Part of the...European Antibody Congress 15th – 17th October 2019, Basel Congress Centre, Basel,...

European Antibody Congress

15th – 17th October 2019, Basel Congress Centre, Basel, Switzerland

Advisory board Ahuva Nissim, Reader in Antibody and Therapeutic Engineering Biochemical Pharmacology, William Harvey Research Institute, Queen Mary University Alain Beck, Senior Director, Biologics CMC and Developability, Pierre Fabre, Associate Editor, mAbs Christian Klein, Head of Oncology Programmes, Department Head Cancer Immunotherapy, Roche Innovation Center Zurich, Roche Pharma Research and Early Development John Delaney, Executive Director of Research, Amgen

Part of the

Confirmed speakersAaron K. Sato, CSO, Twist Bioscience Alain Beck, Senior Director, Biologics CMC and Developability, Pierre Fabre, Associate Editor, mAbs Alessandro Satta, PostDoc Researcher, Fondazione IRCCS, Istituto Nazionale dei Tumori Alexander Rau, PhD Student, University of Stuttgart Andre Choo, Institute Scientist & Director, Antibody Discovery, Bioprocessing Technology Institute, Agency for Science Technology & Research Andrea Marschall, Post-Doc, Brandeis University Andreas Laustsen, Associate Professor, Technical University of Denmark Anke Steinmetz, Senior Researcher, Integrated Drug Discovery, Sanofi Aventis R&D Anne Kvarnhammar, Senior Scientist, Alligator Bioscience Anne Poupon, Research Director, University of Tours Anne-Lise Terrier, Senior Research Officer, Glenmark Pharmaceuticals Armin Sepp, Scientific Leader and GSK Associate Fellow, GSK Arne Skerra, Professor, Technical University of Munich Benjamí Oller-Salvia, Assistant Professor, IQS School of Engineering, Ramon Llull University Bernardo Estupinan, Vice President, Business Development, KBI Biopharma Bernd Voedisch, Lab Head/Investigator III, Novartis Institutes for Biomedical Research Birgit Dreier, Senior Scientist and Group Leader HT-BSF, University of Zurich Bruno Filippi, Senior Research Associate, Z.H.A.W School of Life Sciences and Facility Management Campbell Bunce, Chief Scientific Officer, Abzena Catherine Tarrade, Global Product Manager, Abcam Cecilie Knudsen, Industrial PhD Student, Technical University of Denmark Christian Fischer, Staff Scientist, MRS Application Development, Bruker Biospin Christian Hackenberger, Department Head, Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP), Leibniz-Humboldt Professor for Chemical Biology, Humboldt Universität zu Berlin Christian Klein, Head of Oncology Programmes, Department Head Cancer Immunotherapy, Roche Innovation Center Zurich, Roche Pharma Research and Early Development

Christoph Merten, Group Leader, Microfluidics, European Molecular Biology Laboratory (EMBL) Christoph Roesli, Senior Fellow, Global Drug Development, Novartis Colette Johnston, Senior Director, Early Discovery, Crescendo Biologics Cornelia Mundt, Investigator III, Novartis Dan Bach Kristensen, Principal Scientist, Symphogen Darren Schofield, Senior Scientist, MedImmune David O’Connell, Lecturer & Director, Biomolecular & Biomedical Science, University College Dublin David Maurer, Principal Scientist, Distributed Bio Derek Mason, PhD Candidate, ETH Zurich Faiza Javaid, PhD Student, UCL Florian Wurm, Professor Emeritus, Swiss Federal Institute of Technology Lausanne (EPFL) Frank Stenner, Professor of Medicine, Dep. of Oncology, Head of the Centre of Hemato Oncology, USB Georg Fey, Professor Emeritus, Former Chairman, Chair of Genetics, University of Erlangen-Nuremberg Graziano Seghezzi, Managing Partner, Sofinnova Partners Gundo Diedrich, Director, Antibody Engineering, MacroGenics Guy Hermans, CSO, Isogenica Guy Meno-Tetang, Director, Quantitative Clinical Pharmacology, UCB Pharmaceuticals Hans Keirstead, Chief Executive Officer, Aivita Biomedical Helena Domingues, Examiner, Joint Cluster Biotechnology, Immunology Directorate, European Patent Office Helene Kaplon, Post-Doctoral Fellow, Servier Huaping Tang, Principal Scientist, Regulated Bioanalytics, Merck Ivan Mascanfroni, Senior Scientist, Immunology Biologics, Abbvie Bioresearch Centre Jack Sadowsky, Scientist, Genentech Jacky Schmitt, Vice President Production, CELONIC Group Jennifer Drew, Investigator, GSK Jennifer Jung, Lab Head Mass Spectrometry, Sanofi Jens Wuerthner, Head of Clinical Development, ADC Therapeutics

Jiri Kovarik, Research Investigator, Novartis Johan Nilvebrant, Researcher, K.T.H. Royal Institute of Technology Johannes Maier, Principal Scientist, Schrodinger Inc John Delaney, Executive Director of Research, Amgen John Löfblom, Associate Professor, KTH Royal Institute of Technology Jonny Finlay, CEO, Ultrahuman Keno Gutierrez, Investment Director, M Ventures Kevin Heyries, Co-Founder, Business Development and Strategy Lead, AbCellera Kevin Johnson, Partner, Medicxi Kiyoshi Takayama, Founder and President, NB Health Laboratory Co Konstantin Zoeller, Team Head, Downstream Process Development, Novartis Pharma Krzysztof Bielikowicz, Principal Scientist, Analytical Development, Glenmark Pharmaceuticals Lamine Mbow, Vice President, NBE Discovery, Glenmark Pharma Larry Green, CEO, Ablexis and AlivaMab Discovery Services Madhumita Das, Senior Scientist, BioIVT Marc-Andre Kasper, Research Scientist, FMP Berlin Marco Gobbi, Head, Laboratory of Pharmacodynamics and Pharmacokinetics (PD-PK lab), "Mario Negri" Institute for Pharmacological Research Maren Bleckmann, PostDoc, TU Braunschweig María Gonzalez-Pajuelo, CSO, FairJourney Biologics Mariangela Figini, Staff Researcher, Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori Marina Bacac, Head of Cancer Immunotherapy Department 2 (CIT-2), Roche Pharma Research & Early Development Martin Bader, Head of Biochemical and Analytical Research, Roche Martina Jezowska, Project Manager, CELONIC Group Meelis Kadaja, Director of Business Development, Icosagen Michael Humbert, Co-Founder & Laboratory Director, NTxBio Michael Schopperle, Chief Executive Officer, CureMeta Michel Degueldre, Scientist, UCB Biopharma Mingjie Xie, CEO, Rapid Novor Inc. Nicolas Fischer, Head of Research, Novimmune Nissim Darvish, Senior Managing Director, OrbiMed Oliver Seifert, Scientist, University of Stuttgart

Partha Chowdhury, Senior Director, Head of Antibody Discovery, Sanofi Genzyme Patrick Bulau, Principal Scientist, Roche Pharma Patrick Garidel, Head of Process, Purification and Pharma Development, Boehringer Ingelheim Pavel Strop, Senior Director, Protein Engineering, Bristol-Myers Squibb Pawel Stocki, Senior Principal Scientist, Ossianix Peter Kristensen, Head of Section for Biotechnology, Associate Professor, Aalborg University Philipp Spycher, PSI Founder Fellow, PSI Villigen Preeti Bakrania, Principal Scientist, LifeArc Raj Parekh, General Partner, Advent Life Sciences Robert Wilkinson, Director of Oncology Research, MedImmune Robin Curtis, Senior Lecturer, The University of Manchester Roger Beerli, Chief Scientific Officer, NBE Therapeutics Roy Jefferis, Professor Emeritus, University of Birmingham Ruud de Wildt, Director, Head of Antibody Discovery, GSK Ryuta Wada, Scientist, Upstream Processing, Astellas Pharma Sai Reddy, Assistant Professor of Bimolecular Engineering, E.T.H. Zurich Sandrine Vessillier, Principal Scientist, Head of Immunotoxicology, NIBSC Saskia Villinger, Scientist, Formulation and Process Development, Sanofi R&D Senior representative, Fujifilm Diosynth Technologies Senior Representative, Fusion Antibodies Senior Representative, Gyros Protein Technologies AB Senior representative, MaxCyte Senior Representative, Oxford Genetics Simon Friedensohn, PhD Candidate, ETH Zurich Soraya Hölper, Lab Head Mass Spectrometry, Sanofi Stefan Ewert, Senor Investigator, Novartis Pharma AG Stefan Luzi, Partner, Glide Healthcare Stefan Warmuth, Senior Director CMC & Therapeutic Program Leader, Numab Therapeutics Stefan Zielonka, Associate Director, Protein Engineering and Antibody Technologies, Merck Stephen Hearty, Head of Antibody Research, Immunocore Steve Coats, VP R&D, AstraZeneca Early Oncology

Surjit Dixit, Vice President, Technology, Zymeworks, Inc Sylvain Julien, Chairman and co-founder, e-Zyvec Tangsheng Yi, Scientist, Genentech Tarik Dabdoubi, Team Leader, in vivo Antibody Discovery, Sanofi Tariq Ghayur, Senior Research Fellow, Abbvie Taylor Guo, Co-founder and CSO, IMAB Biopharma Thomas Murray, Scientist II, Antibody Discovery & Protein Engineering, MedImmune Thomas Pillow, Senior Scientist, Genentech Thorsten Lorenz, Head, Early Drug Substance Development, Novartis Thorsten Schmidt, Head of Biologics Research, R&D, Sanofi Ulf Grawunder, Chief Executive Officer, NBE therapeutics Ulrich Rant, CEO, Dynamic Biosensors Vijay Chudasama, Lecturer, Chemistry, UCL Xiaona Jing, Director Global CMC & Pharmaceutical Development, NBE Therapeutics

Vaughn Smider, Professor, The Applied Biomedical Science Institute Xiaonan Li, Lead Scientist, Downstream Processing, Synthon Yingnan Zhang, Senior Scientific Manager, Department of Early Discovery Biochemistry, Genentech Yue Huang, Head of Clinical Pharmacology China, Merck China (131/150)

Workshop moderators Armin Sepp, Systems Modelling and Translational Biology, GSK Guy Meno-Tetang, Director, Quantitative Clinical Pharmacology, UCB Pharmaceuticals Kevin Johnson, Partner, Medicxi Nissim Darvish, Senior Managing Director, OrbiMed

Day 1 – Tuesday 15th October 2019 08:00 Registration opens

08:30 Conference doors open

08:55 Welcome from Terrapinn

Opening Keynotes

09:00 Chair’s opening remarks Alain Beck, Senior Director, Biologics CMC and Developability, Pierre Fabre, Associate Editor, mAbs (CONFIRMED)

09:05 Antibody-drug conjugates: Future directions in clinical and translational strategies

• Provide an overview of the current ADC landscape and challenges

• Discuss the clinical and translational strategies to improve the therapeutic index for ADC’s

• Envision the future landscape for ADC’s Steve Coats, VP R&D, AstraZeneca Early Oncology (CONFIRMED)

09:30

09:55 Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at [email protected] or +44 (0)207 092 1297

10:20 Networking Break

11:20 Plenary roundtable session

TABLE 1 Analytical and structural characterization of mAbs,

biosimilars, ADCs, BsAbs, and Fc fusion proteins Alain Beck, Senior Director, Biologics CMC and Developability,

Pierre Fabre, Associate Editor, mAbs (CONFIRMED)

TABLE 2 Title TBA

Yue Huang, Head of Clinical Pharmacology China, Merck

China (CONFIRMED)

TABLE 3 Therapeutic antibodies-line of sight

Partha Chowdhury, Senior Director, Head of Antibody

Discovery, Sanofi Genzyme (CONFIRMED)

TABLE 4 Establishing early development strategies for therapeutic

proteins Thorsten Lorenz, Head, Early Drug Substance Development,

Novartis (CONFIRMED)

TABLE 5 The development of multiplex IHC targeting biomarker

identification Madhumita Das, Senior Scientist, BioIVT (CONFIRMED)

TABLE 6 Multispecific antibodies: challenges & analytical strategies

Soraya Hölper, Lab Head Mass Spectrometry, Sanofi

(CONFIRMED) Jennifer Jung, Lab Head Mass Spectrometry, Sanofi

(CONFIRMED)

TABLE 7 Title TBA

Christian Fischer, Staff Scientist, MRS Application Development, Bruker Biospin (CONFRIMED)

TABLE 8

TABLE 9

TABLE 10

TABLE 11

TABLE 12

TABLE 13 Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at [email protected] or +44 (0)207 092

1297

TABLE 14 Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at [email protected] or

+44 (0)207 092 1297

TABLE 15 Reserved for supporting partner. If you are interested in being involved,

please contact Derek Cavanagh at [email protected] or +44 (0)207 092 1297

12:35 Networking Lunch

Protein engineering Bispecifics development

Armed antibodies discovery CMC and developability Chaired by: Alain Beck, Senior Director, NBEs

Analytical Chemistry, Pierre Fabre, Associate Editor,

mAbs

mAbs Technology showcase

14:10 Modulating therapeutic window of antibody drug conjugates by protein engineering

• Engineering multiple properties of monoclonal antibodies to maximize the therapeutic window

• Properties such as conjugation location, antibody internalization, antibody affinity, drug and linker type, as well as use of dual payloads will be discussed

Pavel Strop, Senior Director, Protein Engineering, Bristol-Myers Squibb (CONFIRMED)

An overview of pre-clinical activity of T cell bispecific antibodies

• An overview of the pre-clinical activity of two "2:1" TCBs which are currently in clinical development, including combination studies in animal models

Marina Bacac, Head of Cancer Immunotherapy Department 2 (CIT-2), Roche Pharma Research & Early Development (CONFIRMED)

New payloads for antibody-drug conjugates

• Exploring drugs with novel mechanisms of action and learning the requirements for effective ADC payloads

• Impact of drug load on ADC activity

• The importance of payload metabolism and how to avoid using antibody or small molecule engineering

Thomas Pillow, Senior Scientist, Genentech (CONFIRMED)

Structure, heterogeneity and developability assessment of therapeutic antibodies, fusion proteins and ADCs

• Critical quality attributes ranking (CQAs)

• FDA & EMA approved biologics benchmarking

• Multi-dimensional analytical methods

Alain Beck, Senior Director, Biologics CMC and Developability, Pierre Fabre, Associate Editor, mAbs (CONFIRMED)

Discovery of human monoclonal antibodies against snake venom toxins

• Antibody phage display using snake toxins as antigens

• Neutralization of snake toxins using human monoclonal antibodies

• Human oligoclonal antibody mixtures against whole venoms from snakes

• Prospects of using phage display for discovery of antibodies against animal toxins

Andreas Laustsen, Associate Professor, Technical University of Denmark (CONFIRMED)

Bispecific binding analysis with the two-color switchSENSE® biosensor

• Simultaneous detection of interactions of bispecific binders with two antigens

• Analysis of on- and off-rates

• Avidity vs. affinity analysis

• Engineering of binding selectivity

Ulrich Rant, CEO, Dynamic Biosensors (CONFIRMED)

14:30 Developability: evaluating specificity, immunogenicity, functionality &

Simultaneous blockade of multiple immune checkpoint pathways with bispecific DART® molecules

Amunix XTEN® polypeptides and THIOMAB™ antibodies to enable site-specific high-

Title TBA Bernardo Estupinan, Vice President, Business

Therapeutic targeting of GOLPH2 – a cancer supporter and immunity inhibitor

Computational immuno-engineering therapeutics against challenging targets: GPCR antagonists, broad

manufacturability for lead candidate selection

• Understand the latest series of in silico computational models, analytics, in vitro and ex vivo experiments used in developability assessment.

• Characterise a molecules Specificity, Immunogenicity, Safety, Functionality and Manufacturability.

• Data generated informs sequence, structural, formulation and process refinements to select the best candidate for manufacture.

Campbell Bunce, Chief Scientific Officer, Abzena (CONFIRMED)

• MGD019: Dual blockade of CTLA-4 and PD-1 pathways with enhanced targeting of CTLA-4+ / PD-1+ double-positive cells

• MGD013: Synergistic activity via co-inhibition of PD-1 and LAG-3 exhaustion pathways

Gundo Diedrich, Director, Antibody Engineering, MacroGenics (CONFIRMED)

DAR ADCs with acceptable pharmacokinetics and efficacy

• Conjugation and analytics development for high-DAR THIOMAB™ antibody-XTEN®-drug conjugates (TXCs)

• In vitro and in vivo validation of TXC platform

• Application toward delivery of novel payloads

Jack Sadowsky, Scientist, Genentech (CONFIRMED)

Development, KBI Biopharma (CONFIRMED)

• GOLPH2 (GP73/GOLM1), a pro-oncogenic protein in a variety of cancers has hitherto not been targetable

• Novel antibodies with a unique mode of action target GOLPH2 positive tumours

• Preclinical data of these antibodies show high efficacy in vitro in EGFR- and KRAS-mutated cell lines

• Syngeneic animal models and patient derived xenografts confirm efficacy and indicate the way of further clinical development

• GOLPH2 role in blocking immune responses and the clinical implications will be discussed

Frank Stenner, Senior Physician, Head of the Haematology-Oncology Tumour Centre (ZHO), University Hospital Basel (CONFIRMED)

neutralizers, blood-brain barrier transit, and species cross reactivity

• Learn how to: discovery hits against previously challenging targets including GPCRs, pMHC complexes, and rare epitopes

• Discover why: affinity, cross-species coverage, and improved drug-like characteristics is important for an antibody library

• Learn how to: generate thousands of human-like hits in the fraction of the time it takes for traditional methods

David Maurer, Principal Scientist, Distributed Bio - Representing Charles River (CONFIRMED)

14:50 Protein and antibody engineering using yeast surface display

Development of NM21-1480: A novel, monovalent PD-L1 and 4-1BB antibody

Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at

CQA-driven characterisation program for antibodies

Title TBA

Reserved for Oxford Genetics

• Isolation of antibodies with prescribed properties by combining animal immunization and yeast surface display

• Protein engineering and affinity optimization

• Insights into the library construction process

Stefan Zielonka, Associate Director, Protein Engineering and Antibody Technologies, Merck (CONFIRMED)

with tumour directed potency and beneficial safety profile

• Rational design of NM21-1480 for superior potency and a constant EC50, largely independent of PD-L1 expression levels in combination with a wide range of active concentrations

• Tumour restricted 4-1BB signalling that results in superior in-vivo efficacy, when compared to combinations of αPD-(L)1 and α4-1BB mAbs

• No signs for hepatotoxicity and systemic T cell activation in NHPs

• Prolonged half-life supporting convenient dosing schemes

Stefan Warmuth, Senior Director CMC & Therapeutic Program Leader, Numab Therapeutics (CONFIRMED)

[email protected] or +44 (0)207 092 1297

• Timeline and extent of CQA assessment for a typical IgG

• Translation of CQAs to characterization needs

• Realization of a complete characterization program to streamline the compilation of the final control strategy

Christoph Roesli, Senior Fellow, Global Drug Development, Novartis (CONFIRMED)

Larry Green, CEO, Ablexis and AlivaMab Discovery Services (CONFIRMED)

Senior Representative, Oxford Genetics (CONFIRMED)

15:10 Advancing therapeutic protein development using a novel O-glycan-based conjugation approach

Development of Her2 Targeted Bispecific and Bispecific ADC with the Azymetric™ and ZymeLink™ Platforms

Application of anti-glycan antibodies against cancer

• Antibody discovery and development against

Structural heterogeneity, polymorphisms and the immunogenicity of bio-therapeutics

An international collaborative study to establish a 1st reference panel for cytokine release assays

e-Zyvec assembly method : a new modular technology to assemble tailor-made DNA vectors

• Innovative technology utilising a novel peptide-based tag to generate site-specific, homogeneously-labelled recombinant secretory proteins containing modified O-glycans.

• Robust incorporation of functionalised O-glycans to recombinant proteins using a UDP-galactose-4-eperimase KO, serum-free, expression system.

• Externally supplied sugars such as N-acetylgalactosamine (GalNac) or N-azidoacetylgalactosamine (GalNAz), can be utilised to generate site-specific O-glycosylation on demand, e.g. for Click chemistry applications.

• The technology represents an elegant, controllable approach to generate bespoke, consistently labelled recombinant proteins.

Thomas Murray, Scientist II, Antibody Discovery & Protein Engineering, MedImmune (CONFIRMED)

• The Azymetric™ platform allows design of bispecific antibodies while being compatible with standard manufacturing processes

• ZW25 is an Azymetric™ based Her2 targeting biparatopic antibody in Phase 2 trial with multiple novel mechanisms of action

• ΖW49 is a bispecific ADC in Phase 1 trial, conjugating ZW25 to the ZymeLink™ cytotoxic payload

• This presentation will introduce the Azymetric™ and ZymeLink™ platforms and provide an update on the clinical candidates ZW25 and ZW49

Surjit Dixit, Vice President, Technology, Zymeworks, Inc (CONFIRMED)

glycosylated targets on cancer cells

• Characterisation and validation of glycol epitopes

• Evaluation of antibodies as ADCCs, ADCs, CAR-Ts and Bispecific Antibodies

Andre Choo, Institute Scientist & Director, Antibody Discovery, Bioprocessing Technology Institute, Agency for Science Technology & Research (CONFIRMED)

• Administration of a biotherapeutic drug may be prescribed: to introduce/supplement a deficit in a natural (self) protein/glycoprotein (P/GP); to manipulate the activity of a self-molecule or eliminate a population of cells.

• A proportion of patients produce an anti-therapeutic antibody drug (ATA) immune response that may compromise the efficacy of treatment; it may result from: absence of the natural molecule or exposure to an unmatched polymorphic variant; exposure to a molecule lacking structural fidelity with a self P/GP.

(via weblink) Roy Jefferis, Professor Emeritus, University of Birmingham (CONFIRMED)

• In vitro cytokine release assays (CRA) are key for hazard ID of mAbs such as cytokine release syndrome (CRS)

• In an international collaborative study, the comparability of different CRA platforms used for preclinical safety testing was evaluated and inter-laboratory comparisons were assessed with mild, moderate and severe positive controls

• These findings will be used to establish a 1st reference panel for CRA

Sandrine Vessillier, Principal Scientist, Head of Immunotoxicology, National Institute for Biological Standards and Control (NIBSC) (CONFIRMED)

• Limitations in classical cloning methods

• Our technological answer

• Example of applications Sylvain Julien, Chairman and co-founder, e-Zyvec (CONFIRMED)

15:30 Networking break

Protein engineering Bispecifics development Armed antibodies discovery CMC and developability mAbs Technology showcase

16:30 Harnessing antibody light chains to generate multispecific native antibody formats

• The 3 light chain CDRs are sufficient to drive high affinity and specific binding

• Combinatorial pairing of different light chains with a single heavy chain generates bi- and multispecific antibody formats

• These formats fully retain the native structure of a human IgG

• Different applications of this approach will be presented

Nicolas Fischer, Head of Research, Novimmune (CONFIRMED)

ATOR-1144 is a tumour-directed CTLA-4 x GITR bispecific antibody

• ATOR-1144 is a next generation CTLA-4 targeting antibody developed for treatment of solid tumours and haematological malignancies

• Dual targeting of CTLA-4 and GITR is expected to direct the effect to the tumour area

• The mechanisms of action of ATOR-1144 are activation of effector T cells, depletion of Tregs and tumour cells, and activation of NK cells for enhanced tumour cell killing

Anne Kvarnhammar, Senior Scientist, Alligator Bioscience (CONFIRMED)

TRA-1-60, a metastatic cancer target for a novel antibody-drug-conjugate, CM-09

• TRA-1-60 is a single transmembrane plasma glycoprotein expressed in normal embryonic stem cells but not in normal healthy tissues

• TRA-1-60 is re-expressed in many different human cancers including prostate, pancreatic, colon, oesophageal and gastric cancers and increased TRA-1-60 expression correlates with aggressiveness and metastatic potential of the disease

• CM-09 is a high affinity/high specificity antibody-drug-conjugate which targets TRA-1-60 and has potent activity in preclinical cancer models

Michael Schopperle, Chief Executive Officer, CureMeta (CONFIMRED)

Journey of iADCTM from lab bench to clinical supply: CMC outsourcing for innovative biotech start-up

• Overview of ADCs’ CMC challenges, and what new opportunity & challenges enzymatic conjugation bring to CMC development.

• The successful transformation of NBE’s innovative ADC technology to GMP manufacturing platform.

• How to handle CMC outsourcing management in Biotech SMEs- The essence of risk detection and handling.

Xiaona Jing, Director Global CMC & Pharmaceutical Development, NBE Therapeutics (CONFIRMED)

New twists on whole cell phage panning

• Focus on Fab expressing phages

• Cell line and phage library considerations

• Interactions between cells and phages

• Experimental challenges

Cornelia Mundt, Investigator III, Novartis (CONFIRMED)

Title TBA Catherine Tarrade, Global Product Manager, Abcam (CONFIRMED)

16:50 Design and validation of Alexandria™, Isogenica’s fully synthetic human antibody library

• Alexandria™ is Isogenica’s fully synthetic, developability optimized human antibody library

• Alexandria™ offers unrivalled diversity, due to inclusion of many heavy and kappa light chain germlines and use of fully synthetic CDR1, -2 and -3 cassettes across the whole repertoire.

• As such, it avoids the issues of immunodominant epitopes, self-antigen tolerance and skewed diversity intrinsic to immunization based approaches or naïve and semi-synthetic libraries

• We will present validation data on use of the library to generate binders to various target classes

Guy Hermans, CSO, Isogenica (CONFIRMED)

Title TBA Stephen Hearty, Head of Antibody Research, Immunocore (CONFIRMED)

Non-natural amino acid antibody conjugates Vaughn Smider, Professor, The Applied Biomedical Science Institute (CONFIRMED)

Improved scoring function to reliably detect antigen binding sites

• Computational method to detect antigen binding sites using the PIPER protein/protein docking engine

• Improved scoring function factoring in the specifics of antibody/antigen binding

• Detection and analysis of spatially distant binding regions

Johannes Maier, Principal Scientist, Schrodinger Inc (CONFIRMED)

Antibody discovery at GSK with a focus on Immunological and Immuno-oncology targets

• The progress with the isolation of antibodies for a number of projects in the immunology and immune-oncology disease areas using GSKs in-vitro and in-vivo antibody platforms

• Innovative antibody design and selection approaches will be discussed

Ruud de Wildt, Director, Head of Antibody Discovery, GSK (CONFIRMED)

HybriFree: a robust and rapid method for the development of monoclonal antibodies from different host species

Meelis Kadaja, Director of Business Development, Icosagen (CONFIRMED)

17:10 Development of a high affinity monoclonal antibody, MEDI1341, that sequesters extracellular α-synuclein and

Detection and characterisation of non-consensus glycosylation

Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at

Practical consideration of developing size exclusion chromatography for potent bispecific

An allosteric anti-tryptase antibody for the treatment of mast cell-mediated severe asthma

The Journey To “The” Antibody: Tailoring For Success

prevents α-synuclein spreading in Parkinson’s disease models

• Parkinson’s disease progression may arise due to spreading of pathological forms of extracellular alpha-synuclein (α-syn) throughout the brain via a cellular release, uptake and seeding mechanism.

• MEDI1341 is as a high-affinity antibody that binds monomeric and aggregated forms of α-syn, and in vitro, MEDI1341 blocks cell-to-cell transmission of pathologically relevant α-syn preformed fibrils (pffs).

• In vivo, MEDI1341 can enter the brain and sequester extracellular α-syn in the ISF and CSF compartments.

• In a novel lentiviral-based in vivo model of α-syn spreading in the brain, MEDI1341 strongly reduces α-syn accumulation and propagation along axons.

• MEDI1341 has now entered Phase 1 human

during early development of bispecific antibody

• Presence of unexpected species was noticed during development of BEAT bispecific antibody

• Using combination of analytical technologies, it has been identified as glycosylation (non-consensus)

• Site of non-consensus glycosylation and structure of N-glycans present has been determined

Krzysztof Bielikowicz, Principal Scientist, Analytical Development, Glenmark Pharmaceuticals (CONFIRMED)

[email protected] or +44 (0)207 092 1297

• Specificities of BEAT molecules and associated analytical challenges

• Reversible aggregation phenomenon and bispecific antibodies

• Identification and study of parameters influencing reversible aggregate level using design of experiment

Anne-Lise Terrier, Senior Research Officer, Glenmark Pharmaceuticals (CONFIRMED)

• Tryptase is elevated in human asthma samples independent of type 2 inflammation.

• Sequencing of tryptase genetic locus reveals that active -tryptase allele count is associated with increased blood tryptase and inadequate clinical response to Omalizumab.

• Discovery and structural characterization of a non-competitive inhibitory anti-β-tryptase antibody.

• Preclinical characterization of antibody inhibitory activity and pharmacokinetic property in preclinical animal model of humanized mouse and cynomolgus monkeys.

Tangsheng Yi, Scientist, Genentech (CONFIRMED)

• To maximize the possibility to select “the” antibody, at FJB we have taken antibody discovery to an unprecedent level by creating a versatile toolbox that allows the selection by phage display of antibody fragments of different species from large naïve and immune repertoires.

• Ultimately these fragments can be engineered and converted to mono- and bi-specific formats that are produced in CHO cells.

María Gonzalez-Pajuelo, CSO, FairJourney Biologics (CONFIRMED)

clinical trials as a potential novel treatment for halting or slowing the progression of Parkinson’s disease.

Darren Schofield, Senior Scientist, MedImmune

17:30 Creating multifunctional biologics for immuno-oncology using Humabody VH from the Crescendo Mouse

• Crescendo’s proprietary transgenic mouse generates highly diverse fully human VH domain (‘Humabody’) building blocks

• Humabody VH can be combined in various formats which lack the constraints of traditional mAbs, enabling multifunctional molecules to be constructed which deliver enhanced therapeutic benefit

• Examples of differentiated biology will focus on applications in immuno-oncology

Colette Johnson, Senior Director, Early Discovery,

Reserved for supporting partner. If you are interested in being involved, please contact Derek Cavanagh at [email protected] or +44 (0)207 092 1297

Overcoming limitations of current Antibody-Drug Conjugates (ADCs) by a novel linker technology

• Introducing a novel ADC-linker technology enabling site-specific payload conjugation to native antibodies (i.e. no need to reduce or re-engineer the antibody)

• Biophysical characterization of generated ADCs will be shown

• ADC in-vitro and in-vivo performance in comparison to other conjugation technologies will be shown

Philipp Spycher, PSI Founder Fellow, PSI Villigen (CONFIRMED)

Antibody development in the 21st century: Facing the reality that monoclonality does not mean monospecificity

• Polyspecificity is a long-recognised phenomenon in monoclonal antibodies

• Despite this, it is a poorly-addressed factor in clinical success

• Specificity is now a key development characteristic

Jonny Finlay, CEO, Ultrahuman (CONFIRMED)

Antibody discovery platform to mine out the memory B cell repertoire using flow cytometry single-cell sorting technology

• Novel platform that enables large-scale functional interrogation of the natively paired VH:VL antibody repertoire of immunized human immunoglobulin transgenic mice

• We will describe the use of multi-parameter flow cytometry single cell sorting technology for the generation of antigen-specific antibodies with desirable characteristics from IgG+ memory B cell compartment

• A case study will be presented, where a rare highly potent

Title TBA Senior Representative, Gyros Protein Technologies AB (CONFIRMED)

Crescendo Biologics (CONFIRMED)

neutralizing antibody for the treatment of inflammatory diseases was identified

Tarik Dabdoubi, Team Leader, in vivo Antibody Discovery, Sanofi (CONFIRMED)

17:50 Offsite networking drinks

Day 2 – Wednesday 16th October 2019 08:00 Registration open

08:50 Conference Doors open

Combination therapies

09:00 Combination immunotherapies to maximise efficacy

• Immunotherapy/immuno-Oncology (IO) is a rapidly expanding class of drugs which has created a paradigm shift in the treatment of some cancers.

• Progress in understanding the molecular and cellular determinants of response is providing a framework on which patients will benefit from IO therapy and continues to evolve.

• My talk will focus on how best to modulate an anti-cancer immune response through rational/data driven IO combinations Robert Wilkinson, Director of Oncology Research, MedImmune (CONFIRMED)

09:20 Engineering bispecific antibodies for combination cancer immunotherapy

• Overview of the application of antibody engineering technologies to generate engineered antibodies for combination cancer immunotherapy

• Tumor-targeted 4-1BB agonists as off-the-shelf alternatives to CAR-T cells Christian Klein, Head of Oncology Programmes, Department Head Cancer Immunotherapy, Roche Innovation Center Zurich, Roche Pharma Research and Early Development (CONFIRMED)

09:40 Enhancing patient responses with autologous cancer stem cell vaccine in combination with checkpoint inhibitors

• Targeting the cancer stem cell

• Soluble PD-1 as a prognostic and predictive biomarker of efficacy

• Improving outcomes with this combination treatment Hans Keirstead, Chief Executive Officer, Aivita Biomedical (CONFIRMED)

10:00 Panel: Combination therapy strategies Chaired by: Lamine Mbow, Vice President, NBE Discovery, Glenmark Pharmaceuticals (CONFIRMED) Christian Klein, Head of Oncology Programmes, Department Head Cancer Immunotherapy, Roche Innovation Center Zurich, Roche Pharma Research and Early Development (CONFIRMED) Partha Chowdhury, Senior Director, Head of Antibody Discovery, Sanofi Genzyme (CONFIRMED) Hans Keirstead, Chief Executive Officer, Aivita Biomedical (CONFIRMED)

10:30 Networking break

Protein engineering Chaired by: Benjamí Oller-Salvia, Assistant Professor, IQS School of Engineering,

Bispecifics discovery Chaired by: John Delaney,

Executive Director of Research, Amgen

(CONFIRMED)

Armed antibodies development

CMC and developability Chaired by: Patrick Garidel, Head of Process, Purification and Pharma Development,

Manufacture and bioprocessing

Technology showcase Chaired by: Ulf Grawunder, Chief Executive Officer, NBE therapeutics

Ramon Llull University (CONFIRMED)

Boehringer Ingelheim (CONFIRMED)

11:25 Antibody engineering in mammalian cells by genome editing

• Mammalian surface display platform developed by multi-step CRISPR-Cas9 engineering

• Generation of site-directed and error-prone libraries by homology-directed mutagenesis

• Screening immune libraries by enhanced homology-directed repair

Sai Reddy, Assistant Professor of Bimolecular Engineering, E.T.H. Zurich (CONFIRMED)

The future of biologic therapeutics and their unique challenges

• Large molecule protein therapeutics have risen to play a significant role in disease modulation

• Bi-specific protein therapeutics are emerging as the next wave of protein therapeutics

• Bi-specific molecules pose unique challenges to current manufacturing processes

John Delaney, Executive Director of Research, Amgen (CONFIRMED)

Title TBA Title TBA Patrick Garidel, Head of Process, Purification and Pharma Development, Boehringer Ingelheim (CONFIRMED)

High-throughput approaches applied during development, characterization and validation of a monoclonal antibodies purification process

• Demonstrate the use of simulation software (DelftChrom) to develop a chromatographic unit operation

• A high-throughput approach to performing early-stage process characterization of the chromatographic unit operation

• Use Monte Carlo simulation to demonstrate control of the process during process validation stage

Xiaonan Li, Lead Scientist, Downstream Processing, Synthon (CONFIRMED)

MoGRAA® discovery engine to generate the functional therapeutic mAbs targeting GPCRs with a unique single cell analysis technique

• GPCR

• Monoclonal antibody

• Single cell technology Kiyoshi Takayama, Founder and President, NB Health Laboratory Co (CONFIRMED)

11:45 Direct sequencing of polyclonal antibody proteins with mass spectrometry

• Review on Sequencing mAb proteins with Mass Spectrometry

• Challenges on sequencing pAb proteins

• pAb sequencing platform overview

• Example project show case

Mingjie Xie, CEO, Rapid Novor Inc. (CONFIRMED)

From mice to men: the circulation and tissue penetration of biotherapeutics

• The general properties of biotherapeutics: antibodies, antibody fragments, therapeutic proteins

• Extravasation of biotherapeutics: from rodents to humans

• Target engagement by biotherapeutics

• Looking beyond proteins: cellular therapies

Armin Sepp, Scientific Leader and GSK Associate Fellow, GSK (CONFIRMED)

Use of dibrompyridazinediones for site-selective antibody modification

• Site-selective antibody modification

• Disulfide re-bridging

• Bispecifics

• Trispecifics

• Antibody-nanoparticle conjugates

Vijay Chudasama, Lecturer, Chemistry, UCL (CONFRIMED)

Developability screening for lead selection- a more balanced approach

• Assessing developability characteristics is now the norm. However, there has to date been a focus on manufacturing risks versus safety and pharmacology (translational factors) early on in the process

• Our aim is to rebalance our approach to developability screening to include in vitro screens to address these areas

• This talk will give an update on our progress and discuss the challenges and opportunities of this work

Jennifer Drew, Investigator, GSK (CONFIRMED)

Advantages of perfusion processes for the production of difficult to express proteins

• Introduction to Celonic

• Experience with different cell retention devices at Celonic

• Case studies

• Benefits & Challenges of perfusion processes

Jacky Schmitt, Vice President Production, CELONIC Group (CONFIRMED) Martina Jezowska, Project Manager, CELONIC Group (CONFIRMED)

Evaluation of the higher order structure at atomic resolution using NMR

• NMR provides a solution to the need for atomic resolution in HOS characterization

• NMR can be applied to intact molecules at natural abundance, with acquisition times reasonable for routine analysis

• NMR sample preparation is simple, measurement in physiologically relevant solution

• NMR is a high precision analytical technique and produces data that is the ideal input for robust statistical tools required for HOS evaluation

Christian Fischer, Staff Scientist, MRS Application Development, Bruker Biospin (CONFIRMED)

12:05 Efficient incorporation of non-canonical amino acids in phage display via genetic code expansion

• Encoding of a cyclopropene into a

Development of multispecific protein therapeutics – challenges and opportunities

• The presentation will show on several

P5- and Tub-Tag®-labelling: The dream-team for chemical and enzymatic syntheses of stable and efficacious antibody drug conjugates

From discovery into the clinic: examples for the technical development of complex biologics from Roche’s early development pipeline

Arginine to lysine mutations stabilize scFv antibody domains against aggregation

• How to prevent aggregation of

Fermentation-independent manufacturing of biologics

• Scalable, recombinant cell-free system for discovery and manufacturing

phage displayed scFv using PylRS/PylT and an orthogonal ribosome

• Flexibility of position, codon, and non-canonical amino acid

• Incorporation of two distinct ncAAs into a phage displayed scFv enables a concerted dual modification

Benjamí Oller-Salvia Assistant Professor, IQS School of Engineering, Ramon Llull University (CONFIRMED)

examples how new protein engineering idea and innovations can solve “Developability” challenges and opens up new Biology areas

Thorsten Schmidt, Head of Biologics Research, R&D, Sanofi (CONFIRMED)

• P5-labeling enables rapid generation of stably linked ADCs from native antibodies

• Chemoenzymatic Tub-tag® technology facilitates site-specific conjugation to a payload-friendly microenvironment

• Both technologies deliver ADCs with excellent in vivo efficacy and superior linkage stability when compared to FDA-approved ADCs

Marc-Andre Kasper, Research Scientist, FMP Berlin (CONFIRMED)

• Overview on Roche pRED’s portfolio of complex (multi-specific) biologics

• Design principles, developability: how to select the optimal candidate, ready for CMC

• Case studies from the pipeline: from final candidate to Phase I ready process

• Some CMC results from Roche’s advanced pipeline

Martin Bader, Head of Biochemical and Analytical Research, Roche (CONFIRMED)

biotherapeutics by reducing the self-association propensity of buried groups exposed when proteins partially unfold

• We have correlated aggregation behaviour with the conformational /colloidal stabilities and beta-sheet propensity.

• Replacing arginine with lysine increases the colloidal stability of the unfolded state, which is measured in solutions containing chemical denaturant.

• Four single point arginine to lysine mutants all exhibit reduced aggregation propensity indicating that R to K mutations have non-specific stabilizing effects on the colloidal stability of the unfolded states.

Robin Curtis, Senior Lecturer, The University of Manchester (CONFIRMED)

• Production of an engineered vaccine

• Host-free biosynthesis of challenging biosimilars

Michael Humbert, Co-Founder & Laboratory Director, NTxBio (CONFIRMED)

12:25 Overcoming challenges in antibody engineering at LifeArc

Engineering bispecifics and alternative scaffolds

• Strategies for overcoming expression

Anthracycline-based ADCs with potent immune-stimulatory functions (iADCs): Production,

A soap opera: polysorbate challenges and solutions applied to biologics formulation development

Use of Leap-In transposases in biologics research

• Generation of stable cell lines in the context

Title TBA

• Humanisation of challenging targets

• Developability Assessment of Lead candidates

• Example project show case 1

• Example project show case 2

Preeti Bakrania, Principal Scientist, LifeArc (CONFIRMED)

challenges for difficult scaffolds

• Importance of manufacturing host cells in early development

• Accelerated timelines using a single expression continuum

Senior representative, MaxCyte (CONFIRMED)

preclinical validation and characterization of their antitumor efficacy

• Overview of NBE-therapeutics’ sortase-based, site-specific conjugation technology to generate homogenous ADCs

• Highly potent anthracycline payload, providing access to difficult-to-address targets

• Preclinical characterization of the immune-oncology properties of NBE's ADCs

Roger Beerli, Chief Scientific Officer, NBE Therapeutics (CONFIRMED)

• Provide an overview of polysorbate issues and solutions reported in the literature

• Introduce polysorbate analytics for de-risking studies

• Show examples and lessons learned from de-risking approaches for biologics formulations

Saskia Villinger, Scientist, Formulation and Process Development, Sanofi R&D (CONFIRMED)

of Biologics research and Development

• Use of Leap-In transposase system for the generation of cell lines in various host cell lines

• Use of Leap-In transposase system for the generation of antibody-producing CHO cell line

Bernd Voedisch, Lab Head/Investigator III, Novartis Institutes for Biomedical Research (CONFIRMED)

Senior Representative, Fusion Antibodies (CONFIRMED)

12:45 Tuning antibody fragments for theranostic applications with the help of PASylation technology

• PASylation as a novel (immunologically inert) approach to equip antibody fragments with tunable plasma half-life

• Applications for in vivo tumor imaging

• Applications for cytotoxic payload targeting

Triplebody SPM-2 with dual-targeting of CD33 and CD123 mediates efficient lysis of primary blasts from AML-patients and of cellular subsets enriched in leukaemia stem cells in concert with NK cells

• Single-chain triplebodies, a versatile platform of tri-specific antibody derivatives


Moving targets – demonstrating viral clearance in a continuous manufacturing process Konstantin Zoeller, Team Head, Downstream Process Development, Novartis Pharma (CONFIRMED)


• Applications for immune checkpoint blockade

Arne Skerra, Professor, Technical University of Munich (CONFIRMED)

• Dual-targeting creates enhanced lytic activity and enhanced selectivity of lysis

• Triplebody SPM-2 (CD33-CD16-CD123) is very robust and highly effective against

• primary AML blasts and populations enriched in AML leukaemia stem cells (LSCs)

• Triplebodies engaging T-cells as effectors function and are in academic development

Georg Fey, Professor Emeritus, Former Chairman, Chair of Genetics, University of Erlangen-Nuremberg (CONFIRMED)

13:05 Networking lunch

Protein engineering Bispecifics discovery Armed antibodies development

CMC and developability Research Hub Technology showcase Chaired by: Roger Beerli,

Chief Scientific Officer, NBE Therapeutics

14:35 In vitro selection of high affinity binders from novel D9k-Loop and D9k-Surface libraries - a new class of high-specificity, high-stability, high affinity scaffolds

• Designed and created two novel phage displayed libraries of a

Targeted conditional bispecific for treatment of inflammatory diseases

• Improving therapeutic potential of bio-therapeutics by increasing drug concentrations to target

Transitioning anti-ROR1 iADC NBE-002 into the clinic in triple-negative breast cancer

• Rationale for targeting ROR1 in solid tumors and specifically in Triple Negative Breast Cancer.

Application of native MS coupled to various chromatographic techniques in the development of mixed antibody products

• Antibody mixtures pose a significant analytical and characterization

Cell-based vaccination in rabbit for multispanning membrane antigens

• Antibody discovery in rabbit using a syngeneic cell-based vaccination

• Large set of syngeneic rabbit cell population for optimal


uniquely suited protein scaffold format, a highly hydrophilic and stable calcium binding protein, which will lead to the development of high affinity, highly-specific diagnostic and therapeutic binding molecules

• Constructed DNA libraries of mutant forms of the protein with the variable amino acid residues encoded in a loop (D9k-Loop) or on the surface (D9k-Surface)

• The protein scaffolds encoded by the libraries are displayed on the surface of bacteriophage for in vitro selection of high affinity binders to targets of biomedical importance e.g., VHH single domain antibodies for diagnostic development, amyloid fibrils to block secondary nucleation and to selected oncoprotein antigens for the evaluation of neutralising and bispecific scaffold constructs as therapeutic entities.

tissues and limiting systemic exposure

• 2Proteogenomic analysis of inflamed tissues for new targets and biomarkers identification

• 3A case study showing increased efficacy while sparing systemic exposure will be presented using a preclinical model of arthritis

Ivan Mascanfroni, Senior Scientist, Immunology Biologics, Abbvie Bioresearch Centre (CONFIRMED)

• Non-clinical safety and pharmacology of NBE-Therapeutics lead iADC, NBE-002

• Immune-oncology function of NBE-002

Ulf Grawunder, Chief Executive Officer, NBE therapeutics (CONFIRMED)

challenge during biopharmaceutical development

• Various chromatographic techniques can be hyphenated to native MS to provide powerful and new structural insights for mixed antibody products

• Learnings from charge variant (CV) native MS applied to complex mixed antibody products will be presented

• Learnings from the application of size exclusion chromatography (SEC) native MS during early development will be presented with focus on robustness and reproducibility

Dan Bach Kristensen, Principal Scientist, Symphogen (CONFIRMED)

multispanning membrane antigen expression

• Promising alternative to genetic or cross-species cell-based vaccination

Bruno Filippi, Senior Research Associate, Z.H.A.W School of Life Sciences and Facility Management (CONFIRMED)

David O’Connell, Lecturer & Director, Biomolecular & Biomedical Science, University College Dublin (CONFIRMED)

14:55 Transferrin receptor-mediated BBB shuttling antibodies based on VNARs

• Advantages of VNARs as brain shuttles

• Mechanistic requirements for efficient brain transport

• 3Wide range of payload delivery including peptides, enzymes and antibodies

Pawel Stocki, Senior Principal Scientist, Ossianix (CONFIRMED)

Mono- and bispecific antibodies for the Interleukin-1 cytokine family

• Generation and characterization of bispecific antibodies

• Pre-clinical profiling for safety and PD marker

• Evaluation of clinical indications and biomarker strategy

Jiri Kovarik, Research Investigator, Novartis (CONFIRMED)

Building a successful ADC business: From to 15nM to 30000 feet

• Overview of ADC field

• Business opportunities with ADCs

• ADC Therapeutics: from idea to major innovator

• Pipeline update ADC Therapeutics

• Updates of clinical data Jens Wuerthner, Head of Clinical Development, ADC Therapeutics (CONFIRMED)

Assessment of susceptible chemical modification sites of trastuzumab and endogenous human immunoglobulins at physiological conditions

• Quality control testing of chemical degradations in the bio-pharmaceutical industry

• Application of in vitro and in vivo stress conditions to investigate the influence of protein degradation on structure-function

• Rationality of extreme monitoring of low-level alterations in such chemical modifications as critical patient safety parameters in product quality control testing

Patrick Bulau, Principal Scientist, Roche Pharma (CONFIRMED)


15:15 Turning affibody molecules into efficient amyloid-beta binders by dimerization

• Directed evolution of affibody molecules for the amyloid beta peptide yielded dimeric binders with a new mode of binding and structure

• The amyloid beta peptide is sequestered in a tunnel-like cavity, resulting in low pM affinity and efficient aggregation inhibition

• The dimeric binder has been investigated in preclinical studies focused on biodistribution, safety, brain uptake as well as preventive effect in Alzheimer’s disease models

John Löfblom, Associate Professor, KTH Royal Institute of Technology (CONFIRMED)

Bispecific antibody portfolio

• I-Mab and its Bispecific Antibody Portfolio

• Rationale

• Data from selected, more advanced programs

• Proprietary BIMAB platform

Taylor Guo, Co-founder and CSO, IMAB Biopharma (CONFIRMED)



Appraisal of leucine-rich alpha-2-glycoprotein 1 (LRG1) as a target for a potential antibody–drug conjugate (ADC)

• Combine vascular normalisation achieved by antibody-mediated pro-angiogenic LRG1 blockade with affecting cancer cell deterioration (via a drug)

• Site-selective modification of a humanised function-blocking antibody against LRG1 with a disulfide-rebridging pyridazinedione (PD) linker

• Optimisation of bioconjugation reactions to maximise homogeneity of the protein conjugate.

• Generation of the Fab fragment of the full-length antibody and demonstration of functional activity of the Fab by in vivo, ex vivo and in vitro assays of angiogenesis


Faiza Javaid, PhD Student, UCL (CONFIRMED)

15:35 Modulation of effector functions and thermal stability of monoclonal antibody by chemoenzymatic glycoengineering

• Successful generation of IgG1 glycoforms with homogenous Fc N-glycans using ENGase (endo-β-N-acetylglucosaminidase) and its mutant with transglycosylation activity

• Modulation of ADCC activity, C1q and FcRn binding affinity by specific N-glycoform

• Increased thermal stability by terminal galactosylation and decreased thermal stability by core defucosylation and terminal sialylation

Ryuta Wada, Scientist, Astellas Pharma (CONFIRMED)

Db-Ig – a novel platform for the generation of multivalent and multispecific antibody molecules

• Antibody platform

• Multivalency

• Multispecificity

• Homo- and heterodimerization domain

Oliver Seifert, Post-doc, University of Stuttgart (CONFIRMED)

A theranostic PSMA-specific antibody fragment

• A scFv directed against the Prostate Specific Membrane Antigen (PSMA): its in vitro activity, stability, internalization ability, and in vivo specificity

• The optimal target/background ratio when it is used as radiolabelled scFv both SPECTC-CT and PET

• Data suggesting its possible use as therapeutic agent when expressed as a fusion protein with toxin or used to redirect CAR-T

Mariangela Figini, Staff Researcher, Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori (CONFIRMED)

Native peptide mapping – A simple method to routinely monitor higher order structure changes and its relation to functional activity

• Higher order structure routine analysis

• Structure-function relationship

• Stability indicating method development

Michel Degueldre, Scientist, UCB Biopharma (CONFIRMED)

Antibody affinity regulated by a universal switch module

• Fusing calmodulin as a linker into a scFv-fragment to gain a M13 peptide and Ca dependent change in affinity

• MST measurement in "on" and "off" mode with cyclic permutation variations of the calmodulin module

• Comparison of different antibodies using the optimized calmodulin module

Maren Bleckmann, PostDoc, TU Braunschweig (CONFIRMED)



Bioanalysis and PK/PD

17:00 Challenges and solutions with large molecule bioanalysis – how we address PK assay questions from clinical pharmacologists

• Immunoassays are the most widely used method in large molecule PK bioanalysis

• Immunoassays are prone to interferences because they measure the interactions of assay reagents and analytes

• At MSD Global Bioanalytics, we have established a process to ensure large molecule PK assay quality and data integrity

• Cases studies will be shared to highlight our approach to address assay questions raised by clinical pharmacologists related to large molecule clinical pharmacokinetic data Huaping Tang, Principal Scientist, Regulated Bioanalytics, Merck (CONFIRMED)

17:20 A Surface Plasmon Resonance-based assay for rapid and simultaneous measurement of serum concentrations of therapeutic antibodies and anti-drug antibodies

• Therapeutic drug and immunogenicity monitoring is often proposed to guide therapy with biologics, characterised by high inter-individual variability of their blood levels

• Surface Plasmon Resonance (SPR) has the potential to measure serum antibodies in real time and in a few minutes, avoiding the many and long incubation/washing steps of available methods

• We developed a novel SPR-based assay for the simultaneous measurement of serum concentrations of infliximab and anti-infliximab antibodies, and validated it for sensitivity and reproducibility

• Our preliminary data indicate that this method may be well applied to other biotherapeutics Marco Gobbi, Head, Laboratory of Pharmacodynamics and Pharmacokinetics (PD-PK lab), "Mario Negri" Institute for Pharmacological Research (CONFIRMED)

17:40

18:00 Poster presentation and networking drinks

Day 3 – Thursday 17th October 2019 08:00 Registration opens

08:50 Conference doors open

Day 3 plenary session. World leading research

09:00 Chair’s opening remarks

09:05 Andreas Pluckthun (invited)

09:25 CHO cells: from TPA approval (1987) to multi-tons and multi-billions

• Historic remarks

• Complex genetics and physiology of cloned CHO cell populations - do we understand them?

• 20’000 Liter scale today - 500 Liter scale in the future?

• Can CHO cells be replaced by a better (higher yield, cheaper) system? Florian M. Wurm, Professor Emeritus, Swiss Federal Institute of Technology Lausanne (EPFL) (CONFIRMED)

09:45 The power of chemoselectivity: Protein-conjugates for intracellular targeting

• Site-selective conjugates of cyclic cell-penetrating peptides (cCPPs) to proteins enables their non-endosomal cellular uptake (transduction) in living cells

• Combining this delivery strategy with peptide tags and additional chemical modifications directs the protein cargo to specific intracellular compartments

• By using cCPP-conjugation cell-permeable nanobodies were generated, which showed transduction at low µM concentrations

• Live-cell microscopy and functional assays demonstrated the successful cellular delivery of functional biologically and therapeutically relevant proteins Christian Hackenberger, Department Head, Leibniz-Forschungsinstitut für Molekulare Pharmakologie (FMP), Leibniz-Humboldt Professor for Chemical Biology, Humboldt Universität zu Berlin (CONFIRMED)

10:05 Immuno-Oncology: Emerging Targets and Combination Therapies Henry Marshall, Professor, Imperial College London (invited)


Analytics, screening and immune repertoire

technologies Chaired by: Christoph

Merten, Group Leader, Microfluidics, European

Molecular Biology Laboratory (EMBL)

In silico discovery and development for antibodies Chaired by: Anke Steinmetz,

Senior Researcher, Integrated Drug Discovery,

Sanofi Aventis R&D

Nanobodies, peptides, novel modalities and non-

antibody formats

Regulation and investment Research hub Chaired by: Andreas Laustsen, Associate Professor, Technical

University of Denmark

Technology showcase

11:20 High throughput phenotypic screening for functional antibodies using droplet-microfluidics

• New 2-cell platform enabling the screening of antibodies for phenotypic effects on target cells. Compatible with difficult targets such as GPCRs and Ion channels.

• Technology can be adapted for the screening of antigen-specific T-cells

Christoph Merten, Group Leader, Microfluidics, European Molecular Biology Laboratory (EMBL) (CONFIRMED)

Title TBA Anke Steinmetz, Senior Researcher, Integrated Drug Discovery, Sanofi Aventis R&D (CONFIRMED)

Generation and characterization of Affibody affinity probes to Ephrin B3 in non-small cell lung cancer

• A high affinity affibody targeting Ephrin B3 has been developed

• Detailed characterization showed highly specific targeting of Ephrin B3 in vitro and on cells

• The promising characteristics of this probe has potential for tumor imaging applications in vivo

Johan Nilvebrant, Researcher, K.T.H. Royal Institute of Technology (CONFIRMED)

Panel: Investing in biologics

• Panel session lead by senior investors, actively investing

• within the biologics industry

• What do investors look out for in start-ups?

• What are the current trends for biologics?

• Where do we see the industry moving to in the next 5-10 years?

• How can you gain investment?

Kevin Johnson, Partner, Medicxi (CONFIRMED) Keno Gutierrez, Investment Director, M Ventures (CONFIRMED) Nissim Darvish, Senior Managing Director, OrbiMed (CONFIRMED) Graziano Seghezzi, Managing Partner, Sofinnova Partners (CONFIRMED) Raj Parekh, General Partner, Advent Life Sciences (CONFIRMED) Stefan Luzi, Partner, Glide Healthcare (CONFIRMED)

Antibody efficacy inside cells - a systematic approach

• Functions can be knocked down in mice by ER intrabodies

• Knockdown of various membrane receptors with intrabodies

• What's missing for an intrabody pipeline?

Andrea Marschall, Post-Doc, Brandeis University (CONFIRMED)


11:40 Reserved for Abcellera Kevin Heyries, Co-Founder, Business Development and Strategy Lead, AbCellera (CONFIRMED)

Artificial intelligence methods for therapeutic antibodies characterization

• Artificial intelligence allows implementing powerful methods for antibody characterization

• We have developed methods for epitope determination, off-target prediction and sequence substitution

Development of protease inhibitor with phage-displayed alternative peptide scaffold

• Protease regulate multiple biological processes and deregulation of proteolytic activity account for pathogenesis and progression of many diseases

Application of monoclonal antibodies for snakebite envenoming therapy and diagnostics

• Snakebite envenoming is a neglected disease which causes death, disability, and destitution

• Discovery and design of monoclonal antibodies and antibody cocktails


• Combined with experimental validation, these methods allow robust and fast characterization

Anne Poupon, Research Director, University of Tours (CONFIRMED)

• Potent inhibitor against a pathogenic protease with Kd in picomolar range had been derived from phage-displayed alternative peptide scaffold libraries.

• The alternative scaffold inhibitor is highly specific against the protease involved and is super stable under harsh or physiological condition.

Yingnan Zhang, Senior Scientific Manager, Department of Early Discovery Biochemistry, Genentech (CONFIRMED)

for snake venom neutralization

• Early-stage research into the use of monoclonal antibodies for a diagnostic tool for stratification of snakebite patients

Cecilie Knudsen, Industrial PhD Student, Technical University of Denmark (CONFIRMED)

12:00 Deep sequencing analysis of phage selection outputs: Leaving conventional screening behind

• Adaptations to library design and panning strategies

• exploiting the full potential of deep sequencing analysis of phage selection output pools

• identify favourable antibodies without conventional screening

Discovery of antigen-specific sequences in antibody repertoire deep sequencing data by deep learning

• Antigen-specific sequence patterns in antibody repertoire sequencing data are revealed by deep learning

• These patterns are used to select natural antibody variants as well as to design antibodies in-silico

DARPins: binders for diverse applications

• DARPins as valuable tools in various applications

• High-throughput binder selection and validation

Birgit Dreier, Senior Scientist and Group Leader HT-BSF, University of Zurich (CONFIRMED)

Bispecific antibody targeting EGFR and HER3 in TNBC

• New bispecific scDb-Fc for dual targeting of EGFR and HER3.

• Superior inhibition of proliferation and colony formation in vitro of TNBC cell lines.

• Potent tumor growth inhibition in orthotopic MDA-MB-468 xenograft tumor model of the bispecific antibody.


Stefan Ewert, Senor Investigator, Novartis Pharma AG (CONFIRMED)

• Candidate antibodies are expressed in a mammalian display system and proven to bind their predicted antigen

Simon Friedensohn, PhD Candidate, ETH Zurich (CONFIRMED)

• Stem cell formation is strongly inhibited in vitro and in vivo after treatment with scDb-Fc.

Alexander Rau, PhD Student, University of Stuttgart (CONFIRMED)

12:20 Toward single cell proteome analysis using recombinant antibodies

• Phage display as a proteomics discovery tool

• Identification of disease targets

• Recombinant antibody technology

Peter Kristensen, Head of Section for Biotechnology, Associate Professor, Aalborg University (COFIRMED)

Therapeutic antibody engineering and optimization by deep learning

• By leveraging mammalian cell-surface display with CRISPR/Cas9 mediated homology-directed mutagenesis, we have developed an approach to identify thousands of sequences binding a given epitope

• Rationally designed libraries can be used to build machine learning models that can predict antigen binding

• This list containing thousands of binding variants can then be subjected to a number of in silico screening

Synthetic DNA technologies enable single domain antibody discovery

• Utilizing its proprietary DNA writing technology to create oligo pools, genes, and synthetic libraries, Twist Pharma, a division of Twist Bioscience, provides the biotechnology industry with an end-to-end antibody discovery solution

• One solution is our panel of high-quality human single domain libraries (sdAb)

• We will show proof-of-concept screens with these libraries and examples of how modular these sdAb’s are for bispecific antibody development

Patenting antibodies at the EPO – an evolving process

• Driven by new technology platforms and characterization methods

• By the case law

• Strategies may be tailored for a particular antibody depending on the nature of the invention

Helena Domingues, Examiner, Joint Cluster Biotechnology, Immunology Directorate, European Patent Office (CONFIRMED)

A bispecific antibody links TRAIL-based antitumor approach to immunotherapy

• The demonstration of the anti-TRAIL-R2/anti-CD3 scDb to induce retargeting of T cells to kill many tumour types.

• The dissection of the efficient and specific T cell retargeting mediated by the scDb: T-cell activation, proliferation and functional differentiation.

• The proof of principle of its activity in an ex vivo model mimicking a real clinical setting: the treatment of ascitic malignant cells.


algorithms for multi-parameter optimization

Derek Mason, PhD Candidate, ETH Zurich (CONFIRMED)

Aaron K. Sato, CSO, Twist Biopharma (CONFIRMED)

Alessandro Satta, PostDoc Researcher, Fondazione IRCCS, Istituto Nazionale dei Tumori (CONFIRMED)

12:40 Networking lunch

Closing keynotes Chaired by: Alain Beck, Senior Director, Biologics CMC and Developability, Pierre Fabre, Associate Editor, mAbs (CONFIRMED)

14:00 Novel biology of transmembrane TNF (TmTNF) and its implications for developing next-generation anti-TNFs and characterizing biosimilars

• Binding of anti-TNFs to TmTNF on antigen presenting cells (APCs) results in rapid internalization of the anti-TNF/TmTNF complex and reverse signalling via TmTNF

• Internalized anti-TNFs are degraded in the lysosome and anti-TNF derived peptides are productively displayed on the surface of APCs

• These observations are being extended to design the next-generation of anti-TNFs and for functional characterization of biosimilars

Tariq Ghayur, Senior Research Fellow, Abbvie (CONFIRMED)

14:20 Antibody discovery platforms- innovations and applications

• Landscape of different antibody discovery platforms

• How they evolved and the niche they served

• What is at the cutting edge and how they are being applied

• The trajectory into the future Partha Chowdhury, Senior Director, Head of Antibody Discovery, Sanofi Genzyme (CONFIRMED)

14:40 Antibodies to watch for 2020

• Brief Overview mAb therapeutics 1997-2018

• Approvals in 2019

• Antibodies to watch in 2020 Helene Kaplon, Post-Doctoral Fellow, Servier (CONFIRMED)

15:00 Chair’s closing remarks Alain Beck, Senior Director, Biologics CMC and Developability, Pierre Fabre, Associate Editor, mAbs (CONFIRMED)

15:05 Closing remarks from Terrapinn

15:10 End of congress – see you in 2020!

Part of the...European Antibody Congress 15th – 17th October 2019, Basel Congress Centre, Basel,...

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Transcript of Part of the...European Antibody Congress 15th – 17th October 2019, Basel Congress Centre, Basel,...