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
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

11:00 am Antibody Drug Conjugate Development: Current Clinical Status & Future Directions

  • Jia He Analyst, Beacon Target Therapies

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

  • Rakesh Dixit President & Chief Executive Officer, BioNavigen

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

  • Jia He Analyst, Beacon Target Therapies
  • Mike Rigby Project Leader, Bicycle Therapeutics
  • Rakesh Dixit President & Chief Executive Officer, BioNavigen

Manufacturing Stream
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

1:30 pm ROR1 Targeting with the Antibody Drug-Conjugate VLS-101 in Aggressive Non-Hodgkins Lymphoma

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

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

  • Sally Ward Director of Translational Immunology, Centre for Cancer Immunology, University of Southampton

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

  • Sally Ward Director of Translational Immunology, Centre for Cancer Immunology, University of Southampton
  • Brian Lannutti Senior Vice President - Research & Development, Velosbio
  • Graham Cotton Head of Protein Therapeutics, Almac Discovery
  • Nicolas Camper Group Leader, Chemistry, Abzena

Translational Stream
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

1:30 pm Outsourcing the Safe Development & Manufacture of ADCs: Perspectives from the CMOs & Drug Innovators

  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group

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

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

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

  • Ian Schwartz Global Technology Consultant – Proteins and Bioconjugates, Sartorius

2:30 pm Live Discussion & Question Time

  • Horst Bierau Senior Scientific Advisor – Head CMC Science & Intelligence, Merck KGaA
  • Robert Sussman Managing Director, SafeBridge Regulatory & Life Sciences Group
  • Ian Schwartz Global Technology Consultant – Proteins and Bioconjugates, Sartorius

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 Integrated Approach to Provide Actionable Data to Support Programs From Concept to Clinical Material

  • Jeff Carroll Group Leader Process and Analytical Development , Merck
  • Omar Lamm Business Development and Strategy - Biopharmaceutical Development, Merck

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

  • 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 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

5:20 pm Live Discussion & Question Time

  • Andre Dumetz Senior Scientific Investigator, GlaxoSmithKline
  • Anand Subramony Vice President, Antibody Discovery & Protein Engineering, R&D, AstraZeneca
  • David Thurston Chief Scientific Officer, Femtogenix
  • Jeff Carroll Group Leader Process and Analytical Development , Merck
  • Omar Lamm Business Development and Strategy - Biopharmaceutical Development, Merck

5:50 pm Chair’s Closing Remarks

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