Pre-Conference Seminar Day
Tuesday, 29th March 2022
Download the Full Event Guide for full session details.
This workshop will offer a one-day intense learning environment to establish core understanding of the critical areas of ADC research and development. Designed for new entrants to the ADC field, it will deliver critical knowledge gained during the research that led to the development of the currently approved ADCs. Covering the essential elements in ADC discovery and early development, this workshop will enable you to:• Gain familiarity with the fundamental early learnings and key insights that inform ADC design
• Learn about the key insights that allowed early investigators to overcome the initial challenges that hindered early ADC programmes
• Understand the choices and trade-offs in utilising the Chemistry ADC toolbox
• Evaluate payload choices for ADCs
• Review linker design chemistry and what it can bring (“not just the piece in the middle”)
• Understand the impact of conjugation site selection on ADCs
• Gain an understanding of the biological aspects of ADCs
• Choose an optimum antibody format
• Select the most appropriate ADC target which is easily accessible
• Learn about in vitro assays
• Assess key factors in evaluation of efficacy information from in vivo preclinical models
• Gain an understanding of key considerations in toxicology assessment of ADCs
• Gain an overview of the development process for ADCs
• Learn about the challenges and opportunities for further improvement upon ADC design
*Virtual Speaker* John Lambert - Independent Consultant - Cambridge, Massachusetts
David Bramhill - Founder - Bramhill Biological Consulting LLC
Download the Full Event Guide for full session details.
9.55 Chairperson's Opening Remarks
Reviewing Immunostimulatory ADCs
10.00 Targeted C’Dot Drug Conjugates (CDCs) for the Treatment of Folate Receptor Alpha Over-expressing Tumours
- Ultra-small CDCs are a platform for more effective targeted therapy of cancer due to their ability to localise in tumours and be rapidly cleared from normal tissues
- Review how CDCs multivalent tumour targeting and high payload loading allows for the more effective killing of tumours with lower target antigen expression
- Explore the small size and unique surface properties that facilitate deeper penetration into solid tumours and the ability to cross disrupted blood brain barriers to sites of metastatic disease in the brain
Gregory Adams, Chief Scientific Officer, Elucida Oncology
10.30 Preclinical Development of CQ1007, HER2 Ab Immune Agonist Conjugate (AIAC) With the Best-in-Class Potential
- HER2 is a proven target for breast cancer, gastric cancer and other solid tumours
- GQ1007 is HER2 AIAC that has been developed using GeneQuantum’s unique iLDC bioconjugation platform, leading excellent druggability and linker stability
- Review how GQ1007 demonstrates robust in vitro and in vivo anti-tumour activities in multiple preclinical models
- Evaluate how GQ1007 has the potential to become an important therapeutic option for the HER2+ patients who have progressed on current standard therapies, and a combo opportunity with PD1 therapy
Paul Song, Chief Scientific Officer, GeneQuantam Healthcare
11.00 Morning Break
11.30 Bispecific XDC – A Versatile Drug Delivery Platform
- Exploring design features of a bispecific XDC
- Providing a clinical overview of CBP-1008
- Discussing bispecific XDC as a versatile drug delivery platform
Robert Huang, Founder & Chief Executive Officer, Coherent Bio
Exploring Non-Traditional ADCs That Have a Smaller Targeting Agent
12.00 Pan-tumoral Small Molecule-Drug Conjugates Targeting Fibroblast Activation
Protein in Solid Lesions
- OncoFAP is a clinically validated small organic ligand targeting FAP in solid tumours
- Understand how OncoFAP-drug conjugates selectively target tumours in vivo and release high amount of MMAE at the site of disease
- Evaluate how OncoFAP-drug conjugates potently induce anti-tumour response at doses below tumour saturation both in monotherapy and in combination with immunotherapy
Samuele Cazzamalli, Head – Small Molecule Therapeutics, Philochem
12.30 Lunch
13.30 Novel & Advanced ADC Designs to Drive Tumour Immunity - Immunogenic Cell Death, Innate Agnonists & Beyond
- Reviewing how cell-free production enables dual conjugation of precisely positioned payloads in a homogeneous ADC format
- Demonstrating that precise conjugation of a combination of cytotoxic payloads and innate stimulators on a single antibody can outperform the combination of two separate antibody drug conjugates of those same payloads
- Showcasing how multiple payload combinations can now be delivered simultaneously to the tumour micro-environment
- Exploring the use of this technology to generate first-in-class immunostimulatory ADCs that enhance tumour immunogenicity and could form the basis of off-the shelf, personalised in situ-derived cancer vaccines
Trevor Hallam, President of Research & Chief Scientific Officer, utro Biopharma
Delving into Targeted Radiopharmaceutical ADCs
14.00 Radiopharmaceutical Therapy: The Alpha & The Omega
- Exploring the Alpha: OranoMed and the development of 212Pb
- Providing a clinical pipeline update
- The Omega: What are the next steps in the evolution of the radiopharmaceutical industry?
Jason Hurt, Chief Medical Officer, OranoMed
14.30 Afternoon Break
15.00 Site-Specific TLR7-agonist Antibody-Drug Conjugates as Next Generation ADCs
- Presenting on the site-specific TLR7a ADC developed by EuCODE platform with an expanded genetic code
- Reviewing how protein medicinal chemistry enables fine tuning of TLR7a ADC to balance potency and safety in preclinical studies
- Demonstrating how Ambrx’s TLR7a ADCs elicit strong anti-tumour responses as single agents as well as in combination therapies
David Mills, Director, Preclinical Science, Ambrx
Creating a Roadmap to Overcome the Key Challenges With
Translating Non-Traditional ADCs
15.30 Panel Discussion – Exploring the Challenges Associated With Developing
Non-Traditional ADCs
- What are the unique preclinical and clinical challenges that exist?
- Are current preclinical models suitable in being able to understand and translate nontraditional ADCs into the clinic?
- Where do non-traditional ADCs sit in the wider ADC landscape?
Jason Hurt, Chief Medical Officer, OranoMed
Robert Huang, Founder & Chief Executive Officer, Coherent Bio
Greg Adams, Chief Scientific Officer, Elucida Oncology
16.00 End of 2nd ADCs & Beyond; Non-Traditional ADCs Seminar Day
Download the Full Event Guide for full session details.
9.55 Chairperson's Opening Remarks
10.00 Exploring Challenges Associated with Commercial Manufacturing of an ADC – Polivy Case Study
- Exploring collaboration, competence and capacity: The importance of selecting the right partners
- Discussing if breakthrough designation is a blessing or a curse
- Evaluating how to be prepared for dependency on clinical read out
Jan-Oliver Schwabe, Senior Site Manager, F. Hoffman-La Roche
10.30 Panel Discussion – Exploring the Unique Challenges of Late Clinical &
Commercial Manufacturing
- How do the challenges differ to small scale manufacturing?
- In what ways does the relationship with your CDMO differ?
- What challenges are expected as more ADCs become commercially available?
Rolf Werner, Chief Strategic Officer, GeneQuantum Healthcare
Jan-Oliver Schwabe, Senior Site Manager, F. Hoffman-La Roche
11.00 Morning Break
11.30 Regulatory Considerations for ADCs
Colm Reddington, Global Director, Regulatory CMC, AstraZeneca
12.00 Justification of Control of ADC Manufacturing Processes
- Exploring the importance of justification of control, and showcasing a recent case study
- Understanding the role of statistical modelling in CMC control
- Understanding the impact of control processes on the wider ADC process
Hetty Sleijster-Selis, DSP Specialist, Byondis
12.30 Lunch
13.30 Administration of ADCs Using CSTDs: Impact on Drug Product Quality
- Discussing Closed System transfer devices (CSTDs) are recommended by NIOSH and USP <800> to prevent exposure of health care practitioners to hazardous drugs such as ADCs
- Exploring how a lack of CSTD administration/compatibility studies during CMC development can significantly delay clinical use of ADCs in particular in the US
- Examining the impact of 8 different CSTD systems on the quality of an ADC drug product was evaluated in a case study (e.g. via extractable volume, purity, visible and sub-visible particle)
- Discussing the main issues were the formation of visible particles for all except one CSTD, in addition to increased subvisible particle levels
Matthias Winzer, Director, ADC Drug Product Development & Head of Parenterals Research, Merck KGaA
14.00 Innovation of Manufacturability of Antibody Drug Conjugates
- Discussing stable linker platform with limited off-target toxicity of free drug
- Examining the integration of ADC conjugation in final DSP process increasing yield
- Examining ligase-based site-specific matrix assisted continuous conjugation
Rolf Werner, Chief Strategic Officer, GeneQuantum Healthcare
14.30 Afternoon Break
15.00 Towards ADC Purification on Membrane Technology
- Understanding the context to replace classical bind and elute chromatography on resin by flow-through chromatography on membrane
- Sharing strategy for membrane technology evaluation
- Discuss results and acceptance criteria for implementation
Benjamin Fabre, ADC Expert Scientist, Sanofi
15.30 Overcoming Downstream Challenges in the Reduction of Key Process- &
Product-related Impurities of an Antibody Drug Conjugate
- Identifying critical and difficult to remove impurities
- Evaluating development strategies and results
- Discussing transfer, scale-up, and GMP manufacturing results
Brian O’Mara, Associate Director, Downstream Process Development, Ambrx
16.00 End of 3rd CMC Seminar Day