4th biologics biosimilars congress: · pdf filewarm welcome 4th biologics & biosimilars...

4TH BIOLOGICS & BIOSIMILARS

CONGRESS: EUROPE5-6 March 2018

BERLIN, GERMANY

www.global-engage .com

#BiologicsCongress

WARM WELCOME

4TH BIOLOGICS & BIOSIMILARS CONGRESS EUROPE 2018

Building on the success of our 2017 meeting, Global Engage is pleased to announce the 4th Biologics & Biosimilars Congress which will be held on the 5th and 6th March, 2018 in Berlin, Germany. The conference will host over 60 expert speakers and panellists in three tracks across both days, and is expected to attract over 250 attendees and 30 poster presentations. The conference is part of Global Engage’s successful Drug Discovery series which includes our Precision Medicine, Medicinal Chemistry and Synthetic Biology congresses.

Attracting industry, regulatory and academic experts working in all areas of antibody, protein and biosimilar research, the two-day meeting will explore a variety of topics across three tracks. With a strong focus on antibody based therapeutics, tracks 1 and 2 provide industry leaders with the opportunity to present updates on their strategy, pipeline and existing candidates in a variety of areas including antibody discovery and design, immuno-oncology, bispecific antibodies and antibody-drug conjugates. Other talks in these tracks will examine checkpoint inhibitor therapies and recent innovations in the exciting area of T-Cell therapeutics. Track 3 looks to cover developments in fusion proteins, novel scaffolds and immunogenicity considerations across protein biotherapeutics. The Biosimilars track explores themes of similarity, regulation and public perception, alongside presentations on candidate generics in various stages of development. Executive panels and roundtables will foster discussion on the direction of the field, and the approaches required to ensure that the industry continues to flourish.

This two-day interactive meeting will allow you the opportunity to keep up to date with cutting edge strategies, technologies and the latest research, as well as potential to keep abreast of your competitors through access to renowned solution providers, and to make lasting connections with other thought leaders, experts, businesses and entrepreneurs in your field.

SEEMA KUMARAssociate Director, Merck KGaA

VOLKER SCHELLENBERGERCEO and President, Amunix

EXPERT SPEAKERS Include:

ANDREAS PAHLCSO, Heidelberg Pharma

JILL CARTONDirector, Biologics Discovery Janssen

BioTherapeutics, Janssen R&D

DAY 1 – TRACK 1

Antibody Based Therapeutics: discovery and design• Case study – multispecific antibodies• Case study – treatments across the blood-brain barrier• Case study – antibody discovery and optimization• Panel Discussion – developing antibody therapeutics

– strategies, techniques and challenges

DAY 1 – TRACK 2

Antibody-Drug Conjugates: design, stability optimization, linker and payload development• Case study – amanitin based ADCs• Case study – fragment antibody-drug conjugates• Case study – novel carriers, linker and payloads

DAY 1 – TRACK 3

Biosimilars: design and optimization, commercialization strategies, quality control, IP and regulatory issues• Case study – litigation studies• Case study – global regulation trends• Case study – patient-clinic relations• Case study – bringing biosimilars to the commercial market• Panel discussion – progress in the regulatory landscape for biosimilars

DAY 2 – TRACK 1

Immunotherapy• Case study – bispecific t-cell engagers• Case study – solid tumour immunotherapies• Case study – checkpoint blockades• Panel discussion - the impact of bispecific antibodies on oncology

and challenges in developing novel cancer treating biologics

CONFERENCE SYNOPSIS

DAY 2 – TRACK 2

Antibody-Drug Conjugates: case studies• Panel Discussion – Reviewing the progress of Antibody-Drug

Conjugates and the next steps in ADC design• Case study – Payload synthesis and efficacy• Case Study – non-oncological ADCs for sleeping sickness

DAY 2 – TRACK 3

Protein biotherapeutics: alternative scaffolds, fusion proteins, immunogenicity, protein expression• Case study – alternative scaffolds• Case study – fusion proteins• Case study – immunogenicity

Biological Therapeutics• Table 1: New antibody therapeutics:

bi- and multispecifics• Table 2: Discovery and development of antibodies

against benign inflammatory diseases• Table 3: ADC optimisation

ROUNDTABLE SESSIONS

SPONSORS 2018

Gold Sponsors

Other Exhibitors & Content Sponsors


CONFIRMED SPEAKERS

SOFIA REBELO (Chair)Scientist, iBET

JAN NICOLAS KREUTZERCountry Manager, Chemometec

STEPHAN FISCHERCEO, MAB Discovery

DAVIDE BRANDUARDIApplication Scientist, Schrödinger GmbH


ROLAND BUELOWCEO, TeneoBio

ANDREAS PAHLCSO, Heidelberg Pharma

JENS NIEWOEHNERGroup Leader, Roche

GOKHAN YAHIOGLUDirector of Chemistry, Co-founder, Antikor

THOMAS SCHIRRMANNCEO & founder, YUMAB GmbH

NIGEL TEMPERTONSenior Lecturer and Joint Head, Viral Pseudotype Unit, University of Kent

GEORG FERTIGHead of Screening &Functional Assays, Roche

CATHERINE HUTCHINGSConsultant, Heptares

JILL CARTONDirector, Biologics Discovery Janssen BioTherapeutics, Janssen R&D

TREVOR HALLAMCSO, Sutro Biopharma

PHILIP HOWARDFounder & CSO, Spirogen

DANIELA TEIXEIRACOO, Fairjourney Biologics

FIONNUALA MCALEESE-ESERGroup Leader, Antibody Discovery, Bayer

JENNY THIRLWAYTechnical Director, Glythera

THIBAULT HELLEPUTTECEO, DNAlytics

CLAIRE DOBSONAssociate Director Antibody Discovery and Protein Engineering, MedImmune

BARBARA VALSASINAProject and Group Leader, Nerviano Medical Sciences

HITTO KAUFMANNGlobal Vice President Biopharmaceuticals, Sanofi

MARTIN STEEGMAIERHead Discovery & Site Head Large Molecule Research, Pharma Research & Early Development, Roche Innovation Center Munich

ULRICH RANTCEO, Dynamic Biosensors GmbH

ANGUS DALGLEISHProfessor of Oncology, St George’s University of London

JENS LOHRMANNSenior Global Program Manager, Novartis

GUNDO DIEDRICHDirector of Antibody, Engineering, MacroGenics

TIMOTHY LOWINGERCSO, Mersana

VOLKER SCHELLENBERGERCEO and President, Amunix

ROMAN IVANOVVice President, Research & Development, Biocad

BERND SCHLERETHSenior Director, Non-clinical safety, Covagen

DEBORAH CHARYCH Executive Director, Nektar Therapeutics

KARL ANDERSSONCEO, Ridgeview

ADAM CLAUSSScientist, LEO Pharma

LAURENT POIROTHead of Early Discovery, Cellectis


CONFIRMED SPEAKERS

SLAVOLJUB MILOSEVICSenior Director, Head of Technology Innovation, Medigene

WILL GOUNDRYAssociate Principal Scientist, AstraZeneca

ANDREA GONZALEZ-MUNOZScientist I, MedImmune

ISABELL REMUSHead of Biosimilars Western Europe, Sandoz

ALEXANDER BAUMANNEuropean Sales & Technical Support Director, DiscoverX

LISA MUELLERPartner and Chair of the Life Science Group, Michael Best & Friedrich LLP

ANDREW WILLIAMSPartner, McDonnell Boehnen Hulbert & Berghoff LLP

GRZEGORZ ORLIKHead of Medical Affairs, Biosimilars and Generics Europe, Accord Healthcare

ANNICK DE VRIESHead Diagnostics (Biologics), Sanquin Bloedvoorziening

CHRISTIAN MAASCHManaging Consultant Product Development and RA, Xendo

JENNY THIRLWAYTechnical Director, Glythera

YUJI KASUYADirector, Daiichi Sankyo Co., Ltd.

NELS THORSTEINSONScientific Services Manager

VIBHA JAWAPredictive and Clinical Immunogenicity, Pharmacokinetics and Pharmacodynamics Drug Modelling, Merck Sharp and Dohme

AMRIK BASRANCSO, Avacta

MATHIEU CINIERCSO, Affilogic

CALE HALBLEIBDirector of Biopharmaceutical Development, KBI Biopharma

ARMIN SEPPAssociate Fellow, GSK

OLIVER HILLVice President, APOGENIX AG

PAUL WASSMANNAnalytical science and strategy lead, Novartis Pharma AG

ANJAN SELZVice President, Head of Biosimilars EMEA

CONGRESS SCHEDULE

Registration & Refreshments08:00-08:50

08:50-08:55 Global Engage Welcome Address & Morning Chair’s Opening Remarks: Sofia Rebelo, Scientist, iBET

DAY 1 MONDAY 5TH MARCH 2018

09:00-09:35

KEYNOTE ADDRESS:VOLKER SCHELLENBERGERCEO and President, AmunixProTIA – Bispecific T cell engagers designed for local activation in the tumor environment• ProTIAs are highly potent bispecific T cell engagers• ProTIAs are administered to patients as inactive long half-life prodrugs

• Activation by tumor-associated proteases occurs within tumor tissue• The released active form has a short circulation half-life to minimize the risk of systemic exposure• Amunix’ proprietary XTEN™ protein polymer provides half-life modulation, masking of binding sites, and facilitates manufacturing of ProTIA prodrugs

09:35-10:10

ANTIBODY-BASED THERAPEUTICS BIOSIMILARS

KEYNOTE ADDRESS:STEPHAN FISCHERCEO, MAB DiscoveryThe optimal access to functional diversity of antibodies: Single B-cell cloning from Wild-Type rabbitsMAB Discovery successfully applies a unique technical and conceptual

approach to functional diversity of antibodies based on B-cell cloning from immunized wild-type rabbits. One obtains a large number of potent antibodies with very diverse paratopes (binding domains), while keeping the modality, a classical monoclonal antibody, constant. The emerging picture is surprising. The results of presented examples show that functional diversity of antibodies with different paratopes has been very much underestimated. The produced antibody products add significant potential to novel therapies, in particular with validated targets. This outcome is achieved without additional technical and target related risks and provides a very promising alternative to antibody engineering.

08:55-09:00

SOLUTION PROVIDER PRESENTATION:JAN NICOLAS KREUTZERCountry Manager, ChemometecPrecision and Accuracy in Cell Counting

09:35-10:10

KEYNOTE ADDRESS:ISABELL REMUSHead of Biosimilars Western Europe, SandozWhere are we now?

Progress in the story of biosimilars and approaches for the futureFor the past decade biosimilars have played a significant role in the treatment of a broad set of medical conditions, and today these are considered as valid as reference medicines. Sandoz has been at the forefront this innovative treatment alternative, and has helped build trust in biosimilars among healthcare professionals, payors and patients in various ways, including significant investments on medical education, providing increasing data confirming efficacy and safety of Sandoz biosimilars, ten years of in-market experience, demonstrated benefits of biosimilars to society as a whole, and a broad portfolio of biologic treatments for various conditions in both children and adults. While the biosimilars market has increased very rapidly in the past ten years, an immense opportunity still remains ahead to continue to make biosimilars the preferred treatment alternative to allow patients worldwide to access affordable, high quality medicines.

Track Chair: SOFIA REBELO, Scientist, iBET Track Chair: SCOTT TAYLOR, Operations Director, Global Engage



CONGRESS SCHEDULE DAY 1 MONDAY 5TH MARCH 2018

ROLAND BUELOWCEO, TeneoBioMulti-specific antibodies for human therapy

TeneoBio, Inc. is developing a new class of therapeutics, Human Heavy Chain Antibodies (UniAbs™). The high affinity and robust function of UniAbs combine antibody specificity with excellent developability. The UniAbs’ fully human VH domains, UniDabs™, are versatile building blocks for the development of therapeutics with multi-specificity. TeneoBio’s antibody discovery engine is based on UniRat™, a proprietary human heavy chain only, transgenic rat. For antibody discovery we apply a novel sequence-based discovery approach using NGS, bioinformatics and high-throughput recombinant protein expression. We developed multivalent antibodies with superior tumor cell cytotoxicity and specificity including UniAbs targeting CD38 and PDL1and T-cell engaging antibodies targeting BCMA on plasma cells. Our results demonstrate that UniDabs are versatile building blocks for the generation of multi-valent therapeutics with superior potency and specificity.

11:50-12:15

ANDREAS PAHLCSO, Heidelberg PharmaHDP-101 of “ATAC” Platform: Proprietary, Amanitin-based ADC

Applies New Mechanism for Impacting Multiple Myeloma• Heidelberg Pharma: First company

developing RNA Polymerase II inhibitors for cancer treatment

• Amanitin is the most effective and specific inhibitor of RNA Polymerase II

• ATAC: ADC technology harnessed to deliver this new mode of action to cancer patients

• ATACs kill both dividing and dormant tumor cells

• ATACs are effective on low expressed targets

• ATACs have a large therapeutic index and favorable tolerability, no liver toxicity

• Deletion of p53 is a payload-specific predictive biomarker for ATACs

• BCMA is an ideal target due to its restricted expression on malignant Multiple Myeloma cells

• ATAC/HDP-101: ideal approach to target low expressed BCMA on slowly proliferating tumor cells

• HDP-101: High efficacy in animal models; long-lasting remission after single treatment

• First-in-Man starts end of 2018

11:50-12:15

LISA MUELLERPartner and Chair of the Life Science Group, Michael Best & Friedrich LLPGlobal Legal Issues

Associated with BiosimilarsThis presentation will focus on:• The current state of biosimilars

globally including the number of biosimilars currently on market in the major biosimilar "player" countries;

• Regulatory issues and challenges faced by biosimilars globally (e.g., comparability studies, Phase III studies, interchangeability, naming requirements, etc.); and

• Patent challenges faced by biosimilar companies including conducting a freedom-to-operate analysis in various jurisdictions to identify the relevant patents (if any) at issue, ways to minimize risk and high level review of patent litigation involving biosimilars worldwide.

11:50-12:15

ANTIBODY-BASED THERAPEUTICS ANTIBODY-DRUG CONJUGATES BIOSIMILARS

Track Chair: SOFIA REBELO, Scientist, iBET

Track Chair: SEEMA KUMAR, Associate Director, Merck KGaA

Track Chair: SCOTT TAYLOR, Operations Director, Global Engage

10:10-10:40

10:10-10:40

SOLUTION PROVIDER PRESENTATION:DAVIDE BRANDUARDIApplication Scientist, Schrödinger GmbHA Computational Framework for the Detection of Liabilities in BiotherapeuticsModern techniques for antibody generation produce an increasing

number of different antibodies that fit the desired target candidate profile. It is therefore crucial to detect possible liabilities early in the production process. Here we present a novel method for the identification of aggregation hotspots that is based on surface patches of 3D structures. The method includes a scoring function for aggregation propensity factoring in the intensity, size and relative orientation of the respective surface patches. Using this approach we can demonstrate how aggregation-prone regions can be identified and rationally explained. This concept has been expanded in developing a series of structure-based protein descriptors that are used to derive QSAR-based prediction models for aggregation, solubility and viscosity.

SOLUTION PROVIDER PRESENTATION:ALEXANDER BAUMANNEuropean Sales &

Technical Support Director, DiscoverXSeamless Integration of Robust Bio Assays from Development to QC Lot release of BiologicsA quantitative and robust bioassay that is reflective of the MOA of the drug is a critical component of any development program. We have expanded our PathHunter® cell-based assay platform to provide simple bioassays for potency determination and stability testing of biological drugs. These quantitative and robust assays rely on the native biology of the relevant receptor, allowing developers to choose a readout that is truly reflective of the MOA of their drug. Importantly, these are homogeneous assays that use “thaw-and-use” cryopreserved cells and simple protocols to minimize assay variability compared to traditional assays, and are highly scalable and suitable for automation. We will share case studies from our large portfolio of qualified bioassays for several different biosimilar and immuno-oncology targets.

Morning Refreshments / Poster Presentations / One-to-One Partnering Meetings10:40-11:50

CONGRESS SCHEDULE



JENS NIEWOEHNERGroup Leader, RocheEffector functions of Brain Shuttle antibody therapeutics

• Transport of therapeutic antibodies into the brain using Brain Shuttle technology

• Safety aspects of Brain Shuttle molecules with Fc effector function

• Choosing the right format for safety and efficacy

12:15-12:40

GOKHAN YAHIOGLUDirector of Chemistry, Co-founder, AntikorNot too big-not too small: Fragment Drug

Conjugates (FDCs) as alternatives to ADCs for solid tumoursAntikor is developing a proprietary platform to discover and develop FDCs for solid tumours. ADCs have failed to deliver on their early promise with over 20 clinical development trials discontinued. It is clear that one size does not fit all indications and addressing difficult solid tumours requires an alternative approach. Using smaller antibody formats is an attractive option due to their faster elimination from the circulation and enhanced tumour penetration. Antikor’s OptiLink technology where payload loading is optimised to obtain high drug-to-antibody ratio FDCs, allows the early delivery of a bigger cytotoxic ‘hit’. Compelling data with our scFv antibody format FDCs show: • Optimal PK/PD properties • Superior in vivo efficacy in Her2 models

for breast and gastric cancer compared to the ADC

• Rapid tumour penetration and clearance

• Better tolerability and are less toxic than the ADC equivalent

We believe this fast-in-fast-out approach will result in low systemic exposure and an improved TI.

12:15-12:40

12:15-12:40

ANDREW WILLIAMSPartner, McDonnell Boehnen Hulbert & Berghoff LLP Strategies for

Coping with the Evolving Landscape of Biosimilars Patent Resolution in the United StatesThe United States passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 to bring biosimilar drug products to market. Nevertheless, the first biosimilar application was filed by Sandoz in July 2014 to market a biosimilar of Amgen’s filgrastim. The U.S. Supreme Court issued an opinion for that case in 2017 that provided guidance for resolving patent disputes under the BPCIA. This presentation will review such issues as:• When should a biosimilar applicant

participate in the BPCIA’s “patent dance,” if ever?

• Is there any reason to wait until application approval to provide the mandatory “notice of commercial marketing,” and why?

• Should a biosimilar applicant use the post-issuance patent-review procedures at the U.S. Patent Office or wait to allege invalidity during the district court proceeding?

12:40-13:10

SOLUTION PROVIDER PRESENTATION:THOMAS SCHIRRMANNCEO & founder, YUMAB GmbHYUMAB – Human monoclonal antibodies for immunotherapyYUMAB’s proprietary fully human antibody platform integrates modular technologies from early discovery to lead optimization for all types of antibody drug formats (IgGs, scFvs, Fabs, ADCs, bispecifics, fusion proteins, CARs). Our core

technology employs powerful in vitro selection and high throughput screening from one of the World’s largest natural human antibody library collections and achieves excellent success-rates and broad epitope coverage not restricted by the in vivo immune response. YUMAB offers tailored service solutions for individual antibody development problems including antibody discovery for difficult targets, predesigned epitope specificity, interspecies cross-reactivity for animal models, patient specific libraries, advanced humanization technologies, optimized antibody engineering solutions (affinity, stability, manufacturability), target discovery, bioassay, and biomarker development. This presentation introduces the YUMAB platform and shows case studies from our pipeline.

Lunch / One-to-One Partnering Meetings13:10-14:10

CONGRESS SCHEDULE DAY 1 MONDAY 5TH MARCH 2018


Track Chair: NIGEL TEMPERTON, Senior Lecturer and Joint Head, Viral Pseudotype Unit, University of Kent

Track Chair: SEEMA KUMAR, Associate Director, Merck KGaA


ANTIBODY-BASED THERAPEUTICS ANTIBODY-DRUG CONJUGATES BIOSIMILARS

PANEL DISCUSSION:Developing Antibody based therapeutics – strategies, techniques and challenges

TANVIR TABISHHead of Drug Product Development for Gene Therapy and Coagulation Factors, Shire

CATHERINE HUTCHINGSConsultant, Heptares

JILL CARTONDirector, Biologics Discovery Janssen BioTherapeutics, Janssen R&D14:10-15:00

TREVOR HALLAMCSO, Sutro BiopharmaWill Optimized Single Molecular ADC Species Set New

Precedents For Clinical Performance?• Cell-free antibody production enables

use of reactive non-natural amino acids to generate precisely positioned irreversible conjugates with high fidelity.

• Ability to rapidly generate many variants of full length IgG species with different conjugation sites within days at quantities and quality sufficient for pharmacodynamic and toxicological assessment allows iterative design to optimize ADC performance and reduces preclinical development times by 18 months

• We’ll provide updates on our lead clinical development candidates.

14:10-14:35

ANJAN SELZVice President, Head of Biosimilars EMEAProject Management for Biosimilars – from inception through to approval

• Some generic principles• Some biosimilar specific principles• The defining moments for successful

biosimilar development

14:10-14:35

PHILIP HOWARDChief Scientific Officer, Spirogen / Senior Fellow, MedImmuneAntibody-Pyrrolobenzodiazepine Conjugates

Dr Howard’s talk will cover the development of Pyrrolobenzodiazepine (PBD) payloads for use in Antibody Conjugates. The presentation will also give an update on the clinical progress of Antibody PBD Conjugates.

14:35-15:00

GRZEGORZ ORLIKHead of Medical Affairs, Biosimilars and Generics Europe, Accord Healthcare

Challenges in medical communication for biosimilar productsCommunication about biosimilar products changes. Some issues become less critical, but we have other emerging. Typical points cover:• Similarity vs. identity to reference• Product• Substitution and interchangeability• Safety (with special focus on

autoimmunity)• Communication of pricing policy and

access to the treatment

14:10-14:35

CONGRESS SCHEDULE



SOLUTION PROVIDER PRESENTATION:DANIELA TEIXEIRACOO, Fairjourney BiologicsThe journey to “the” antibody: accessing a versatile toolboxFairjourney Biologics, an established company with an outstanding track record of biotech and Big pharma partners, offers a range of

assets and services on antibody engineering, discovery and production. Being a profitable biotech company, Fairjourney Biologics has implemented a co-development and R&D arm to complement its fee-for-service main unit. The company has developed a full suite of primers for generation of antibody libraries from different species and has validated various naïve human Fab and llama VHH phage display libraries. Fairjourney Biologics has one of the biggest in the world antibody discovery teams available to partner and it has entered into agreements with academia, biotech companies and Big pharma to systematically explore ground breaking targets and creating new ventures. 15:25-15:55

15:25-15:55

Afternoon Refreshments / Poster Presentations / One-to-One Partnering Meetings15:55-16:45

ANTIBODY-BASED THERAPEUTICS BIOSIMILARS

CHRISTIAN MAASCHManaging ConsultantRA CMC/Biotech, XendoDeutschland GmbhAre you on track? -

Rapidly evolving regulatory landscapefor the Development of BiosimilarsIt is an exciting time for companies joining the Biosimilar race. As we get more experienced to apply more advanced technologies, as well as new production processes for biologics, the regulatory landscape and recent strategies for the development of a Biosimilar are rapidly evolving at the same time. In Biosimilar development, it is not easy to keep track on best development practices and rapidly evolving regulatory expectations. Additionally, trends can be observed within leading health agencies to become more open for discussions and accept new scientific- and product-tailored development strategies to establish and demonstrate Biosimilar comparability. As usual, it´s all about risk assessment, impact evaluation and scientific-based justifications, but agencies are actively paving the way for Biosimiliars by new regulatory procedures and guidelines.

SEEMA KUMARAssociate Director, Merck KGaAADC Bioanalytical Strategies: PK Assay Continuity Between

Discovery and DevelopmentDepending on the PK question that needs to be answered, the strategies and bioanalytical approaches employed for ADC assay development may need to be adapted. At the discovery stage, due to the limited availability of critical reagents, time and resources, flexible “fit-for-purpose” assays are often employed. On the contrary, the late stage non-clinical drug development typically requires qualified and validated assays. The differences in critical reagents and assay formats/platforms adopted at different stages of drug development may impact the observed analyte concentration and the associated PK profile/parameters. However by applying rational scientific understanding of what each assay format and assay reagent is measuring, an appropriate interpretation of observed data can be made. Case studies on assay continuity during various stages of non-clinical development of ADC (Discovery to Development) will be presented.

15:00-15:25

15:00-15:25

JILL CARTONDirector, Biologics Discovery Janssen BioTherapeutics, Janssen R&DAdvancing antibody

discovery for efficient antibody therapeutics developmentWhile the biologics market is expanding rapidly with novel and effective therapeutics, the challenges in discovery are steadily increasing. Discovery must be more nimble, efficient, and seamless with development. This requires a well-designed discovery process, access to excellent and diverse molecule sources, and earlier alignment with the development organization. Several cases studies will demonstrate our lessons learned and adaptions.

15:00-15:25

ANNICK DE VRIESHead Diagnostics (Biologics), Sanquin BloedvoorzieningSerum level

measurements for biologics/biosimilars: real life data• Experience from routine diagnostics

on PK and ADA measurements• One dos/multitude of serum levels;

impact of immunogenicity on PK• Validation of PK/ADA setup for

originators for biosimilars

CONGRESS SCHEDULE



17:40-18:05

17:40-18:05

BARBARA VALSASINAProject and Group Leader, Nerviano Medical Sciences NMS ADC platform: focus on Thienoindoles, a novel class of potent toxins highly suitable for ADC generation

• ADC platform at NMS. • The toxin NMS-P528 and the corresponding drug-linker

NMS-P945, optimized members of the thienoindole class, highly suited for conjugation with targeted antibodies due to their favourable physicochemical properties

• Preclinical in vitro and in vivo obtained results with selected model antibodies bearing NMS-P945 drug linker.

CLAIRE DOBSONAssociate Director Antibody Discovery and Protein Engineering, MedImmuneEngineering pH dependent antigen binding antibodies to overcome target mediated clearance in vivo

• Antibodies targeting membrane bound antigens with a high rate of synthesis are rapidly eliminated from plasma by antigen mediated clearance, thus compromising their therapeutic utility.

• We describe a protein engineering approach to create a pH dependent antigen binding antibody directed to a GPCR. The antibody binds to its antigen in plasma (pH7.4) and following endocytosis dissociates from the antigen in the acidic endosome (pH5.8).

• The antigen is subsequently degraded by proteolysis in the lysosome and the antibody is recycled back to the cell surface via FcRn enabling it to bind to another antigen.

• The resulting antibody has an extended half-life in vivo and its efficacy is not limited by dose.

Chair's Closing Remarks / End of Day One18:05

Networking Drinks Reception18:05-19:05

ANTIBODY-BASED THERAPEUTICS ANTIBODY-DRUG CONJUGATES

JENNY THIRLWAYTechnical Director, GlytheraAssessing the therapeutic efficacy of novel toxins conjugated using the stable PermaLink© technologyAntibody Drug Conjugates (ADCs) are an

emerging class of targeted therapeutics with the potential to improve therapeutic index over traditional chemotherapy. By combining the targeting power of antibodies with the cell killing capability of potent cytotoxic molecules, it is possible to kill cancer cells more effectively whilst reducing debilitating side effects. Glythera's PermaLink® technology has been validated in a range of ADC models and demonstrated improved stability, efficacy and tolerability profiles. Using these important differentiators Glythera has accessed a portfolio of toxins with known and novel modes of action and has completed the three part ADC jigsaw by additionally accessing novel antibodies through its partners.

16:45-17:10

16:45-17:10

FIONNUALA MCALEESE-ESERGroup Leader, Antibody Discovery, BayerInnovative Strategies for Antibody Discovery and Optimization at BayerBayer is developing antibodies, antibody-drug conjugates, recombinant proteins and bispecific

antibodies in the areas of oncology, gynecology, ophthalmology, cardiovascular disease and hematological disorders. To this end, Bayer employs both in vitro and in vivo strategies during the lead discovery phase to increase antibody diversity towards the target of interest and to quickly identify the most promising candidates for further development. In addition, phenotypic screening methods are currently being used to identify new and disease relevant targets and function-blocking antibodies. Following in vivo validation, lead antibody candidates typically enter an optimization phase where the affinity, potency, species crossreactivity profile as well as developability characteristics are improved as required. Various lead finding strategies and lead optimization methods will be discussed together with examples of outcomes.

17:10-17:40

SOLUTION PROVIDER PRESENTATION:THIBAULT HELLEPUTTECEO, DNAlyticsPrecision Medicine for Biologics Prescription• Biologics play a central role in Rheumatoid diseases management and many biosimilars are being developed as well.• Overall these therapies represent a huge cost and patients show highly variable response levels.

• Metabolic characterization of each patient coupled to artificial intelligence approaches are progressively leading to precision medicine strategies in Rheumatology.

ANTIBODY-BASED THERAPEUTICS ANTIBODY-DRUG CONJUGATES


Refreshments08:00-08:50

BIOLOGICS

MARTIN STEEGMAIERHead Discovery & Site Head Large Molecule Research, Pharma Research & Early Development, Roche Innovation Center MunichPioneering antibody technology – Advancing transformative cancer immunotherapy agents• Therapeutic efforts to engage the immune system against cancer has generated exciting breakthroughs and clinicaly meaningful benefit to a subset of patients. New bi- and multi-specific antibodies are now in various phases of clinical

development and will become the next generation of antibody-based therapies.• We have generated a portfolio of T cell bispecific antibodies and novel, engineered targeted immune-modulators that show promising pre-

clinical and clinical activity as single agent or in combination with other cancer immunotherapy agents. • The CrossMAb technology has proven to be very versatile, allowing the generation of various bispecific antibody formats providing great

opportunity to tackle novel biology and to convey superior efficacy.• Examples will be given how antibody format fundamentally influences the mode of action and activity of these novel immunotherapy agents.

08:50-09:25

KEYNOTE ADDRESS:HITTO KAUFMANNGlobal Vice President Biopharmaceuticals, SanofiDeveloping Next Generation Biologics• Adapting to the evolution of diverse biologics pipelines• Innovation as a key driver to deliver superior medicines to patients• Convergence of technologies

09:25-10:00

IMMUNOTHERAPY PROTEIN BIOTHERAPEUTICS

10:00-10:30

Morning Refreshments / Poster Presentations / One-to-One Partnering Meetings10:30-11:40

DAY 2 TUESDAY 6TH MARCH 2018CONGRESS SCHEDULE

SOLUTION PROVIDER PRESENTATION:NELS THORSTEINSONScientific Services Manager

Prediction of Protein-Protein Binding Sites and Epitope MappingWe present a method for identifying important interaction sites in protein interfaces and carrying out epitope mapping using MOE software. An analysis is carried out of molecular properties mapped onto the protein surface to determine patches which play a role in determining properties and binding interactions. Docking calculations generate an ensemble of protein-protein poses, sampling orientational space. An interaction fingerprint encoding patch contacts is used to generate pose clusters ranked by ensemble free energy, and used to extract consensus interactions comprising the predicted epitope for each cluster. This methodology can be combined with experiment to generate high-quality models. A case study is presented in which hydrogen-deuterium exchange data are used to extract key interactions from calculations performed on an ensemble of interacting chain models.

10:00-10:30

SOLUTION PROVIDER PRESENTATION:ULRICH RANTCEO, Dynamic Biosensors GmbHBiophysical characterization of bispecific antibodies for enhancement of dual-targeting specificityThe measurement of binding rates and avidity effects in the

simultaneous engagement of two antigens by a bispecific antibody is key for optimizing target specificity early in the development process. I will describe the utilization of the switchSENSE® biosensor to emulate the display of two different target antigens on a cancer cell surface. Precise control of the relative abundance and spatial arrangement of two antigen species on the sensor is achieved using DNA-guided surface functionalization and dual-color fluorescence detection. The quantitative analysis provides insight on how to adjust the individual affinities of the bispecific antibody arms, so that most favorable conjoint action is achieved, i.e., maximal on-target and minimal off-target binding, respectively.

08:50-08:55 Track Chair: Jack Beard, Conference Producer, Global Engage

Track Chair: JACK BEARD, Conference Producer, Global Engage Track Chair: YUJI KASUYA, Director, Daiichi Sankyo Co., Ltd.


PANEL DISCUSSION:The impact of bispecific antibodies on oncology and challenges in developing novel cancer treating biologics

VOLKER SCHELLENBERGER (Chair)CEO and President, Amunix

ROLAND BUELOWCEO, TeneoBio

ROMAN IVANOVVice President, Research & Development, Biocad

BERND SCHLERETHSenior Director, Non-clinical safety, Covagen

12:05-12:55

PANEL DISCUSSION:Reviewing the progress of Antibody-Drug Conjugates and the next steps in ADC design

PHILIP HOWARDChief Scientific Officer,Spirogen / Senior Fellow,MedImmune


GOKHAN YAHIOGLUDirector of Chemistry, Co-founder, Antikor

TIMOTHY LOWINGERCSO, Mersana

DEBORAH CHARYCHExecutive Director, Nektar Therapeutics

12:05-12:55AMRIK BASRANCSO, AvactaAffimer Therapeutics: A novel Protein Scaffold for Modulating Checkpoint Inhibitors

Affimer therapeutics are based on the human protein Stefin A, a small (12kDa) intracellular protease inhibitor. We have used phage display to identify molecules that bind to PD-L1 with single digit nM affinity and compete for the PD-1/CD80 epitope. The Affimer protein was also shown to compete against Atezolizumab for PD-L1. The Affimer scaffold is amenable to formatting as a genetic fusion with the Fc region of an antibody and is expressed transiently at high levels from HEK293 cells. We have also demonstrated PK and efficacy in a mouse syngeneic model using a surrogate tool Affimer protein.

12:05-12:30

MATHIEU CINIERCSO, AffilogicThe use of the Nanofitin alternative scaffold as a versatile platform for radioimaging and drug

conjugate: a case study with anti-EGFR Nanofitins cross-reacting on both the human and murine EGFRKey advantages of the Nanofitin technology as a vector for radioimaging• Possibility to tailor the selection to obtain

cross-reactive Nanofitin▷ Better significance of the preclinical studies in murine model in term of biodistribution

• Fast systemic clearance▷ Compatible with fast decaying radio-isotope

12:30-12:55


TIMOTHY LOWINGERCSO, MersanaDolaflexin ADCs: Increasing Therapeutic Index via High DAR

and a Controlled Bystander EffectDolaflexin is a polymer-based antibody drug conjugation platform which allows for high DAR (typically 10-15) without compromising physicochemical or pharmacokinetic properties. The novel auristatin payload, AF-HPA, incorporated in Dolaflexin was designed to have a “controlled bystander effect,” which also contributes to efficacy and increased tolerability. Examples of the application of Dolaflexin to ADCs, such as XMT-1522 and XMT-1536 currently in clinical development, will be presented.

11:40-12:05

VIBHA JAWAPredictive and Clinical Immunogenicity, Pharmacokinetics and Pharmacodynamics Drug Modelling, Merck Sharp and Dohme

Considerations for developing novel biologics for Immune modulatory targetsDevelopability of a biologic relies on multiple factors like expression, potency, manufacturability, stability and immunogenicity risk. A comprehensive evaluation of these developability parameters during early stage of biologic development can help identify and mitigate the potential issues later in development. This effort is especially needed for novel modalities like nanobodies, bispecifics, fusion proteins that are being developed primarily for immune modulating targets. This talk will cover the risk assessment approaches and tools that can be used to identify and optimize such developability attributes.

11:40-12:05

11:40-12:05

Track Chair: ANGUS DALGLEISH, Professor of Oncology, St George’s University of London

Track Chair: JENS LOHRMANN, Senior Global Program Manager, Novartis

Track Chair: YUJI KASUYA, Director, Daiichi Sankyo Co., Ltd.

GUNDODIEDRICHDirector of AntibodyEngineering,MacroGenicsDevelopment of

Optimized DART® and TRIDENT™Molecules for Immuno-Oncology• Important features of DART and

TRIDENT formats: optimizing the relative position and number of binding sites in bi- or tri-specific molecules

• Dual blockade of immune checkpoints: PD-1 x LAG3, PD-1 x CTLA-4 DART molecules

• Tumor microenvironment localization of immune cell co-stimulation via bispecific CD137 DART molecules

IMMUNOTHERAPY PROTEIN BIOTHERAPEUTICSANTIBODY DRUG CONJUGATES



SOLUTION PROVIDER PRESENTATION:KARL ANDERSSONCEO, RidgeviewTime-resolved interaction analysis on living cells: Comprehensive data generates new knowledge and better decisions• Enabling precise interaction analysis of biologicals and bispecifics interacting with cell-surface receptors on living cells with LigandTracer

• Using detailed binding data to decipher underlying biology and support mode of action determinations

• Selecting binders based on clear and highly repeatable binding characteristics obtained relevant, cell-based environment

12:55-13:25

12:55-13:25

SOLUTION PROVIDER PRESENTATION:CALE HALBLEIBDirector of Biopharmaceutical

Development, KBI Biopharma Balancing Colloidal and Conformational Stability Factors in Biological Formulation SelectionThe long-term stability of a protein therapeutic formulation is key to its viability as a drug product. A significant challenge during protein formulation development is the generation and interpretation of data that is predictive of long-term stability. While chemical stability of the API may be important for long-term product quality, it is the assessment of physical stability that typically allows discrimination amongst protein formulations. For many biologicals, prediction of physical stability involves balancing countervailing impacts of conformational and colloidal stability. At this presentation, we will link the theoretical aspects of molecular stability to the approaches and tools used by KBI Biopharma BVBA for biologicals formulation development.

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12:05-12:55

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12:05-12:55

▷ Simple radioactive waste handling▷ Better patient compliance▷ Higher production capacity

• No cysteine – regioselective conjugation allowed

• High stability – ease of chemical conjugation

• No accumulation in healthy organ• High tumor to blood ratio at short time

frameKey advantages of the Nanofitin technology as a vector for drug conjugate• Small scaffold – high tissue penetration• Fast clearance can be tuned to allow

longer resilience via proprietary half life extension technology

• Examples will be given of the versatlity of the scaffold

▷ Can be easily conjugated to payload via chemical conjugation or genetic fusion (immunotoxin, immuno enzyme)▷ Can be conjugated to Nanoparticle

12:30-12:55

Lunch / One-to-One Partnering Meetings13:25-14:30


LAURENT POIROTHead of Early Discovery, CellectisTALEN-engineeredCAR T-cells forallogeneic adoptive therapies

• LEN technology allows highest "ready for the clinic" efficiency of gene editing for human T-cells.

• The specificity of TALEN can be finetuned to avoid off-target cleavage even for multiplex gene-editing.

• TALEN gene-editing expands the potential or CAR T-cells.


14:55-15:20

14:55-15:20

14:30-15:20

BERND SCHLERETHSenior Director, Non-clinical safety, CovagenImmunogenicity of bispecific antibody

constructs and what about the targets?• Immunogenicity of novel

biotherapeutics is a major hurdle in drug development

• Here, we report on the immunogenicity of a novel bispecific antibody construct (TNFa/IL-17 dual cytokine inhibitor) for the treatment of inflammatory diseases

• Interestingly, our data indicate that the immunogenicity is a consequence of dual target engagement and target structure rather than the intrinsic characteristics of the bispecific antibody construct

14:30-14:55

ARMIN SEPPAssociate Fellow, GSKA PET imaging study of the tissue distribution and elimination kinetics of an 89Zr-

labelled albumin-binding domain antibody (AlbudAb) in healthy volunteersWe have studied the tissue distribution and elimination kinetics of 89Zr-labelled albumin-binding domain antibody (AlbudAb) in healthy human volunteers. Extended plasma half-life was observed and combined with PET imaging data which indicated rapid initial tracer distribution in the vasculature followed by gradual tissue-dependent penetration which will be analyzed by physiologically-based pharmacokinetic (PBPK) modeling. Albumin-like plasma PK suggests that AlbudAbs can be useful for increasing and modulating the exposure of therapeutic payloads attached to the molecule.

14:30-14:55

ROUNDTABLE DISCUSSIONS:

Table 1: New antibody therapeutics: bi- and multispecificsROMAN IVANOVVice President, Research & Development, Biocad

Table 2: Discovery and development of antibodies against benign inflammatory diseasesADAM CLAUSSScientist, LEO Pharma

Table 3: ADC optimisationJENS LOHRMANNSenior Global Program Manager, Novartis

15:20-15:45

15:20-15:45

15:20-15:45

PAUL WASSMANNAnalytical science and strategy lead, Novartis Pharma AGAn analytical tool-

box enabling efficient lead candidate selection during Developability Assessment of Therapeutic ProteinsEarly lead selection of biotherapeutics during preclinical development requires careful characterization of a variety of molecule properties to reduce the risk to encounter unexpected obstacles during technical development. Unlike monoclonal antibodies with defined strategies addressing common liabilities, therapeutic proteins pose next level challenges setting-up a strategy for identification of candidates with best developability characteristics. To support a target profile based characterization during developability assessment of

OLIVER HILLVice President, APOGENIX AGEngineering hexavalent TNFR-SF Agonists for Cancer Immunotherapy

The HERA technology platform developed by Apogenix is based on trivalent but single-chain molecular mimics of the TNF-SF Receptor binding domains (scTNFSF-RBDs) fused to a dimerization scaffold. Being hexavalent by design, the HERA fusion proteins are potent TNFR-SF agonists on their own and do not need secondary crosslinking events for their activity. The underlying engineering concept as well as selected in vitro and in vivo data obtained with HERA-CD40L, HERA-CD27L and HERA-GITRL will be presented.

SLAVOLJUB MILOSEVICSenior Director, Head of Technology Innovation, Medigene Combining innovative

bioinformatics, cellular tools and robotics to advance adoptive T cell therapyIt became clear in recent years that genetically-modified patient lymphocytes will become standard treatment in patients with different malignancies. To eliminate tumor cells, patient lymphocytes must be equipped with new receptors (e.g. chimeric-antigen receptors – CARs or T cell receptors – TCRs) recognizing specific targets (antigens) on tumor cells. CARs recognize surface antigens whereas TCRs see peptide-MHC ligands derived from the whole transcriptome. Therefore, isolation of tumor-specific TCRs represents a complex task. We at Medigene have developed and employ

WILL GOUNDRYAssociate Principal Scientist, AstraZenecaChallenges and Opportunities in the Synthesis of ADC Payloads

• An overview of ADC payloads currently in development

• A detailed discussion of AstraZeneca’s payloads

• What challenges should you consider when scaling up the synthesis of an ADC payload?

• A case study for the scale-up of AstraZeneca’s Tubulysin payload

• Future perspective: what are the opportunities for new payloads

Track Chair: JACK BEARD, Conference Producer, Global Engage

Track Chair: JENS LOHRMANN, Senior Global Program Manager, Novartis


IMMUNOTHERAPY ANTIBODY-DRUG CONJUGATES BIOSIMILARS


Conference Close16:10

15:45-16:10

15:45-16:10

15:45-16:10

DEBORAH CHARYCHExecutive Director, Nektar TherapeuticsHarnessing potent cytokine agonist

pathways for immuno-oncology and beyondMany potent endogenous proteins that activate important biological pathways are difficult to translate into exogenous therapies because of toxicities, poor pharmacokinetics or sub-optimal pharmacodynamics. We have engineered endogenous proteins and exogenous small molecules using polymer technology to enable viable medicines. NKTR-214 is in Phase 2 clinical trials and a key example of how polymer conjugation can bias the well-known IL2 receptor pathway to favor CD8 T cell tumor infiltration over Tregs. Other examples to be discussed are NKTR-255, an IL15 receptor agonist and NKTR-262, a small molecule conjugate that stimulates toll-like receptor (TLR). Each agent has been conjugated in unique ways to elicit desirable and controlled pharmacological and immunological outcomes.

ANDREA GONZALEZ-MUNOZScientist I, MedImmuneAn Antibody Drug

Conjugate to Fight Sleeping Sickness• Emerging role of ADCs in non-

oncological therapeutic areas• Case study: Generation of ADC

against T.brucei, parasite causing sleeping sickness

POSTER PRESENTATIONS

MAKING A POSTER PRESENTATION

Poster presentation sessions will take place in breaks and alongside the other breakout sessions of the conference. Your presentation will be displayed in a dedicated area, with the other accepted posters from industry and academic presenters. We also issue a poster eBook to all attendees with your full abstract in and can share your poster as a PDF after the meeting if you desire (optional). Whether looking for funding, employment opportunities or simply wanting to share your work with a like-minded and focused group, these are an excellent way to join the heart of this congress.

In order to present a poster at the congress you need to be registered as a delegate. Please note that there is limited space available and poster space is assigned on a first come first served basis (subject to checks and successful registration). We charge an admin fee of €100 to industry delegates to present, that goes towards the shared cost of providing the poster presentation area and display boards, guides etc. This fee is waived for those representing academic institutions and not for profit organisations.

CHRISTIAN MAASCHManaging Consultant Product Development and RA, XendoBiophysical Methods

to take center stage in orthogonal analytics for comparability exercises and quality tasks of biologicsUnderstanding the structure-function relationship of a biotech product is vital to the development of a Biosimilar. Awareness of this is important, and by selecting the right assays at the right time, it is possible reduce costs and risks in the development process and to contribute to the pivotal evidence to demonstrate comparability. By applying best practice orthogonal methods and approaches for characterization, information regarding the structural, binding interactions and functional properties of the biological product are linked - providing a greater understanding and interpretation of the determined structure-function relationship and CQAs at molecular level. Herein we show examples and insights on how the orthogonal use of biophysical methods, as SPR gained increasing importance and acceptance to support manufacturing, QC, bioanalytics and comparability studies.

15:20-15:45

15:20-15:45

15:20-15:45

therapeutic proteins, an analytical tool-box concept is used at Novartis. The concept will be presented and supported by selected case studies.

sophisticated bioinformatic, cellular and robotic techniques to improve target antigen assessment and specific clinical lead TCR candidate isolation. We use our TCR platform for isolation of TCRs recognizing tumor-specific antigens as well as neoantigens.

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