Day One
Tuesday, 3rd March, 2020
8:30 am Chair’s Opening Remarks
8:40 am Developing ADCs During Pandemic Outbreak
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 Roundtable Discussion: Optimising ADCs to Deliver Less or Non-cytotoxic Payloads
- Discussing the benefits of less or non-cytotoxic payloads
- Investigating further into high DAR ADCs, can you have a
DAR of 40? - What are the challenges of less or non-cytotoxic payloads
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
Brian Lannutti, Senior Vice President - Research & Development, Velosbio
13.50 Panel Discussion: Exploring the Benefits of Introducing Novel Linker Technologies
- Fitting a novel linker technology into your ADC strategy
- Deciding the best linker technology, making comparisons with what’s already out there and the new
- What’s hot and what’s not?
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
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
Synopsis
- Gain key insights into hydrophobicity
- Explore novel linkers
- Assess data trends
4:20 pm Session Reserved for Merck
4:40 pm Sharing the Story of a Recently Approved Molecule; ADC Control Strategy Development
Synopsis
- Understanding the journey to approval
- Presenting updates from the clinic
- Looking to the future