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Scientific Program - Day 1
Thursday October, 10

8.00

Chair’s Opening Remarks

John Lambert
Executive Vice President, Emeritus &
Distinguished Fellow
ImmunoGen

8.10

Keynote: Celebrating 10 Years of World ADC- How far the Field Has Come & Where we are Going

• Ten years ago, there was only one marketed ADC, MylotargTM, that was approved in 2000. However, within one year of the first World ADC meeting, MylotargTM was withdrawn from the US and EU markets following a failed phase 3 trial
• However, the approvals of AdcetrisTM (in 2011 for HL and ALCL) and KadcylaTM (in 2013 for HER2+ metastatic breast cancer), two ADCs utilizing potent tubulin agents as payloads, re-ignited enthusiasm for using antibodies for targeted delivery of cytotoxic agents to cancer tissue. In 2017, MylotargTM was re-approved for treatment of AML, and another calicheamicin conjugate, BesponsaTM, received approval for treating B-ALL
• Today, KadclyaTM sales exceed $1 billion annually. There are more than 83 different ADCs currently in clinical development. While there are many factors to ensuring the creation on a successful ADC (right target, right antibody, right linker properties and attachment site(s), right payload), getting it right can create ADCs that can become important medicines for treating human disease (especially cancer)

John Lambert
Executive Vice President, Emeritus &
Distinguished Fellow
ImmunoGen

8.40

Keynote: Learning from Failures & Enabling Innovations in ADCs to Fight Against Deadly Cancers

• What is common among clinically successful ADCs?
• What went wrong with some clinically unsuccessful ADCs?
• Top five lessons learned from the development of ADCs in the last two decades
• Next Generation ADCs meeting the five rights

Rakesh Dixit
President & Chief Executive Officer
BIONAVIGEN, LLC

9.10

Speed Networking

This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations
with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the ADC field and
establish meaningful business relationships.

10.00

Morning Refreshments

Clinical Stream

Confirmed Chair:

Sri Ghatta, Director & Clinical Scientist, Genmab 

CMC Stream

Confirmed Chair:

Lisa McDermott, Head of Process & Analytical Development ,
Millipore Sigma

Discovery Stream

Confirmed Chair:

Peter Senter, Vice President & Distinguished Research Fellow, Seattle Genetics

Translational Stream

Confirmed Chair:

Gail Lewis Phillips, Senior Scientist - Translational Oncology, Genentech

Operational Lessons Learned from Phase I Studies & Failures

Exploring Methods to Improve Scalability & Capacity of Manufacturing Processes

Understanding the Relationship Between Payload, Linker & Antibody to Increase Efficacy

Using DMPK Modelling to Mitigate Toxicities

10.30

Reviewing the ADC Clinical Pipeline

• Update on the key movements in the clinic
• Insight into the rapidly evolving pipeline
• Analysis of novel clinical ADCs

Letrishka Anthony, Senior Analyst, Beacon Targeted Therapies, Hanson Wade

10.30

Key CMC Considerations for Robust ADC Process Development & How to Effectively Manage the CMC Supply Chain

• Delve into the unique technical challenges of ADC process development
• Share experiences on how to confidently manage the complexity in ADC supply chains
• Discuss insights on how to transfer ADC processes to cGMP manufacture

Eric Lacoste, Head of Bio-Organic Team & Chemistry, Manufacturing, Control & Project Manager, Sanof

10.30

Site-Specific Antibody-Drug Conjugates Carrying Multiple Drugs per Cysteine Conjugation Site

• A novel cysteine-based conjugation platform for the preparation of site-specific high drug load per cysteine conjugation site is presented
• This entails site-specific antibody drug conjugates carrying multiple drugs per cysteine conjugation site

Nazzareno Dimasi, Associate Director Research & Development, AstraZeneca

10.30 Controlling PK/PD Fate: Model Informed Development of Antibody Prodrugs

• Introduction to Probody™ therapeutics (Pb-Tx) and Probody drug conjugates (PDC)
•Determinants of Pb-Tx PK/PD as captured by quantitative systems pharmacology (QSP) modeling
• Robustness of QSP clinical projections for Pb-Tx PK/PD

Mark Stroh, Clinical Pharmacology, CytomX

11.00

Phase 1 Study of ABBV-085, an Antibody-Drug Conjugate Targeting LRRC15, in Sarcomas & Other Advanced Solid Tumors

• LRRC15 target identification and biological relevance in cancer
• ABBV-085, a LRRC15 targeting optimized MMAE (auristatin) ADC
• Phase 1 clinical trial design, escalation and expansion cohort data
• Clinical safety and efficacy observations from the completed Phase 1

James Purcell, Senior Scientist & Program Director, Oncology, AbbVie

11.00

Thinking to the Future of ADCs

  • Reviewing the complexity of supply chain for ADCs
  • Secure Commercial supply
  • Looking to the future of ADCs

Giorgio Salciarini, Technical Business Development Manager, BSP

11.00

De-risking ADC Development Through Design & Developability Assessment

• Key criteria when selecting an antibody for ADC development
• Designing ADCs so they can easily undergo a systematic evaluation and optimization of their in vitro and in vivo biological properties
• Using a flexible approach for producing stable ADCs with defined location and extent of drug loading
• Identify liabilities in ADC candidates early in the developability process, reducingrisk and expenditure in later costly stages of development
• Establish and implement a plan to modify drug design early in the process to remove liabilities
• Select a lead candidate for manufacture with a minimized cost and risk profile

Mark Frigerio, VP Design & Development, Abzena

11.00

IKS01, A Next Generation Antibody Drug Conjugate Designed to be Efficacious in Tumors with Low & Moderate Levels of Target Expression

• Advanced bioconjugation technology, PermaLink, provides 100% stability with improved ADC safety and tolerability
• Next generation payloads demonstrate superior outcome compared to benchmark technologies

Robert Lutz, Chief Science Officer, Iksuda

11.30

Therapeutic Targeting of Prostate-Specific Membrane Antigen (PSMA)

• Differences in radionuclide vs drug payloads
• Differences in targeting vehicles: antibody vs small molecules
• Is there a need for treatment selection by target expression?

Scott Tagawa, Associate Professor in Hematology, Oncology, Clinical Medicine & Urology Weill Cornell - Cornell University

11.30

Sharing Common Manufacturing & Molecular Misconceptions

• It is important to survey this data for generalizations and guidelines to accelerate development of promising new candidates, oversimplification of experimental findings can lead to misunderstanding that compromises drug development
• In addition, the body of knowledge that has accumulated around ADCs puts us in a position to question portions of the testing paradigm that were put in place in the absence of such data. Some such questions will be posed for discussion

Damon Meyer, Associate Director, Conjugation Process Development, Seattle Genetics

11.30

Modulating the Potency & Physicochemical Properties of PBD Payloads

• Next generation PBD payloads
• Warhead optimisation
• Exploring the effect of N10 Capping groups

  • Exploring DAR1 PBD ADCs

Philip Howard, Chief Scientific Officer, Spirogen

11.30

Analyzing the Clinical Development of STRO-001 & STRO-002

• Review preclinical and IND enabling data for STRO-001 and STRO-002, two novel ADCs generated with cell-free protein synthesis and site-specific conjugation technology
• Provide clinical development update for STRO-001 for treatment of myeloma and B-cell lymphoma
• Deliver clinical development update for STRO-002 for treatment of ovarian cancer

Shannon Matheny, Executive Director, Clinical Science, Sutro Bio

12.00

Targeting CD205-positive Solid Tumors with a Novel Antibody Drug Conjugate to Reverse Immune Tolerance

• OBT076 includes a fully human antibody targeting CD205, which is overexpressed in subsets of Her2 negative cancer
• In addition to HER2 negative breast cancer, the investigational agent is being developed for a number of other CD205 driven cancers such as gastric cancer, triple-negative metastatic breast cancer, bladder cancer and pancreatic cancers as well as Non-Hodgkin Lymphoma and several other solid and liquid cancers

Arnima Bisht , Director, Oxford Biotherapeutics

12.00

When to Apply Design of Experiments (DoE) to ADC Development 

• Example of a DoE applied to Analytical method development
• When DoE is not an applicable tool and what can be implemented in its place
• Highlights from a project where a 2-block response surface DoE increased process robustness

Justin Sweeley, Senior Technology Manager, Biologics, Novasep

12.00

Exploring Single Molecule PEG Linkers for ADCs

• Proprietary synthetic process for high purity linear and branched single molecule PEGs
• Proprietary Analytical method of high purity single molecule PEGs for quality control
•The pendant type PEG linkers that improve the hydrophilicity of ADCs

Michael J. Roberts, Scientific Consultant, NOF America Corporation

 

12.15  ESelective Multi-site Bioconjugation Tools for Next-generation Therapeutics

  • Novel site-specific protein modification platforms in both eukaryotes and E. coliCustom functionalization and site-selection for protein engineering with improved therapeutic characteristics such as half-life, dosage, toxicity, etc.
  • Incorporation of multiple, modular, and distinct attachment handles for modification with more than one unique payload or ligand
  • Introduction to Protein Recovery Unit (PRU) and Multi-site Innovation Program (MIP) to unlock new therapeutic paradigms

James Italia, Founder & Vice President - Commercial Development, BrickBio

12.00

Antibody Targeted Amanitin Conjugates (ATACs)

  • Antigen-Targeted Amanitin-Conjugates (ATACs) represent a new class of ADCs using the payload Amanitin.
  • This payload introduces a novel mode of action into oncology therapy, the inhibition of RNA polymerase II.
  • The technology platform includes Amanitin supply, site-specific conjugation, demonstrated safety profile and biomarker.
  • HDP-101 is the first ATAC directed against BCMA entering Phase I trials in 2020

Andreas Pahl, Chief Scientific Officer, Member Board & Executive Vice President, Heidelberg Pharma

12.30

Lunch & Networking

12.30

Sartorius Lunch Seminar: Reaction Related Impurity Removal Using Scalable & Chemically Compatible Technologies

 

Ian Schwartz
Global Bioconjugation Technology Consultant
Sartorius Stedium Biotech

Jieyu Zhou
Associate Director,
Bioconjugate Chemistry,
Abzena

Operational Challenges in Clinical Trials & Innovations to Overcome This

Ensuring an Efficient Supply Chain Process

Delving into Innovative Technologies for Payloads & Linkers

Sharing Strategies to Advance Preclinical Development

2.00

Ligand Targeted Cancer Therapy: A Tactical Swing from Chemo to Radiotherapy

• Brief development history of small molecule drug conjugates (SMDCs)
• Comparison of targeted chemo vs. radioligand therapy
• Overview of 177Lu-PSMA-617 and next generation RLTs

Chris Leamon, Vice President, Research, Endocyte

2.00

Creating & Sticking to a Time Efficient Supply Chain Process

Sabra Hanspal, Senior Scientist, AbbVie CMO

2.00

Discovering Various Payload-Linker Combinations for Optimized Efficacy

• Payload and linker-payload design
• In vitro screening of payloads and ADCs
• Confidently assess ADC in vivo efficacy

Thomas Nittoli, Research & Development, Regeneron

2.00

Modifying an Old Platform to Identify New ADC Targets

• Tumor specific human antibodies were identified by panning on tumor cells isolated by laser capture microdissection. Rapidly internalizing antibodies were identified using HCA assays
• Lead candidate antibodies were used to identify a promising new target in mCRPC and Multiple Myeloma
• A vc-MMAE antibody conjugate was developed (FOR46) and patients are currently being dosed at multiple clinical sites

Marc Nasoff, Chief Scientific Officer, Fortis Therapeutics

2.30

Development of AVID100, an AntiEGFR ADC with a Novel Mechanism for Tumor Selective Cytotoxicity

• AVID100 is being evaluated in Phase 2a dose-expansion cohorts of patients with EGFR-overexpressing SCCHN, sqNSCLC, and TNBC
• AVID100 is highly potent and selectively cytotoxic against EGFR-expressing cancer cells, while sparing normal EGFRpositive keratinocytes
• AVID100 effectively inhibits tumor growth in mouse xenograft studies across a variety of a cancer types
• AVID100 was well-tolerated in a Phase 1a dose-escalation trial in patients with advanced solid tumors with only modest skin toxicity observed

Maureen O'Connor, Chief Scientific Officer, Forbius

2.30

Challenges of Technology Transfer for Early Stage ADC Manufacturing

• A summary of the challenges: tight timelines, multiple CMOs, no platform process
• Strategies to use to overcome the challenges: development and tech transfer in parallel, incremental scale up, detailed tech transfer documents
• Lessons learned from Ambrx ADC programs

Brian O'Mara, Associate Director -
Downstream Process Development, Ambrx

2.30

Homogeneous Antibody Functionalization Via Orthogonally Reactive Lysine & Arginine Residues In One Step & One Pot

• We describe a new blend of chemistry and biology by developing the first site-specific antibody conjugation technology that employs an engineered arginine residue. We achieved this by replacing a uniquely reactive lysine residue at the bottom of a deep pocket that forms the active site of a catalytic antibody with an arginine residue and by demonstrating that the ensuing uniquely reactive arginine residue can be selectively conjugated to various phenylglyoxal derivatives
• The distinctive arginine and lysine residues can be combined in one antibody molecule to afford orthogonal conjugation of two different cargos with high precision and efficiency under mild conditions in a one-step and one-pot reactione Step and One Pot

Christoph Rader, Associate Professor, Department of Immunology & Microbiology, The Scripps Research Institute

2.30

ADCascade: A New Clinically Based Approach for Target Validation, Lead Design & Selection

  • Current focus of ADC development is highly complex conjugation chemistry. Some ADC are now approved and marketed but clinical efficacy and safety concerns continue.
  • A new approach, ADCascade is needed for target validation, lead selection and conjugation chemistry
  • Augment target validation with clinically characterized patient tissues to identify patient subgroup of interest
  • Enhance lead selection of ADC through rational design and a cascade approach to evaluate linker and payload combinations with binding studies to clinically characterized on and off-target tissue

Jonathan Goldman, Chief Executive Officer, Abzena

3.00

Tisotumab Vedotin: Update from Clinical Study InnovaTV 201

• Tisotumab vedotin`s (TV) early clinical studies
• Data from Cervical cancer cohort of InnovaTV201
• Ocular adverse events mitigation plan and data from InnovaTV201

Sri Ghatta, Director & Clinical Scientist, GenMab

3.00

Disposable Technologies for ADC Manufacturing - Design Considerations

  • Unique Requirements of CDMOs
  • Design Criteria
  • Features and Benefits of Final Design

Jon Gingrich
VP of Business Development & Marketing
ADC Bio

3.00

A New OHPAS Linker for Phenolic Payload Conjugation

• Structure & Assembly of OHPAS linker:SuFEX (Sulfur Fluorine Exchange) Chemistry
• Stabilities (chemical & biological) and Lability upon Triggering
• Payload Release Mechanisms and Kinetics
• Application to ADCs

Tae Kyo Park, Chief Executive Officer, IntoCell

3.00

Synergistic Combinations of ADCs & Small Molecules that have Potential for Clinical Implementation

• ADCs have failed to meet expectations of single-agent efficacy in clinical settings. To expand their therapeutic index and augment ADC impact, we sought to identify small molecule synergies with ADC payloads to guide strategies in clinical therapy
• Develop a method for in vitro highthroughput screening of small molecule combinations in 1,536-well plates. The workflow is amenable to diverse solvents, enabling the future study of bio therapeutics and small molecules
• Screen a 2,400-compound, oncology focused and annotated library in combination with common ADC payloads and identified synergistic pairings determined by the Bliss synergy metric

Jacob Roth, Research Fellow, National Centre for Advancing Translational Sciences

3.30

Scientific Poster Session & Afternoon Refreshments

The Poster Session is an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new and existing relationships. During this session over 60 scientific posters will be presented from novel linker designs to validation of site specific conjugation technologies and more informative in vivo models.

Uncovering the Wave of Next Generation Successful ADCs

5.00

“Light Path” – Leveraging Lonza’s Experience with Timelines & Cost Reduction of Bioconjugate Drug Substance Supply

• Discover Lonza’s ADC capabilities and learn about future capacity increases at the manufacturing site in Switzerland
• Roll-out of a novel ADC manufacturing offer/concept for customers: BioConjugates LightPath Development
• Fast generation of ADC drug substance for to support clinical phase I trials. Utilization of Lonza’s bioconjugation experience to reduce customer effort to a minimum and accelerate project timelines

Patrick Dennler
Lab Head / Scientific Specialist
Lonza

5.30

ZW49 A Bispecific HER2-targeted ADC: Next Generation ADC Combining Azymetric & ZymeLink Platforms

• Discuss ZW49, a biparatopic antibody-drug conjugate armed with our proprietary ZymeLink™ cytotoxic payload

In vivo efficacy compared to approved and leading clinical-stage HER2-targeted ADCs
• GLP toxicology studies predict an enhanced therapeutic window enabling extended dosing in the clinic

Tony Polverino
Chief Scientific Officer
Zymeworks

6.00

Development of a Novel Chemical Site-Specific ADC Conjugation Platform with Enhanced Therapeutic Window

• The chemical conjugation of antibodies in a site-directed manner remains an area of great interest and active efforts within the ADC community are being made
• Overcome the lack of sensitivity that can be dialled in toward specific residue during the chemical modification
• Analyze a new platform for the site-selective conjugation of antibodies through the use of a novel class of IgG Fc-affinity peptide reagents to install payload-compatible linkers to well-defined amino acid residues. The activity of these resulting DAR2 ADCs
will be reviewed and assessed compared to the state-of-the-art

Brian Mendelsohn
Director
Ajinomoto Biopharma Services

6.30

Chair’s Closing Remarks

John Lambert