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September 18-20, 2018
Boston, MA

 

Day One
Wednesday, September 19

Day Two
Thursday, September 20

07.30
Registration & Networking

08:20 
Chair’s Opening Remarks

08.30
Challenges & Opportunities in Development of Bispecifics and Combination Biology

Synopsis

  • Understanding the importance of bispecifics as therapeutics in high unmet medical needs human diseases
  • Evaluating the challenges involved in bispecific target selection, effector or ADC enhanced format selection, CMC and overall developability challenges
  • Assessing the clinical pipeline of bispecifics and success rates
  • Looking ahead: What is the future of the bispecific field?

 

09:00 
Bispecific Technology for Multiple Avenues of T-Cell Activation

Synopsis

  • Investigating checkpoint bispecifics to improve therapeutic index: PD1 x CTLA4
  • Developing triple checkpoint blockade: LAG3 x CTLA4 bispecific plus anti-PD1
  • Checkpoint plus costim: PD1 x ICOS
  • Potency-tuned IL15 for prolonged T cell stimulation

 

 

09.30
Model Aided Drug Invention (MADI) Case Studies in Research: In Silico Differentiation for Dual Targeting PD-1 and Tim-3 in I/O, and Predicting Optimal Drug Properties of a Bispecific Biologic to Maximize Tissue Targeting in OA

  • John Burke President, CEO & Co-Founder, Applied BioMath

Synopsis

  • MADI is a rigorous fit-for-purpose model development process which aims to quantitatively integrate knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms.
  • Exploring two case studies that highlight examples of MADI efforts that have de-risked projects, accelerated the discovery and development of best-in-class therapeutics, and impacted critical decisions, in the continuum from preclinical exploration to clinical research.
  • Integrating systems modeling to predict optimal drug properties targeting PD-1 and TIM3 in immuno-oncology for bispecific biologics and fixed dose combinations.
  • Investigating MADI approaches to determine best in class properties for targeted anabolic growth factor to arthritic joints

10.00
Speed Networking & Morning Refreshments

Track Chair

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

11:30 Engineering Bispecific Antibodies to Match Target & Disease Biology: ABT-165 (dilpacimab) as a Case Study

  • ABT-165 is a bispecific antibody targeting DLL4 and VEGF with multiple distinct MOAs
  • ABT-165 was uniquely engineered to match target and disease biology with the consideration of efficacy, safety and developability
  • ABT-165  demonstrated favorable in vivo efficacy, pharmacokinetic and safety profiles in pre-clinical models, and currently is being investigated in Phase II clinical studies for the treatment of solid tumors

Jijie Gu, Head of Target Validation, Immunology Research, AbbVie

12:00 Validating Target With Biologies Amenable to Bispecific Targeting: CD47 Case Study

  • Understanding CD47 as an immune checkpoint controlling both the innate and the adaptive immune responses
  • Highlighting how the blockade of tumor-expressed CD47 with bispecific antibodies promotes tumor cell phagocytosis, antigen cross-presentation, and T cell-mediated immunity
  • Investigating how bispecific antibodies allow selective blockade of the ubiquitously expressed CD47 on tumor cells, representing an advantage in terms of drug pharmacology and safety as compared to CD47 targeting monoclonal antibodies

Krzysztof Masternak, Head of Biology, NovImmune

Track Chair

Robert Mabry, VP, Protein Science, Cogen Therapeutics

11:30 Understanding the True Value of Combinations of In Silico and In Vitro Analytical Approaches for Bispecifics

 Highlighting the diverse array of modelling approaches to characterize mechanism of action and therapeutic window

  • Utilizing next generation sequencing to guide in silico work
  • Case study: Antibody engineering guided by computer simulation in the development of a therapeutic targeting the CGRP receptor

 Igor D’Angelo, Senior Scientist & Team Lead, Antibody Engineering, Amgen

12:00 Engineering Functional and Developable TNFRS Bispecific Antibodies

Analytical Strategies for the Development of Bispecific Antibodies

  • In-silico and experimental tools to assess developability
  • In-depth characterization of side products for bispecific antibodies such as T cell bispecifics
  • Functional characterization of bispecific antibodies during early development

Martin Bader, Head of Biochemical and Analytical Research, Roche

12.30
Lunch & Networking

13.30 Preclinical Characterization of BiTE® Antibody Constructs for the Treatment of Cancer

  • Understanding approaches to validate new BiTE constructs preclinically to lay a robust path to the clinic
  • Toxicological assessments for bispecific constructs
  • Evolving the BiTE platform to improve half-life

Matthias Friedrich, Scientific Director, Amgen

14.00 Utilizing Oncolytic Vectors to Augment the Efficacy of BiTE Therapeutics Against Solid Tumors

  • Understanding the delivery challenges involved in targeting solid tumors
  • Developing oncolytic vectors as delivery vehicles to target direct on-tumor effects
  • Analyzing the advantages of this approach in solving delivery challenges and enhancing the effects of bispecifics

Christine Engeland, Cancer Researcher, National Center for Tumor Diseases

13.30 Development of T-Cell Redirecting Fully Human Bispecific Antibodies

  • Bispecific antibodies are a promising new class of molecules for treatment of a variety of oncology indication
  • Regeneron’s lead bispecific antibody REGN1979 (CD20xCD3) has entered clinical testing and shows promising activity in Phase 1 studies
  • REGN4018, a first in class Muc16xCD3 bispecific antibody, has completed pre-clinical evaluation and has entered clinical development this year

Eric Smith, Director, Regeneron

14.00 A Predictive In Vitro Preclinical Package to Assess the Safety and Efficacy of TCR-Based Bispecific Biologics

  • Introducing ImmTAC molecules: Fully humanized bispecific soluble T cell receptors targeting cancer
  • The challenges involved in preclinical safety and efficacy testing without using animal models: our current preclinical package
  • Sharing examples of novel in vitro models for testing bispecifics

Andrea Stacey, Group Leader, Preclinical Biology, Immunocore

14.30
Afternoon Refreshments & Poster Viewing

Improving Manufacturing & Developability

15.30
Rapid CMC Development of Different Formats of Bispecifics Using Traditional Up- and Down-Stream Methods

  • Phil Hammond Director, Therapeutics Preclinical Development, Zymeworks

Synopsis

  • Generating bispecifics using a number of industry-standard cell-line development approaches
  • Highlighting scalability and repeatability of bispecific production at scales of up to 3x2000L
  • Showcasing the rapid CMC development of a number of bispecific formats through case studies
  • Demonstrating that approaches in CMC development and corresponding manufacturing costs of bispecifics is comparable to traditional monoclonal antibodies

 

 

16.00
Showcasing Effective CMC Development for Bispecific Antibodies

Synopsis

  • Dispelling misconceptions about the complexities and challenges involved in developing and manufacturing bispecifics
  • Applying platform-based approaches for developability assessment as well as for development and manufacture
  • Highlighting streamlined approach from DNA to FIH GMP manufacturing processes
  • Case studies detailing CMC approaches in the development of a range of bispecific therapeutics

 

 

16.30
Engineering Functional and Developable TNFRS Bispecific Antibodies

Synopsis

  • Talk details to be confirmed

17.00
Chair’s Closing Remarks

Focus Evening: Strategic Business Considerations in Developing and Commercializing Bispecifics

Synopsis

More bispecifics are reaching late stage clinical development than ever before, and it’s clear that significant investments continue to be made to collaboratively advance these therapeutics.

To align with this trend, this evening deep-dive evening shifts the focus from the technical to the strategic, analysing the current state of the bispecifics business landscape to ensure you’re set to make strategic decisions with greater confidence in the coming months.

17.45
Chair’s Welcome to the Focus Evening

18.00
Panel Discussion: Analysing Deal Structures and their Impact on the Bispecific Space

Synopsis

  • Understanding how elements of deals such as exclusivities actually work
  • Investigating how closely commercial collaborations and deals are tied to research
  • Fostering mutually beneficial collaborations and deals between small biotechs and large pharmaceutical companies

 

 

18.45
Mastermind Discussion Groups

Synopsis

This collaborative exercise will enable you to collectively discuss the commercialization of bispecifics. Gain insights and perspectives from colleagues at various stages of development in the field and benchmark your progress against a variety of companies and organizations.

19.15
Chair’s Closing Remarks