload classes
  • Evaluating Nicotinamide Phosphoribosyltransferase (NAMPT) Inhibitors as a novel payload class with non-antimitotic mode of action
  • Assessing the discovery of potent and selective ADCs with Eg5 inhibitors through linker and payload optimisation

Alexei Karpov, Senior Investigator I, Novartis

12.00 Efficacy of the Antibody-Drug Conjugate W0101 in Preclinical Models of IGF-1 Receptor Overexpressing Solid Tumours

  • Evaluating W0101; a unique IGF1Rtargeted ADC, designed to deliver a highly potent cytotoxic auristatin derivative selectively to IGF-1R overexpressing tumour cells
  • The monoclonal antibody (hz208F2-4) used to prepare the ADC was selected for its specific binding properties to IGF-1R compared to the insulin receptor (IR), and for its internalization properties
  • Examining how W0101 induced receptor-dependent cell cytotoxicity in vitro when applied to various cell lines overexpressing IGF-1R but it did not affect normal cells

Barbara AKLA, Senior Scientist, Pierre Fabre

12.00 Phase 1 Interim Data of MORAb-202 as Eribulin Conjugated Anti FRATargeted ADC

  • • MORAb-202 is the first ADC which is loaded with HALAVEN® as payload
  • • HALAVEN® is an approved drug which exhibits unique effects on tumor microenvironment
  • • The interim data of MORAb-202 Phase 1 study in Japan is to be discussed

Keiji Furuuchi, Director, Preclinical Development Epochal Precision AntiCancer Therapeutics (EPAT), OBG, Eisai

 

12.00 Thinking to the Future of ADCs

  • Reviewing the complexity of supply chain for ADCs
  • Securing commercial supply
  • Looking to the future of ADCs

Giorgio Salciarini, Senior Manager - Technical Business Development, BSP

12:30 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 & Founder, NBE Therapeutics

12.30 Panel DIscussion: Putting Antibodies Through the PK Case Study 

  • Selecting the case study that protects
  • the antibody by increasing half life
  • Modifying antibodies by increasing the half life

12.30 Fast, Easy & Accurate DAR Measurement using SCIEX X500B QTOF System & BioPharmaView™ Software

  • Evaluating high resolution molecular weight (MW) determination
  • Demonstrating and detailed report generation
  • Reviewing to operate X500B Mass Spectrometer

Sibylle Heidelberger, Senior Specialist - Support, SCIEX

12:30 From Research to Commercial: A Conjugation Scale-up Primer • What is involved in scale-up beyond volume

  • What are the challenges from development to Phase I and beyond
  • Managing expectations in moving to GMP manufacturing

Rich Reynolds, Principal Scientist, Conjugation Process Development, Seattle Genetics

13.00 Panel Discussion: Validating Tblabeled Radioconjugates for Cancer Therapy 

  • Delving into the exciting world of radioconjugates this panel will focus on the challenges that come with these novel formats
  • Validating Tblabeled Radioconjugates for Cancer Therapy with Auger Electrons

13.00 Targeting the Receptor for Advanced Glycation Endproducts (RAGE): An ADC Perspective

  • Reviewing the preclinical development of RAGE-ADC versions • Focusing on ovarian cancer
  • Update on Swansea ADC clinical pipeline and development platforms

Deya Gonzalez , Associate Professor, University of Swansea

13.00 Translational Modelling for a Novel ADC to Support Safe & Efficacious Dosing Regimen in Patients

  •  A PKPD model was developed using PK and tumour growth data collected from mouse xenograft tumour and allow to characterize the tumour-static concentrations (TSC) where the tumour growth and killing rates nullify each other
  • Targeting trough concentrations of W0101 above the in vivo TSC value, a clinical efficacious dosing regimen could be predicted
  • A PK-Toxicodynamic model was developed to characterize ADC induced toxicity in monkey and used to simulate potential patient outcomes

Julie Desrivot-Quénelle, PKPD Project Lead, Pierre Fabre

13.00 When to Apply Design of Experiments (DoE) to ADC Development

• Example of a DoE applied to Analytical method development

• When DoE is not an applicable tool and what can be implemented in its place

• Highlights from a project where a 2-block response surface DoE increased process robustness

Justin Sweeley, Senior Technology Manager, Biologics, Novasep

1:30 pm Lunch & Networking

Refreshing the “Middle-Man”, Looking at & Enhancing Novel Linker Technologies

Delving into the World of Alternative Format Conjugates to Enhance Tumour Penetration

Building your ADC Toolkit; Exploring the Best in Vitro & in Vivo Tools for Preclinical Translation

Reviewing How Drug Product & Formulation Enhances Process Development

15.00 OligoTEA Linkers: A Platform for Multifunctional Antibody Conjugates & Quantification of Intracellular Processes

  • Reviewing site-specific conjugation techniques
  • Understanding how sequence-defined linkers affect in vitro ADC potency
  • Analysing the quantification of intracellular bond degradation rate

Christopher A. Alabi, Associate Professor, Cornell University

15.00 Encoded Self-Assembling Chemical Libraries for the Discovery of New Small Molecules for Tumour-Associated Antigens

  • High-Throughput Screening represented for years the main screening technology for the selection of novel small ligands to target Tumor-Associated Antigens. Nevertheless, most efficient and fastest screening methods are required
  • ESAC (Encoded Self-Assembling Chemical Libraries) technology is a valid alternative to classic screening method to identify different small ligands against TumourAssociated Antigens that can be used for drug delivery and imaging of solid tumours and metastatic lesions

Jacopo Millull, Research Associate Scientist, Philogen

15.00 Studying Catabolism & the Journey Taken by the ADC

Ashutosh Pathak, ADC Therapeutics

15.00 Preformulation & Analytical Characterisation of ADCs

  • Discussing screening methods for the early formulation development of ADCs
  • Extended insights into Dynamic light scattering as powerful screening tool
  • Overview on Polysorbate analytics and stability

Steffan Woell, Principal Scientist, Merck

15:30 Site-selective Antibody Conjugation Enabled by Disulfide Bridging & Cysteine-to-lysine Transfer

  • The development and optimisation of the Next Generation Maleimide and Pyridazinedione reagent classes for the construction of ADCs
  • The rapid formation of robustly stable ADCs from native antibodies by rebridging the native disulfide bonds
  • A new approach to antibody conjugation will be presented, in which cysteine residues are employed as hooks to deliver acylating residues to specific lysines

Jamie Baker, Reader in Chemical Biology, University College London

15.30 Broadening the Therapeutic Window with Bispecific ADCs, do Bispecific Drug Conjugates Improve Targeting?

  • Discuss ZW49, a biparatopic antibodydrug conjugate armed with our proprietary ZymeLink™ cytotoxic payload
  • In vivo efficacy compared to approved and leading clinical-stage HER2targeted ADCs
  • GLP toxicology studies predict an enhanced therapeutic window enabling extended dosing in the clinic

John Babcook, Senior Vice President of Discovery Research, Zymeworks

15:30 Reductive Desulfuration as an Important Tool in Detection of Small molecule Modifications to Payload of Antibody Drug Conjugates

  • Method development of desulfuration of the thioether linker in ADC. The reaction conditions were optimized for release of the payload to take advantage of the high resolution and high mass accuracy of the Orbitrap to characterize metabolism of the payload.
  • Application of the technique in model ADCs. The resulted information enables characterization of the payload of ADC following its incubation in hepatocytes, liver microsomes and buffers as illustrated by the identification of a hydrolyzed thiosuccinimide ring of SigmaMAb ADC mimic following incubation in buffer.

Jack Wang, Senior Scientist, Johnson & Johnson

15.30 ThioBridge™ as a Tool for the Design, Optimisation & Manufacture of ADCs

  • Demonstrating how ThioBridge™ conjugation is a flexible approach for producing stable ADCs with defined location and extent of drug loading
  • Highlighting how the simple design of ThioBridge™ ADCs means they can easily undergo a systematic determination and optimisation of their in vitro and in vivo biological properties
  • ThioBridge™ targets natural disulfides with highly reproducible conjugation profiles at milligram to gram scales
  • Evaluating Abzena’s capabilities for design, optimisation and manufacturing of ADCs

Mark Frigerio, Director Chemistry UK, AbzenaAbzena

16.00 Exploring how a New Linker Technology can Improve the ADC Tolerability

  • Discussing novel approaches to sitespecific conjugation of antibodies using symmetrical PBD payloads
  • Understanding the importance of linker payload flexibility in this context
  • Examining the impact of this technology on therapeutic index improvement

Balakumar Vijayakrishnan, Group Leader, Spirogen

16.00 Bispecific ADCs Targeting HER2: Intracellular Trafficking of the Antibody Dictates the Choice of Linker-Payload

  • Assessing how Bispecific ADCs bridging HER2 and high turnover proteins travel to lysosomes and improve efficacy of HER2 ADCs with stable linker-DM1 • Analysing Biparatopic HER2 ADCs that induce target recycling and require cleavable linker for greater efficacy
  • Combining various bispecific antibody approaches with correct linker-payload technology may allow to generate ADCs with better efficacy and safety profiles

Julian Andreev, Research Fellow, Regeneron Pharmaceuticals

16:00 Alternative Assays – Immunogeneicity & Metabolite ID

Session Reserved

16:00 Process Development & Manufacturing of Cysteine Linked Antibody-Drug Conjugates – Control of Product Heterogeneity

  • Addressing challenges and strategies for ADC manufacturing • Assessing control of product heterogeneity
  • Sharing improvements for future processes

Guy De Roo, Project Leader, Downstream Processing Synthon

4:30 pm Afternoon Refreshments & Networking

5:30 pm Reviewing the ADC Clinical Pipeline

Synopsis

  • Update on the key movements in the clinic
  • Gain insight into the rapidly evolving pipeline
  • Analyse of novel clinical ADCs

6:00 pm Process Understanding & Automated Processing Development to Ensure First Pass Manufacturing Success of ADCs

Synopsis

  • Explore studies needed for clinical supplies and for commercial readiness with the goal of providing evidence of process consistency
  • Review the use of automated systems for gathering information for early phase process transfers to manufacturing
  • Does that ensure appropriate ranges are evaluated and ensure deep process understanding?

6:30 pm Chair’s Closing Remarks

  • Alain Beck Senior Director, Biologics CMC & developability, Pierre Fabre