Pre-Conference Seminar Day
8:50 am Pre-Conference Seminar Day
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This workshop will offer a one day intense learning environment to establish core skills and understanding in the critical areas of ADC research and development. Designed for new entrants to the ADC field it will deliver critical knowledge in a number of the key problem areas that hinder antibody drug conjugate programs. Covering essential elements in ADC discovery and early development, this workshop will enable you to:
- Gain an overview of the development process for ADCs
- Improve payload and linker design chemistry
- Understand the impact of conjugation site selection on your ADC
- Choose/choice of optimum “antibody” format
- Select the most appropriate ADC target which is easily accessible
- Learn about cellular assays
- Review the advantages and disadvantages of different preclinical animal models
- Develop early stage assays and learn how to effectively interpret the data
Workshop Leader: John Lambert, Independent Consultant, Attager Consulting
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8.50 am Chair's Opening Remarks
9.00 Bicycle Conjugates to Target Solid Tumours
- Bicycles, constrained bicyclic peptides, offer antibody-like affinity and selectivity in a small molecule format
- Bicycle Toxin Conjugates are now in clinical development, offering rapid tumour penetration with limited plasma exposure
- Discover how Bicycles can be used to stimulate Immuno-oncology targets such as CD137, which can be targeted to tumour cells using Bicycle tumour-targeted immune cell agonising molecules (TICAs™)
Gavin Bennet, Senior Director - Drug Development, Bicycle Therapeutics
9.20 NBE-002, an Anthracycline-based Immune-Stimulatory Antibody Drug Conjugate (iADC) Targeting ROR1
- Presenting pre-clincal data on NBE-002, a novel ROR1-targeting ADC based on Sortase A-mediated, site-specific conjugation of a derivative of the highly potent anthracycline PNU-159682
- NBE-002 is a highly effective and promising targeted therapeutic for the treatment of ROR1-positive TNBC and other solid tumour indications and is currently in clinical development
- Due to the pronounced immune-modulatory functions of the PNU payload, NBE-002 is particularly well suited for combination therapy with immune checkpoint inhibitors
Roger Beerli, Chief Scientific Officer, NBE-Therapeutics
9.40 Exploring Alternative Applications of ADCs in Translational Drug Discovery
- The field is beginning to provide examples of ADC approaches beyond cell-killing cytotoxic agents
- Exploring alternative applications of ADCs to achieve targeted delivery of other classes of small molecules, providing a potential solution to challenging problems in drug discovery
- Case study: Initial development of a non-internalising ADC, with a view to selectively inhibiting an extracellular protein
Elizabeth Love, Senior Scientist - Drug conjugates, Biologics & Analysis, LifeArc
10.00 Live Discussion & Question Time
Gavin Bennet, Senior Director - Drug Development, Bicycle Therapeutics
Roger Beerli, Chief Scientific Officer, NBE-Therapeutics
Elizabeth Love, Senior Scientist - Drug conjugates, Biologics & Analysis, LifeArc
10.30 Morning Break
11.30 Novel Approaches to Native Antibody Modification
- Exploring Functional disulfide re-bridging
- Evaluating Reversible covalent conjugation
- Exploring the use of chemical linkers to form bi- and tri-specifics
Vijay Chudasuma, Professor - Organic Chemistry & Chemical Biology, UCL
11.50 Drug Conjugates Based on Engineered Affibody Molecules
- Affibody molecules are small engineered alternative scaffold affinity proteins, which may be designed to bind to receptors over-expressed on different tumour cells
- Affibody molecules can be site specifically loaded with the cytotoxic drug DM1, creating homogenous conjugates with a desired drug-to-affibody ratio
- Understand how HER2-specific affibody drug conjugates slow tumour growth and increase survival in an animal model of ovarian cancer
Torbjörn Gräslund, Professor in Medical Protein Technology, KTH Royal institute of Technology
12.10 Sharing the Benefit of Small Molecule Drug Conjugates, in Solid Tumour
• More details to follow
Christopher Scott, Professor - Pharmaceutical Biosciences, QUB
12.30 Live Discussion & Question Time
Vijay Chudasuma, Professor - Organic Chemistry & Chemical Biology, UCL
Torbjörn Gräslund, Professor in Medical Protein Technology, KTH Royal institute of Technology
Christopher Scott, Professor - Pharmaceutical Biosciences, QUB
13.00 Lunch Break
14.00 Antibody-Antibiotic Conjugate for the Treatment of Melioidosis
- Antibodies have been assessed and demonstrated ability to opsonise Burkholderia pseudomallei in vitro as well as demonstrating anti-virulence effects
- Two antibiotics have been successfully incorporated into a cathepsin cleavable linker, the cleaved products are functional against bacteria in vitro
- A down-selected antibody and antibiotic-linker have recently been incorporated into a full antibody-antibiotic conjugate and is currently being investigated in macrophage cell infection assays
Adam Taylor, Scientist, Defence Science & Technology Laboratory – DSTL
14.20 Preclinical characterization of GQ1007, Her2 Ab immune agonist conjugate based on AIAC platform with the best-in-class potential
- Her2 is a proven target for breast cancer, gastric cancer and other solid tumors
- GQ1007 was developed using GeneQuantum’s unique bioconjugation platform (iLDC)
- GQ1007 demonstrates robust in vitro and in vivo activities in multiple preclinical models with best in class potential
Paul Song, Chief Scientific Officer, Genequantum
14.40 Tumour-Targeted Immune-Stimulating Antibody Conjugates (ISAC): A New Class of Immuno-oncology Therapeutics
- Introducing Bolt’s ISAC technology platform as the next evolution in immune-oncology and antibody drug conjugates
- Showcasing key features of ISAC technology and mechanism of action
- Demonstrating the promise of the ISAC platform and Bolt’s approach to develop this new class
Shelley Ackerman, Senior Scientist, Bolt Biotherapeutics
15.00 Live Discussion & Question Time
Paul Song, Chief Scientific Officer, Genequantum
Adam Taylor, Scientist, Defence Science & Technology Laboratory – DSTL
Shelley Ackerman, Senior Scientist, Bolt Biotherapeutics
15.30 Chair's Closing Remarks
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9.00 Case Studies in Late Phase & Commercial Manufacturing
- More details to follow
Dorota Roberts, Associate Director Technical Product Steward – Biologics, Seagen
9.20 Applying QbD to Biologics Development DP Process, from Development to Validation – An ADC Case Study
- Introduction: Quality by Design and Process Validation Strategy
- Case study: Process design stage
- Case study: Process qualification stage
Marie Leman, Drug Product Team Leader & Tech Transfer Leader, Sanofi
9.40 Panel Discussion: Simplifying Your Global Manufacturing Supply Chain
- What went wrong? Discussing lessons learned from managing late stage manufacturing supply chains
- Effectively managing complex global supply chains
- Exploring opportunities to work with partners in emerging ADC geos such as Asia
10.00 Live Discussion & Question Tim
Dorota Roberts, Associate Director Technical Product Steward – Biologics, Seagen
Marie Leman, Drug Product Team Leader & Tech Transfer Leader, Sanofi
10.30 Morning Refreshments
11.30 Panel Discussion: Case Studies - Sharing Insights for Overcoming Regulatory Roadblocks
- Building operational plans and regulatory strategies for late phase CMC
- Supporting global regulatory filings and responding to health authority questions
- Inspection, ways to set up and manage a commercial specification through the life cycle of the product
11.50 A to Z Guide of ADC Generation & Stability Assessment
- This presentation covers an end-to-end summary of antibody-drug conjugate (ADC generation and assessment. A rational approach was employed to generate a pool of ADCs by introducing ad hoc mutations that allowed the site-specific conjugation of 4 different Pyrrolobenzodiazepines (PBDs) from the Spirogen library
- The resulting ADCs have been extensively characterised in different formulations with respect to their (bio)physical properties
- Pre-formulation and real-time stability studies provided useful insights on the effect of different excipients on the physical and chemical stability of the ADCs in the liquid state
Maria Laura Greco, Marie Curie Research Fellow, AstraZeneca
12.10 Miniaturised Formulation Screenings for ADCs on Microtiter Plates
- Only marginal amounts of drug substance are available for formulation development of ADCs in preclinical and early clinical development phases
- Miniaturised formulation screening formats are required, which may be realised in microtiter plates
- This talk presents findings on suitable equipment, materials and conditions for agitation-induced stress
Steffen Wöll, Principal Scientist, Merck
12.30 Live Discussion & Question Time
Victoria Wei, Associate Director, Johnson & Johnson
Steffen Wöll, Principal Scientist, Merck
13.00 Lunch & Networking
14.00 IMPD strategies and considerations for early phase clinical trial applications
- ICH Q11 application for ADC: a biologic or semi-synthetic drug substance
- Proposal for regulatory starting materials
- Lean approaches
- A case study for an ADC outside of Oncology
Victoria Wei, Associate Director, Johnson & Johnson
14.20 Sharing a Platform for Automated Conjugations
- An automation platform has been developed in-house to allow rapid ADC preparation
- This modulated approach is adaptable to a variety of conjugation chemistries and purification techniques
- It is a valuable tool for antibody, linker, payload screening, and conjugation optimization
Sean (Xiang) Zheng, Senior Staff Scientist & Head of ADC Conjugation Lab, Regeneron
14.40 Live Discussion & Question Time
Maria Laura Greco, Marie Curie Research Fellow, AstraZeneca
Sean (Xiang) Zheng, Senior Staff Scientist & Head of ADC Conjugation Lab, Regeneron
15.00 Chair's Closing Remarks