Pre-Conference Seminar Day
8:50 am Pre-Conference Seminar Day
Download the Full Event Guide for full session details.
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
Download the Full Event Guide for full session details.
8.50 am Chair's Opening Remarks
Gavin Bennet, Senior Director - Drug Development, Bicycle Therapeutics
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 Appraisal of LRG1 as a Target for a Potential Antibody-drug Conjugate
Faiza Javaid, PhD Student, 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 Live Discussion & Question Time
Faiza Javaid, PhD Student, UCL
Torbjörn Gräslund, Professor in Medical Protein Technology, KTH Royal institute of Technology
12.30 Lunch Break
13.30 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
13.50 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 Healthcare
14.10 Next Generation ADCs: BoltbodyTM Immune Stimulating Antibody Conjugates
- Immune Stimulating Antibody Conjugates (ISACs) provide unexpected biological advantages over mixture of antibody and TLR agonist
- Treatment with ISACs elicits durable anti-tumor immunity and clearance of large, established tumors
- Tumor clearance following ISAC treatment leads to T cell-dependent immunologic memory and epitope spreading
Shelley Ackerman, Senior Scientist, Bolt Biotherapeutics
14.30 Live Discussion & Question Time
Paul Song, Chief Scientific Officer, Genequantum Healthcare
Adam Taylor, Scientist, Defence Science & Technology Laboratory – DSTL
Shelley Ackerman, Senior Scientist, Bolt Biotherapeutics
15.00 Chair's Closing Remarks
Download the Full Event Guide for full session details.
9.00 Chair's Opening Remarks
Dorota Roberts, Associate Director Technical Product Steward – Biologics, Seagen
9.10 Case Studies in Late Phase & Commercial Manufacturing
- Case of Multivariate Analysis (MVA) in manufacturing processes
- Applied learning from MVA and optimized Design of Experiments (DoE)
- Case of ADC Product Genealogy from Bulk mAb Intermediate to DP
- Statistical Considerations - Continued Process Verification
Dorota Roberts, Associate Director Technical Product Steward – Biologics, Seagen
9.30 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
9.50 Technology Driven Empowerment of Biologics
- Open Therapeutic Window for Efficient Therapy
- Safety First with Closed System ADC Process
- Empowerment Biologics with Stable Linker Toxins
- Integrated and segregated Pre-viral IDS and Post-viral ADC Process
Rolf G. Werner, Chief Operation Officer, GeneQuantum Healthcare Co., Ltd.
10.10 Live Discussion & Question Time
Dorota Roberts, Associate Director Technical Product Steward – Biologics, Seagen
Marie Leman, Drug Product Team Leader & Tech Transfer Leader, Sanofi
Rolf G. Werner, Chief Operation Officer, GeneQuantum Healthcare Co., Ltd.
10.40 Morning Refreshments
11.40 Towards ADC Purification on Membrane Technology: An Easy & Fast Process
- Understand the context to replace classical bind elute chromatography by membrane technology
- Share strategy for membrane technology evaluation
- Discuss results and possible acceptance criteria for implementation in the ADC process
Audrey Bendelac, ADC Scientific Manager, Process Development, Sanofi
12.00 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
12.20 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
12.40 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, 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
Horst Bierau, Senior Scientific Advisor – Head CMC Science & Intelligence, Merck KGaA
13.00 Live Discussion & Question Time
Audrey Bendelac, Senior Scientific Advisor – Head CMC Science & Intelligence, Sanofi
Maria Laura Greco, Marie Curie Research Fellow, AstraZeneca
Steffen Wöll, Principal Scientist, Merck
13.10 Chair's Closing Remarks