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Next Generation Protein Therapeutics Summit
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Agenda
Note: To view the agenda for an individual conference theme, please download that specific PDF brochure.
Event-at-a-Glance | |||||||||||
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Monday, June 25 |
Tuesday, June 26 |
Wednesday, June 27 |
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| Beyond Antibodies | |||||||||||
| Protein Engineering & Design | |||||||||||
| Intracellular Biologics & Alternative Delivery | |||||||||||
| Optimizing Properties of Next-Generation Biologics | |||||||||||
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7:45
Registration and Coffee
Beyond Antibodies
8:10
Chairperson's Remarks
Robert Mabry, Ph.D., Group Leader, Antibody Engineering, Adimab, Inc. Keynote Presentation
8:15
New Protein Engineering Tools for BiologyThe Protein Engineering field has changed dramatically since the early uses of improving enzymes and selecting antibodies for industrial and pharmaceutical applications. There are now a whole raft of genetically encoded cellular tools for understanding protein function in cells and animals. I will present some recent work from my lab to engineer enzymes and antibodies to activate proteins inside and outside of cells, as well as their applications for proteomics, signaling, and potential therapeutic use. James A.Wells, Ph.D., Professor, Pharmaceutical Chemistry, Cellular and Molecular Pharmacology, University of California, San Francisco
9:00
Teaching an Old Scaffold New Tricks
Here, we report a new fibronectin type III domain (FN3) library that utilizes alternative positions for presenting amino acid diversity centered on a β-sheet. This new library was highly potent in producing binding proteins (termed "monobodies"). Structural studies confirmed successful design of a distinct mode of target recognition, demonstrating the utility of different surfaces of a single immunoglobulin-like scaffold to generate binding proteins with diverse characteristics. Together, this work illustrates a protein design strategy that goes beyond the conventional "antibody mimic" mindset, which should be broadly applicable to molecular scaffold systems. Shohei Koide, Ph.D., Professor, Biochemistry & Molecular Biology, University of Chicago
9:45
Networking Refreshment Break and Opening of Posters/Exhibits
Novel Scaffolds
10:30
Antagonistic VEGF Variants Engineered to Simultaneously Bind to and Inhibit VEGFR2 and Alphav Beta3 Integrin
We used an antagonistic VEGF ligand as a molecular scaffold to engineer dual-specific proteins that simultaneously bound to VEGFR2 and alphav beta3 integrin with antibody-like affinities. These dual-specific proteins more potently inhibited angiogenic processes in vitro and in vivo compared to mono-specific targeting agents. Instead of relying on antibody associating domains or physical linkage, this work highlights an approach to creating dual-specific proteins where additional functionality is introduced into a protein ligand to complement its existing properties. Jennifer Cochran, Ph.D., Assistant Professor, Bioengineering, Stanford University
11:00
Anticalins: Next Generation Clinical Stage Technology with Applications across Multiple Disease Areas and Targets
Anticalins® are an emerging class of highly differentiated therapeutic proteins based on a human protein scaffold called lipocalins. Anticalins display straightforward manufacturing and engineering flexibility such as multispecificity. Here we will provide an overview of the Anticalin drug platform and present preclinical and clinical data including favourable results of a first in human Phase I study of PRS-050 (anti-VEGF-A). PRS-050 displayed a complete lack of immunogenicity in humans at therapeutically relevant doses. PRS-050 captures an important building block in the creation of multispecific Anticalins that open the door to new pharmacology and superior drug candidates versus existing and emerging therapies. Additional drug candidates are also progressing towards human validation and the differentiating properties of these molecules will be presented and discussed. This combination of 'fit for purpose' pharmacological and pharmaceutical properties will be illustrated across several Anticalin case studies. Laurent Audoly, Ph.D., Chief Scientific Officer, Pieris AG, Germany
11:30
Enabling Novel Therapies Using DARPins
Examples taken from our drug pipeline candidates in clinical and preclinical development show that DARPins have the potential to bring biologics therapy beyond what's possible with antibodies. The powerful DARPin platform enables novel therapeutic concepts in which we can tailor efficacy, PK, and mechanism of action at will. H. Kaspar Binz, Ph.D., Vice President and Co-Founder, Molecular Partners AG, Switzerland
12:00
Domain Antibodies in Development at GSK
Abstract not available at time of print. Adam Walker, Ph.D., Investigator, Biopharmaceuticals R&D, GlaxoSmithKline, United Kingdom
12:30
Networking Luncheon and Poster/Exhibit Viewing
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Beyond Antibodies
1:40
Chairperson's Remarks
Paul Watt, Ph.D., CEO, Phylogica, Australia Moving Alternative Scaffolds to the Clinic
1:45
Phylomer Libraries for the Discovery of Custom Scaffolds Suitable for Intracellular or Extracellular Targets
Phylomer peptides can exhibit superior functional hit-rates, when compared to randomly derived peptides and several Phylomer hits have been identified which have picomolar target affinities, before any sequence maturation. Structurally-related clusters of orthologous Phylomer sequences suggest common families of folds, which are ideally suited to binding to particular targets and direct lead optimization efforts. Phylomer libraries can also be used to identify new cell penetrating peptides for delivery of macromolecules into cells. Some of these cell penetrating Phylomers are specific for particular cell types and most belong to new families, including those with a net negative charge Paul Watt, Ph.D., CEO, Phylogica, Australia
2:15
Moving Adnectins into the Cardiovascular Disease Space: Adnectin Inhibitors of PCSK9 Demonstrate Robust LDL Lowering & Target Engagement in Preclinical Models
PCSK9 is perhaps the most promising drug target for treating cardiovascular disease (CVD) since the discovery of statins. PCSK9 negatively regulates LDL metabolism by binding to LDLR and targeting it for degradation, thus reducing LDL clearance and increasing CVD risk. We have developed potent Adnectin™ inhibitors of PCSK9 using PROfusion. Preclinical data on Adnectin modulation of this exciting target will be presented; these data represent expansion of Adnectins into a novel therapeutic area for biologics. Tracy Mitchell, Ph.D., Principal Scientist, Discovery Pharmacokinetics, Adnexus Therapeutics, a Bristol-Myers Squibb R&D Company
2:45
Alphabodies™ - A Novel, Proprietary Platform Technology
Alphabodies™ are small (10 to 14 kDa) single chain alpha helical proteins that are structurally unrelated to any known biological. They are designed to be exceptionally stable and versatile. Due to their unique structure and inherent stability, Alphabodies™ are able to bind to a wide range of target classes, including complex intracellular as well as extracellular epitopes. Thore Hettmann, Ph.D., Head of Therapeutic Development, Complix, Belgium
3:15
Networking Refreshment Break and Poster/Exhibit Viewing
3:45
Affilin - The Ubiquitin-based Therapeutic Drug Platform
Scil Proteins develops biotherapeutics based on Ubiquitin as a new scaffold. Ubiquitin is a small and highly stable human protein whose sequence is fully conserved across all mammalian species, simplifying preclinical development. Examples of Affilins engineered to picomolar affinity and high specificity, fusions with effector molecules or dimeric constructs and applications will be presented. Ulrich Haupts, Ph.D., Chief Scientific Officer, Scil Proteins GmbH, Germany
4:15
Clinical Advances with Affibody Molecules: Non-Antibody Alternative Scaffold Proteins
Affibody molecules have favorable therapeutic and diagnostic properties. Data from a recently finalized phase I/II clinical trial on a potential companion diagnostic for HER2-targeted treatments will be presented. A therapeutic drug based on the same binder is in development, as well as a vascular targeting PDGFR-specific binder. Recent progress on the Affibody technology will be discussed. Fredrik Frejd, Ph.D., Vice President, Research, Affibody AB, Sweden
4:45
Glycan Targeting Decoy Proteins as Novel Anti-inflammatory Biopharmaceuticals
Glycosaminoglycans (GAGs) play a major role in many (patho-)physiological conditions such as inflammatory processes and oncology. Since these cell surface- and matrix- related glycans are poorly immunogenic, they are resistant to mAb approaches. We have developed the CellJammer platform technology to engineer chemokines and other GAG-binding proteins to become glycan-targeting decoy proteins which show strong anti-inflammatory activity in vivo. Data on our CXCL-8 and CCL-2 based decoy proteins with potential applications in COPD and MS will be presented. Andreas Kungl, Ph.D., Chief Scientific Officer, ProtAffin Biotechnologie AG, Austria
5:15
The Ig-Like Α3 Domain of Soluble MICA Can Be Engineered to Bind Specific Targets and Recruit NK-Cells to Kill the Targeted Cells In Vitro
Membrane-bound MICA and MICB are natural ligands for the NKG2D receptor on NK- and certain T-cells. A platform using M13 phage display of the α3 domain of MICA provides the means for selecting and isolating a diversity of targeting motifs for soluble MICA molecules. This form of soluble MICA captures the potency of MICA-NKG2D innate immunity but with the important enhancement of adaptive specificity. We are developing such targeted, soluble MICA molecules as acute immunotherapy to eliminate specific infected or malignant cells in humans. David W.Martin, Jr., M.D., CEO, AvidBiotics |
Protein Engineering & DesignOptimizing Properties of Next-Generation Biologics
1:40
Chairperson's Remarks
Henry B.Lowman, Ph.D., Chief Scientific Officer, CytomX Therapeutics, Inc. New Protein Technologies and Optimization Strategies
1:45
Safety and Efficacy of Probody™ Therapeutics in Preclinical Models
CytomX Therapeutics has devised a novel approach to enhance the tissue specificity of antibodies that recognize target antigens in both diseased and normal tissues. The antigen-combining site of a conventional antibody is blocked with a masking peptide, which can be released by the action of endogenous proteases that are preferentially localized or overexpressed in diseased tissue. By virtue of their protease-regulated antigen binding, these molecules have the potential for reduced mechanism-based toxicities, improved pharmacokinetics and increased therapeutic indices. We have demonstrated efficacy of such molecules in xenograft tumor models and are actively pursuing preclinical development. Henry B.Lowman, Ph.D., Chief Scientific Officer, CytomX Therapeutics, Inc.
2:15
Use of Infologs™ to Accelerate Bioengineering
Gene synthesis allows flexible incorporation of existing knowledge into the design of gene libraries for bioengineering. We describe a variety of gene library design strategies available from DNA2.0 and provide examples of our ProteinGPS™ and GeneGPS™ technologies, which maximize search efficiency for the optimization of protein function and expression. Mark Welch, Ph.D., Director, Gene Design, DNA 2.0, Inc.
2:45
Expression and Production Strategies for Novel Biotherapeutics
Abstract not available at time of print. Silvane Di Cesare, Ph.D., Manager, Wacker Biotech GmbH, Germany
3:15
Networking Refreshment Break and Poster/Exhibit Viewing
Beyond PEG: Half-Life Extension Strategies
3:45
PASylation, the Biological Alternative to PEGylation
We have developed a polypeptide sequence comprising the three small amino acids Pro, Ala, and Ser which forms a hydrophilic random coil with expanded hydrodynamic volume very similar to PEG but can be directly attached to a recombinant protein by way of genetic fusion. Here we present preclinical data on in vivo efficacy from our proprietary and partnered programs including human growth hormone, leptin, interferon, Fab fragments as well as peptide hormones. We also demonstrate that PASylation allows the facile functional coupling of two different bioactive proteins or peptides, paving the way to bispecific drugs with extended plasma half-life. Arne Skerra, Ph.D., Professor of Biological Chemistry, Technical University of Munich, and CEO, XL-protein GmbH, Germany
4:15
Half-Life Extension Through HESylation®
HESylation® is an innovative drug delivery technology developed by Fresenius Kabi that utilises hydroxyethyl starch [HES] as biodegradable and versatile polymer for a customized modification of drugs like therapeutic proteins. This modification leads to an increased in vivo efficacy due to e.g. prolongation of the circulation half-life by reducing the renal clearance or by increasing the stability of the molecule. We present in vivo data on the performance of biologicals including cytokines and growth factors. Additional data regarding the comparably low viscosity of HES conjugates, which helps to overcome formulation and syringeability issues, will be shown. Frank Hacket, Ph.D., Director, Project, Alliance & Innovation Management HESylation®, Fresenius Kabi Deutschland GmbH, Germany Half-Life Technology Review
4:45
Strategies to Extend the Half-life of Small Recombinant Protein Therapeutics
With a growing number of small protein therapeutics being developed, including recombinant antibodies and the emerging class of novel scaffold proteins, half-life extension strategies have become increasingly important to improve their pharmacokinetic and pharmacodynamic properties. An overview of the various strategies to extend the half-life of recombinant antibodies as well as results from a comparative study including novel strategies utilizing binding to serum albumin and serum immunoglobulins will presented and discussed. Roland Kontermann, Ph.D., Professor of Biomedical Engineering, University of Stuttgart, Germany Strategy Discussion Forum
5:15
Novel Half-Life Extension Strategies and Applications
Ronald Kontermann, Ph.D., Professor of Biomedical Engineering, University of Stuttgart, Germany Fredrik Frejd, Ph.D., Vice President Research, Affibody AB, Sweden Arne Skerra, Ph.D., Professor of Biological Chemistry, Technical University of Munich, and CEO, XL-protein GmbH, Germany |
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5:45
Networking Cocktail Reception and Poster/Exhibit Viewing
Sponsored by
Keynote Presentation
8:15
Armed Antibodies for the Therapy of Cancerand of Rheumatoid ArthritisSome components of the sub-endothelial extracellular matrix (ECM) are undetectable in normal adult tissues, but are abundantly expressed around neo-vascular structures in cancer and in chronic inflammation. I will present clinical and preclinical results, showing how antibodies can be used to deliver bioactive molecules (drugs, cytokines, photosensitizers, radionuclides, etc. ) to components of the modified ECM, with a striking therapeutic benefit. Dario Neri, Ph.D., Professor of Biomacromolecules, Institute of Pharmaceutical Sciences, Swiss Federal Institute of Technology (ETH), Switzerland Keynote Presentation
9:00
Targeted Potentiation of Endosomal Release of Macromolecular PayloadsRelease of endocytosed payloads from endolysosomal compartments is a typical rate limiting step for gene therapy, siRNA delivery, immunotoxins, nanoparticulate drugs, and antibody drug conjugates, striking a difficult balance to avoid general plasma membrane destabilization (toxicity), while maintaining efficient permeabilization within the endosomes of targeted cells (efficacy). Natural selection has crafted solutions to this problem used by pathogens such as viruses and intracellular bacteria. We describe here targeted cytolysins that greatly potentiate siRNA and immunotoxins. Karl Dane Wittrup, Ph.D., C.P. Dubbs Professor, Chemical Engineering & Biological Engineering, Massachusetts Institute of Technology
9:45
Networking Refreshment Break and Poster/Exhibit Viewing
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Beyond AntibodiesProtein Engineering & DesignChairperson: Dragan Grabulovski, Ph.D., Chief Scientific Officer, Covagen AG, Switzerland Novel Bispecific and Multivalent Molecules
10:15
Agonistic Biologics from Multivalent Scaffold Proteins
Tn3 is a non-antibody scaffold protein based on a fibronectin type III domain. We show how this scaffold can be engineered to generate multivalent proteins by fusion to other proteins, or to itself. This versatility was exploited to create highly potent superagonists of TRAIL-R2 that can induce apoptosis of tumor cell lines in vitro and in vivo. We show how affinity, valency and molecular format can all be manipulated to modulate agonistic activity. Manuel Baca, Ph.D., Fellow, Antibody Discovery & Protein Engineering, MedImmune, Inc.
10:45
Centyrins: A Novel Platform with Multiple Capabilities
Alternative scaffolds share properties with antibodies in terms of their specificity and potency and with small molecules in terms of simplicity and size. The Centyrin platform, based upon a consensus fibronectin domain, has been optimized to enable routine selection of Centyrins that inhibit multiple classes of proteins. We will describe the characterization of mono and multi-specific Centyrins that inhibit soluble cytokines, ligand/cell-surface receptors, and enzymatic activity and function in animal models of disease. Kristen Picha, Ph.D., Director of Biology, Janssen Research & Development, Centyrex Venture
11:15
Development of Biparatopic Nanobodies® into Therapeutic Candidates with Improved Biological Properties
The Nanobody platform allows the ability to design modular drugs based on Nanobody building blocks, thereby combining more than one function in the final drug format. Using case studies, data will be presented to highlight how biparatopic Nanobodies can simultaneously engage two epitopes on the same target and present a high-value opportunity for therapeutic gain such as blocking different target-dependent signaling pathways or enable novel mechanisms of actions that cannot be achieved with conventional antibodies or combination of antibodies. Hilde Revets, Ph.D., Senior Research Fellow, Ablynx, NV, Belgium
11:45
Fynomers Improve Blockbuster Antibodies
Fynomers represent a new class of binding molecules based on the Fyn SH3 domain. We will show the broad applicability of our large phage display library (comprising more than 8 x 10e10 clones), novel bispecific Fynomer-Antibody fusion formats as well as in vitro and in vivo experiments for specific IL-17A/TNF inhibition. In addition, we will show the intrinsic drug-like properties of Fynomers and engineering methods to tailor the half-life in vivo. Simon Brack, Ph.D., Head of Lead Discovery, Covagen AG, Switzerland
12:15
Networking Luncheon and Poster/Exhibit Viewing
1:30
Azymetric™ and AlbuCORE™ Platforms: Antibody and Alternative Protein Scaffolds for Developing Bispecific and Multi-valent Molecules
Structure guided computational modeling and simulation approaches were used to characterize and engineer antibodies and alternative protein scaffolds for bispecificity and/or multivalency. For the Azymetric™ platform, the CH3 domain of IgG1 antibodies were engineered such that highly pure and highly stable heterodimeric antibodies were produced and characterized using mass spectrometry and differential scanning calorimetry, respectively. As an alternative to antibodies, current developments in the multivalent AlbuCORE™ platform will also be discussed. Together, we are using both the Azymetric™ and AlbuCORE™ platforms for internal and external development of best-in-class therapeutics for multiple indications. Surjit Dixit Ph.D., Chief Technology Officer, Zymeworks, Inc.
2:00
IMCgp100: a Bispecific TCR Anti-CD3 Fusion for the Treatment of Malignant Melanoma
ImmTACs are soluble, high affinity T cell Receptors fused to an anti-CD3 scFv domain for re-directed T cell killing of tumors. ImmTACs have pico-molar potency and are able to recognize very low levels of target antigen, overcoming down-regulation of HLA-peptide by tumors. The presentation will cover engineering of these reagents and demonstration of efficacy in vitro and in animal models. It will conclude with a discussion of on-going clinical trials with IMCgp100 in malignant melanoma patients, including gaining regulatory approval without the need for toxicity studies in animals. Rebecca Ashfield, Ph.D., Portfolio and Collaborations Manager, Immunocore Ltd., United Kingdom
2:30
Atrimers: Combining Multi-valency with Multi-specificity to Generate Potent Therapeutics
Atrimers™ are tetranectin-based trimeric proteins programmable in their three C-type lectin domains (CTLD) to specifically activate or block a target protein. We have designed multiple Atrimer libraries by randomizing and extending three loops within each CTLD. Each individual loop region can be selected to bind with high affinity to a unique epitope on a given target. Binders to three different epitopes on a single target or multiple different targets can readily be engineered within a given monomeric CTLD. The monomeric, multi-specific subunits naturally trimerize upon production in mammalian or bacterial hosts, yielding potent trivalent multi-epitopic binders with a very unique footprint and differentiating biological outcome. Anke Kretz-Rommel, Ph.D., Vice President, R&D, Anaphore, Inc.
3:00
Networking Refreshment Break & Last Chance for Poster/Exhibit Viewing
3:30
Bispecific SCORPION™ Molecules Targeting CD80/86 and IL10R Selectively Inhibit Antigen Presenting Cells
Emergent BioSolutions' SCORPION™ (multi-specific protein therapeutics) are bispecific proteins with two different binding domains that can simultaneously engage two different targets. Using this technology, we constructed bispecific molecules recognizing validated targets, CD80/86 and IL10R. Our SCORPION molecules, CTLA4 X IL10 monomer and anti-CD86 X IL10 monomer exhibited potent synergistic activity in blocking T cell proliferation in human mixed lymphocyte reactions when compared to CTLA4-Ig or IL10 alone. These bispecific SCORPION molecules combine different mechanism of actions to effectively inhibit antigen presenting cells and may find clinical application in multiple autoimmune and inflammatory disease indications. In vitro and in vivo data will be presented. Philip Tan, Ph.D., Associate Director, Applied Research, Emergent Product Development Seattle
4:00
Engineering of IL-23/IL-17A/F Neutralizing Bispecific Antibodies
A multi-specific antibody which antagonizes IL-23, IL-17A, IL-17AF, and IL-17F presents an innovative therapeutic for inflammatory disorders. We evaluated a panel of novel and validated bispecific antibody-like formats and identified a lead candidate molecule which potently inhibits all 4 cytokines while maintaining biophysical and production properties similar to traditional antibodies. Brenda Stevens, Scientist, Protein Engineering, Zymogenetics, Inc., A Bristol-Myers Squibb Company Strategy Discussion Forum
4:30
Engineering Bispecific Molecules
Dragan Grabulovski, Ph.D., Chief Scientific Officer, Covagen AG, Switzerland
5:15
Close of Day Two
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Intracellular Biologics & Alternative DeliveryOptimizing Properties of Next-Generation BiologicsChairperson: Arne Skerra, Ph.D., Professor of Biological Chemistry, Technical University of Munich, and CEO, XL-protein GmbH, Germany Cell Penetrating Peptides and Proteins
10:15
Cell-penetration - From Peptides to Protein Scaffolds
Research on peptide and protein delivery has mostly focused on cell-penetrating peptides. However, there are also disulfide bridge-containing toxins showing cell penetration and proteins have been rendered delivery competent through introduction of positive charge, providing advantages of increased stability and conformational constraints. Here, I will summarize the state-of-the-art in this emerging subject and provide first-hand examples on the development of cell-penetrating peptide scaffolds. Roland Brock, Ph.D., Head, Department of Biochemstry, Nijmegen Centre for Molecular Life Sciences, Radboud University Nijmegen Medical Centre, The Netherlands
10:45
Novel Chemical Entities Introduced into Cells via a Bacterial Transporter
There are a number of methods to deliver bioactive peptides and proteins into mammalian cells for biotechnological purposes. However, most approaches do not allow for routine delivery of chemical entities such as peptidomimetics, mirror image peptides, cyclic peptides, and intrabodies. Here, I will present a macromolecular delivery platform based on an engineered bacterial transport machine that allows for facile delivery of bioactive peptide and protein variants to the cytosol of cells. Bradley L.Pentelute, Ph.D., Assistant Professor of Chemistry, Massachusetts Institute of Technology
11:15
Intraphilins: A New Class of Highly Potent Intracellular Biologics
Permeon Biologics™, Inc. is developing a new class of intracellular biologics based on the Intraphilin™ Technology Platform. This platform was derived from the supercharged protein technology discovered by Dr. David R.Liu (Harvard/HHMI). The company has identified a unique set of novel supercharged human proteins that enable functional proteins to enter cells with higher activity than previous technologies, such as cell-penetrating peptides. Moreover, these Intraphilins have desirable drug-like properties and have shown early promising preclinical results. Speaker TBA, Permeon Biologics Strategy Discussion Forum
11:45
The Holy Grail: Getting Protein Therapeutics inside Cells
12:15
Networking Luncheon and Poster/Exhibit Viewing
1:25
Chairperson's Remarks
Robert Hayes, Ph.D., Vice President and Venture Leader, Janssen Research & Development, Centyrex Venture Alternative Delivery Strategies
1:30
Alternative Delivery Routes for Localizing Antibody Fragments - Opening the Door to New Treatment Options
Antibodies are predominantly administered intravenously leading to systemic flooding of patients with potent biologicals, also in indications where spatially and temporally restricted effects are preferred. With the advent of small, robust, high affinity antibody fragments, alternative delivery routes to confined body compartments are being developed which will be summarized. Titus Kretzschmar, Ph.D., Chief Scientific Officer, Delenex Therapeutics AG, Switzerland
2:00
Exploiting the Biophysical Properties of Centyrins for Biologics Drug Development
Alternative scaffolds represent an emerging class of protein therapeutics. We have designed novel consensus FN3 domains, called Centyrins, which have high thermal stability, excellent solubility, and exhibit high levels of soluble expression in E.coli. We are exploiting the properties of this scaffold to develop a series of molecules aimed at broadening the therapeutic applications of biologics to areas such as bispecific drugs, intracellular inhibitors, and for use in alternative routes of drug delivery. Robert Hayes, Ph.D., Vice President and Venture Leader, Janssen Research & Development, Centyrex Venture
2:30
ALX-0171: A Highly Potent Nanobody® as Inhalation Treatment for Respiratory Syncytial Virus Infection
Nanobodies are therapeutic proteins based on the smallest functional fragments of naturally occurring heavy chain only antibodies. Due to their unique nature they can be formatted to achieve specific features such as high potency while retaining characteristic physico-chemical properties allowing, in the case of ALX-0171 direct delivery to the airways by nebulisation. A Phase 1 clinical trial is currently in preparation to assess tolerability and safety in man. Erik Depla, Ph.D., Senior Project Manager, Ablynx, Belgium
3:00
Networking Refreshment Break & Last Chance for Poster/Exhibit Viewing
3:30
Novel Analgesic Peptides
Rapid-acting, potent pain medicines without unwanted side effects, like addiction and respiratory depression, remain an unmet medical need. A series of novel peptides that have the potential to meet this need have been discovered. These new drugs have been combined with a non-invasive delivery system that provides a very rapid (5 minutes or less), dose-dependent onset of pain relief in a nonclinical model. The presentation will cover the discovery, methodology, properties, and activities of the peptides, nonclinical data from an acute pain model, and a review of the compound formulation and delivery system. Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corporation
4:00
Delivery of Alternative Scaffolds Using Encapsulated Cell Technology
Encapsulated Cell Technology (ECT) is an implantable bioreactor system capable of secreting biologics within a patient for over 2 years in US clinical trials. Originally designed for ophthalmic cytokine therapy, we show ECT can be adapted to secrete biologics from antibody scaffolds including Mab, Fab, ScFv and Fc-fusions. Vincent Ling, Ph.D., Head of Biological Sciences, Neurotech Pharmaceuticals
4:30
Close of Day Two
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Happy Hour @ Pier 39 Overlooking San Francisco Bay
5:45-7:45
This networking reception (included in the conference registration fee) is at Players Sports Grill & Arcade, which has sweeping views of San Francisco Bay, and is just two blocks from the Hyatt. Enjoy buffet finger food, complimentary drinks (beer, wine, soft drinks) plus free arcade games and pool tables. Advance RSVP is required when registering online.
7:45
Morning Coffee
8:10
Chairperson's Remarks
Paul Watt, Ph.D., CEO, Phylogica, Australia
8:15
iPEP - Interfering Peptides Targeting Protein-Protein Interactions
Protein-protein interaction surfaces are attractive yet challenging targets for disease intervention. We use rational design in combination with in-vivo and in-vitro selection systems to generate interfering peptides (iPEP) specifically targeting intracellular protein interaction domains. Different selection strategies, the generation of iPEPs against Jun, Fos, AF10 and Mitf as well as photo-switchable iPEPs will be discussed. Katja M.Arndt, Ph.D., Professor of Molecular Biotechnology, University of Potsdam, Germany
9:00
Mirror Protein Therapeutics: A Novel D-Amino Acid Scaffold
We have developed synthetic antibody libraries that fulfill all of the roles of natural antibodies and extend the use of antibody technologies to many challenging problems. Extending the synthetic concept even further, we have developed novel binding scaffolds that enable applications beyond the range of antibodies, and these include the development of scaffolds that can be synthesized completely using peptide chemistry and scaffolds that fold and function inside cells. Sachdev Sidhu, Ph.D., Associate Professor, Banting & Best Department of Medical Research, University of Toronto, Canada
9:45
Networking Refreshment Break
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Protein Engineering & DesignChairperson: Olivier Laurent, Ph.D., Director, Protein Science, CovX, Pfizer Biotherapeutics R&D Creative Protein Engineering
10:15
A pH-sensitive Anti-PCSK9-antibody: Improving PK and Cholesterol Lowering by Increasing Antibody-antigen-binding Cycles and Reducing Target-mediated Clearance
Target-mediated clearance and high antigen load can hamper the efficacy and dosage of many therapeutic antibodies. Therapeutic antibodies engineered for pH-sensitive binding to their target antigen can improve drug efficacy and dosage by improving the pharmacokinetics (PK) and pharmacodynamics (PD). PCSK9 represents a very promising therapeutic target for hypercholesteremia with several antibodies currently in clinical trials. Javier Chaparro-Riggers, Ph.D., Senior Principle Scientist, Protein Engineering, Rinat, Pfizer, Inc.
10:45
Engineering Chimeric Cytokines
Eukaryotic proteins have been widely exploited in protein engineering and in biotherapeutics by making chimeric proteins, with Fc domain fusions being a classic example. There are fewer examples of subdomains or especially domain fragments functioning in this way. In order to create superior treatments for dry eye disease, we have shown that the IL-1 protein family does have domain fragments that function in this way, and this can be exploited to make proteins with properties superior to and/or different from the parental proteins. We will present data in support of this and describe progress in bringing a novel therapeutic of this type to the clinic. Thomas Barnes, Ph.D., Vice President of Discovery, Eleven Biotherapeutics
11:15
Site-directed Conjugation to Wild Type Antibody
Scientists at CovX have identified a naturally occurring conjugation site in the conserved region of the IgG chains. This site allows for the conjugation of molecules to a unique location on the surface of most wild type antibodies (> 70% specificity). This entirely novel approach maintains the activity of the antibody and the molecule attached to it while resulting in a well-defined population of conjugates. Olivier Laurent, Ph.D., Director, Protein Science, CovX, Pfizer Biotherapeutics R&D
11:45
Zybodies: Multi-Specific, Antibody-Based Therapeutics
Zybodies comprise fully functional monoclonal antibodies with short target-binding peptides recombinantly fused to the termini of the mAb heavy and light chains. The production and characterization of trastuzumab-based Zybodies will be presented. These Zybodies simultaneously target multiple signaling pathways, inhibit tumor cell proliferation, and demonstrate superior efficacy in xenograft tumor models. The data establish Zybodies as stable macromolecules that coordinately target multiple biological pathways thereby conferring novel functional properties, not achievable with conventional mAbs. Rodger Smith, Ph.D., Principal Scientist, Biopharmaceutical Research, Zyngenia, Inc. |
Optimizing Properties of Next-Generation BiologicsStrategy Discussion Forum
10:15
Immunogenicity Strategies for Scaffolds and Next-Generation Protein Therapeutics
Strategy Discussion Forum
11:15
Engineering Proteins for Improved Manufacturability and Production
H. Kaspar Binz, Ph.D., Vice President and Co-Founder, Molecular Partners AG, Switzerland Robert Hayes, Ph.D., Vice President and Venture Leader, Janssen Research & Development, Centyrex Venture
12:15
End of Optimizing Properties of Next-Generation Biologics. Attendees are invited to join Protein Engineering & Design at 1:25
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12:15
Lunch on your own
Protein Engineering & Design
1:25
Chairperson's Remarks
Brian Kuhlman, Ph.D., Associate Professor of Biochemistry and Biophysics, University of North Carolina at Chapel Hill Computational Protein Design
1:30
Computational Design of Protein Interactions and Stability
The molecular modeling program Rosetta has been used to design novel protein-protein interactions and increase the thermodynamic stability of proteins. The designed interactions make use of stabilizing anchor points such as metal binding and βετα-strand interactions, while protein stability has been boosted by over 10 kcal/mol by core remodeling. Brian Kuhlman, Ph.D., Associate Professor of Biochemistry and Biophysics, University of North Carolina at Chapel Hill
2:00
Computational Design and Engineering of Non-conventional Scaffolds for New Therapeutics and Diagnostics
We combine computational protein design with high-throughput characterization and optimization of design variants using in vitro selection to isolate high-affinity and specificity binders of, in principle, any target surface. This strategy has yielded two proteins based on non-conventional scaffolds, which bind and inhibit influenza hemagglutinin at subnanomolar affinity and neutralize virus infectivity in cell culture, as well as a novel thermostable and pH dependent human IgG binder that could serve in diagnostics and antibody purification. Eva-Maria Strauch, Ph.D., Senior Fellow, Laboratory of David Baker, University of Washington
2:30
Molecular Basis of a Million-fold Affinity Maturation Process in a Protein-protein Interaction
Protein engineering is becoming increasingly important for pharmaceutical applications where controlling the specificity and affinity of engineered proteins is required to create targeted protein therapeutics. Affinity increases of several thousand-fold are now routine for a variety of protein engineering approaches, and the structural and energetic bases of affinity maturation have been investigated in a number of such cases. Previously, a 3-million-fold affinity maturation process was achieved in a protein-protein interaction composed of a variant T-cell receptor fragment and a bacterial superantigen. Here, we present the molecular basis of this affinity increase. Using X-ray crystallography, shotgun reversion/replacement scanning mutagenesis, and computational analysis, we describe, in molecular detail, a process by which extrainterfacial regions of a protein complex can be rationally manipulated to significantly improve protein engineering outcomes. Eric J.Sundberg, Ph.D., Associate Professor, University of Maryland School of Medicine
3:00
Networking Refreshment Break
3:30
Computation-guided Vaccine Design
Starting from crystal structures of virus-neutralizing monoclonal antibodies in complex with their epitopes, we employ computational design and in vitro screening of computation-guided mutagenesis libraries to engineer novel, minimal protein antigens that stabilize epitopes in their antibody-bound conformations and bind with high affinity and specificity to the target antibodies. Results for HIV and RSV will be presented. The methods involve protein backbone manipulation and can be employed to control protein structure and interaction more generally. William Schief, Ph.D., Principle Scientist, International AIDS Vaccine Initiative and Associate Professor of Immunology, The Scripps Research Institute Synthetic Biology Approaches for Biotherapeutics
4:00
A Protein Therapeutic Modality Founded on Molecular Regulation
I will describe a general synthetic biology strategy for designing protein therapeutics that autonomously activates a therapeutic function in response to a specific cancer marker of choice. As a demonstration of this approach, we created a prodrug-activating enzyme that selectively kills human cancer cells that accumulate hypoxia-inducible factor 1α. Marc Ostermeier, Ph.D., Professor and Vice Chair, Chemical and Biomolecular Engineering Department, Johns Hopkins University
4:30
Developing Homogenous Semi-Synthetic Biomolecules with Formylglycine-Generating Enzyme
One significant obstacle to the creation of a chemically altered biologic is to produce the protein in a homogenous form while maintaining its function. One solution to this problem is to introduce a unique chemical handle into the target protein that is orthogonal to the remainder of the proteome through chemoenzymatic transformations.combining the power of molecular biology with the precision and flexibility of synthetic chemistry, we have begun to develop an "aldehyde tagging" methodology to enable the generation of new classes of homogenous, enhanced proteins including novel antibody drug conjugates. David Rabuka, Ph.D., Chief Scientific Officer, Redwood Biosciences
5:00
Close of Conference
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