p-139_adc summit
TRANSCRIPT
SMi presents the 4th annual…
PLUS INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPWednesday 20th May 2014, Holiday Inn Bloomsbury Hotel, London, UK
ADCs: A Journey Through Development Workshop leaders: Dr Richard Turner, Principal Consultant, Natalie Thomas, Consultant, Simon Bishop, Associate Consultant, BioDesk
8.30am - 12.30pm
18 -19
MAY2015Holiday Inn Bloomsbury Hotel, London, UK
ADC Summit 2015Elevating ADCs to peak performance in the clinic
www.drugconjugates.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
REGISTER BY THE 27TH FEBRUARY AND SAVE £300 • REGISTER BY THE 31ST MARCH AND SAVE £100
CONFERENCE CHAIRS:
Mahendra Deonarain, Chief Science Officer,
Antikor Biopharma Ltd.
David Thurston, Professor of Drug Discovery
King’s College London
KEY SPEAKERS INCLUDE:
Angela Romanelli, Senior Director,
Biomarkers ImmunoGen, Inc
Christophe Bonny, Chief Scientific Officer,
Bicycle Therapeutics Limited
Klaus Bosslet, Head Discovery Oncology, Pharma
Research & Early Development, Roche Innovation
Centre Penzberg
Iontcho Vlahov, Vice President of Discovery
Chemistry, Endocyte Inc.
Vijay Chudasama, Research Associate, University
College London
BUSINESS BENEFITS FOR 2015:
• Hear more about the payload developments
• Receive updates on ADCs in clinical trials
• Learn more about biodistribution and tumour
penetrations
• Aim for improvement of the therapeutic index
• Discover strategies for effective targeting and
managing ADC off-target toxicities
• Understand the status of the development of novel
binding moieties
@SMIPHARM
Register online at: www.drugconjugates.com • Alternatively fax y
ADC Summit 2015Day One | Monday 18th May 2015
8.30 Registration & Coffee
9.00 Chairman's Opening RemarksMahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd.
ADVANCING ADC/RIT THERAPIES - PART 1
OPENING ADDRESS 9.10 Biomarkers: Improving drug development success by linking
ADC therapy to the right patient•Translating our biological understanding into successful
development of meaningful therapies for patients throughBiomarkers
•Targeting antigen expression is only the starting point, it isnecessary but not sufficient
•Thinking beyond payload delivery: How does tumourbiology impact sensitivity to the ADC payload?
•Building the right biomarker test: The right assay on the rightsample is critical for enabling selection of the right patientin the clinic
Angela Romanelli, Senior Director of Biomarkers, ImmunoGen, Inc.
9.50 Designing novel warheads for targeted therapies: Efficient strategiesfor making natural tubulysins, analogs, and their conjugates•Any tubulysin is too toxic to be used as antineoplastic
agent itself; instead, they are excellent candidates for thedesign of ligand-drug conjugates for cancer targeting
•New methodologies for the synthesis of natural tubulysinsand their analogs
•Design of new tubulysin analogs with improved cytotoxicityand stability profiles
Iontcho Vlahov, Vice President of Discovery Chemistry,Endocyte, Inc.
10.30 Morning Coffee
11.00 RG7787, a Mesothelin-binding Pseudomonas exotoxin-basedcytolytic fusion protein •Pay load delivery •Tumour selective protein synthesis inhibition and impact on
immune-suppression in tumour mass •In vitro and in vivo potency and efficacy on very slowly
growing large tumours•Recombinant fusion protein as advantageous alternative
technology compared to ADCsKlaus Bosslet, Head Discovery Oncology, Pharma Research& Early Development, Roche Innovation Centre Penzberg
11.40 Arming disease-targeting ligands with cytokines and withcytotoxic drugs•Use of highly validated vascular targeting antibodies for
pharmacodelivery applications.•Antibody-cytokine fusions: From the bench to the clinic•Cancer cures with non-internalising antibodies and low-
molecular weight ligandsGiulio Casi, Head of Targeted Cytotoxics Development,Philochem AG
12.20 Networking Lunch
A MATTER OF SIZE: EXPLORING THE SMALL
KEYNOTE ADDRESS1.20 High affinity bicyclic peptides:
Application to payloads in oncology•Scaffold-constrained bicyclic peptides (bicycles) show
target-binding properties similar to antibodies, but in a 100-fold smaller format
•Bicycles penetrate tumours rapidly, delivering highconcentrations of payloads over hours, thus allowingefficient tumour killing while minimizing systemic toxin exposure
•In vivo POC data using different targets and payloads willbe presented
Christophe Bonny, Chief Scientific Officer, Bicycle Therapeutics Limited
2.00 The Nanobody® platform: Opportunities for next generationdrug conjugates•Nanobodies are clinically validated small antibody
fragments derived from heavy-chain only camelid antibodies•Explore the formatting flexibility allowing full control over
valency and multi-specificity •Multiple conjugation chemistries possible•Understand the manufacturing propertiesCarlo Boutton, Director of Technology, Ablynx
2.40 Seriously? Folic acid can replace an antibody for targetingpotent warheads to tumours?•The folate receptor is a tumour biomarker target •What are small molecule drug conjugates (SMDC)?•Use of companion imaging for selection of biomarker
positive patients•16 years of SMDC clinical developmentChristopher P. Leamon, VP, Research, Endocyte, Inc.
3.20 Afternoon Tea
3.50 Round Table Discussion: A matter of size: Is the future small?•Does size matter? •What size do you need and why?•How best can you use the consequences of size? •Discuss the data that is available to prove itPeter Bach, Director, BioPharmaLogic Ltd.
4.20 Can You Handle Highly Potent Compounds Safely? Are You Sure?•Biological and chemical substance occupational hazards•Facilities, features and equipment for handling ADC
components•How do you know if it’s safe for your workers?•Integration of health and safety into ADC projectsJustin Mason-Home, Managing Director, SafeBridge Europe
5.00 Using IP to benefit from ADC technologies•Types of patent protection available for ADC
technologies•Data requirements for ADC patents and when to file•Freedom to operate challenges for ADC•How to benefit from IP transactions - legal challenges and
opportunitiesJames Legg, Patent Attorney, Boult Wade Tennant
5.20 Chairman's Closing Remarks and Close of Day One
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ADC Summit 2015Day Two | Tuesday 19th May 2015
Supported by
8.30 Registration & Coffee
9.00 Chairman's Opening RemarksDavid Thurston, Professor of Drug Discovery, King’s CollegeLondon
ADVANCING ADC/RIT THERAPIES - PART 2
KEYNOTE ADDRESS9.10 The onward march of ADCs – How near the end are we?
•How do ADC technologies compare to other types ofanticancer therapies?
•What are the pros and cons of ADCs vs. other therapies?•What are the likely new developments in ADC technologies
to help them stay ahead?•What are the major competitors for ADCs in the coming
decades?David Thurston, Professor of Drug Discovery, King’s CollegeLondon
9.50 Small is beautiful-antibody-targeted nanomedicines•Nanomedicine is a rapidly developing field of
macromolecular drug development•Advances in industrial production mean that more of these
experimental agents can be translated to the clinic •Antibodies can modify the characteristics of
nanomedicines and improve therapeutic effects•Recent work in the field from ourselves and others will be
discussed, highlighting how antibody-nanoparticles mayrepresent a novel ADC platform
Chris Scott, Chair of Pharmaceutical Biosciences, QueensUniversity Belfast
10.30 Morning Coffee
11.00 Opti-linked antibody fragments as ADCs•Optimizing single chain Fvs for bioconjugation •High DAR •Maintaining good PK•Ensuring good QAMahendra Deonarain, Chief Scientific Officer, AntikorBiopharma Ltd
11.40 From modified peptides to modified proteins: New approaches to immunological recognition•Application of sortase as a convenient approach to
quantitative modification of proteins•Alternative approaches to the generation of multicyclic
peptides•Selection and application of affimers as alternatives to
antibodies in diagnostic applications.Michael Webb, Associate Professor, University of Leeds
12.20 Networking Lunch
LINKING AND LOADING
1.20 Robust disulfide bridging reagents enable delivery of a well-characterised and multi-functional ADC platform•Homogeneous ADCs•Site-selective modification •Bispecifics•Orthogonal click functionalisationVijay Chudasama, Research Associate, University College London
2.00 Click chemistry-triggered activation of ADCs in vivo •New linker concept to expand the range of ADC targets to
poorly internalizing receptors, extracellular matrixconstituents and stroma
•ADC administration followed by chemical probe that reactswith the linker on the tumour-bound ADC, releasing thedrug in the extracellular matrix
•Maximized bystander effect: Potentially advantageous inheterogeneous or poorly penetrated tumours
•Proof of principle data in tumour-bearing mice with anti-TAG72 ADC comprising CC49 mAb and model drugdoxorubicin
Marc Robillard, CEO, Tagworks Pharmaceuticals
2.40 Sortase-mediated antibody conjugation (SMAC™):Generation of homogeneous, site-specifically conjugatedantibody drug conjugates•Sortase enzymes provide a robust and efficient means to
attach toxic payloads to antibodies.•Highly site-specific conjugation yields homogenous drug
product with defined efficacy, PK properties and safetyprofile.
•Peptide-based linker structure circumvents IP issues and isexpected to provide superior serum stability.
•Production of dual payload ADCs may help addressresistance and provide opportunity to tackle tumourheterogeneity and quiescence
Roger Beerli, Vice President Research & Development, NBE-Therapeutics AG
3.20 Afternoon Tea
4.00 Clinical development of ADCs: The EU landscape, trial designand the impact of the new clinical trial regulation•Overview of the landscape of clinical studies on ADCs in
Europe•Clinical trial design considerations: Patient population,
endpoint selection, comparator choice, dose regimenselection.
•The impact of implementation of the Clinical TrialRegulation on conduct of clinical studies in Europe
•Regulatory strategies in Europe to expedite time to marketNatalie Thomas, Consultant, Clinical Network Services (UK) Ltd
4.20 Chairman’s Closing Remarks and Close of Day TwoDavid Thurston, Professor of Drug Discovery, King’s CollegeLondon
HALF-DAY POST-CONFERENCE WORKSHOPWednesday 20th May 2014
8.30am - 12.30pmHoliday Inn Bloomsbury Hotel, London, UK
ADCs: A Journey Through Development
Workshop Leaders:Dr Richard Turner, Principal Consultant, BioDesk
Dr Natalie Thomas, Consultant, BioDeskDr Simon Bishop, Associate Consultant, BioDesk
Overview of workshop:
This workshop will provide attendees with an overview ofdata requirements for ADCs through the developmentlifecycle, outlining the key CMC challenges and mitigationstrategies for the product types, and first-in-man enablingpreclinical development activities to ensure a smoothtransition from bench to bedside. Clinical study designs fromPhase 1 will be discussed through the use of case studies. Theworkshop will then take attendees on a journey through theadditional data requirements to support Phase II and IIIclinical development. At each stage the differences in datarequirements between the US and EU will be discussed. Thefinal component of the workshop will introduce the route toultimate approval of an ADC in the US and EU.
Why should delegates attend this workshop:
Delegates will gain an understanding of: • Regulatory and product development requirements for
entry in to the clinical and marketing authorisation• Common pitfalls and mitigation strategies in ADC
development to allow anticipation of regulators’concerns at clinical trial application and marketingauthorisation application stages
• Regulatory requirement distinctions between the US andEU, and regulatory options available to expedite time tomarket
Programme
8.30 Registration and coffee
9.00 Opening Remarks
9.15 CMC Development: ADC Specifics
10.15 Enabling First-in-Human Studies• Pre-clinical data requirements • Trial design to maximise knowledge gained from
early stage clinical studies
10.45 Coffee break
11.15 Beyond Phase I Clinical Studies• Clinical case studies – successful and less
successful approaches. • Key recommendations for trial design to maximise
the likelihood of success
11.45 Key regulatory drivers for an expedited globaldevelopment • Regulatory considerations for a global
development program including key differencesfor US and EU approvals
• Regulatory strategies to maximise efficiency tomarket
12.15 Closing remarks
12.30 End of workshop
About the workshop hosts:
Dr Richard Turner, BioDesk's Principal Consultant in the UKoffice, has been working in biopharmaceuticaldevelopment for over 20 years. Richard is a formerpharmaceutical and scientific assessor at the MedicinesControl Agency (now known as the UK MHRA) and hasworked in senior Regulatory positions in a number ofbiopharmaceutical development companies andconsultancies including Daiichi Sankyo, Lonza Biologics, ERAConsulting, Elan and Antisoma.
Dr Natalie Thomas is a Consultant with CNS (UK) and hasover ten years’ pharmaceutical industry and consultingexperience, initially in early stage oncology drugdevelopment and more recently in regulatory affairs.Natalie has worked on products at all stages ofdevelopment, supporting companies from discoverythrough to marketing authorisation.
Dr Simon Bishop is an Associate Consultant with three years’experience in technical writing. At CNS, Simon works withclinical documentation, including protocols, Investigator’sBrochures and study reports, marketing authorisationapplications and regulatory documentation regardingpaediatrics and orphan drugs. Simon has a PhD indevelopmental neurobiology and previously worked for theNature Publishing Group as a scientific literature editor.
About the Clinical Network Services:
Clinical Network Services (CNS) is auniquely integrated service group focusedon product development headquarteredin Australia with offices in New Zealand,the UK and the USA. Through BioDesk we
provide a comprehensive range of services in the strategicplanning and delivery of CMC/non-clinical developmentprograms, then, leveraging our extremely pragmaticregulatory environment, we can rapidly initiate phase 1 & 2clinical trials in Australia/New Zealand.
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ADC SUMMIT 2015 Conference: Monday 18th May & Tuesday 19th May 2015, Holiday Inn Bloomsbury Hotel, London, UK Workshop: Wednesday 20th May 2015, London
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