26-28 March, 2018
ProArte Maritim Hotel, Berlin, Germany

Register by Monday, 15th January to save up to €400!

Day One
Tuesday 27th March, 2018

Day Two
Wednesday 28th March, 2018

09.00
Chair’s Opening Remarks

  • Alain Beck Senior Director, Physio-Chemistry Department, Pierre-Fabre

09.10
Preclinical & Clinical Safety & Efficacy of a Novel Tumour-Initiating Cell Targeted ADC

  • Scott Dylla Chief Scientific Officer, AbbVie-Stemcentrx

Synopsis

  • Tumour-initiating cells (TIC) underlie tumour growth and recurrence
  • Understanding tumour heterogeneity and TIC identity facilitates novel ADC target discovery
  • Effective targeted killing of TICs should translate into substantial preclinical and clinical activity
  • Careful preclinical determination of a therapeutic index to predict clinical results

09.40
The Dolaflexin Platform for High-Loaded Auristatin ADCs

Synopsis

  • The Dolaflexin platform enables high loading of an auristatin derivative, thereby increasing efficacy in low-expressing tumours
  • The auristatin derivative AF-hydroxypropyl-amide (AF-HPA) exerts a controlled bystander effect that improves tolerability
  • XMT-1522 is a HER2-targeted Dolaflexin ADC currently in Phase 1 for patients with Her2+ breast, gastric or lung cancer
  • XMT-1536 is a NaPi2b-targeted Dolaflexin ADC currently in Phase 1 for patients with ovarian or lung cancer

10.10
Morning Refreshments & Networking

Validating the Next Generation of Tumour Associated Antigens & Formats

Stream Chair: Anette Sommer, Principal Scientist, Bayer 

11.00 Getting Small to Enhance Targeting: Non-Internalizing Small Molecule-Drug Conjugates for the Treatment of Solid Tumours

  • Reviewing experimental evidence for ADCs and SMDCs that suggests that it may be possible to release cytotoxic payloads in the tumour extracellular space
  • Exploring CAIX, which is up-regulated in hypoxic cells and is over-expressed in approximately 90% of clear-cell renal cell carcinomas. The protein is known because it does not efficiently internalize upon binding of antibodies or small ligands
  • Acetazolamide-based SMDC products may represent a promising class of targeted agents for the treatment of CAIX-positive solid tumours, as single agents or in combination with immunotherapy

Samuele Cazzamalli, Post Doc – Group of Professor Neri, ETH Zurich

11.30 uPARAP: A Novel ADC target on Sarcomas & Glioblastomas with Unique Endocytic Properties

  • uPARAP is associated with cancer cells of several rare cancer types
  • uPARAP is a professional endocytic receptor with highly efficient internalization and receptor recycling properties
  • Data demonstrates preclinical proof-of-concept of ADC efficacy in vitro and in vivo

Christoffer Nielsen, Senior Scientist, The Finsen Laboratory

12.00 Panel Discussion: In Depth Review of IgG Antibody’s vs. Emerging Formats for Next Generation ADCs

  • What can we learn from the field of antibody engineering?
  • What are the advantages and disadvantages of the plethora of emerging alternative carriers?
  • What are the latest lessons we’ve gleaned from the validation of novel formats in clinical development?

A Selection of Speakers from the Day’s Faculty

Mitigating Off-Target Toxicity - Preclinical Learnings to Better Inform Clinical Development

Stream Chair: Kurt Gish, Associate Director II, AbbVie

11.00 Developing Next Generation ADCs

  • Discovery and translational development of novel ADCs
  • Learnings from maximising the clinical therapeutic window of ADCs
  • Considerations for preclinical development

Daisuke Okajima, Researcher, Daiichi Sankyo

11.30 Preclinical Strategies to Maximise Therapeutic Index of Highly Potent ADCs

  • Leveraging preclinical models to explore exposure response relationships that can inform clinical trial design
  • Evaluating the relationship between stability and toxicity to identify optimal drug to antibody ratios
  • Exploring translatability of preclinical safety findings with highly potent ADCs to the clinic

Mary Jane Hinrichs, Principal Toxicologist, MedImmune

12.00 Application of a PK-PD Modelling & Simulation In Antibody-Drug Conjugate Development

  • Preclinical to clinical translation
  • Bystander effect of ADCs
  • Binding site barrier of ADCs
  • Cell-level pharmacokinetics of ADC

Aman Singh, PK-PD Scientist, Johnson & Johnson

Seamless Supply Chains & Quality Control Strategies to Support Production

11.00  Antibody Drug Conjugate Process Development & Manufacturing Platform Using Single Use Technologies

  • Single-use manufacturing technologies allow companies to quickly bring GMP manufacturing capability online and with less capital investment
  • Learn about a platform for ADC process development and manufacturing that uses standardized approaches to accelerate development timelines and increase manufacturing predictability while decreasing risks of scale up from development though clinical and commercial manufacture
  • Discuss chemical compatibility of the materials described in the platform to solvents typically used in ADC process

To be Confirmed, Sartorius Stedim 

11.30 Title to be Confirmed

  • More details to follow

To be Confirmed, PROVEO 

12.00 Panel Discussion: Managing Change Through the Course of ADC Development & Evolution of Methods for Novel Compounds

  • What is the timing for changes with the analytical method and process as compounds advance through testing?
  • What variance is there based on dealing with stochastic vs site specific & highly potent vs payloads of lower activity?
  • As more companies try more things what are the risks/challenges with exposure/cleaning validation with ADCs of varying activity?

Tami Wu, Associate Director, Quality Control, Seattle Genetics

Alexander Chu-Kung, Principal Engineer, AbbVie

Norbert Schuelke, Senior Director, Head of Purification & Bioconjugation Process Development, Takeda

12.30
Lunch & Networking

Looking to the Future: Exploring the Next Generation Antibody-Drug Conjugate Technologies

13.30
Leveraging Prior Knowledge in ADC Product Development & Quality Control

  • Tami Wu Associate Director, Quality Control, Seattle Genetics

Synopsis

  • Understanding your molecule is critical when it’s as complex as an ADC
  • Measuring your CQAs requires multiple complimentary tools
  • Managing the diversity of Seattle Genetics’ pipeline of candidates

14.00
Enhance Understanding of Clinical Toxicity of ADCs: a Meta-Analysis of Payloads

  • Dawei Xuan Senior Director, Clinical Pharmacology, Pfizer

Synopsis

  • A model-based, meta-analysis approach was implemented to improve understanding of key clinical toxicity profiles of ADCs
  • Gain quantitative insight into incidence of hematological toxicities, hepatotoxicity, peripheral neuropathy, and ocular toxicity across different ADC payload classes including MMAE, MMAF, DM1, and DM4, and between solid and hematological cancers
  • Current analysis suggests that key G3/4 toxicities of ADCs in the clinic are likely off-target and related to payload

14.30
Afternoon Refreshments & Networking

15.30
Where do ADCs sit in the Clinical Landscape? Comparison of ADCs with Current Standard of Care

Synopsis

  • Discuss how the current approved ADCs have or have not changed the therapeutic landscape
  • Explore the ability and/or sequence of ADCs in combination with other therapies

16.00
Title to be Confirmed

  • To be Confirmed, Seattle Genetics

Synopsis

  • More details to follow

16.30
Chair’s Closing Remarks

  • Alain Beck Senior Director, Physio-Chemistry Department, Pierre-Fabre