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 Developing ADCs During Pandemic Outbreak

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

Synopsis

  • Discussing the impact of the Covid-19 pandemic on ADC R&D
  • Evaluating progress within the ADC space in the last 12 months
  • Reviewing ADCs to watch in 2021 and beyond

9:00 am Novel Application of a CD25-Targeted, Pyrrolobenzodiazepine (PBD) Dimer-Based ADC as Immunotherapeutic Agent

Synopsis

  • Currently, ADCs are predominantly used to directly target antigen-positive tumour cells
  • This presentation will provide proof-of-concept for a novel application of a CD25-targeted, PBD-based ADC as immunotherapeutic agent, since the main mode of action relies on the ADC directly targeting T regulatory immune cells, rather than tumour cells
  • Additional data will be presented showing promising combination partners tested with the CD25-ADC in preclinical models

9:20 am Overview of the European Regulatory Experience in the Review of Clinical Studies with Antibody Drug Conjugate (ADC) Products

Synopsis

  • Highlighting salient features of clinical development programmes
  • Summary of important issues and how these were addressed
  • Key learnings and some reflections for future development programmes

9:40 am Live Discussion & Question Time

10:00 am Morning Refreshments & Virtual Speed Networking

Discovery Stream

Translational Stream

Manufacturing Stream

Asking the Question; Should Payloads be Super Potent?

Are There Alternate Ways Improve Understanding of the Toxicity Profile of ADCs

Managing Complex Supply Chains

11.00 Delving into Hydrophilic & Low Potency Payloads

  • Providing an update on PBD payloads
  • Developing Hydrophilic payloads
  • Designing Low Potency payloads

Phil Howard, Chief Scientific Officer, Spirogen

 

11.20 Session Reserved for AbTis

 

11.40 Targeting CD37 with Alpha- & Beta-Emitting Radioimmunoconjugates

  • Review CD37 as target for radioimmunotherapy
  • Analyse preclinical and clinical data for treatment of non-Hodgkin lymphoma with the beta-emitting radioimmunoconjugate 177Lu-lilotomab satetraxetan (Betalutin®)
  • Evaluate preclinical data for treatment of chronic lymphocytic leukaemia and non-Hodgkin lymphoma with the alpha emitting radioimmunoconjugate 212Pb-TCMCNNV003 (Alpha37)

Jostein Dahl, Chief Scientific Officer, Nordic Nanovector

 

12.00 Live Discussion & Question Time

Phil Howard, Chief Scientific Officer, Spirogen

Jostein Dahl, Chief Scientific Officer, Nordic Nanovector

11.00 Antibody Drug Conjugate Development: Current Clinical Status & Future Directions

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

Jia He, Senior Research Analyst, Beacon Targeted Therapies

 

11.20 Panel Discussion: Improving Translatability by Modelling & Understanding the Dose & Efficacy & the Dose Toxicity Relationship

  • Discussing fundamental challenges of mechanisms of chemical of drug toxicity
  • Delving into cancer drug resistance mechanisms
  • Screening for toxicity in the early studies to optimise the design

 

11.40 BT8009: A Bicycle Toxin Conjugate Targeting Nectin-4 for the Treatment of Solid Tumours

  • BT8009 binds to Nectin-4 with high affinity and selectivity
  • BTC format allows rapid tumour penetration and delivery
    of cytotoxic payload MMAE
  • A Phase I/II trial of BT8009 is underway in patients with advanced solid tumours associated with Nectin-4 expression

Gavin Bennet, Senior Director - Drug Development, Bicycle Therapeutics

 

12.00 Live Discussion & Question Time

Jia He, Senior Research Analyst, Beacon Targeted Therapies

Gavin Bennet, Senior Director - Drug Development, Bicycle Therapeutics

11.00 Exploring How to Overcome Supply Chain Challenges When Faced with a Pandemic

Session Reserved for Piramal

 

11.20 Three is the Magic Number! CMC Learning from Three Payload Classes

  • CMC learning from the process development and scale-up of three different payload classes
  • A discussion of the synthesis, purification and isolation of the payloads
  • Case studies demonstrating route design to minimise high potency manufacturing

William Goundry, Principal Scientist, AstraZeneca

 

11.40 Looking to Satisfy the Growing Demand of Capacity & Capabilities for ADCs

  • A quick look to the most recent data to check how the ADCs market is evolving
  • Drivers and challenges in ADCs manufacturing: Outsourcing or In house?
  • Assessing the basics of Integration and our model to support ADCs needs
  • Presenting our conjugation and fill/finish capabilities

Giorgio Salciarini, Senior Manager – Technical Business Development, BSP Pharmaceuticals

 

12.00 Live Discussion & Question Time

William Goundry, Principal Scientist, AstraZeneca

Giorgio Salciarini, Senior Manager – Technical Business Development, BSP Pharmaceuticals

12:30 pm Lunch & Networking

What Is the Best Conjugation Strategy for your ADC & Showcasing Novel Linker Technologies?

Are we Improving the Therapeutic Index or do we Still have a Narrow TI but just a Lower Dose?

Working Collaboratively with Multiple CMOs VSOne CMO

13.30 ROR1 Targeting with the Antibody Drug-conjugate VLS-101 in Aggressive Non-Hodgkins Lymphoma

  • ROR1 is an onco-embryonic cell surface receptor with expression in various cancers.
  • The novel antibody-drug conjugate VLS-101 demonstrates promising in vivo activity in preclinical Lynphoma models.
  • Confirm ROR1 as a target and demonstrate the therapeutic potential of using an ADC directed toward ROR1 for the treatment of hematological cancers.

Brian Lannutti, Senior Vice President - Research & Development, Velosbio

 

13.50 A Differentiated Next Generation Protein Drug Conjugate for the Treatment of ROR1 Positive Tumours

  • Novel ROR1 specific protein drug conjugates (PDCs) have been developed, based on small VNAR targeting domains, that offer potential improvements over conventional ADC approaches.
  • By exploiting a novel cleavable linker payload platform, a pre-clinical candidate has been identified which is highly efficacious in vivo in ROR1+ TNBC and other tumour models where it shows sustained and durable regressions.
  • The flexible formatting provided by our protein-based approach provides ready access to ROR1 targeting bi specific and bi-paratopic drug conjugates.

Graham Cotton, Head of Protein Therapeutics, Almac Discovery

 

14.10 ALTA Technology: Engineering ADCs for Improved Payload Delivery

  • Engineering ADCs with greater pH-dependent binding to HER2 results in 2-3 fold increases in payload delivery to lysosomes
  • The engineered ADCs have substantially greater efficacy in treating tumours in mouse xenograft models expressing intermediate levels of HER2
  • Hear how this platform technology is expected to widen the therapeutic window for ADCs that target HER2 and other tumour markers

Sally Ward, Professor - Molecular, Immunology & Director - Translational Immunology, University of Southampton

 

14.30 Live Discussion & Question Time

Brian Lannutti, Senior Vice President - Research &Development, Velosbio

Graham Cotton, Head of Protein Therapeutics, Almac Discovery

Sally Ward, Professor - Molecular, Immunology & Director - Translational Immunology, University of Southampton

13.30 PBD-based ADCs: From Bench to Bedside

  • Explore Pyrrolobenzadiazepine warheads for ADCs
  • Preclinical development and clinical dose setting based on nonclinical data
  • Update on clinical development of PBD-based ADCs

Lolke De Haan, Head of Toxicology, ADC Therapeutics

 

13.50 Panel Discussion: Sharing Experience with Filing INDs & BLA & What the Regulatory Agencies are Looking for

  • Delving into filing an IND
  • Filing the perfect BLA
  • What do the agencies want?

 

14.10 Adcager® - ADC Targeting Receptor for Advanced Glycation End-Products in Gynaecological Cancer

  • Developed for ovarian and endometrial cancer treatment
  • Preclinical in vivo and 3D ex vivo characterisation
  • Demonstrating effectiveness against other cancer models
  • Discovery pipeline

Steve Conlan, Professor - Molecular & Cell Biology, University of Swansea

 

14.30 Live Discussion & Question Time

Lolke De Haan, Head of Toxicology, ADC Therapeutics

Steve Conlon, Professor, Swansea

13.30 Outsourcing the Safe Development & Manufacture of ADCs: Perspectives from the CMOs & Drug Innovators Session Reserved for Safebridge Consultants

Session Reserved for Safebridge Consultants 

 

13.50 The Formidable Challenge of Controlling High Mannose-Type N Glycans in Therapeutic mAbs

  • Glycosylation is a critical quality attribute for mAbs because their clinical efficacy and safety are significantly affected by their glycosylation profile
  • As opposed to endogenous IgGs, marketed therapeutic mAbs contain higher levels of high mannose glycans, which can affect efficacy, pharmacokinetics, and stability
  • Discussing how current trends in biopharmaceutical manufacturing, such as process intensification and the rise of biosimilars, emphasize the need for a thorough understanding of the cellular processes, as well as the biotechnical process aspects that govern the production of high mannose-type N-glycans, in order to establish robust manufacturing processes

Horst Bierau, Senior Scientific Advisor – Head CMC
Science & Intelligence, Merck

 

14.10 Session reserved for Sartorius

Ian Schwartz, Global Biconjugate and Antibody-Drug Conjugates Consultant, Sartorius

 

14.30 Live Discussion & Question Time

Horst Bierau, Senior Scientific Advisor – Head CMC Science & Intelligence, Merck

3:00 pm Afternoon Refreshments & Poster Session

Focusing on Novel Technologies to Give Next Generation ADCs

4:00 pm Understanding Off Target Toxicity in ADCs

  • Anand Subramony Vice President, Antibody Discovery & Protein Engineering, R&D, AstraZeneca

Synopsis

  • Gain key insights into hydrophobicity
  • Explore novel linkers
  • Assess data trends

4:20 pm Session Reserved for Merck

4:40 pm Sharing the Challenges Associated with the Development of a Drug Substance Control Strategy for an Antibody Drug Conjugate

  • Andre Dumetz Senior Scientific Investigator, GlaxoSmithKline

Synopsis

  • Here is presented the case of an ADC for which a drug substance control strategy was developed under an accelerated timeline.
  • Information published by regulatory agencies at the time of approval is reviewed to highlight critical quality attributes that are typically controlled through the drug substance control strategy. Then, a quality by design (QbD) framework used for monoclonal antibodies is presented emphasizing how it can be readily adapted to ADCs.
  • Both similarities and differences are discussed, as well as the challenges associated with accelerated timelines. Last, a discussion is presented on how an established control strategy built on sound QbD principles can be leveraged to support product specifications in view of a regulatory submission.

5:00 pm Live Discussion & Question Time

  • Anand Subramony Vice President, Antibody Discovery & Protein Engineering, R&D, AstraZeneca
  • Andre Dumetz Senior Scientific Investigator, GlaxoSmithKline

5:30 pm Chair’s Closing Remarks

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