World Bispecific 2016

September 28-30, 2016 | Boston, MA

Day One

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Wednesday September 28

08:00
Registration & Networking

08:20
Chair’s Opening Remarks

Janine Schuurman, VP, Research, GenMab

Janine Schuurman

08:30
Approaches To Identify Target Pairs And Antibody Combinations To Design And Select Bi- And Multi-Specific Biologics With Novel Biology

  • Development of methods to screen for target and mAb combinations with novel biology
  • Design and generation of novel multi-specific biologics to control T cell activation

Tariq Ghayur, Senior Research Fellow, AbbVie

Tariq Ghayur

Tariq Ghayur received his Ph.D (1987) in Immunology from the Department of Physiology, McGill University, Montreal, Canada and did his post-doctoral training at McGill (1987-’88) and Dana Farber Cancer Institute (1988-’90). He joined AbbVie Inc. in 1990. Tariq has worked on both small molecule and therapeutic antibody discovery programs and from 1998-2004 led two therapeutic antibody discovery project teams and delivered 2 drug development candidates. Currently, he leads the dual variable domain Ig (DVD – Ig™) Initiative and the Novel Biologics group at AbbVie. He holds several patents and is the author of many peer-reviewed scientific publications. In addition to therapeutic antibodies and antibody generation technologies, his areas of interest are antibody engineering, inflammation, lymphocyte and antigen presenting cell biology, cytokine biology and transplantation rejection.

09:00
Bispecific Antibody Engineering In Drug Discovery And Development At Roche

  • Requirements and anticipated modes of action for bispecific antibodies from an engineering perspective
  • Challenges in identification and screening of bispecific antibody combinations
  • Investigating selected examples including FAP-DR5, T cell bispecifics and the brain shuttle format

Claudio Sustmann, Head, Molecular Engineering and Functional Characterization, , Roche

Claudio Sustmann

09:30
Speed Networking

10:30
Morning Refreshments

DEVELOPMENT STREAM: Optimize In Vitro Assays To Accelerate Early Development

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

Joan Ballesteros, CSO, Vivia Biotech

11:30 - Considerations In The Design Of Assays And Processes For Producing And Characterizing Bispecific IgG In A Four-Chain Co-Expression System

  • Short overview of an approach for generating bispecific IgG using a four–chain co-transfection methodology, without the need for post purification recombination processes such as reduction/oxidation
  • Transient and stable cell line considerations in production of bispecific IgG
  • Analytical assays for verifying protein homogeneity and light chain pairing fidelity

Nathan Higginson-Scott, Senior Principal Scientist, Pfizer

12:00 - Designing An Entirely In Vitro Preclinical Package For Screening Of TCR-Based Bispecific Compounds

  • An overview of the ImmTAC platform: T cell receptor-based bi-specific biologics for redirected tumor killing
  • Considerations for safety assessments of TCR-based therapies
  • In vitro cell assays to assess the potency and safety profiles of drug candidates
  • Molecular and bioinformatic tools for predicting off-target activity (toxicity)

Dan Blat, Senior Scientist, Immunocore

DISCOVERY STREAM: Uncover and Validate Novel Targets

11:00 - Navigating The Design Of Bispecifics: Matching Format To Biology

  • Differentiating biologies that are particularly amenable to bispecific therapeutics
  • Key considerations in aligning bispecific format to target biology
  • Demonstrating superiority of bispecifics in comparison with combination approaches

Shaun Lippow, Head of Protein Platform Technologies, Bayer HealthCare

11:30 - Improving The Bispecific Antibody Platform: Simultaneously Delivering ADCC And NK Cell Expansion Signals With IL-15 Trikes

  • Lessons learned from the creation of bispecific antibodies engaging NK cells to vastly improve their ability to kill through antibody dependent cell-mediated cytotoxicity (ADCC)
  • Investigate a new bioengineered drug whereby the cytokine IL15 is cross-linked into the BsAb scaffold,  creating a new platform whereby NK expansion is maximized while ADCC is promoted
  • Discussion of the structure, function, rationale, animal studies, and clinical potential of these IL-15 TriKes

Daniel Vallera, Professor, University of Minnesota

12:00 - Case Study: Utilizing Next Generation Ex Vivo Screening Systems For the Discovery Of Bispecific Antibodies

  • Robust bispecific antibody platform capable of generating large and diverse panels of bispecific candidates for screening
  • Panels of Patient-derived organoids (tumor and normal tissue) grown ex vivo in 3D culture
  • High-content based imaging used as a read-out to measure drug effects on organoid growth and morphology
  • Lead candidate bispecifics identified targeting the wnt pathway with novel modes of action

Mark Throsby, CSO, Merus

12:30
Lunch & Networking

DEVELOPMENT STREAM: Validate Efficacy In Vivo

14:00 - Developing Robust Analytical Tools to Rapidly Advance Candidate Therapeutics

  • Dual binding assay developed to be primary initial release assay to support development and commercialization
  • Single target binding assays developed to support characterization of the molecule as well as for comparability purposes
  • Cell-based assay implemented as early as possible to generate parallel data along with dual binding assay to support potential commercial implementation of dual binding assay as release assay

Kimberly Reese, Scientist, Janssen

14:30 - Construction Of Bispecific Mab2 Molecules Against EGFR And HGF Targets Using Fc Fragment (Fcab) Modular Technology

  • Bispecific antibody format that allows a “plug and play” modular strategy
  • Enhancement of in vivo activity in a bispecific format over combination therapy in a murine system
  • Novel in vivo biology using a bispecific antibody against EGFR and HGF

Mihriban Tuna, VP, Discovery, F-Star

15:00 - Costimulatory T Cell Engagement With The CD137/HER2 Bispecific PRS-343: From Flexible Design To In Vivo Proof Of Concept And Beyond

  • Strong proof of concept and developability data for CD137/HER2 bispecific PRS-343
  • Investigating why immuno-stimulatory receptor targeting requires bispecifics for efficacy and safety
  • How the versatile Anticalin-based multispecifics platform allows selecting the optimal bispecific geometry for a desired biological effect

Marlon Hinner, Director, Immuno-Oncology, Pieris

DISCOVERY STREAM: Enhance Target Synergy

14:00 - Advances In Bispecific Antibody Formats: Modelling A New Cross-Over Design To Address Novel Biology

  • Modelling and engineering of a new bispecific antibody format confirmed by crystal structure
  • Modulating half-life, valency, and potency – Fv & target selection
  • Examining the latest engineering stability and device-ability data
  • Production in standard CHO process

Anke Steinmetz, Senior Researcher, Sanofi

14:30 - Development Of Multispecific Antibody Technology And The Application For Cancer Immunotherapy

  • Understanding T cell biology and the art of antibody engineering
  • Discussing the development of multispecific antibody technology
  • Learning how multispecific technology could be used to design molecules to fine tune T cell functions for tumor killing

Feng Dong, Senior Scientist, AbbVie

15:00
Afternoon Refreshments & Networking

Improve Developability and Manufacturability

16:00
Rapid Production Of Bispecific Antibodies Using ‘Off-The-Shelf’ IgG

  • Photoreactive antibody binding domains (pAbBDs) enable bispecific antibodies to be created in hours
  • Bispecific antibodies can be prepared using any ‘off-the-shelf’ IgG
  • The resulting bispecific antibodies are highly potent and exhibit no loss in IgG affinity

Andrew Tsourkas, Professor, Department of Bioengineering, University of Pennsylvania

Andrew Tsourkas

16:30
Empowering A Commercial Anti-TNFα Antibody Through Fusion With A Potent Anti-IL-23 Alphabody: The Development Of The Bispecific Therapeutic CMX04

  • Examining rationale and design options for a novel bispecific format
  • Analyzing anti-TFNα and anti-IL-23 potency
  • Insights into the manufacturing, serum stability, solubility at high concentrations and PK profile of CMX04

17:00
A Novel MET-EGFR Bispecific Antibody LY3164530 Shows Pre-clinical Advantage Over Combining MET and EGFR Antibodies In Tumor Inhibition and Overcoming Resistance

  • Development and optimization of BsAb for superior pre-clinical biological activities
  • Mechanism of action and pre-clinical differentiation
  • Biomarker and potential tailoring strategies

Ling Liu, Research Fellow, Eli Lilly

Speaker Outline

17:30
Chair’s Closing Remarks