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A: ADC payloads: Availability and mechanisms of action

Workshop Leaders: David Thurston, Professor of Drug Discovery, King’s College London

Paul Jackson, Project Manager, Femtogenix08.30 – 12.30

B: Developments in high potency API manufacturing

Workshop Leaders: Richard Denk, Head Sales Containment, SKAN AG

Martin Glaettlim, Sales Engineering Containment, SKAN AG13.30 – 17.30

PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday 25th May 2016, Holiday Inn Kensington Forum, London, UK

REGISTER BY 29TH FEBRUARY AND RECEIVE A £400 DISCOUNTREGISTER BY 31ST MARCH AND RECEIVE A £200 DISCOUNT

@SMIPHARM #SMiADC

SMi Present the 5th Annual Conference on…

ADC SummitHoliday Inn Kensington Forum, London, UK

23 - 24

MAY2016

Exploring the latest innovations in conjugation approaches and technologies for the development of next generation ADCs

Highlights for 2016: • Takeda presents how ADCETRIS® (brentuximab vedotin)

developed to treat Hodgkin Lymphoma• Advancement in ADCs:

A step closer to magic bullets in war against cancer• Safety at the forefront - homogeneity of ADCs for highly

effective and safer cancer therapy

Sponsored by

Chairs for 2016: Rakesh Dixit,

Vice President, R & D, MedImmune

Mahendra Deonarain, Chief Science Offi cer, Antikor Biopharma Ltd

Featured Speakers: • Ashish Gautam, Global Medical Lead – ADCETRIS, Takeda • Ben-Fillippo Krippendorff, Principal Scientist, Roche • Jeremy Parker, Principal Scientist, Pharmaceutical

Development, AstraZeneca • Debbie Meyer, Senior Principal Scientist, Pfi zer • Jens Lohrmann, Senior Global Program Manager, Novartis

ADC SummitDay One | Monday 23rd May 2016 www.adcsummit.com

Register online at: www.adcsummit.com • Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Sponsored by

08.30 Registration and Coffee

09.00 Chairman’s opening remarks Rakesh Dixit, Vice President, R & D, MedImmune

OPENING ADDRESS09.10 Advancement in antibody drug conjugates: A step closer to

magic bullets in war against cancer • The 5 Rs of ADCs: the right target, the right linker, the right

warhead, the right antibody, the right site of conjugation • Recent developments with site-specific conjugation

improving the therapeutic index of ADCs • Exploring how reducing hydrophobicity of homogeneous

ADCs can improve therapeutic index • Discussing how the stability of the linker can improve

therapeutic index • Discussing the on- and off-target toxicity issues • Clinical development of ADCs Rakesh Dixit, Vice President, R & D, MedImmune

INNOVATIONS IN ADC

09.50 Warheads for targeted therapies of cancer: Strategies for designing and efficient synthesis of DNA cross-linkers

• Some DNA cross-linkers are too toxic to be used as antineoplastic agents; instead, they are excellent candidates for the design of ligand-drug conjugates for cancer targeting

• New concept for design of DNA cross-linkers • Efficient total synthesis of cross-linker derivatives for

conjugation Iontcho Vlahov, VP Discovery Chemistry, Endocyte, Inc.

10.30 Morning Coffee

11.00 Development of best-in-class, homogeneous ADCs for highly effective and safer cancer therapy

• Sortase-mediated antibody conjugation (SMAC™): 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 safety profile

• Peptide-based linker structure circumvents IP issues and provides superior serum stability

• In vivo data on lead ADCs generated using site-specific SMAC™ - technology will be presented

Roger R. Beerli, Chief Scientific Officer, NBE-Therapeutics Ltd.

11.40 Preclinical efficacy of a novel anti-C4.4a (LYPD3) antibody drug conjugate BAY 1129980 for the treatment of lung cancer

• C4.4a (LYPD3) is a novel targeting antigen overexpressed in several cancer indications

• Design of BAY 1129980 employing a novel auristatin • Discuss the in vitro and in vivo efficacy profile • Phase 1 clinical studies updates (NCT02134197) Joerg Willuda, Senior Scientist, Bayer

12.20 Networking Lunch

13.50 Producing better ADCs using ThioBridge™ conjugation • Disulfide re-bridging conjugation to reduce ADC

heterogeneity • ThioBridge™ linkers provide stable conjugation • PK profiles of ThioBridge™ ADCs vs maleimide conjugation • Development of more efficacious ADCs George Badescu, Director of Scientific Affairs, Abzena

14.30 Novel site-specific conjugation tools • N-terminal serine modification for antibody conjugation:

SeriMabs • Excellent in vitro activity achieved through site-specific

conjugation • Site-specific conjugates are stable and efficacious in vivo Thomas A. Keating, Director, Biochemistry, ImmunoGen, Inc.

15.10 Afternoon Tea

NOVEL ADC TECHNOLOGIES

15.50 A Novel FRET reagent reveals the intracellular processing of antibody-drug conjugates

• Our FRET assay provides a facile and robust assessment of intracellular ADC activation

• The antigen-mediated antibody internalization is determined by the nature of cell, not by the nature of antigen

• A certain tumor cell showed a limited cytosolic transport of the payload despite the efficient linker cleavage

Byoung-Chul Lee, Scientist, Protein Chemistry, Genentech

16.20 Expanding the scope of ADC targets through novel conjugation technologies

• APN linkers with increased serum stability • New generation of DM1- and MMAE-based payloads • Expanding the scope of ADC targets by fine-tuning the drug

release mechanism Oleksandr (Sasha) Koniev, CEO & Founder, Syndivia

17.00 Platform technologies for homogeneous and versatile protein modification

• Functional disulfide re-bridging • Controlled dual “click” functionalisation • Site-selective antibody conjugation • Photodynamic therapy • Reversible and irreversible cysteine modification Vijay Chudasama, Lecturer Organic Chemistry and Chemical

Biology, University College London 17.40 Chairman’s Closing Remarks and Close of Day One Rakesh Dixit, Vice President, R & D, MedImmune

Abzena offers a suite of complementary services and technologies. Its range of technologies include immunogenicity assessment, antibody drug conjugation, protein engineering, PEGylation, cell line development, GMP manufacturing and a range of bespoke assays to enables the development of better biopharmaceuticals which will have a greater chance of reaching the market. www.abzena.com

Sponsorship and Exhibition OpportunitiesSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry.

Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk

Official Media Partners

ADC SummitDay Two | Tuesday 24th May 2016 www.adcsummit.com

08.30 Registration and Coffee

09.00 Chairman’s opening remarks Mahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd

LEARNING FROM KADCYLA AND ADCETRIS

OPENING ADDRESS / KEYNOTE ADDRESS09.10 ADCETRIS® (brentuximab vedotin) developed to treat

Hodgkin Lymphoma • Development of ADCETRIS® - Takeda and Seattle Genetics

alliance • Exploring the mechanism pathway of ADCETRIS® • Data published to date from ADCETRIS® registration studies • Ongoing ADCETRIS® clinical development Ashish Gautam, Global Medical Lead - ADCETRIS, Takeda

09.50 Predicting tissue distribution and clearance of antibody formats to improve selectivity of targeted therapies

• Estimating the tissue distribution of antibodies and antibody fragments based on plasma pharmacokinetics

• Estimation of ADC distribution and tissue specific clearances that influence the therapeutic window

• Optimise biotherapeutic modalities with optimal biodistribution properties to target (and avoid) specific tissues

Ben-Fillippo Krippendorff, Principal Scientist, Roche

10.30 Morning Coffee

CHALLENGES AND LESSONS LEARNT

11.00 Impact of drug loading on ADC target binding and cytotoxicity • Demonstrating the impact of different levels of drug loading • ADC target binding and cytotoxicity • Case studies Debbie Meyer, Senior Principal Scientist, Pfizer

11.40 Targeting Cadherin-6 (CDH6) with a novel ADC for the treatment of ovarian and renal cancers

• ADC lead selection covering optimal choice of antibody and linker/payload

• PK/PD studies to evaluate MoA and projected efficacious dose

• Population-scale in vivo assessment in ovarian cancer PTX clinical trial

Carl Uli Bialucha, Senior Investigator, Novartis Institutes For Biomedical Research

12.20 Networking Lunch

13.50 Engineering and development of novel immunotargeted

nanotherapeutics

• Engineering considerations for a novel antibody directed

nanotherapeutic

• Target expression and demonstration of targeting

• Preclinical demonstration of activity and altered tox profile

• Diagnostic development and clinical trial design for

upcoming Phase I

Daryl Drummond, Senior Director, Nanotherapeutics,

Merrimack Pharmaceuticals Inc

14.30 The design, synthesis and scale-up of an ADC tubulysin

payload

• Development of novel ADC payloads based on Tubulysins

• Identification and development of synthetic routes

• Scale up of chemistry to deliver material for toxicology and

clinical studies

Jeremy Parker, Principal Scientist, Pharmaceutical

Development, AstraZeneca

15.10 Afternoon Tea

15.50 Challenges and lessons learnt in ADC CMC development and

outsourcing

• Buy vs. make: Considerations and critical success factors

• Scale-up and site transfer of a conjugation process with

impact on key product quality attributes: case studies

• Analytical transfers: considerations and lessons learned from

a challenging assay transfers

Jens Lohrmann, Senior Global Program Manager, Novartis

16.20 Fragment drug conjugates (FDCs): A unique drug class or just

smaller ADCs?

• Using optimised single chain Fvs to obtain high

drug-to-antibody ratio (DAR)

• Impact of drug/linker structure on FDC properties

• Dosing, PK and penetration issues

Mahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd

17.00 Chairman’s Closing Remarks and Close of Day Two

Mahendra Deonarain, Chief Science Officer, Antikor Biopharma Ltd

Register online at: www.adcsummit.com • Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

Want to know how you can get involved? Interested in promoting your services to this market? Contact Honey De Gracia, SMi Marketing on +44 (0) 207 827 6102 or email: hdegracia@smi-online.co.uk

Supported by

A: ADC payloads: Availability and mechanisms of action

Workshop Leaders: David Thurston, Professor of Drug Discovery,

King’s College London

Paul Jackson, Project Manager, Femtogenix

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 25th May 2016

08.30 – 12.30Holiday Inn Kensington Forum, London, UK

Want to know how you can get involved? Interested in promoting your services to this market? Contact Honey De Gracia, SMi Marketing on +44 (0) 207 827 6102 or email: hdegracia@smi-online.co.uk

Overview of workshopThis workshop will focus on the variety of chemical and biological payloads available for attaching to antibodies, and those in the discovery and/or development phase. Discussion will be based on how the structure and mechanism of action of payloads can affect their toxicities and clinical activities when attached to antibodies, and how the best payload can be identifi ed for a particular cancer type and/or antibody.

Programme

08.30 Registration 09.00 Mechanisms of actions • The range of payload types commercially

available and their mechanism of actions • Payloads at the discovery or development

stages

10.00 Molecular modelling technique • Molecular modeling approaches to

payload discovery • Designing maximum cytotoxicity into

payloads

11.00 Morning Coffee

11.30 Design and engineering of payloads • Engineering payloads to not release

prematurely • Strategies to minimise the hydrophobicity • Ensuring maximum resistance to

P-glycoprotein pumps in payload design

12.30 End of Workshop A

About the workshop leaders: David Thurston is a Professor of Drug Discovery in the Institute of Pharmaceutical Science at King’s College London. He has a fi rst degree in pharmacy and a PhD in synthetic medicinal chemistry. David is one of the scientifi c co-founders of Spirogen Ltd (recently acquired by AstraZeneca), and acted as CSO for the company from its formation in 2000 until 2011. He is also a co-founder of Transcriptogen Ltd, which focusses on the discovery and development of small-molecule transcription factor inhibitors as oncology agents, and Femtogenix Ltd which is involved with the discovery of novel DNA Minor Groove Binding Agents (MGBAs) with potential application as ADC payloads. David has published widely in medicinal chemistry/chemistry journals, is author of the textbook “Chemistry and Pharmacology of Anticancer Drugs”, and Editor-in-Chief of the Drug Discovery book series of the Royal Society of Chemistry.

Dr. Jackson holds an undergraduate degree in the pharmaceutical sciences (LJMU), an MSc in Bioinformatics (University of Liverpool) and a PhD in Computational Drug Discovery (King’s College London). He has extensive experience in in silico methods, including structure-, ligand- and fragment-based drug design. He has also been involved in the development of QSAR, lead optimization and molecular docking techniques. Both his PhD and post-doctoral research have involved the development of novel computational chemistry methods (e.g., molecular dynamics simulation techniques) for the design and evaluation of ADC payloads, which has contributed to Femtogenix’s novel payload discovery platform.

B: Developments in high potency API manufacturing

Workshop Leaders: Richard Denk, Head Sales Containment, SKAN AGMartin Glaettlim, Sales Engineering Containment,

SKAN AG

HALF-DAY POST-CONFERENCE WORKSHOPWednesday 25th May 2016

13.30 – 17.30Holiday Inn Kensington Forum, London, UK

Overview of workshopADC payloads typically present high toxicity at extremely low doses when unconjugated, resulting in very low Occupational Exposure Levels (OEL). Their production requires chemistry carried out at small scale under high containment in a GMP compliant environment. For these reasons, any activity related to ADC payloads production requires a contained and specially designed environment, including those for R&D, analytical, production, storage.

Programme13.30 Registration

14.00 What does containment mean for very low OEL’s

• Containment in low nanogram levels requires a new approach how to design the containment and the process

• What technologies are on the market • How to design the containment for the

API production as well as for the aseptic processing

16.00 Afternoon Tea

16.30 Case study on a low OEL aseptic processing solution

• Important considerations and parameters during design of low OEL aseptic processing

• How to combine EHS and GMP • Final design implementation

17.30 End of Workshop B

About the workshop leaders:Richard Denk, Head Sales Containment, SKAN AGRichard Denk has studied mechanical engineering and is working at the company SKAN AG, headquartered in Allschwil in the position of Head Containment Group. Mr. Denk founded 8 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the Containment Manual in September 2015. The Containment Manual does provide a full overview on Containment. Furthermore, Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

Martin Glättli is the Sales Engineer for containment at SKAN AG in Switzerland. He is a frequent speaker at industry events, and writes articles for pharmaceutical engineering journals on a regular basis.For over 10 years Martin has acquired in-depth knowledge of environment-protected process design and realized state-of-the-art solutions for various well-known companies. His current work focuses on offering solutions for cleaning and maintenance-friendly containment design, as well as closing the gap between the requirements of contained processing and sterile processing technology.

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VENUE Holiday Inn Kensington Forum, 97 Cromwell Rd, London SW7 4DN, UK

5th ANNUAL ADC SUMMITConference: Monday 23rd & Tuesday 24th May 2016, Holiday Inn Kensington Forum, London, UK Workshops: Wednesday 25th May 2016, London, UK

4 WAYS TO REGISTER www.adcsummit.com

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