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September 26-28 2017
The Seaport Hotel and WTC, Boston, MA

Day One

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Wednesday September 27 2017

08.00
Registration & Networking

08.20
Chair’s Opening Remarks

Janine Schuurman, Vice President, Research, Genmab

Janine Schuurman

08.30
Lessons Learned from the Clinical Development of Bispecifics

  • Investigating strategies to ensure the successful development of bispecifics in the context of unpredictable biologies and outcomes
  • Understanding how clinical experience can feed back and improve earlier development
  • Case study: overcoming unexpected immunogenicity of anti-TNF therapeutics – transferrable lessons to enhance your bispecific development

Tariq Ghayur, Senior Research Fellow, Abbvie

Tariq Ghayur

09.00
Engineering Bispecific Antibodies for Cancer therapy – a Unique Perspective for Pediatric Solid Tumors Spanning Three Decades

  • Contrasting how conventional IgG monoclonal antibodies (mAbs) relying on Fc-dependent mechanisms are constrained by low killing potency, poor cell trafficking, and inefficient epitope spread, whereas bispecific antibodies (BsAb) have the potential to turn circulating polyclonal T cells into tumor infiltrating cytotoxic T cells despite the immunosuppressive tumor microenvironment
  • Understanding how BsAb allows T-cell mediated immunotherapy to bypass the need for the expression of HLA and of costimulatory molecules on tumor targets, as well as prior immunization
  • Exploiting BsAb to deliver massive doses of radiation in multistep targeting with vastly improved therapeutic ratios

Nai-Kong Cheung, Head, Neuroblastoma Program, MSKCC

Nai-Kong Cheung

09.30
Speed Networking & Morning Refreshments

Discovery Track: Selecting & Validating Novel Targets Successfully

11.00 - Information Content & Molecular Complexity: Importance of Library Design to Selection Results

  • Investigating how bispecific antibodies often require specific binding modes from their individual components to maximize potency and efficacy
  • Analyzing the effect of library design and size on the outcome of a selection for component of a tri-specific anti-HIV-1 entry inhibitors
  • Sharing insights into how large and carefully designed libraries can increase the probability of success when selecting for a molecule with specific functional features

Jonathan Davis, Principal Scientist, Protein Design, Bristol-Myers Squibb

11.30 - Optimization of Binding Strengths in a Tissue-Targeted Erythropoietin

  • Understanding how binding features of parent molecules may not be optimal in a bispecific.
  • Investigating how weak/moderate binding plus avidity can enhance specificity and how binding constants can affect both PK and signaling activity
  • We need a new roadmap for quantitative optimization of elements in multidomain engineered proteins.  We are working in a multidimensional landscape and need new design approaches beyond simply increasing throughput

Jeffrey Way, Senior Staff Scientist, Wyss Institute, Harvard University

Development Track: Laying the Foundations for Clinical Success Through Rational Early Development Strategies

11.00 - A New Mechanism of Action for Bispecific Antibodies Activating Tumor-Specific Antigen T Cells

  • Novel proprietary ex vivo assay for bispecific antibodies (BsAbs) in hematological malignancies patient samples
  • BsAbs can generate CTLs that kill tumor independent of BsAb and target, probably tumorspecific antigen CTLs immunosuppressed in bone marrow, same as TILs in solid tumors
  • New design of multi-specific antibodies from new MOA empowered by the screening of 100s of constructs ex vivo
  • Novel proprietary assay can screen combinations BsAbs and checkpoint inhibitors

Vivia Biotech

11.30 - Structural Optimization of Bispecific Antibodies for Conditional Immune Activation

  • Understanding how the formats make impact on mechanism of action
  • Controlling the toxicity of immune agonists by design
  • Learning to design better scFv as building blocks

Yoshiko Akamatsu, Senior Principal Research Scientist, Abbvie

12.00
Lunch & Networking

Investigating & Contrasting Innovative Bispecific Constructs

13.30
Avoiding Pitfalls in Format Design – Understanding Why Bispecifics Have Behaved Unexpectedly in the Past to Give a Greater Certainty in Moving into the Clinic in the Future

  • Analysing the advantages and disadvantages of a variety of bispecific formats
  • Performing a reality check on the hype surrounding bispecifics – addressing the need to improve potency, control immunogenicity risk and enhance developability
  • Key lessons learned from the development and advancement of therapeutic bispecifics in oncology

Dale Ludwig, CSO, Biologics Technology, Oncology Research, Eli Lilly

SANYO DIGITAL CAMERA

14.00
Making Room for Two Paratopes on an Fv: Introducing the DutaFab Platform

  • The DutaFab platform delivers fully human dual targeting Fab molecules with two independent paratopes
  • Heavy and light chain both contribute to high affinity target binding for each of the paratopes
  • Binders can be mixed and matched and reformatted into antibody formats as desired
  • This creates novel bispecifics structurally essentially indistinguishable from a standard monospecific Fab or antibody
  • We introduce the platform technology and discuss applications

Marlon Hinner, Group Leader, In Vitro Display, Roche

Marlon Hinner

14.15
Panel Discussion: Investigating Comparisons Between Formats – Lessons Learned that will Inform Future Format Design

  • Head to head comparisons investigating why certain arrangements of domains are more efficacious than others in addressing the same targets
  • Investigating how in vitro performance compares to in vivo performance for the different formats currently available
  • Understanding which formats and approaches can successfully meet the criteria required for manufacturability

Robert Mabry, Senior Director, Protein Sciences & Antibody Technology, Jounce

Robert Mabry

Stan Blein, Senior Director & Head, Antibody Engineering Innovation & Development, Glenmark

Stan Blein

Marlon Hinner, Group Leader, In Vitro Display, Roche

Marlon Hinner

14.45
Afternoon Refreshments & Networking

Improving the Developability of Bispecifics

15.15
Engineered Fab Domains Promote Efficient Production of Bispecific Antibodies in a Single Cell

  • Single cell process simplifies bispecific antibody production compared to established assembly process from two component antibodies
  • Molecular insights into how engineered Fab domains drive orthogonal pairing of cognate light and heavy chains
  • More complex characterization of single cell bispecific antibody overcome with high resolution analytics
  • Single cell process translates to stable cell line development, a key step for clinical development

Christoph Spiess, Senior Scientist, Antibody Engineering, Genentech

Christoph Spiess

15.45
Site-Specific Bioconjugation Approaches for the Preparation of Novel Bispecific Antibody Platforms

  • Chemical crosslinking techniques can be used to rapidly prepare highly uniform bispecific antibody constructs, opening up an opportunity to screen for optimal antigen binding pairs
  • Proximity-based sortase ligation can be used to site-specifically modify bispecific antibodies with chemical moieties (e.g. imaging agents, PEG) in a modular fashion, during standard protein purification protocols

Andrew Tsourkas, Professor, Bioengineering, University of Pennsylvania

Andrew Tsourkas

16.15
Developability & Analytical Characterization to Enable the Optimal Selection of Bispecific Antibodies

  • Analytical characterization of developability attributes of bispecific antibodies during discovery
  • Selection of highly developable lead molecules with minimum downstream issues
  • Key learning for bispecific antibody production, purification, and characterization

Laurence Fayadat-Dilman, Director, Protein Sciences, Merck

Laurence Fayadet-Dilman

16.45
Chair’s Closing Remarks

Janine Schuurman, Vice President, Research, Genmab

Janine Schuurman