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Key Sessions

David Baker, PhD

Towards Next Generation de novo Designed Protein Therapeutics

University of Washington

Rachael Clark, MD, PhD

TCR Sequencing: Transforming the Diagnosis and Care of Cutaneous T cell Lymphomas

Harvard Medical School

Bahija Jallal, PhD

Benralizumab, A Monoclonal Antibody Engineered for Enhanced NK-cell Mediated Eosinophil Depletion

Medimmune and AstraZeneca

7:15am - 8:15am

Registration and Coffee

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Showing of Streams
10:05am - 10:35am

Networking Refreshment Break

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Showing of Streams
Showing of Streams
Showing of Streams
Showing of Streams
Showing of Streams
4:00pm - 4:45pm

Networking Refreshment Break and Opening of Exhibit Hall

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Showing of Streams
6:15pm - 7:15pm
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Opening Night Reception with Exhibits and Poster Viewing

Please join your fellow attendees in the exhibit hall for an evening of networking while enjoying beverages, and hors d'oeuvres!

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7:15am - 8:15am 60 mins
Registration and Coffee
8:15am - 8:25am 10 mins
Keynote Presentations
Chairperson's Opening Remarks
  • Kerry Chester, PhD - Professor of Molecular Medicine, UCL Cancer Institute
8:25am - 9:10am 45 mins
Keynote Presentations
Keynote Presentation TBA
9:10am - 9:15am 5 mins
Keynote Presentations
Keynote Questions
9:15am - 10:00am 45 mins
Info
Keynote Presentations
Towards Next Generation de novo Designed Protein Therapeutics
  • David Baker, PhD - Professor of Biochemistry, University of Washington

This presentation will describe recent advances in de novo protein design, and the application of these advances to new therapeutic and vaccine modalities.

10:00am - 10:05am 5 mins
Keynote Presentations
Keynote Questions
10:05am - 10:35am 30 mins
Networking Refreshment Break
10:35am - 11:20am 45 mins
Info
Keynote Presentations
TCR Sequencing: Transforming the Diagnosis and Care of Cutaneous T cell Lymphomas
  • Rachael Clark, MD, PhD - Shing-Yiu Yip and Cecilia M. Hepp Associate Professor of Dermatology, Harvard Medical School

Cutaneous T cell lymphomas are a heterogeneous collection of non-Hodgkin’s lymphomas that arise from T cells tropic for the skin. High throughput TCR sequencing (HTS) is transforming the care of patients with these cancers.  HTS provides rapid and accurate diagnoses, allows direct measurement of malignant T cells in skin before and after therapeutic interventions and discriminates patients with indolent lymphomas from those that will develop progressive, often lethal disease.

11:20am - 11:25am 5 mins
Keynote Presentations
Keynote Questions
11:25am - 12:10pm 45 mins
Info
Keynote Presentations
Benralizumab, A Monoclonal Antibody Engineered for Enhanced NK-cell Mediated Eosinophil Depletion
  • Bahija Jallal, PhD - President and Executive Vice President, Medimmune and AstraZeneca

Eosinophilia in patients with asthma correlates with increased exacerbation susceptibility. Benralizumab is a humanized, monoclonal antibody that targets the IL-5 receptor alpha antigen on eosinophils. Afucosylation of benralizumab enhances antibody-dependent cell-mediated cytotoxicity activity resulting in potent and rapid depletion of eosinophils. Benralizumab has demonstrated clinical efficacy in two pivotal Phase III trials, resulting in reductions of asthma exacerbations.

12:10pm - 12:15pm 5 mins
Keynote Presentations
Keynote Questions
12:15pm - 1:15pm 60 mins
Info
Scientific Luncheon Briefing 1
Accelerate Your Antibody Discovery with High throughput Array SPR
  • Yasmina Abdiche, PhD - Chief Scientific Officer, Carterra

Carterra’s new LSA platform enables high throughput antibody characterization, including kinetics, affinity, epitope binning, mapping, and quantitation with minimal sample consumption. We will demonstrate capture kinetics and epitope binning studies on a 384-antibody array, providing key parameters to make informed decisions quickly and confidently to streamline library-to-leads

12:15pm - 1:15pm 60 mins
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Scientific Luncheon Briefing 2
Ligand Scientific Briefing
12:15pm - 1:15pm 60 mins
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Scientific Luncheon Briefing 3
SGI-DNA Scientific Briefing
12:15pm - 1:15pm 60 mins
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Scientific Luncheon Briefing 4
Positioning for Success in Discovery and Development with AlivaMab Mouse and AlivaMab Discovery Services
  • Larry Green, PhD - CEO, Ablexis & AlivaMab Discovery Services

Transgenic mice have delivered more than twice as many approved antibody drugs as in vitro display technologies.  Ablexis’ AlivaMab Mouse is the only transgenic animal designed for the efficient discovery and development of therapeutic antibodies.  The team at AlivaMab Discovery Services, with its deep expertise, provides solutions to the challenges of outsourcing the successful discovery of the next generation of human therapeutic antibodies.

1:15pm - 1:45pm 30 mins
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Scientific Briefing 1
Build Better Antibodies with Machine Learning and SynBio
  • Claes Gustafsson, Ph.D. - Chief Commercial Officer and Co-Founder, ATUM

ATUM has built and deployed a unique pipeline for the efficient design and manufacturing of antibody genes, proteins and cell lines enabling fast and accurate engineering of optimized antibody molecules. Several independent case studies will be presented.

1:15pm - 1:45pm 30 mins
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Scientific Briefing 2
Speeding Discovery and Development with High-Throughput, High-Precision Characterization of Clonal Populations
  • Troy Lionberger, PhD - Senior Manager, Technology Development, Berkeley Lights

Characterizing thousands of single cells or clones rapidly is critical for success in drug discovery and development. Applying light and semiconductor technology in a nanofluidic chip, the Beacon platform isolates single cells, cultures, assays, and exports clones of interest in an automated process. What use to take weeks to months now just takes days.

1:15pm - 1:45pm 30 mins
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Scientific Briefing 3
Validation of the Alexandria™ Fully Synthetic Human Fab Library
  • Guy Hermans, Ph.D. - Chief Scientific Officer, Isogenica

We have previously discussed the design and synthesis of Alexandria™, Isogenica's fully synthetic human Fab library. Here, we will provide an update on the validation of this library, both in its fully diversified and common light chain formats, using example antigen selection campaigns.

1:15pm - 1:45pm 30 mins
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Scientific Briefing 4
WSGR Scientific Briefing
1:45pm - 2:15pm 30 mins
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Scientific Briefing 1
An Integrated Approach to Managing Immunogenicity Risk and Optimum Protein Design
  • Emilee Knowlton, Ph.D. - Immunology Sales Specialist, ProImmune Inc.

Integrated platforms can be used to mitigate immunogenicity risk and characterize immune responses during the drug design and development stages.  ProImmune offers mutational activity mapping for optimal protein design, DC-T/T cell proliferation assays for biologic lead selection/optimization, a Mass Spectrometry assay for characterization of antigen presentation; HLA-peptide binding assays to characterize individual epitopes & undiluted whole blood cytokine storm assays.

1:45pm - 2:15pm 30 mins
Info
Scientific Briefing 2
High Throughput Antibody Characterization Workshop by ForteBio
1:45pm - 2:15pm 30 mins
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Scientific Briefing 3
Mabplex Scientific Briefing
1:45pm - 2:15pm 30 mins
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Scientific Briefing 4
The Systems Immunology Revolution: How Computational Design Has Enabled Thousands of Clinic-ready Antibodies in Weeks
  • Jacob Glanville, PhD - Chief Science Officer, Distributed Bio, Inc.
2:25pm - 2:30pm 5 mins
Track 1: Novel Methods to Interrogate Receptors As Targets
Chairperson's Remarks
  • Andreas Plückthun, PhD - Professor and Director, University of Zurich
2:25pm - 2:30pm 5 mins
Track 2: Immunogenicity
Co-Chairs’ Remarks
  • Paul Carter, PhD - Senior Director and Staff Scientist , Antibody Engineering, Genentech, Inc.
  • Valerie Quarmby - Staff Scientist and Director, BioAnalytical Sciences, Genentech, A member of the Roche Group, USA
2:30pm - 3:00pm 30 mins
Track 1: Novel Methods to Interrogate Receptors As Targets
Clinically Important Receptors and Techniques for Interrogating Them
  • Ira Mellman, PhD - VP, Cancer Immunology, Genentech
2:30pm - 3:00pm 30 mins
Info
Track 2: Immunogenicity
Immunogenicity in Biotherapeutic Development
  • Valerie Quarmby - Staff Scientist and Director, BioAnalytical Sciences, Genentech, A member of the Roche Group, USA

Every biotherapeutic has the potential to elicit unwanted immune responses in treated patients. These may compromise safety or efficacy; if there is a profound impact on the drug’s risk/benefit profile, immunogenicity can even cause termination of drug development. This talk will review immunogenicity and discuss approaches to risk mitigation.

3:00pm - 3:30pm 30 mins
Info
Track 1: Novel Methods to Interrogate Receptors As Targets
More Than Blocking Ligands: Designing Therapeutic Proteins to Surface Receptors
  • Andreas Plückthun, PhD - Professor and Director, University of Zurich

Therapeutic proteins can be designed that uncouple surface receptors from signaling, and crosslink them in inactive forms and induce their internalization and even degradation. Design strategies to achieve such activities will be discussed for several surface receptors of great importance in a variety of tumors. Several novel analysis methods have been developed to untangle the mode of action of these therapeutic proteins on the cell surface.

3:00pm - 3:30pm 30 mins
Info
Track 2: Immunogenicity
Post Hoc Assessment of the Immunogenicity of Bioengineered Factor VIIa Demonstrates the Use of Preclinical Tools
  • Kasper Lamberth, PhD - Principal Scientist, Screening & Bioassay Technology, Novo Nordisk A/S

The development of a bioengineered recombinant Factor VIIa (rFVIIa) analog was discontinued after phase 3 trials due to development of ADAs. The FVIIa analog has three mutations compared to the unmodified parent molecule rFVIIa. By using computational and experimental methods we demonstrate that the observed ADAs could have been elicited by neo-epitopes in the engineered-protein

3:30pm - 4:00pm 30 mins
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Track 1: Novel Methods to Interrogate Receptors As Targets
Decoding Ligand Receptor Interactions
  • Bernd Wollscheid, PhD - Professor, Chemical & Systems Biology, Institute of Molecular Systems Biology and Department of Health Sciences and Technology (D-HEST), ETH Zurich

Cellular responses depend on the interactions of extracellular ligands, such as nutrients, growth factors, or drugs, with specific cell-surface receptors. The sensitivity of these interactions to non-physiological conditions makes them challenging to study using in vitro assays. HATRIC-based Ligand Receptor Capture technology (HATRIC-LRC) enables antibody target validation within the native nanoscale organization of the surfaceome.

3:30pm - 4:00pm 30 mins
Track 2: Immunogenicity
A Mechanistic Model of the Immune System to Predict Biotherapeutic Immunogenicity
  • Xiaoying Chen - Principal Scientist, Pfizer
4:00pm - 4:45pm 45 mins
Networking Refreshment Break and Opening of Exhibit Hall
4:45pm - 5:15pm 30 mins
Info
Track 1: Novel Methods to Interrogate Receptors As Targets
Pathology from the Molecular Scale on Up
  • Garry Nolan, PhD - Richard and Carlota A. Harris Professor, Stanford School of Medicine

High parameter single cell analysis has driven deep understanding of immune processes.  Using a next-generation single-cell “mass cytometry” platform we quantify surface and cytokine or drug responsive indices of kinase target with 45 or more parameter analyses (e.g. 45 antibodies, viability, nucleic acid content, and relative cell size).  Similarly, we have developed two advanced technologies termed MIBI and CODEX that enable deep phenotyping of solid tissue in both fresh frozen and FFPE formats (50 – 100 markers). Collectively, the systems allow for subcellular analysis from the 70nm resolution scale to whole tissue in 3D. I will present evidence of deep internal order in immune functionality demonstrating that differentiation and immune activities have evolved with a definable “shape”.  Further, specific cellular neighborhoods of immune cells are now definable with unique abilities to affect cellular phenotypes—and these neighborhoods alter in various cancer disease states.   In addition to cancer, these shapes and neighborhoods are altered during immune action and “imprinted” during, and after, pathogen attack, traumatic injury, or auto-immune disease.  Hierarchies of functionally defined trans-cellular modules are observed that can be used for mechanistic and clinical insights in cancer and immune therapies.

4:45pm - 5:15pm 30 mins
Track 2: Immunogenicity
Approaches to Immune Response Mitigation - Use of Systemic and Targeted Approaches to Immune Suppression
  • Amy Rosenberg, MD - Director, Division of Biotechnology Review and Research III, CDER, US FDA
5:15pm - 5:45pm 30 mins
Info
Track 1: Novel Methods to Interrogate Receptors As Targets
Emerging Approaches to Modulate Receptor Function in Stem Cells
  • Rami Hannoush, PhD - Principal Scientist & Group Leader, Genentech

The Frizzled (FZD) 7 receptor (FZD7) is enriched in LGR5+ intestinal stem cells and plays a critical role in their self-renewal. This presentation will highlight our group’s peptide drug discovery approaches for targeting specific FZD isoforms, providing new structural insights into the molecular arrangement of members of the FZD receptor family and their mode of regulation. The peptides discovered modulate stem cell function in intestinal organoids and can be utilized as probes to further study the role of individual FZD receptors in cancer stem cell biology.

5:15pm - 5:45pm 30 mins
Info
Track 2: Immunogenicity
Emicizumab Case Study: A Risk Mitigation Practice of Immunogenicity and Its Clinical Relevance
  • Shuichi Chiba, PhD - Department Manager, Safety Assessment, Chugai Pharmaceutical Co. Ltd.

A case of de-immunization practice during the molecular designing process of an engineered bispecific antibody, emicizumab, will be presented. Although the lead molecule shows low immunogenic potential in in silico analysis, our in vitro assay suggested the higher possibility of immunogenicity. The final candidate has been selected after several trials of in vitro assay and shows low immunogenicity in the clinical trials

5:45pm - 6:15pm 30 mins
Info
Track 1: Novel Methods to Interrogate Receptors As Targets
xPloration™: A Platform Enabling High-throughput Functional Screening of Antibody Libraries
  • Jennifer Cochran, Ph.D. - Professor and Department Chair of Bioengineering, Stanford University

We present a novel platform for rapid antibody discovery based on cell binding and functional activity readouts. Our microcapillary array technology, which is essentially a 1-20 million well microtiter plate, allows us to screen antibody libraries, displayed on or secreted by yeast and mammalian cells, using a wide variety of assay formats.  Additionally, our human inspired synthetic antibody library is enabling the rapid isolation of antibodies against a number of clinically-relevant targets.

5:45pm - 6:15pm 30 mins
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Track 2: Immunogenicity
Secukinumab Demonstrates Significantly Lower In vitro Immunogenicity Potential Compared to Ixekizumab and Other Therapeutic Antibodies
  • Frank Kolbinger, PhD - Executive Director, Novartis Pharma AG

Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL-17A, has been shown to have significant efficacy in the treatment of moderate to severe plaque psoriasis (PsO) demonstrating a rapid onset of action and sustained responses with a favorable safety profile. Biotherapeutics, including monoclonal antibodies (mAbs), can be immunogenic, potentially generating anti-drug antibodies (ADAs) that can cause hypersensitivity and/or compromise efficacy. Clinically, secukinumab has been shown to have a low rate of ADAs in a pooled analysis of Phase 3 trials. Using in vitro techniques, we wanted to understand the potential reasons for this low clinical immunogenicity incidence rate. We therefore analyzed peptides presented by antigen-presenting cells and T cell precursor frequencies for 4 different mAbs: secukinumab, ixekizumab, adalimumab and ustekinumab and observed that secukinumab demonstrated a low in vitro immunogenicity potential compared with other therapeutic antibodies used to treat PsO patients. Results from these in vitro studies will be presented along with a more detailed evaluation of the T-cell peptide specificities of antibody-reactive T-cell clones.

6:15pm - 7:15pm 60 mins
Info
Opening Night Reception with Exhibits and Poster Viewing

Please join your fellow attendees in the exhibit hall for an evening of networking while enjoying beverages, and hors d'oeuvres!