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Next Generation Protein Therapeutics

June 13-15, 2016 * Parc 55 Hilton, San Francisco, CA

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Drive the future of molecule design further.
Accelerate promising new molecules into differentiated products.

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

June 13-15, 2016
Parc 55 Hilton
San Francisco, CA

Agenda

Agenda

Monday, June 13, 2016

8:00
Chairperson's Opening Remarks

Keynote Presentations

8:15
Julian Bertschinger, Ph.D.
Case Study
Successful Biotech Entrepreneurship - Leading from Ground Level to Company Trade Sale
Covagen was established by Julian Bertschinger and Dragan Grabulovski in 2007 to develop bispecific antibodies called FynomAbs for the treatment of inflammatory diseases and cancer. The company raised more than USD 60 million venture capital, and entered a strategic collaboration with Mitsubishi Tanabe Pharma Corp. in 2012, eventually catching the attention of the Janssen affiliate Cilag, who acquired Covagen in 2014.
Julian Bertschinger, Ph.D., Vice President, Janssen R&D and Managing Director, Covagen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, Switzerland

9:00
Janice Reichert, Ph.D.
New Data
Antibodies to Watch in 2016: Mid-Year Update
Marketing approvals for antibody therapeutics reached an all-time high in 2015, but are company pipelines robust enough for a repeat performance in 2016? Early indications are that matching the record of 9 approvals in the US or EU is achievable in 2016. Antibody therapeutics in Phase 3 studies and regulatory review, and those already approved in 2016, will be discussed.
Janice Reichert, Ph.D., Executive Director, The Antibody Society

9:45
Networking Refreshment Break in Poster & Exhibit Hall

Creative Protein Engineering and Design Approaches

10:15
Case StudyNew Data
Blocking IL-17 In Vivo with Unparalleled Affinity Using an Engineered Affibody Based Ligand Trap
Psoriasis is an IL-17 driven disease. An Affibody® based 18.6 kDa ligand trap engineered to block IL-17 with femtomolar affinity will be described. The potency and long plasma half-life translates to superior efficacy in vitro and in vivo compared to antibodies on the market and in development. In addition, the minimized format allows for alternative routes of administration.
Fredrik Frejd, Ph.D., Chief Scientific Officer, Affibody AB, Sweden

10:45
New Data
Smart Fusions of Cytotoxic Peptides with RNA and PNA Derivatives
I propose the idea to use the RNA molecules expressed upon disease-type gene expression as instructors for the chemical synthesis of cytotoxic peptidomimetics. By this approach, synergy between the nucleic acid and protein worlds will be harnessed. First experiments show that conjugation with cytotoxic peptides enhances the activity of antisense molecules designed to restore apoptosis in tumor cells.
Oliver Seitz, Ph.D., Professor, Department of Chemistry, Humboldt University Berlin, Germany

11:15
New Data
High Throughput Protein Analysis and Engineering Using Microcapillary Arrays
We developed a new high-throughput screening platform that allows researchers to assay the functional activity of millions of protein variants, displayed on or secreted from cells. This talk will describe several protein analysis and engineering applications performed with this new technology platform.
Jennifer Cochran, Ph.D., Associate Professor of Bioengineering and Chemical Engineering, Stanford University

11:45
Concurrent Technology Workshops

12:15
Networking Luncheon in the Poster & Exhibit Hall

Moderated Discussion on The Impact of WHO Changes on How Antibodies Will be Named

1:25
Chairperson's Remarks

Featured Presentation

1:30
High Throughput Functional Screening and/or Single Cell Sequencing
Christopher Love, Ph.D., Associate Professor of Chemical Engineering, MIT

2:00
Case StudyNew Data
Characterization of Next Generation Antibody Therapeutics with Designed and Engineered Fc Regions
Many approaches of IgG engineering are currently applied to modulate the binding affinity of antibodies to Fc recognizing receptors including to various FcR's and to FcRn. This includes modification of binding to the human Fc receptor neonatal (FcRn) which is is responsible for endosomal antibody transport and mediation of antibody half-life. A possible pitfall of such approaches is the isolated view only at the Fc domain. This presentation covers analytical tools, engineering concepts and various observations that we made with different Fc-engineered antibodies. These analyses reveal that Fc-engineering cannot be based of analyzing the Fc regions just by themselves, instead antibodies must be considered as a whole entity for appropriate Fc engineering.
Tilman Schlothauer, Ph.D., Principal Scientist, Functional Characterization, Large Molecule Research, Pharma Research and Early Development(pRED), Roche Innovation Center Penzberg, Germany

2:30
New Data
Protein Engineering of Intrabodies with Potential for Gene Therapy
Going from phage display selection of human antibodies to a mouse knockdown phenotype in a single cloning step opens the way for both a functional approach for the discovery of target/antibody drug combinations and a new therapeutic paradigm.
Stefan Dübel, Ph.D., Professor, Institute of Biochemistry, Biotechnology and Bioinformatics, Technische Universität Braunschweig, Germany

3:00
Networking Refreshment Break in Poster & Exhibit Hall

Creative Protein Engineering and Design Approaches (continued)

3:30
New Data
Developing Molecules by Design for Influenza
Rosetta computational design can create proteins that target neutralizing epitopes on Influenza hemagglutinin. These designed proteins bind like broadly neutralizing antibodies, but in a smaller molecule that is both more manufacturable and stable. In animal models they inhibit the function of hemagglutinin and prevent viral infectivity. These computationally designed binders represent a new class of protein therapeutics for infectious diseases.
Aaron A. Chevalier, Ph.D., Chief Technology Officer, Virvio, Inc.

4:00
New Data
Multivalent Antibody-TRAIL Fusion Proteins for Cancer Therapy
The antibody-mediated delivery of TRAIL fusion proteins showed selective induction of tumor cell death. We have engineered optimized single-chain derivatives of TRAIL and different homodimerization modules to generate multivalent antibody-scTRAIL fusion proteins with improved properties. Tumor targeting as well as enhancing the valency of scTRAIL fusion proteins provides enforced apoptosis induction together with good antitumoral activity and tolerance in vivo.
Oliver Seifert, Ph.D., Institute of Cell Biology and Immunology, University of Stuttgart, Germany

4:30
Case StudyNew Data
Designing and Developing Truly Native Bispecific Human Antibodies
Development of bispecific antibodies has been hampered by expression and stability issues. Bispecific κλ bodies benefit from an unmodified human IgG structure, are expressed at multigram per liter and effectively purified using a generic downstream process. The components of the κλ-body platform and its robustness will be highlighted by the discovery of a CD19xCD47 κλ body and its development for immuno-oncology.
Nicolas Fischer, Ph.D., Head of Research Department, NovImmune SA, Switzerland

5:00
Networking Cocktail Reception in the Poster & Exhibit Hall

Tuesday, June 14, 2016

8:00
Chairperson's Opening Remarks

Beyond Standard Biologics

8:15
Case Study
OPN-305, A First In Class Toll Like Receptor (TLR) Antibody Inhibitor
Opsona Therapeutics is a leading immunology drug development company focused on novel therapeutic approaches to key targets of the innate immune system. The targeting of TLRs has the potential to treat a diverse range of major human diseases including autoimmune/inflammatory diseases with specific focus on solid organ transplantation and oncology. The lead compound OPN-305 is a first in class humanized state of the art IgG4 molecule inhibiting TLR2, which is currently in clinical development for solid organ transplantation and oncology.
Martin Welschof, Ph.D., CEO, Opsona Therapeutics Ltd., Ireland

8:45
New Data
Nanobodies Against Kv1.3 Demonstrating Unique Selectivity and Developability
Nanobodies® are a novel class of antibody-derived therapeutic proteins based on single-domain antibody fragments. Ablynx has generated Nanobodies against Kv1.3 showing picomolar potencies in a bioassay and using electrophysiology various functional profiles were characterized. Electrophysiology-based counter screens demonstrated more than 10 000 fold selectivity over all closest related ion channels. Biological activity was demonstrated in a rat in vivo model.
Diane Van Hoorick, Ph.D., Senior Project Leader, Technology, Ablynx, Belgium

9:15
New Data
Recombinant GPCRs as Targets for Biopharmaceutical Development
Stabilized receptors provide a breakthrough solution that addresses the essential challenge of reliably generating functional antibodies targeting GPCRs. This technology enables production of purified, correctly folded receptor protein that can be removed from the cell membrane and utilized as antigen. The platform has synergy with both in vitro and in vivo antibody discovery processes enabling the generation of diverse panels of functional antibodies directed to this important target class for implementation as therapeutics.
Catherine Hutchings, Ph.D., Consultant, Antibody Alliance Management & Strategic Partnering, Heptares Therapeutics, United Kingdom

9:45
Networking Refreshment Break in Poster & Exhibit Hall

Bispecifics, Multispecifics and Novel Modes of Action

10:30
New Data
Hapten-Directed Spontaneous Disulfide Shuffling: A Universal Technology for Site-Directed Covalent Coupling of Payloads to Antibodies
Hapten-binding antibodies with accessible cysteine in proximity to the binding pocket were designed to covalently attach payloads to the antibody. Payloads carrying thiols become positioned on the antibody and linked by spontaneous redox shuffling. Attachment works with different haptens, antibodies and payloads. Applications include modulation of pharmacokinetics of small compounds as well as payload linkage to targeting vehicles in a reduction-releasable manner.
Ulrich Brinkmann, Ph.D., Expert Scientist, Large Molecule Research, Pharma Research and Early Development(PRED), Roche Innovation Center Penzberg, Germany

11:00
Case StudyNew Data
A Next Generation Bispecific Tetravalent Antibody Format Demonstrates Synergistic Activity Relative to the Combination of Two Parental Monospecific Antibodies
Biomunex has developed a modular bispecific tetravalent antibody format, termed BiXAb. This format yields antibodies with excellent manufacturability and superior drug-like properties. Unlike other bispecific formats, BiXAbs display excellent binding to both antigens. In vivo, the BiXAb demonstrated synergistic activity compared to the combination of two parental monospecific antibodies. Several BiXAbs are rapidly advanced through the pre-clinical pipeline.
Eugene Zhukovsky, Ph.D., Chief Scientific Officer, Research, Biomunex Pharmaceuticals, France

11:30
New Data
Bispecific FynomAbs: Differentiated Therapeutic Candidates with Tailored Architecture and Novel Modes-of-Action
Covagen develops bispecific FynomAbs by fusing its human Fynomer binding protein to antibodies, resulting in bispecific protein therapeutics with novel modes-of-action and enhanced efficacy for the treatment of inflammatory diseases and cancer. This talk will highlight the impact of FynomAb architecture on bioactivity, and will provide case studies demonstrating that FynomAbs with tailored architecture provide increased efficacy and improved tumor selectivity.
Simon Brack, Ph.D., Director, Discovery Research, Covagen, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, Switzerland

12:00
Concurrent Technology Workshops

12:30
Networking Luncheon in the Poster & Exhibit Hall

Moderated Discussions in the Poster & Exhibit Hall

1:55
Chairperson's Remarks

Bispecifics, Multispecifics and Novel Modes of Action (continued)

2:00
New Data
Protein Engineering of Multispecific Anticalin-Based Therapeutics
Anticalins® represent a novel class of ~ 18kDa non-Ig scaffold target-binding proteins derived from human lipocalins. They exhibit a structurally conserved framework, a β-barrel with an attached α-helix, which supports four hypervariable loops forming a cup-shaped binding site. Anticalins with high affinity and selectivity toward multiple targets have been generated using recombinant/synthetic DNA technology and combinatorial library selection. Novel Anticalin-based drug candidates have been engineered in multiple structural formats, including as bi- and multi-specific anticalin/antibody genetic fusions, for a range of clinical indications including first-in-class cancer immunotherapies.
Louis Matis, M.D., Chief Development Officer, Pieris Pharmaceuticals, Inc.

2:30
New Data
Humabodies: The Next Generation of Modular Therapeutics
Crescendo Biologics is a biopharmaceutical company involved in discovering and developing potent, highly differentiated Humabody-V₈™ therapeutics. Humabodies are small, have excellent biophysical properties and are 100% human, offering a range of plug and play options for generating novel multi-specific biologics. Crescendo's proprietary pipeline is focused on innovative medicines for treating cancer, including Humabody Drug Conjugates(HDCs) and multispecific immune-checkpoint modulators.
Brian McGuinness, Ph.D., MBA, Vice President, Discovery, Crescendo Biologics

3:00
Case StudyNew Data
Development of Optimized Bispecific Therapeutics
Many factors contribute to the success or failure of bispecific therapeutics from research through development stages. We employ a toolbox approach to allow optimization of spacing geometry, valency, affinity, and stabilization strategies to generate optimally effective and developable drug candidates. Comparisons across different bispecific platforms as well as case studies of successful drug candidate development will be presented.
G. Jonah Rainey, Ph.D., Senior Scientist, Research, Antibody Discovery and Protein Engineering, MedImmune

3:30
Networking Refreshment Break in Poster & Exhibit Hall

Creative Engineering for Applications Beyond Cancer

4:00
Designing and Discovering Transformative Antibody Therapeutics at Roche
The range of therapeutic uses for bispecific antibodies is expanding beyond oncology. This presentation will show the state of the art in bispecific heterodimeric IgG antibodies, with an emphasis on recent progress using CrossMAb technology to generate novel bispecific therapeutics. Examples given will include new bispecific molecules for ophthalmology indications and the use of Roche's Brain Shuttle technology to treat neurological disorders.
Martin Steegmaier, Ph.D., Head of Discovery, Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Penzberg, Germany

4:30
Case Study
Clinical Development of Recombinant Enzyme Using an Innovative Expression System
BryoTechnology is a plant-based cGMP expression platform adding value to product-quality and -reproducibility. It comes with an excellent safety profile, free of human pathogens, antibiotics and animal derived components. Advantages of moss-based production will be discussed along the development of moss-aGal, a plant-made version of human alpha-galactosidase for enzyme replacement therapy (ERT) in Fabry patients. The enzyme exhibits an extraordinary homogenous N-glycosylation profile being relevant for cellular uptake into patient`s cells.
Andreas Schaaf, Ph.D., Head of Research & Development, Greenovation Biotech GmbH, Germany

5:00
Happy Hour Offsite Reception

Wednesday, June 15, 2016

8:00
Chairperson's Remarks

Pre-clinical and Clinical Data/Updates for Next Generation Biologics

Featured Presentation

8:15
New Data
DARPin™ Platform: Enabling the Generation of Multi-Functional Drugs for Ophthalmology and Oncology
The DARPin™ platform enables the efficient generation of multi-functional drugs. I will present the background on different multi-domain DARPinTM drugs that are being developed for ophthalmology and oncology indications. Interim data on the first-in-human systemic clinical phase I of MP0250, a multi-domain oncology drug candidate targeting VEGF and HGF, will be presented.
H. Kaspar Binz, Ph.D., Vice President and Co-Founder, Molecular Partners AG, Switzerland

8:45
Bispecific T-Cell Engagers (BiTE®) in the Treatment of Cancer: The Blincyto® (Blinatumomab) Experience in Lymphoid Malignancies
BLINCYTO ® is a prototypical Bispecific T-Cell Engager (BiTE®) that redirects T cells to CD19+ B cells. BLINCYTO® facilitates the formation of an immunologic synapse, resulting in T-cell activation, cytokine release, and target cell lysis with EC50 in the picomolar range. BLINCYTO® has been tested in B-lineage malignancies, most notably precursor Acute Lymphoblastic Leukemia (ALL) and Non Hodgkins Lymphoma (NHL).
Jonathan Benjamin MD, Ph.D., Clinical Research Medical Director, Global Development, Hematology-Oncology, Amgen

9:15
Case StudyNew Data
Engineering Alphabodies to Generate Potent Druggable Inhibitors of Intracellular Protein-Protein Interactions
Cell Penetrating Alphabodies (CPABs) are a proprietary protein scaffold for targeting intracellular PPI. In this presentation we show that anti-Mcl-1 CPABs efficiently enter the cytosol, bind specifically to the target and kill tumour cells. Integration of an albumin binding moiety tunes the half-life of CPABs such that a proper time-window is created for excellent tumour uptake in animal models of cancer.
Yvonne McGrath, Ph.D., Chief Scientific Officer, Complix

9:45
Networking Refreshment Break in Poster & Exhibit Hall

Overcoming Delivery Challenges with Novel Approaches

10:15
New Data
Increased Brain Penetration and Potency of a Therapeutic Antibody Using a Fused Trans-BBB Shuttle
Biotherapeutics have a vast potential for treating brain disorders but their use has so far been limited by inefficient translocation across the blood-brain barrier (BBB). We have engineered a format- and affinity-optimized transferrin-receptor binding Brain Shuttle module which mediates effective trans-BBB shuttling of fused biologics. The presentation will cover engineering details, efficacy of the trans-BBB delivery in vitro, as well as efficacy and increased potency in animals & models of Alzheimer's disease.
Jens Niewöhner, Ph.D., Principal Scientist, Large Molecule Research, Pharma Research and Early Development(pRED), Roche Innovation Center Penzberg, Germany

10:45
New Data
More Efficient Intracellular Delivery of Proteins with Cell Penetrating Phylomer Peptides
Phylomer peptide libraries derived from biodiverse genomes were screened for new cell penetrating peptides (CPPs) for more efficient delivery of macromolecules into cells with an 'endosome escape trap' which select specifically for cytoplasmic delivery. These new cell penetrating Phylomers known as FPPs are not toxic and can be targeted to particular cell types using receptor binding domains. A split GFP complementation assay showed Phylomer FPPs to be significantly more efficient at cytoplasmic delivery than conventional CPPs such as TAT or R9. Phylomer FPPs have been shown to effectively deliver a 90 amino acid MYC inhibitor in a mouse model of breast cancer.
Paula Cunningham, Ph.D., Group Leader, Bioassay Development, Phylogica, Australia

11:15
Oral Insulin in the Clinic: Clinical Outcomes and Future Prospectives
The key elements of a novel oral drug delivery platform will be introduced. Application of this platform toward delivery of insulin and exenatide to manage diabetes, has established its feasibility, safety and efficacy. Evidence of drug bioavailability in treated target populations, will be presented. The physiological benefits of oral versus subcutaneous insulin delivery will be discussed.
Miriam Kidron, Ph.D., Chief Scientific, Oramed Pharmaceuticals Inc., Israel

11:45
Concurrent Technology Workshops

12:15
Lunch on Your Own

1:25
Chairperson's Remarks

Immuno-Oncology

1:30
Engineered T Cells for Cancer Therapy
Marco Ruella, M.D., Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania

2:00
New Data
Synergistic Innate and Adaptive Immunotherapy
Certain integrins are overexpressed in many tumor types relative to healthy tissue, but prior attempts to functionally antagonize integrins failed in cancer clinical trials. As an alternative approach, we employed an integrin-targeted antibody-like construct together with IL-2 cytokine therapy. This strategy, independent of integrin antagonism, elicited significant anti-tumor adaptive and innate immune responses in multiple syngeneic mouse models of cancer.
Byron Kwan, Ph.D., Graduate Student, Biological Engineering, MIT

2:30
Efficacy and Safety of Tumor Targeted Immunocytokines Containing Engineered 'De-Toxified' IL2
A novel class of monomeric tumor-targeted immunocytokines is described, where a single, engineered IL-2 variant (IL2v) with abolished IL-2Ra (CD25) binding is fused to the C-terminus of an antibody with a heterodimeric Fc-part. For tumor targeting, high affinity antibodies against CEA or FAP are used. Safety and efficacy data will be discussed.
Ekkehard Moessner, Ph.D., Large Molecule Research, Roche Pharma Research and Early Development, Roche Innovation Center Zurich, Switzerland

3:00
Networking Refreshment Break

3:30
New Data
Immunomodulatory Antibodies and Combinations Beyond PD-1
T cell checkpoint inhibitors set a clinical paradigm providing significant benefit to patients diagnosed with advanced cancer. Despite success, the majority of patients do not respond to PD-1, PD-L1 or CTLA-4 blockade. Raising the number of patients benefiting from cancer immunotherapy requires novel therapeutic approaches aimed at these non-responders, for instance using novel immunomodulatory antibodies and combination with active immunization.
Andrea van Elsas, Ph.D., Chief Scientific Officer, Aduro Biotech Europe, The Netherlands

4:00
Combination Innate Immunomodulation with Agonistic Anti-CD137 mAbs
Despite the promise of tumor-targeting monoclonal antibodies (mAbs), response rates are suboptimal. Natural killer cells are important effector cells mediating antibody dependent cell-mediated cytotoxicity (ADCC). Agonistic antibodies to CD137, an activation molecule which is expressed following exposure to antibody-bound tumor cells, can augment ADCC and synergize with mAbs in murine tumor models. Anti-CD137 is now being investigated in clinical trials.
Holbrook E. Kohrt, Ph.D., MD, Assistant Professor, Medicine - Oncology, Stanford University

4:30
Antibody-Cytokine Fusions for Immunotherapy of Cancer
Antibodies can be used as delivery vehicles for the direct delivery other bioactive molecules, such or cytokines, to the site of disease, preventing damage to healthy tissues. The targeting of tumor angiogenesis markers with immunocytokines is particularly attractive for developing cancer therapeutics, since these markers are exclusively expressed in diseased tissues. This strategy can also be extended to any disease characterized by over-proliferation of new blood vessels. This talk will cover the latest advanced preclinical and clinical data on armed antibodies discovered and developed by the Philogen group.
Catherine L. Pemberton-Ross, Ph.D., Senior Scientist in Antibody Engineering, Antibody Discovery, Philochem, Switzerland

5:00
Close of Next Generation Protein Summit

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