Pre-Conference Seminar Day
Monday, 13th March, 2023

Intro to ADCs

Your 101 Session for Beginners in the ADC Field

10:00 am Intro to ADCs

Synopsis

  • 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
  • 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 familiarity with the fundamental early learnings that inform ADC design
  • Learn about the key insights that allowed early investigators to overcome the initial challenges that hindered early ADC programmes
  • 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

4:00 pm End of Seminar Day

1st ADCs in Combinations Day

Your Must Attend Session for Insight Into Combination Rationale & Best Practices on When & How to Combine Your ADCs

10:00 am Case Study: Highlighting the Advantages of Combining ADCs With Checkpoint Inhibitors

Synopsis

  • Analysing positive preclinical data suggesting that the combination of
  • ADCs with checkpoint inhibitors lead to increased tumour destruction and immunologic memory retention
  • Outlining positive clinical results of combining ADCs with checkpoint inhibitors

10:30 am Panel Discussion: Can ADCs with Checkpoint Inhibitors

Synopsis

  • Outlining ADCs as key partners in combination across indications
  • Informing ADC combination development: right dose and schedule
  • Emerging strategies to guide ADC combination development

11:00 am AbbVie’s Leading ADC Combination Therapies Pipeline

Synopsis

  • Outlining AbbVie’s promising clinical data with respect to their antibody-drug conjugate pipeline
  • Analysing clinical data previously presented at ASCO
  • Outlining the future of this exciting technology

11:30 am Morning Refreshment Break

12:30 pm Exploring Challenges & New Opportunities for Combining Antibody Drug Conjugates & Cancer Immunotherapies

  • Rakesh Dixit President, Chief Scientific Officer, Regio Biosciences

Synopsis

  • Learning from the success of the combination of chemotherapies and Immuno-oncology (IO) drugs
  • Discussing the successful combination of ADC and IO drugs in Cancer Therapeutics
  • Outlining mechanism-based combination of IO drugs and ADCs to treat immunologically cold cancers
  • Reviewing the challenges and opportunities to improve the therapeutic value of ADC and IO combinations

1:00 pm Analysing Specific Immune Combinations Including Checkpoint Inhibitors

Synopsis

  • Discussing the rationale behind targeting immunostimulants or immunoinhibitory molecules
  • Analysing specific immune combinations including checkpoint inhibitors, STING agonists, and TLR agonists
  • Enhancing the fundamental understanding of the mechanisms and how we can design co-therapies to enhance the immune response

1:30 pm Lunch Break & Networking

2:30 pm Future Perspectives on Antibody Drug Conjugate Combination Development

  • Manoj Chiney Director, Clinical Pharmacology, Gilead Sciences

Synopsis

  • Outlining ADCs as key partners in combination across indications
  • Informing ADC combination development: right dose and schedule
  • Emerging strategies to guide ADC combination development

3:00 pm Roundtable Think Tank: What Are the Challenges With Manufacturing Multi Domain Drugs?

Synopsis

  • Outlining the key process development and manufacturing challenges with developing multi domain drugs, and how to prepare for these throughout preclinical and clinical development

3:30 pm Roundtable Think Tank: Outlining the Analytical Challenges When Developing ADCs in Combinations

Synopsis

  • Analysing how the current analytical tools for single-agent ADCs need to be adapted for analytical analysis of combination ADCs
  • Discussing the new technologies that are necessary to serve this new field

4:00 pm End of Seminar Day

1st Next Generation ADCs Day

With a Growing Number of Non-Traditional Payloads Being Used in Preclinical & Clinical Development, this Seminar Day is Your One-stop-shop to Exploring the Opportunities Assoc

10:00 am An Overview of the Novel Conjugates Field

  • Paul Song Chief Scientific Officer, Genequantum Healthcare

Synopsis

  • Outlining the current clinical progress of non-cytotoxic payloads
  • Discussing novel updates to the field since the last World ADC conference
  • Discussing the various advantages of different novel conjugates, and whether companies should be incorporating them into their pipeline

10:30 am Case Study: Radiotherapeutics for Hematologic Malignancies?

Synopsis

  • Discussing radio-conjugation methods, clinical development strategies, and identifying indications
  • Exploring Waldenstroms macroglobulinemia, multiple myeloma, and lymphomas
  • Planning for the market and future directions

11:00 am Case Study: A First-In-Class Peptide Drug Conjugate (PDC) Platform Targeting Sortilin (SORT1) Receptor Positive Cancers

Synopsis

  • Understanding why the normal function of a scavenger receptor, SORT1, can be exploited to rapidly transport novel peptide drug conjugates (PDCs) into cancer cells
  • Discussing the over expression of SORT1 in many solid tumours
  • Learn about Thera’s lead PDC candidate, TH1902, across multiple solid tumours
  • Review the potential of this novel SORT1+ platform for future developments

11:30 am Morning Refreshment Break

12:30 pm Outlining FAP-Targeted Small Molecule Conjugates for the Delivery of Biocidal Radionuclides to the Tumour Microenvironment

Synopsis

  • Learn how OncoFAP is a portable and clinically validated tumour-homing moiety with a small organic structure
  • Explore how OncoFAP-radionuclide conjugates efficiently accumulate to tumours after systemic administration in mice and patients, with exquisite selectivity for the target lesions
  • Discuss how OncoFAP-Lutetium-177 derivatives potently induce anti-cancer activity in tumour bearing mice both in monotherapy and in combination with immunotherapy

1:00 pm Novel Methods for the Modification of Cysteines & Disulfides for the Construction of Antibody Conjugates, Chemical Bispecifics & “Synthetic Antibodies”

  • Vijay Chudasama Professor, Organic Chemistry & Chemical Biology, University College London

Synopsis

  • Overview of the use of pyridazinediones (PDs) for the site-selective modification of full antibodies and antibody fragments
  • Outlining recent highlights on chemical bispecific construction
  • Exploring plug-and-play chemical-based antibody construction from fragments

1:30 pm Lunch Break & Networking

2:30 pm C’Dot Drug Conjugates (CDCs)- A Novel and Versatile Platform for the Targeted Tumor Delivery of a Wide Range of Payloads

Synopsis

  • Description of the C'Dot platform
  • Overview of preclinical and clinical experience
  • Discussion of potential advantages over ADCs

3:00 pm Highlighting the Potential of Bicycle Conjugates to Target Solid Tumours

Synopsis

  • Exploring the advantages of using bicyclic peptides in targeted therapies
  • Discovering the potential of bicycle toxin conjugates and discussing their clinical

3:30 pm Bispecific XDC – A Versatile Drug Delivery Platform

Synopsis

  • Design and mechanism of Bi-XDC: Leveraging bi-ligand synergies on multiple dimensions to drug the undruggable targets and pipeline of Bi- XDC platform Clinical Progress of CBP- 1008 and CBP-1018

4:00 pm End of Seminar Day

4th CMC Day

Address the Unique Late-Phase & Commercial Manufacturing Challenges that ADC Developers are Facing

10:00 am Discussing the Process of Choosing the Right CMO/CDMO & Outlining Appropriate Selection Criteria

Synopsis

  • Deliberating on the appropriate selection criteria to prioritise when choosing the correct CMO/CDMO, including discussing the cost, quality, and speed triangle
  • Articulating the current vendor landscape for manufacturing ADCs

10:30 am Roundtable Think Tank: Working Effectively With Your CMO to Minimise Manufacturing Timelines & Maximise Product Quality in Late-Stage Products

Synopsis

  • Outlining key considerations to minimise manufacturing timelines, including effective communication, efficient processes, and accurate forward planning

11:00 am Enhancing Communication & Teamwork in Late-Stage Manufacturing

  • Dan Milano Director, Process Development, ImmunoGen

Synopsis

  • Outlining the key considerations for streamlined process and analytical activities
  • Understanding how your CDMO should become an extension of your development team during late-stage manufacturing

11:30 am Morning Refreshment Break

12:30 pm Roundtable Discussion: Understanding When & How to Scale Up CMC Effectively

Synopsis

  • Exploring the most effective timelines for an effective scale up
  • Discussing the best ways to prepare for scale up through early-stage development
  • Setting the precedent for an efficient and safe CMC scale up

1:00 pm Outlining the Current CMC Regulatory Landscape for Late-Stage Manufacturing

  • Dawn Spiller Senior Director, Group Manager, Regulatory CMC, AstraZeneca

Synopsis

  • Outlining improvements in process development to ready yourself for late phase and commercial supply
  • Highlighting the current regulatory environment and key specifications for Phase II development and beyond

1:30 pm Lunch Break & Networking

2:30 pm Panel Discussion: Highlighting Common Late-Stage Manufacturing Challenges & How to Pre-Empt Them

Synopsis

  • Learning from those in the field who have faced and overcame late-stage manufacturing challenges
  • Highlighting process changes that can be implemented to prepare for future challenges
  • Selecting appropriate materials for use in process validation
  • Outline strategies for addressing accelerated development when faced with the complex supply chain

3:00 pm Outlining the Challenges in Maintaining Robust Analytical Tools in Late-Stage Process Development

Synopsis

  • Discussing the development of analytical techniques from Phase I-IV
  • Outlining the challenges in identifying robust analytical tools suitable for complex antibody-drug conjugates
  • Exploring the possibility of using real-time analytics in late-stage manufacturing

3:30 pm Working with CMOs – The HPAPI Safety Relationship

Synopsis

  • Discussing potent drug safety and the customer/CMO relationship
  • Exploring toxicological hazards and exposure risk assessments
  • Analysing methods of controls and containment
  • Expanding on procedures, training and awareness
  • Outlining commercial, business and due diligence – HPAPI matters

4:00 pm End of Seminar Day