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
Asking the Question; Should Payloads be Super Potent?
Asking the Question; Should Payloads be Super Potent?
11:00 am Delving into Hydrophilic & Low Potency Payloads
Synopsis
- Providing an update on PBD payloads
- Developing Hydrophilic payloads
- Designing Low Potency payloads
11:20 am Site Specific Conjugation Technology to Use Native Antibodies
Synopsis
- Stable and Cleavable Linker with Site Specific Conjugation
- No Mutation or Engineering Necessary for Antibodies
- CMC Advantages
11:40 am Targeting CD37 with Alpha- & Beta-Emitting Radioimmunoconjugates
Synopsis
- 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)
12:00 pm Live Discussion & Question Time
Translational Stream
Are There Alternate Ways Improve Understanding of the Toxicity Profile of ADCs
Are There Alternate Ways Improve Understanding of the Toxicity Profile of ADCs
11:00 am Antibody Drug Conjugate Development: Current Clinical Status & Future Directions
Synopsis
- Update on the key movements in the clinic
- Gain insight into the rapidly evolving pipeline
- Analyse novel clinical ADCs
11:20 am Translational Safety & Efficacy of ADCs from Animals to Humans
11:40 am BT8009: A Bicycle Toxin Conjugate Targeting Nectin-4 for the Treatment of Solid Tumours
Synopsis
- 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
12:00 pm Live Discussion & Question Time
Manufacturing Stream
Managing Complex Supply Chains
Managing Complex Supply Chains
11:00 am PROVEO: Integrated Solution for ADC Manufacturing
Synopsis
- Tailored service platform with clear and flexible contractual framework Simplified supply chain: from Key
- Starting materials to DS and DP
- Complete integrated Project Management system
- The importance of a coordinated Quality System
- Supporting Manufacturing network
11:20 am Three is the Magic Number! CMC Learning from Three Payload Classes
Synopsis
- 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
11:40 am Looking to Satisfy the Growing Demand of Capacity & Capabilities for ADCs
Synopsis
- 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 ADC’s needs
- Presenting our conjugation and fill/finish capabilities
12:00 pm Live Discussion & Question Time
12:30 pm Lunch & Networking
Discovery Stream
Exploring the ROR1 Target & Technologies to Explore Alternative Tumour Targets
Exploring the ROR1 Target & Technologies to Explore Alternative Tumour Targets
1:30 pm ROR1 Targeting with the Antibody Drug-Conjugate VLS-101 in Aggressive Non-Hodgkins Lymphoma
Synopsis
- 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
1:50 pm A Differentiated Next Generation Protein Drug Conjugate for the Treatment of ROR1 Positive Tumours
Synopsis
- 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 bispecific and bi-paratopic drug conjugates.
2:10 pm ALTA Technology: Engineering ADCs for Improved Payload Delivery
Synopsis
- 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
2:30 pm Live Discussion & Question Time
Translational Stream
Are we Improving the Therapeutic Index or do we Still have a Narrow TI but just a Lower Dose?
Are we Improving the Therapeutic Index or do we Still have a Narrow TI but just a Lower Dose?
1:30 pm PBD-based ADCs: From Bench to Bedside
Synopsis
- Explore Pyrrolobenzadiazepine warheads for ADCs
- Preclinical development and clinical dose setting based on nonclinical data
- Update on clinical development of PBD-based ADCs
1:50 pm Catalent’s SMARTag® Technology: Differentiated Solutions for Optimal ADCs
Synopsis
- SMARTag is a clinical-stage ADC technology featuring site-specific conjugation with multiple linker and warhead options.
- 6 CRs and 2 PRs among 22 patients were achieved by TRPH-222, a CD22-targeted SMARTag conjugate, in the dose-escalation stage of a Phase 1 trial for R/R B-cell lymphoma.
- We are using new linkers to achieve proprietary high DAR ADCs featuring topoisomerase I inhibitor payloads.
- We have demonstrated conjugate stability—even with cleavable linkers—to deliver efficacy with improved tolerability and a wider therapeutic window
2:10 pm Adcager® – ADC Targeting Receptor for Advanced Glycation End-Products in Gynaecological Cancer
Synopsis
- Developed for ovarian and endometrial cancer treatment
- Preclinical in vivo and 3D ex vivo characterisation
- Demonstrating effectiveness against other cancer models
- Discovery pipeline
2:30 pm Live Discussion & Question Time
Manufacturing Stream
Delving into Strategies to Improve Process Development & Safety in Manufacturing
Delving into Strategies to Improve Process Development & Safety in Manufacturing
1:30 pm Outsourcing the Safe Development & Manufacture of ADCs: Perspectives from the CMOs & Drug Innovators
Synopsis
- How the hazards of ADCs and their components are evaluated
- Procedures for handling these compounds safely
- Information to be exchanged between the drug innovator and CMO to ensure that safe manufacture takes place
1:50 pm The Formidable Challenge of Controlling High Mannose-Type N-Glycans in Therapeutic mAbs
Synopsis
- 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, emphasise 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
2:10 pm Bioconjugate Process Development & Manufacture using Scalable and Chemically Compatible Technologies
2:30 pm Live Discussion & Question Time
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 Integrated Approach to Provide Actionable Data to Support Programs From Concept to Clinical Material
Synopsis
• Display impact of raw material characterization on conjugation chemistry
• Discuss examples where incomplete characterization delayed timelines
• Showcase the importance of an integrated offering from early development through manufacturing
4:40 pm Sharing the Challenges Associated with the Development of a Drug Substance Control Strategy for an Antibody Drug Conjugate
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 New Developments with the Pyridinobenzodiazepine (PDD) ADC Payload Platform
Synopsis
• Updates will be presented on the PDD platform, including high potency and low potency alkylators
• A new high potency G-alkylator will be disclosed that exhibits a profile suitable for use in ADCs targeting solid tumours
• Examples of efficacy and toxicity data for ADCs carrying the low-potency PDD G-monoalkylating payload FGX20-75 will be
discussed