EAC 2017 Day 1, Tuesday 31st October 2017

08:00 Registration Opens

08:50 Conference doors open

08:55

Welcome from Terrapinn

Opening Keynotes – Antibodies and immunotherapy

Michael Kalos
09:05

Keynote: Combination strategies in Immuno-oncology: the future is now

  • First generation immunotherapies highlight the promise of harnessing the immune system to target cancer, but most patients do not receive durable benefit
  • The complexity of the immune system and cancer interphase necessitates the development of combination therapies 
  • Development of rational combination therapies requires deep understanding of both the disease and the immunological landscape of patients 
 
Dr Roy Baynes
09:35

Keynote: Anti PD-1 antibody therapy – a broad spectrum anticancer monotherapy and a backbone in combination therapy

  • A biologically informed screening phase 2 program has identified broad spectrum monotherapy activity
  • Pivotal trials have led to an expanding list of approved monotherapy indications
  • Biomarker research is aimed at identifying those who benefit maximally from monotherapy and those who might be studied with biologically informed combination therapies
  • An ever expanding number of highly active combinations are being advanced
 
Dr Puja Sapra
10:05

Keynote: Evolution of DNA damaging antibody-drug conjugates

  • From bench to bedside: explore the discovery and development Inotuzumab Ozogamicin
  • Preclinical development of novel DNA-damaging ADCs

10:35 Networking Break

round tables
11:35

Plenary Roundtable Discussion Session

9 senior level tables hosted by thought leaders on key challenges and opportunities in antibody drug development. Participants are invited to join the group discussions on a topic of importance to them.
  • TABLE 1 Analytical and structural characterization of mAbs, biosimilars, ADCs, BsAbs, pAbs
  • Dr Alain Beck

    Dr Alain Beck, Senior Director, NBEs Analytical Chemistry, Centre d'Immunologie Pierre Fabre

  • TABLE 2 Providing precision histopathology for discovery and development
  • Jeremy Clarke

    Jeremy Clarke, Director of Commercial Development, Asterand Bioscience

  • TABLE 3 Assessing target specificity of biotherapeutics
  • Dr Jim Freeth

    Dr Jim Freeth, Managing Director, Retrogenix

  • TABLE 4 Strategies for tackling cancer
  • Joern Schmitz

    Joern Schmitz, Department Head, Fraunhofer I.M.E.

  • TABLE 5 Next generation therapeutic vaccines : viral, bacterial and cell based
  • Eric Halioua

    Eric Halioua, President and Chief Executive Officer, PDC*line pharma SA

  • TABLE 6 Determining effective combinations of immune checkpoint inhibitors and biomarkers
  • Jae Sly

    Jae Sly, Director of Strategic Business Development, ACRO Biosystems Inc

  • TABLE 7 Immunotherapy for solid tumours
  • TABLE 8 Biomarkers
  • TABLE 9 Preclinical models
  • 12:20

    Speed Networking

    A fun, exciting and effective way to make a lot of initial connections (in a very different environment from the standard business networking meetings)

    12:35 Networking Lunch

    13:15-13:45 Lunchtime Seminar: Overcoming the challenges of intact biotherapeutics characterization with ultra-high resolution mass spectrometers and the latest in automated biopharmaceutical software package Biopharma Compass 2.0
     
     
    Hosted by Catherine Evans, Business Development Manager Europe, Bruker Daltronik

    Discovery – Armed antibodies Early discovery and analytics

    Develop – Bispecifics Preclinical development

    Moving to Phase III and beyond

    Chaired by: Alain Beck, Head of Physico-Chemistry Department, Pierre Fabre, Associate Editor, mAbs

    Chaired by Roy Baynes, Senior Vice President & Head, Global Clinical Development, Chief Medical Officer, MSD

    Chaired by Michael Streit, Senior Director, Clinical Leader Research, Translational Medicine and Early Development, Oncology, Janssen

    14:10

    Insights of multilevel state-of-the art analytical methods for antibody-based product structural assessment

    • Emerging 2D-LC-MS methods for mAbs and ADCs
    • Orthogonal chromatographic and electrophoretic methods hyphenated to Mass Spec
    • FDA/EMA approved mAbs and ADCs and 3G-ADCs case studies
     
    14:10

    Silencing of antibodies – why would we silence IgG?

    • Anti c-kit ADC antibody was stopped in phase 1 due to hypersensitivity reactions of patients
    • Due to Fc effector functions?
    • Are our antibodies really silent?
    • “Silent” versions were tested in sensitive assays, such as mast cell degranulation assay
    14:10

    Fill and finish processing of biopharmaceutical manufacture

    • Basic data acquisition focusing on the main physical chemistry properties of the drug product.
    • Preliminary calculations of process parameters based on prior knowledge using simulation tools in order to anticipate process parameters of freezing, thawing, mixing, filtration and filling parameters.
    • Set-up of Design space using Lab scale tests for each operation units in order to fine tune the calculation results. Thanks to preliminary calculations the number of experiments to be performed is reduced.
    • Set-up of robust and efficient scale-up that can leads to stable products in the monitored quality attributes
     
    14:30

    Protein LC-MS/MS applied for bioanalytics

    • LC-MS/MS for large molecules offers orthogonality and complementary readouts to traditional ligand binding assays
    • Hybrid LC-MS/MS as the answer to increasing demands in sensitivity?
    • Case studies for pharmacokinetic, pharmacodynamic and immunogenicity studies (PK/PD/IG) by LC-MS/MS
     
    14:30

    Bispecific antibodies mediate selective, safe and effective blockade of the immune checkpoint CD47

    • Using Novimmune’s κλ body platform, we have developed a series of bispecific antibodies with unbalanced affinities towards each target, that enable selective blockade of CD47 on tumor cells.
    • Co-engagement of a tumor associated antigen and CD47 leads to superior tumor cell killing by macrophage in vitro and in vivo, leading to significantly increased efficacy in several animal models and to modification of the tumor micro-environment.
    • For NI-1701, GMP manufacturing and preclinical package have been completed enabling entry into Phase I clinical trial for hematological malignancies.
     
    14:30

    Lessons learned and facing the future for immunotherapy

    • An introspective look at the advances, shortcomings and downfalls of ImmunoTherapy
    • Discovery, development and optimization of novel pathways.
    • ImmunoMonitors - platform technologies incorporating critical reagents and innovation
     
    14:50

    Developing bispecific antibody therapeutics in immuno-oncology

    • A bispecific antibody (mAb2) which can bind and block murine LAG-3 and PD-L1 with high affinity was engineered and characterised
    • The anti-LAG-3/PD-L1 mAb2 inhibits LAG-3 and PD-L1 resulting in T cell activation in vitro
    • In vivo efficacy demonstrated, where the mAb2 significantly decreased tumour burden in the MC38 and CT26  murine colon carcinoma models with comparable anti¬tumour activity to the antibodies given in combination
    • Preclinical data package supports developing an anti-human LAG-3/PD-L1 mAb2 for the treatment of cancer
     
    14:50

    Collaborations between big pharma and biotechs – running a format through phase III and commercialisation

    • Innovative clinical development planning and implementation
    • Regulatory strategies for first-in-class compounds
    • Rationale combination strategies to expand and defend the approved asset
     
    15:10

    Uncovering critical receptors and safety screening for target specificity using human cell microarray technology

    • A powerful approach to identify specific receptors for phenotypic antibodies and immune  checkpoint ligands
    • Efficient off-target profiling of biotherapeutics including antibodies, ADCs, scFvs and whole CAR T cells
     
    15:10

    ATOR-1015, a bispecific immunomodulatory antibody targeting OX40 and CTLA-4

    • Generation of ATOR-1015 – engineering of a stable bispecific immunomodulating bispecific antibody
    • Functional assessment of ATOR-1015 In vitro and in vivo
    • Drugability assessment of ATOR-1015
     
    15:10

    Biologics development in fast-evolving Chinese market – an industry perspective

    • Biologics represent increasing share of the R&D pipeline for Chinese domestic and MNC pharma
    • Innovative modalities and MOA are gaining attention from local investment
    • Fast-evolving regulatory landscape and R&D infrastructure facilitate NBE and Biosimilar advancement
     

    15:30 Networking Break

    Regulations and antibody INN

    16:30

    Recent changes on EPO policy and insights into how to protect antibodies and related technologies

    • Impact of the Early Certainty policy
    • The Unified Patent and the Unified Patent Court are they coming?
    • Requirement for clarification at the search stage
    • Broad claims in a crowded field
     
    16:50

    Patenting a strategically designed antibody-based portfolio in the United States

    • Balancing claim scope with enablement and written description support
    • Obviousness in the U.S. versus Europe and the rest of the world
    • Lifecycle management for antibody-based inventions
     
    17:10

    Panel: Antibody nomenclature and INN strategies

    • Panel to discuss the current confusion surrounding antibody nomenclature
    • Why does the naming system have to be changed?
    • What problems are these causing in the clinic and the lab?
    • Suggestions on how this system can be improved
     
    17:50

    FDA Update: Antibody therapeutics focusing on ADCs, bispecifics and cancer immunotherapies

    • An update on regulation from the FDA focusing ADCs, bispecifics, cancer immunotherapies
    • What do the new biosimilar developments mean in terms of regulation considerations?
    Via weblink
     

    18:10 Offsite Networking Drinks

    last published: 20/Oct/17 09:45 GMT