European Antibody Congress - Agenda Day 1


European Antibody Congress 2018, Day 1

08:00 Registration Opens

08:30 Conference doors open


Welcome from Terrapinn

Opening Keynotes

Chaired by Alain Beck, Senior Director, NBEs Analytical Chemistry, Pierre Fabre, Associate Editor, mAbs

Peter Senter

Targeted drug delivery for cancer therapy

  • Overview of antibody drug conjugates
  • Challenges to the field
  • Recent advancements in delivery, specificity, and optimizing activity
Dr Rakesh Dixit

Advancements in antibody drug conjugates: therapeutic challenges of safety and efficacy

  • Next generation ADCs with improved antibodies, payload, linkers, conjugation technology
  • Lessons learned from the clinical development of ADCs
  • Maximizing efficacy while minimizing toxicities
  • ADC disposition, PK-PD challenges
  • Translational challenges to ADC development
  • Looking at the future of ADCs
Katherine Bowers

Formulation development cornerstone: building a successful journey from expression to patient

  • Discuss the critical aspect of formulation development to ensure the successful manufacturing and delivery of protein therapeutics
  • Provide an overview of the workflows and philosophies that are being adopted to ensure efficient, yet scientifically sound formulation selection
  • Share some experimental examples of the importance of considering a protein’s unique characteristics when selecting a final formulation

10:20 Networking refreshment break

round tables

Plenary roundtable session

Table 1: Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, pAbs
Dr Alain Beck

Dr Alain Beck, Senior Director, Biologics CMC & Developability, Centre d'Immunologie Pierre Fabre

Table 2: Indication selection/expansion and early biomarker discovery for bispecifics
Dr Jiri Kovarik

Dr Jiri Kovarik, Research Investigator, N.I.B.R.

Table 4: Muilti-specific formatomics – how much format diversity is required to address biology and developability?
Thomas Huber

Thomas Huber, Senior Investigator, Novartis Institute for Biomedical Research

Table 5: Therapeutic challenges of safety and efficacy in ADCs
Dr Rakesh Dixit

Dr Rakesh Dixit, Vice President R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

Table 6: The role of bioassays in assessment of critical quality attributes
Baolin Zhang

Baolin Zhang, Senior Investigator and Review Team Leader, F.D.A. C.D.E.R.

Table 7: Advances in multiplexing for clinical diagnosis
Lee Dawson

Lee Dawson, Senior Scientist, Molecular Pathology Group, BioIVT

Table 8: Antibody discovery platforms: current trends
Partha Chowdhury

Partha Chowdhury, Senior Director and Head, Antibody Discovery, Sanofi Genzyme

12:35 Networking Lunch

Engineering and structure

Bispecific development - Pre-clinical development

Armed antibody discovery


Chaired by Robert Kelley, Principal Scientist, Drug development, Genentech

Chaired by Ezio Bonvini, Senior Vice President, Research, and Chief Scientific Officer, Macrogenics

Chaired by Thomas Nittoli, Director of R&D Chemistry, Regeneron

Chaired by Marjorie Shapiro, Supervisory Biologist Office of Biotechnology Products, CDER, FDA

Antibodies - Protein Engineering

Protein engineering to increase the potential of a therapeutic antibody Fab for long-acting delivery to the eye

  • Formulation and stability pose challenges for ocular biotherapeutics
  • Selection or re-engineering of protein therapeutics may be required for ocular delivery
  • Antibody Fab formulation and/or conjugation can be used to alter dosing frequency
Antibodies - Bispecifics

Immunoglobulin domain interface exchange as a platform technology to engineer bispecific antibodies

  • Bispecific antibodies based on heavy chain hetero-dimerization
  • Common light chain format
  • Clinical stage antibodies
Antibodies - Armed Antibodies

Antibody-tubulysin conjugates display activity in MDR+ and bystander activity models

  • Tubulysin M and stabilized analogues were compared as ADC payloads
  • Quaternary ammonium-linked tubulysin linkers were evaluated for activity in models of multidrug resistance and antigen-heterogeneity
  • Tubulysin linkers are a promising payload class, combining potency in MDR+ and antigen-heterogeneous tumor models in a structure-dependent manner
Antibodies - Regulation and Investment

Bioassays for therapeutic proteins: design, validation and beyond

  • Bioassays are an integral component of quality control testing in the development of therapeutic proteins, including monoclonal antibodies.
  • Assay acceptability depends on product type, mechanism of action, associated risk, phases of development, and availability of other quality data
  • This presentation provides regulatory expectations on bioassays with case studies highlighting the relevant issues commonly seen in the regulatory submissions
Antibodies - Protein Engineering

Structural and functional role of antibody variable domain glycosylation

  • What is the impact of variable domain glycans on structural aspects of IgG?
  • How do variable domain glycans shape the repertoire of antibody responses?
  • How is the functionality and immunobiology of IgG modulated by variable domain glycans?
Antibodies - Bispecifics

Analytical characterisation of BEAT bispecific antibodies

  • Glenmark’s BEAT technology features heterodimerisation of heavy chain by bio-mimicry
  • scFv x FAB format allows for versatile combinations without use of common light chain
  • BEAT molecules have unique features – beneficial for manufacturing process, and requiring appropriate application of analytical techniques
  • This presentation would provide an overview of analytical techniques used for BEAT molecules, compared to “classic” monoclonal antibodies
Antibodies - Regulation and Investment

An FDA perspective on the implementation of state-of-the-art analytical methods and understanding structure-function relationships

  • Evolution of the analytical tool box
  • Implementation of state of the art methods and FDA expectations
  • Evolution of understanding mAb structure-function relationships and FDA expectations
Antibodies - Protein Engineering

Engineering of highly selective anti- Aβ42 antibody with picomolar affinity for the treatment of Alzheimer’s disease

  • MEDI1814 is a novel, high affinity, Abeta-42 antibody being developed for the treatment of Alzheimer’s Disease
  • The antibody selectively binds and sequesters the most neurotoxic forms of the amyloid beta peptide, Aβx-42, whilst avoiding the non-toxic forms of Aβ40
  • This presentation will cover the discovery, in vitro characteristics, pre-clinical evaluation and phase 1 clinical trial data with MEDI1814
Antibodies - Bispecifics

Bispecific antibodies against Infectious and neurodegenerative diseases

  • A combination of computational and experimental data to modulate protein properties
  • Engineered human monoclonal antibodies in a Bispecific molecule against Zika Virus
  • Bispecific antibody against Prions with therapeutic potential
Antibodies - Armed Antibodies

Development of potent and efficacious ADCs with payloads that target tubulin

  • Payload and linker development
  • In vitro screening
  • In vivo efficacy
Antibodies - Regulation and Investment

When the cake gets small: broad antibody claims in a crammed field

  • The breadth of allowable claims depends on the available prior art
  • A well characterized epitope may form the basis of a broad claim
  • Broad antibody composition claims
  • Good fall back position needed in case of attack in Opposition proceedings
Antibodies - Protein Engineering

Validation and applications of llamdA™, Isogenica’s synthetic VHH library

  • llamdA™ is Isogenica’s fully synthetic, developability optimized VHH library
  • We will present validation data on use of the library to generate binders to various target classes
  • Examples will be provided on the use of formatting into multivalent VHHs enables rapid development of high potency leads
  • Recent developments on the generation of VHH to membrane proteins will be included
Antibodies - Bispecifics

The CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects trough tumor-directed immune activation

  • ATOR-1015 is a CTLA-4 x OX40 bispecific immune activating antibody developed for tumor-directed immunotherapy
  • ATOR-1015 binds both targets simultaneously, promoting cell-cell interactions expected to enhance the immuno-stimulating effects
  • The mode of action of ATOR-1015 is a combination of regulatory T cell (Treg) depletion and effector T cell activation
Antibodies - Armed Antibodies

Extended Q&A

Your opportunity to ask the speakers your questions.
Antibodies - Regulation and Investment

Extended regulatory Q&A

  • The floor will be opened to an extended Q&A session for our regulatory speakers
  • The session will be moderated byMarjorie Shapiro, Supervisory BiologistOffice of Biotechnology Products, CDER, FDA

15:30 Networking refreshment break

Engineering and structure

Bispecific development - Clinical development

Armed antibody discovery


Chaired by Per-Ola Freskgård, Expert Scientist, pRED Roche Innovation Centre Basel

Chaired by Ezio Bonvini, Senior Vice President, Research, and Chief Scientific Officer, Macrogenics

Chaired by Anna Tafuri, Medical Director, Translational Medical Oncology, Bayer AG

Chaired by Alain Vertes, Managing Director, NxR Biotechnologies

Antibodies - Protein Engineering

Efficient and safe antibody delivery across the blood brain barrier

  • The cerebrovascular network constitutes an efficient route for biologics to the brain
  • Engagement with the Blood Brain Barrier receptor crucial for efficient brain exposure
  • Antibodies with full effector function can be delivered in a stealth mode to the brain
Antibodies - Armed Antibodies

Targeted alpha therapy: hopes and challenges of a novel anti-cancer approach

  • The alpha particle-emitter thorium-227 can be conjugated through a chelator to a wide range of targeting molecules (e.g. monoclonal antibodies)
  • High linear energy transfer of alpha particles results in clusterer double-strand DNA damage in targeted tumor
  • Limited range of alpha-irradiation (2-10 cell diameters) reduces damage to healthy tissues surrounding tumor cells
  • Preliminary evidence suggest that alpha-particles induce in vitro immunogenic cell death
  • Alpha therapy enables clinically feasible supply logistic with centralized manufacturing sites, 48h drug product delivery and out-patient treatment
Antibodies - Regulation and Investment

Panel: Investors in biologics

  • 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?
Antibodies - Protein Engineering

Managing unwanted immune responses to antibodies including utilisation of MHC-Associated Peptide Proteomics (MAPPs)

  • Present accurate and sensitive ways to assess the potential immunogenicity and development of anti-drug antibodies against proteins and antibodies ex vivo by measuring CD4+ T cell responses
  • Methods for managing and reducing potential immunogenicity, and introduce MHC-Associated Peptide Proteomics (MAPPs) to augment data sets to better inform immunogenicity risk
Antibodies - Bispecifics

Hooking TRAIL-R2 to “educate” immune system to recognize cancer cells

  • The construction of the Bispecific antibody (anti-TRAIL-R2/anti-CD3) with a focus on the importance of the choice of a format suitable to obtain a stable reagent
  • Different experimental approaches from which we observed that our Bispecific Antibody can induce T-cell activation without off-target toxicity
  • The demonstration that this reagent is potentially useful in many tumour types for which alternative therapies are needed including melanoma, breast cancer (the triple-negative subtype) and ovarian cancer
  • An ex vivo human ovarian cancer model, that may represent a realistic simulation beyond the animal model
Antibodies - Armed Antibodies

Protein-polymer conjugation to increase residence time of a Fab therapeutic in the eye

  • Understanding the role that hydrodynamic size plays in clearance from the vitreous
  • Polymer-Fab conjugation as a strategy for extending size
  • Development of a accompanying biophysical toolbox

CMC and Developability

Chaired by Hans-Martin Mueller, Director BioProcess Development, MSD

Antibodies - Protein Engineering

Antibody engineering to overcome antigen 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 present a case study to describe a protein engineering approach to generate a pH dependent binding antibody directed to a receptor
  • The resulting antibody has an extended half-life in vivo and its efficacy is not limited by dose
Antibodies - Bispecifics

Identification of a PD-L1 binding FCAB: A potent inhibitor of immunosuppressive signals

  • F-star has produced an Fcab, an antibody Fc domain modified to bind to a target, specific to PD-L1 The Fcab exhibits high affinity to human PD-L1 that translates into strong potency in cell-based functional assays
  • An anti-murine surrogate molecule, with similar potency, also exhibits activity in an MC38 syngeneic tumour model. This activity is improved when the Fcab is paired with Fabs targeting other immune checkpoint regulators
Antibodies - Armed Antibodies

Differentiating DeBouganin’s MOA from small molecules as ADC payloads

  • The In vitro potency of deBouganin versus that of traditional small molecule drugs as payloads for tumour-targeted therapeutics (ADCs) will be discussed
  • Data will be presented demonstrating that deBouganin induces biomarkers associated with immunogenic cell death and does not enrich the presence of immunosuppressive cell surface markers
  • The presented studies will support the use of DeBouganin-loaded ADCs to both directly kill tumour cells and spark host immune responses that could pair well with the use of checkpoint inhibitors
Antibodies - CMC and Developability

Developability assessment of therapeutic proteins – a toolbox for tackling increasing complexity

  • The concept of developability assessment of therapeutic proteins
  • Analytical challenges upon the shifting of biologics portfolio
  • Strategies and tool-box addressing the new demand
  • Case studies highlighting the analytical method development
Antibodies - Protein Engineering

Brain delivery and intracellular sorting of affinity variants of the anti-TfR antibody OX26

  • Antibody engineering has been used to create affinity variants of the mouse anti-rat transferrin receptor antibody OX26
  • We found an inverse correlation between antibody affinity and brain penetration, and efficacy in a model of inflammatory pain when coupled to the peptide galanin
  • Cell fractionation revealed the affinity variants had different intracellular fates, helping us understand how changes in affinity improve brain exposure
Antibodies - Bispecifics

Bispecific DART® Molecules in the age of cancer immunotherapy: redirected T cell killing and beyond

  • Notwithstanding recent progress, unmet needs still exist in immunotherapy of cancer
  • Bispecific molecules may offer unique opportunities to address such needs
  • Application of the DART platform in redirected T‐cell killing, checkpoint blockade and co‐stimulation will be presented
Antibodies - Armed Antibodies

Treating tissue factor-positive cancers with antibody drug conjugates that do not affect blood clotting

  • Antibodies against Tissue Factor (TF) that do not interfere with the coagulation cascade were identified by using a yeast-based selection system and various cell-based assays
  • A selection of antibodies conjugated to the prototypic cytotoxic agent monomethyl auristatin E (MMAE) was tested in cell- and patient-derived xenograft models
  • The coagulation-inert ADCs were as efficacious as tisotumab vedotin, a clinical stage MMAE-based ADC against TF that affected blood clotting
Antibodies - CMC and Developability

Modern analytical development of biologics

  • Feasibility of modern analytical tools for biologics development
  • Innovative approaches for process analytics
  • Trends and upcoming requirements for the analytical control of biopharmaceuticals

Targeting and specificity

Antibodies - Protein Engineering

Mechanistic insight into transferrin receptor-mediated BBB shuttling antibodies based on VNARs

  • Novel approach for discovery of BBB penetrating antibodies
  • Optimisation of efficacy of BBB transporters
  • Mechanistic requirements for VNAR-based BBB shuttling antibodies
Antibodies - Bispecifics

BiTE® antibody constructs in clinic and development

  • Following the approval of blinatumomab in relapsed/refractory ALL multiple BiTE candidates have entered or are about to enter the clinic in various indications
  • Give an update on Amgen’s BiTE pipeline at the discovery, translational, and early clinical stage of development
Antibodies - Armed Antibodies

Turning native antibodies into homogeneous ADCs without antibody engineering

  • A new site-specific method to generate homogeneous ADCs will be introduced that does not require antibody engineering
  • Versatility of method will be shown
  • Comprehensive characterization of generated ADCs will be presented
Antibodies - CMC and Developability

Mammalian display: antibody discovery, affinity maturation and developability screening in IgG format

  • Integration of IgG libraries into mammalian cells by CRISPR/Cas9 and TALE nucleases
  • Multi-parametric FACS used to discover antibodies with desired specificity, binding affinity, species cross-reactivity and expression level
  • Mammalian display for ultra-high throughput developability screening
  • Utility of Intellicyte iQue for human antibody screening
Antibodies - Protein Engineering

Structure guided rational design of de novo antibody specificity

  • Engineered rat specificity de novo into Amgen’s lead anti-migraine molecule (AMG334
  • Fine tuning of specificity to gain Rat specificity without losing the human one
  • Structural computational approach, used in parallel with other engineering yielding the best results in terms of time vs effort vs cost
  • Investigated deep sequencing to enhance and de-risk the Ab engineering process
Antibodies - Bispecifics

Extended Q&A

An opportunity to ask the speakers your questions!
Antibodies - Armed Antibodies

DARPin-photosensitizer conjugates for EpCAM-directed photodynamic therapy of ovarian cancer

  • Designed ankyrin repeat proteins
  • Photodynamic therapy
  • Ovarian cancer
  • Epithelial cell adhesion molecule (EpCAM)
Antibodies - CMC and Developability

Extended Q&A

Extended Q&A - your chance to ask our speakers questions!

18:30 Offsite networking drinks

last published: 28/Oct/18 15:15 GMT


There are two parts to the Festival of Biologics: the five world-class international conferences covering Antibodies, Immunotherapy, BioSimilars, Clinical Trials, and High Potency APIs; and an exhibition featuring the most exciting technology and solutions for pharma and biotech. There is a registration fee to attend the conferences. To visit the exhibition is free.


Conference 29 - 31 October • Exhibition & Seminars 29 - 31 October

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