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Next Generation Protein Therapeutics

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Cross-Fertilize Ideas from Multiple Disciplines and Turn Promising New Molecules into Differentiated Products

May 18-20, 2015 | Parc 55 Hilton | San Francisco, CA

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Agenda

Agenda

  Download the Agenda-at-a-Glance PDF, featuring all 3 co-located events

Monday, May 18, 2015

7:00
Registration and Coffee

8:00
Chairperson's Remarks
Jennifer R. Cochran, Ph.D., Associate Professor of Bioengineering and Chemical Engineering, Stanford University

Keynote Presentations

8:15
Peter Senter, Ph.D.
Potent Antibody Drug Conjugates for Cancer Therapy
Peter Senter, Ph.D., Vice President,Chemistry, Seattle Genetics

8:45
Paul J. Carter, Ph.D.
Bispecific Antibodies - Are We There Yet?
Bispecific antibodies are coming of age with 2 approved for human therapy and >30 more in clinical development. Efficient production of bispecific IgG in a single host cell is challenging because of many potential unwanted chain pairings. Engineered Fab pairs have been combined with knobs-into-holes Fc mutations for more efficient production of bispecific IgG in a single host cell.
Paul J. Carter, Ph.D., Staff Scientist and Senior Director, Antibody Engineering, Genentech, Inc.

9:15
Andreas Plückthun, Ph.D.
New Engineering and Application Perspectives of Scaffold Proteins
Andreas Plückthun, Ph.D., Director, Department of Biochemistry, University of Zurich, Switzerland

9:45
Networking Refreshment Break in Poster and Exhibit Hall

10:10
Chairperson's Remarks
Jennifer R. Cochran, Ph.D., Associate Professor of Bioengineering and Chemical Engineering, Stanford University

Development of Immunotherapies

Featured Presentation

10:15
Karl Dane Wittrup, Ph.D.
Integrin-targeted Cancer Immunotherapy
Karl Dane Wittrup, Ph.D., C.P. Dubbs Professor and Associate Director, Koch Institute at MIT, Massachusetts Institute of Technology

10:45
Manipulation of the Immune Response To Cancer Through Inhibition of the PD-1 Pathway
Gary Starling, Ph.D., Associate Vice President, Biologics Discovery Operations, Merck Research Laboratories

11:15
An Alternative Platform for Fusing Cytokines to Antibodies
Previously, researchers created antibody-cytokine fusion proteins with N-terminal antibody and C-terminal cytokine components. For whole IgG fusions, the cytokines have been fused to the free heavy chain C-terminus. A novel method of fusing the cytokine to the heavy chain-bound C-terminus of the antibody light chain has created a new platform with major changes in PK properties and biological activities.
Stephen Gillies, Ph.D., Chief Executive Officer and Founder, Provenance Biopharmaceuticals Corp.

Featured Presentation

11:45
Tumor-Targeted Drug Delivery Via XTEN™, A Protein-Polymer Offering Precisely Controlled Structure and Valency
Amunix developed a hydrophilic protein-polymer (XTEN™) with long half-life in circulation that is rapidly degraded upon internalization. XTEN facilitates the orthogonal conjugation of multiple toxins and targeting moieties with precisely controlled stoichiometry. The hydrophilic nature of XTEN allows high drug loads and reduces toxicity resulting from non-specific internalization. XTEN-drugs can be linked to many tumor-specific ligands such as peptides, scaffolds, and antibody fragments and full antibodies.
Volker Schellenberger, Ph.D., President and CEO, Amunix Operating Inc.

12:15
Networking Luncheon in Poster and Exhibit Hall

1:25
Chairperson's Remarks
Manuel Baca, Ph.D., Fellow, Antibody Discovery and Protein Engineering, MedImmune LLC

Emerging Methods and Technologies for Screening, Selection and Sequencing

1:30
The Role of NGS and In Vitro Selection for Hit Identification and Optimization at BMS
Applications of NGS with in vitro selection will be discussed. This will include methods to recover low-abundance sequences from a diverse population and additional methods for rapid optimization of antibodies and other polypeptides.
Martin Wright, Ph.D., Associate Director, Selection Technologies, Bristol-Myers Squibb

2:00
Next-Generation Sequencing and Protein Mass Spectrometry for the Comprehensive Analysis of Human Cellular and Serum Antibody Repertoires
We have developed an experimental pipeline enabling the molecular analysis of antigen-specific antibodies in human blood. The integration of high-resolution protein mass spectrometry of affinity purified antibody (Ig-seq) in parallel with NextGen sequencing of peripheral B cell V-gene repertoires (BCR-seq) provides a direct means to comprehensive delineation of the antibody repertoire and the potential for therapeutic antibody discovery.
Gregory C. Ippolito, Ph.D., Research Assistant Professor, Department of Molecular Biosciences, The University of Texas at Austin

2:30
Applying Deep Sequencing to Antibody Selections
Andrew Bradbury, Ph.D., Research Scientist and Group Leader, Los Alamos National Laboratory

3:00
Networking Refreshment Break in Poster & Exhibit Hall

Disruptive Technologies and Approaches in Protein Discovery, Engineering and Design

3:30
A New Technology Platform that Enables High-Throughput Analysis and Engineering of Antibodies, Biosensors, and Enzymes
We developed a new screening platform that allows researchers to assay the functional activity of millions of protein variants, displayed on or secreted from bacteria or yeast. This potentially transformative technology, which is essentially a 10 million well microtiter plate the size of a penny, has enabled a broad range of protein engineering applications, including antibody, enzyme, and biosensor engineering from bacteria or yeast libraries.
Jennifer R. Cochran, Ph.D., Associate Professor of Bioengineering and Chemical Engineering, Stanford University

4:00
Protease-Resistant Human IgGs, Novel Antibodies with Novel Properties for Treatment of Cancers and Infectious Disease Agents
Human IgGs, particularly the IgG1 isotype typically used in cancer treatments, are highly susceptible to cleavage by proteases elaborated by solid tumors. Specific cleavage results in complete loss of Fc-mediated cell-killing functions without a concomitant loss in antigen-binding capability or circulating half-life. We have generated modified human IgGs that are protease-resistant and possess complement and/or FcγR-mediated functions for treatment of solid tumors.
William R. Strohl, Ph.D., Vice President and Head, Biotechnology Center of Excellence, Janssen R&D

4:30
Engineering Albumin to Tailor Half-Life and Improve Efficacy of Protein Drugs
The half-life of molecules can be increased by association, conjugation or fusion to albumin, due to a combination of size and recycling via the neonatal Fc receptor (FcRn). We will describe the generation and application of novel albumin variants with an increased affinity to FcRn, which demonstrate an extended circulatory half-life in NMRI mice, hFcRn transgenic mice and cynomolgus monkeys.
Filipa Antunes, Research Scientist and Project Manager, Novozymes Biopharma

5:00
Networking Cocktail Reception in Poster and Exhibit Hall

6:00
Dinner Discussions
(Additional registration fee required - see registration page for details)
Please join us for this highly interactive 3 hour evening exchange in a roundtable format, which encourages participants to share their experiences and concerns amongst several discussion topics that include:
  • GPCRs, Ion Channels and Other Membrane Targets - The Next Hot Targets! Why? What are the Challenges?
    Moderator: Catherine Hutchings, Ph.D., Antibody Alliance Management & Strategic Partnering, Heptares Therapeutics Ltd., United Kingdom
  • Delivery Approaches for Intracellular Biologics
    Moderator: Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd., Australia
  • Strategies for Plasma Half-Life Extension of Biopharmaceuticals
    Moderator: Arne Skerra, Ph.D., Professor, Chief Scientific Officer, XL-protein GmbH, Germany
  • Non-Antibody Targeting Moieties
    Moderator: Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc.
  • Clinical Translatability of Current ADC Programs: Does Patient Selection/Tailoring Improve Success
    Moderator: Alan C. Rigby, Ph.D., Vice President, ADC Biology, Eli Lilly and Company
  • Site-Specific Conjugation and its Progress Towards Clinical Development
    Moderator: Jagath Reddy Junutula, Ph.D., Vice President, Antibody Discovery & Development, Cellerant Therapeutics, Inc.
  • CRISPR's Influence on Therapeutic Development
    Moderator: Ben Haley, Ph.D., Scientist, Genentech
  • What Technological Breakthroughs will Make a Difference to Cell line Development: Enthusiasm Tempered by Realism
    Moderator: Alan Dickson, Ph.D., Professor of Biotechnology, Director, Centre of Excellence in Biopharmaceuticals, Co-Director, BioProNET, The University of Manchester, United Kingdom
  • Cell Line Authentication
    Moderator: Leonard P. Freedman, Ph.D., President, Global Biological Standards Institute
  • Smart Polymers as Drug Linkers and to Extend Half-Life
    Moderator: Volker Schellenberger, Ph.D., President and CEO, Amunix Operating Inc.

Tuesday, May 19, 2015

7:30
Coffee

Track One

8:00
Chairperson's Remarks
Robert Mabry, Ph.D., Associate Director, Antibody Discovery and Bispecific Engineering, Adimab, Inc.

Unlocking New Biology with Novel Scaffolds and Antibody Fragments as Therapeutics

8:15
Adnectins in Engineered, Multi-Component Biologics
Dasa Lipovsek, Ph.D., Senior Principal Scientist, Bristol-Myers Squibb

8:45
Targeted Depletion of Pathogenic T Cells for the Therapy of Chronic Inflammatory Diseases
David Urech, Ph.D., Co-CEO and Chief Scientific Officer, Numab, Switzerland

9:15
In Vitro V(D)J Recombination: A Robust Strategy for Generating Fully Human Agonist and Antagonist Antibodies to GPCRs
V(D)J recombination allows for the de novo generation of large human antibody repertoires in a mammalian display format. Utilizing an autocrine-like strategy, cells both express the GPCRs in their full length and unmodified functional structure and the human antibodies generated de novo by the cell line. Anti-GPCR antibodies are identified as IgG surface positive cells or directly as agonists.
Michael Gallo, Ph.D., President, Innovative Targeting Solutions, Inc.

Track Two

8:00
Chairperson's Remarks
Dragan Grabulovski, Ph.D., Chief Scientific Officer, Covagen AG, Switzerland

Novel Therapeutic Peptide Development

8:15
Phylomer Derived Cell Penetrating Peptides Facilitate More Efficient Delivery of Peptides and Proteins to the Cytoplasm
Phylomer peptide libraries have been screened for new cell penetrating peptides for delivery of macromolecules and nanoparticles into cells. A novel genetic screen known as the 'endosome escape trap' enables the isolation of rare CPP's which more efficiently deliver their cargoes to the cytoplasm. Some of these cell penetrating Phylomers can be targeted to particular cell types. Phylogica has developed a variety of functional assays to determine the extent of cytoplasmic delivery of peptide and protein cargoes to the cytoplasm or nucleus. These assays have shown Phylomer CPP's to be 37-160 times more efficient than TAT. These tools are now being applied in screens targeting transcription factor oncoproteins such as cMyc and for more efficient intracellular delivery of protein toxins where they enable nanomolar potencies.
Paul Watt, Ph.D., Chief Scientific Officer, Phylogica Ltd., Australia

8:45
Orally Delivered and Injected Constrained Peptides for Inflammatory Bowel Disease
Mark Smythe, Ph.D., Founder and Vice President, Protagonist Therapeutics

9:15
Discovery and Development of Unnatural Peptide Drugs
Kristopher Josephson, Ph.D., Senior Director, Discovery Research, Ra Pharmaceuticals, Inc.

9:45
Networking Refreshment Break in Poster and Exhibit Hall

Addressing Difficult Targets with Protein Therapeutics

10:30
Venoms to Drugs: Harnessing Disulfide-Rich Peptides from Venomous Animals to Target Neuronal Ion Channels Involved in Human Disease
The venoms of arthropod predators are dominated by hyperstable disulfide-rich peptides that evolved to target neuronal ion channels in prey and predators. We use these natural combinatorial libraries of ion channel modulators to isolate peptides that target ion channels involved in human disease. I will show examples of peptides that are providing leads for treatment of pain, epilepsy and stroke.
Glenn F. King, Ph.D., Professor and NHMRC Principal Research Fellow, Institute for Molecular Bioscience, The University of Queensland, Australia

11:00
GPCR Structure Guided Drug Discovery
Stabilized receptors offer a breakthrough solution to the central challenge of reliably making pharmacologically active antibodies against GPCRs. They enable the production of purified, properly folded and functional protein when removed from the cell membrane for use as an antigen. This presentation provides several examples that provide important validation of this solution and further demonstrates that StaR antigens preserve biologically relevant epitopes, thereby enabling generation of diverse panels of functional antibodies for use as therapeutics.
Catherine Hutchings, Ph.D., Antibody Alliance Management & Strategic Partnering, Heptares Therapeutics Ltd., United Kingdom

Delivery of Proteins

10:30
Creating Biologics that Cross the Blood-Brain Barrier using a Peptide Conjugation Strategy
Peptides that cross the blood-brain barrier via receptor-mediated transcytosis can be conjugated to biologic therapeutics such as peptides, monoclonal antibodies, and antibody-drug conjugates thus creating brain-penetrant biologics for neuro-oncology and other CNS disorders.
Jean Lachowicz, Ph.D., Chief Scientific Officer, Angiochem

11:00
Precision Delivery of Biologics into the Cytosol of Cells
Functionalization of complex molecules in a site-selective manner is a major challenge in chemistry. Here we report a novel and robust method of site-selective cysteine arylation of peptides and proteins. We show this method can be used for macrocyclization of peptides and for the site-selective modification of proteins and antibodies. This chemistry provides new avenues to modify biomolecules for research and therapeutics.
Bradley L. Pentelute, Ph.D., Pfizer-Laubach Career Development Professor, Associate Member, Broad Institute of Harvard and MIT, Member, Center for Environmental Health Sciences MIT, Massachusetts Institute of Technology

Plenary Sessions

Spotlight Presentation

11:30
Tools & Technologies For Comprehensive Immunogenicity Risk Management
Emilee Knowlton, Ph.D., Immunology Sales Specialist, ProImmune, Inc.

12:00
Networking Luncheon in Poster and Exhibit Hall

1:25
Chairperson's Remarks
Dimiter Dimitrov, Ph.D., Senior Investigator, Protein Interactions, National Cancer Institute, NIH

Site-Specific Conjugation Methods and Strategies

1:30
Overcome Key Challenges in Antibody Drug Conjugate Design through the SMARTag Technology Platform
  • Enabling precise & programmable site specific chemical protein modification
  • The development of novel conjugation chemistry resulting in ADCs with enhanced stability
  • Linker chemistry that optimizes the potency of the cytotoxic payload
Robyn Barfield, Ph.D., Group Leader, Bioconjugation, Catalent Pharma Solutions

2:00
De-risking ADC Development Through Cell-free Based Rapid Make-test Cycles
The cell-free Xpress CF+ platform offers the ability to rapidly generate 1000s of antibodies with site-specific chemical linkers in short timeframes. This in turn enables screening efforts to look at critical quality attributes of potential ADC drug candidates at a very early stage in microtiter formats; therefore either identifying viable drug candidates or informing re-engineering efforts of promising leads. Overall, aspects of developability and manufacturability testing can be incorporated during lead selection, allowing for early stage de-risking of ADC drug discovery efforts.
Alexander Steiner, M.S., Director, Protein Biochemistry, Sutro

2:30
Site-specific Conjugation Through Carbohydrates
Conjugation of antibodies with small molecules through glycans will be overviewed. A method based on naturally occurring N-linked glycans will be discussed in detail. This method was used for generation of antibody drug conjugates against cancer-related targets which were extensively characterized.
Dimiter Dimitrov, Ph.D., Senior Investigator, Protein Interactions, National Cancer Institute, NIH

3:00
Networking Refreshment Break and Last Chance for Poster and Exhibit Viewing

Next Generation Bioconjugates

Featured Presentation

3:45
Robert Lutz, Ph.D. Clinical Development of ADCs Lessons Learned and Where Do We Go From Here
A look at the successes and challenges encountered in the clinic with current ADC technologies and how this clinical experience is shaping future development efforts. Where will new technologies have impact? This talk will focus on where we have been and where we are going in the effort to improve ADC therapies.
Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc.

4:15
PEG Alternatives - New Applications of PASylation for Therapeutic Protein Development
PASylation is a biodegradable substitute with biophysical properties very similar to PEG. This technology allows the simple genetic fusion (or chemical coupling) of a therapeutic protein or peptide with a voluminous hydrophilic polypeptide composed of Pro, Ala, and/or Ser to retard kidney filtration. PASylation has been successfully applied to Fab fragments, cytokines, hormones, adipokines, incretins, lipocalins etc., leading to therapeutic drug candidates with increased bioactivity and prolonged action.
Arne Skerra, Ph.D., Professor, Chief Scientific Officer, XL-protein GmbH, Germany

4:45
Close of Tuesday Sessions

5:00
Join Us... Happy Hour @ Pier 39 Overlooking San Francisco Bay
This networking reception is at Players Sports Grill & Arcade, which has sweeping views of San Francisco Bay. Enjoy buffet finger food and drinks (beer, wine, soft drinks) plus arcade games and pool tables. Transportation will be provided. Limited tickets for this event remain for an additional $125 fee. If you want to register for this reception, please stop by the registration desk to reserve your spot.

Wednesday, May 20, 2015

7:30
Coffee

8:00
Chairperson's Remarks
Arne Skerra, Ph.D., Professor, Chief Scientific Officer, XL-protein GmbH, Germany

Keynote Presentations

8:15
Patrick Baeuerle
Development of Bite® Antibody Construct Blinatumomab - The First FDA-Approved Bispecific Antibody
Bispecific T cell-engaging (BiTE®) antibody constructs can transiently link tumor cells with otherwise inactive cytotoxic T cells for induction of potent redirected lysis of attached tumor cells. One example is blinatumomab (AMG 103), a CD19/-CD3-bispecific BiTE® antibody construct for the treatment of acute lymphocytic leukemia (ALL) and non-Hodgkin's lymphoma (NHL), which has been filed in the EU for treatment of relapsed/refractory ALL, and approved in the US by the FDA in December 2014. Two other BiTE® antibody constructs, called AMG 211/MEDI-565 (CEA/CD3-specific) and AMG 212/BAY2010112 (PSMA/CD3-bispecific) are in early clinical development for the treatment of solid tumors. A BiTE® antibody construct specific for CD33 and CD3, called AMG 330, is in formal preclinical development, and has shown high activity in ex-vivo experiments by redirecting autologous patient T cells for lysis of acute myelogenous leukemia (AML) blasts. Blinatumomab and all other BiTE® antibody constructs can activate T cells in a highly efficient manner that is strictly dependent on the presence of target cells, elicit serial lysis of target cells by T cells, induce T cell proliferation, and act at subnanomolar concentrations. In a Phase 1 dose escalation study, blinatumomab showed a complete (CR)/partial response (PR) rate of 68% at a target dose level of 60 micrograms/squaremeter/day in relapsed or refractory NHL patients with, for instance, follicular, mantle cell lymphoma, or diffuse large B cell lymphoma. Initial phase 2 studies investigating monotherapy with blinatumomab in patients with minimal residual disease (N=20) or relapsed/refractory (r/r) ALL (N= 36) revealed molecular/MRD response and complete hematologic response (CR and CRh) rates in the range of 69-80% at a target dose level of 15 micrograms/squaremeter/day. A larger phase 2 study in r/r ALL patients (N=189) at a fixed dose of 9 µg per day for one week and a maintenance dose of 28 µg per day for the remaining treatment period confirmed a CR/CRh rate of 43%. Clinically most relevant safety events were neurological. An overview of the clinical program and insights into the mode of action, immunopharmacology, safety profile, and clinical activity of blinatumomab will be provided.
Patrick Baeuerle, Vice President, Research; General Manager, Amgen Research GmbH, Germany

8:45
James A. Wells, Ph.D.
Engineered Proteins for Signaling
Jim Wells, Ph.D., Professor and Chair, Pharmaceutical Chemistry, UCSF

9:15
Mark S. Dennis
Receptor-Mediated Delivery of Bispecific Antibodies into the Primate Brain: Challenges and Safety Findings
Mark Dennis, Ph.D., Principal Scientist, Antibody Engineering, Genentech, Inc.

9:45
Networking Refreshment Break

Bispecific and Multispecifics - New Development Approaches, Design, and Results from the Clinic

10:15
An Open Cell Free Protein Synthesis Platform to Discover Novel Antibodies and Bispecifics
Using our cell free expression platform, Sutro can expression of antibodies and fragments using a bacterial extract system. We can quickly discover novel antibody fragments (e.g. scFv and Fabs) to any relevant disease target using ribosome display with our extract system. Finally, we can reformat these antibody leads in a many different bispecific frameworks and test them for binding and functionality. Several case studies will be presented to exemplify the power of this system for antibody and bispecific discovery.
Aaron K. Sato, Ph.D., Vice President, Research, Sutro Biopharma, Inc.

11:15
Engineering Novel Bispecific Antibody/Fusion Protein for Enhanced Biological Activity
Zhenping Zhu, M.D., Ph.D., Executive Vice President, Global Biologics, Kadmon Corporation

11:45
Technology Workshop Presentations

12:15
Lunch on your Own

1:25
Chairperson's Remarks
H. Kaspar Binz, Ph.D., Vice President and Co-Founder, Molecular Partners AG, Switzerland

Bispecific and Multispecifics - New Development Approaches, Design, and Results from the Clinic (continued)

1:30
Closing in Cancer Using Multi-Specific DARPins
The robustness of the DARPin platform enables the combination of biologics with known mode of action and exploring biologics with novel mechanisms of action. Multi-specific DARPin drug candidates will be discussed highlighting their differentiation, including candidates in clinical and preclinical development.
Kaspar Binz, Ph.D., Vice President, Protein Engineering and Co-Founder, Molecular Partners AG, Switzerland

2:00
CD3-Folate Bioconjugates for the Treatment of Ovarian Cancer
Olivier Laurent, Ph.D., Vice President, CMC, Ambrx

2:30
Improving the Developability of a Bispecific Scaffold with Protein Design
Steven Jacobs, Ph.D., Associate Scientific Director, Biologics Research, Janssen R&D

3:00
Roundtable Discussions & Networking Refreshment Break

Bispecific and Multispecifics - New Development Approaches, Design, and Results from the Clinic (continued)

3:30
Nanobodies as a Versatile and Clinically Validated Approach for Multi-Specifics
Antonin de Fougerolles, Ph.D., Chief Scientific Officer, Ablynx, Belgium

4:00
Discovery and Characterization of COVA322 - A Clinical-Stage Bispecific TNF/IL-17A Inhibitor
Michela Silacci, Ph.D., Director, Discovery Research, Covagen AG, one of the Janssen Pharmaceutical Companies of J&J, Switzerland

4:30
Engineered Affibody-Based Ligand-Trap that Block IL-17 with Unparalleled In Vivo Potency
Il-17 is a potent inducer of tissue inflammation. Here we describe the engineering of a scaffold based ligand trap designed to block IL-17 mediated pathology. The trap is based on the modular Affibody scaffold for IL-17 inhibition, and an albumin binding domain for extended plasma half-life supporting once monthly dosing. The fusion protein has unparalleled potency with complete blocking of the dimeric interleukin. These properties translate to superior efficacy in vitro and in vivo compared to antibodies in clinical development.
Foachim Feldwisch, Ph.D., Director, Preclinical Development, Affibody AB, Sweden

5:00
Close of Conferences

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