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June 26-28, 2013
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Next Generation Protein Therapeutics Summit
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Agenda
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7:30
Registration and Coffee
8:25
Chairman's Remarks
Paul Watt, Ph.D., CEO, Phylogica Ltd., Australia Keynote Presentations
8:30
Protein Engineering with an Expanded Genetic CodeWe have developed methods to genetically encode unnatural amino acids with novel chemical and biological properties in bacteria, yeast and mammalian cells. This technology allows one to chemically modify the structures of proteins with medicinal chemistry like control to produce homogeneous protein conjugates. Here we describe the application of this technology to the generation of antibody-drug conjugates, bispecific antibodies, antibody-nucleic acid conjugates and vaccines. Peter G. Schultz, Ph.D., Professor of Chemistry, The Scripps Research Institute; Founding Director, California Institute for Biomedical Research Clinical Update
9:15
Case
Antibody-Drug Conjugates: Current and Future DevelopmentsStudy The presentation illuminates the role that different natural products are currently playing as ADCs change the landscape of cancer therapy. The ADC modality and its components, essential aspects of tumor cell biology and their impact on pharmacology and safety of ADCs are discussed, with particular focus on clinical dose fractionation studies conducted with two calicheamicin conjugates in the clinic: (CMC-544/Inotuzumab Ozogamicin and Mylotarg/Gemtuzumab Ozogamicin). Hans-Peter Gerber, Ph.D., Executive Director, BioConjugates Discovery and Development, Oncology Research, Pfizer Inc.
10:00
Networking Refreshment Break in Exhibit and Poster Hall
Beyond Antibodies: Differentiation Strategies for Alternative ScaffoldsFeatured Presentation
10:45
Challenges and Opportunities in Developing Scaffold Therapeutics in an Antibody WorldAlternative scaffolds are a promising class of protein therapeutics, but identifying opportunities where these can have a meaningful advantage over antibody-based approaches is a significant challenge. Progress on our efforts to develop differentiated scaffold-based therapeutics is shared, as well as insights on how to meet the scaffold vs. antibody challenge. Manuel Baca, Ph.D., Fellow, Antibody Discovery & Protein Engineering, MedImmune, LLC Clinical Update
11:15
Affibody Molecules: Novel Tools for Targeted Therapy
Affibody molecules are small scaffold proteins that are highly suited for use as molecular recognition modules. The ease of production as well as high stability have recently prompted their use both for targeting of PEGylated docetaxel to xenografted tumors as well as for functionalizing antibodies for better efficacy by fusion. In the clinic, they show ability for quantification of target expression in patients with breast cancer metastases. Fredrik Frejd, Ph.D., Vice President, Research, Affibody AB, Sweden
11:45
Anticalins® Make a Difference: Recent Advances and New Multispecific Formats with Low Developability Risk
Anticalins® represent a differentiated and superior clinical-stage class of next generation therapeutic proteins that address existing limitations of antibodies. In particular, the development of multispecific therapeutic proteins opens the door to new and exciting biology. Pieris has developed a platform for the efficient generation of multispecific drug candidates (bi, tri- and beyond) that seize the necessary pharmacological and pharmaceutical properties required to minimize attrition and deliver on transformative product profiles. We present data on one of our multispecific drug candidate programs - PRS190 - a multispecific therapeutic protein targeting the Th17 pathway. Shane Olwill, Ph.D., Senior Director Pharmacology and Program Leader Oncology, Pieris AG, Germany
12:15
Networking Luncheon in Exhibit and Poster Hall
Concurrent Tracks |
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1:25
Chairman's Remarks
Dana Ault-Riché, Ph.D., CEO, Reflexion Pharmaceuticals Creative Protein Engineering & Design
1:30
Human Therapeutic Enzymes for Cancer Therapy via Systemic Amino Acid Depletion
We have developed a suite of biochemically and pharmacologically engineered human enzymes that exploit defects in amino acid metabolism observed in numerous tumor types. These defects range from loss of de novo synthesis capacity to inactive salvage pathways and can be druggable targets. To create drugs that metabolically impact tumor survival we use protein engineering techniques to create enzymes displaying the requisite catalytic and pharmacological properties to systemically deplete the required factor and thus specifically starve the tumor. Everett M. Stone, Ph.D., Research Scientist, Biomedical Engineering, Laboratory of George Georgiou, University of Texas at Austin Unpublished Data
2:00
Protein Conformational Stabilization to Selectively Inhibit Deubiquitinases
Protein function and conformation are often inextricably linked, such that the shapes and motions of a protein define its activity. Here we combine computational design with macromolecular display to engineer functional conformations of ubiquitin that specifically bind and inhibit oncogenic deubiquitinases. Targeting USP7/HAUSP yields molecules that are active in mammalian cells, enabling dissection of the signaling pathway. Our conformational engineering approach suggests new avenues to rationally control the biological function of proteins by altering their structure and dynamics. Jacob Corn, Ph.D., Scientist, Early Discovery Biochemistry, Genentech, Inc. Unpublished Data
2:30
TwoB-Ig: A Novel Engineered Fc Variant with Selectively Enhanced FcγRIIb Binding over Both FcγRIIa (R131) and FcγRIIa (H131)
Inhibitory FcγRIIb is an attractive target for antibody therapeutics. Pure selectivity for FcγRIIb is highly desirable for Fc variants to exploit FcγRIIb signaling, because enhancing the binding to other activating FcγRs, not only to FcγRIIb, would cause adverse effects. However, there is no report about Fc variants with such selectivity. We report a novel Fc variant with selectively enhanced FcγRIIb binding over all the active FcγRs including both FcγRIIa allotypes, the most homologous FcγR to FcγRIIb. Futa Mimoto, Researcher, Research Division, Chugai Pharmaceutical Co. Ltd., Japan
3:00
From Hybridoma to Clinical Candidate - Application of Multiplexed SPR in Funnel Selection
Monoclonal antibodies (mAbs) is one of the largest classes of biopharmaceuticals with 23 products approved for use in various indications, including oncology, rheumatic diseases, infectious diseases and organ transplantation. Most successfully marketed monoclonal antibody drugs are originated from hybridoma. It becomes critical that the candidates with high molecular binding affinity, broad epitope diversity, superior efficacy and potency, and optimal physical and chemical properties are selected from hybridoma at fast pace for further development to be successful in such a competitive drug market. In this presentation, an array based SPR technology, ProteOn XPR36, is applied in kinetic and affinity screening process, which enables delivery of clincal candidates with high quality. Helen Wu, Scientist III, Boehringer Ingleheim Sponsored by 
3:30
Networking Refreshment Break in Exhibit and Poster Hall
Speed Networking Session
Join us during this afternoon's refreshment break for a Speed Networking Session which will introduce you to companies that develop novel tools and technologies or provide research or production services to help advance your next-generation protein therapeutics and bioconjugates programs from discovery to clinic to market. Unpublished Data
4:15
Use of Mirror Proteins to Treat Ocular and Lung Diseases
Mirror proteins tightly and specifically engage their targets, are resistant to proteolytic metabolism, are non-immunogenic and physically stable, giving them near ideal properties for use as drugs. They are also small enough to be manufactured at large scale using chemical manufacturing. Reflexion is utilizing these advantages to develop drugs for ocular diseases, in which small dosage volumes are required and pulmonary diseases, in which direct delivery of the drug to the lung by inhalation, is preferred. Dana Ault-Riché, Ph.D., CEO, Reflexion Pharmaceuticals
4:45
Rapid Engineering of a Novel Heteromeric Antibody Scaffold
Asymmetric antibodies can broaden therapeutic application of IgGs, but can be difficult to manufacture. Iterative rational engineering and rapid design cycles were employed to design a novel heteromeric antibody backbone. The results of initial characterization suggest that this robust format can be used to generate therapeutic antibodies to a multitude of targets. Melissa Geddie, Ph.D., Senior Scientist, Antibody Technology, Merrimack Pharmaceuticals Unpublished Data
5:15
Targeting the HER3 Pathway using Affibody Molecules and Bispecific Albumin-binding Domains
We have developed low picomolar HER3-specific Affibody molecules using phage display in combination with a novel bacterial display technology. Biodistribution studies in mice indicate specific targeting of HER3 in vivo. The Affibody molecules suppress ligand-induced HER3, HER2, Akt and Erk phosphorylation and inhibit cancer cell growth with subnanomolar IC50. Evaluation of bispecific Affibody molecules targeting HER3/HER2 and bispecific single-domains based on an albumin-binding domain are presented. John Löfblom, Assistant Professor, Division of Protein Technology, School of Biotechnology, KTH Royal Institute of Technology, Sweden |
1:25
Chairman's Remarks
Mark J. Federspiel, Ph.D., Associate Professor, Department of Molecular Medicine, Mayo Clinic Targeting Strategies & Protein DeliveryFeatured PresentationUnpublished Data
1:30
Optimization and Safety of Transfer'rin Bispecifics across the Blood-Brain BarrierReceptor-mediated transcytosis is a promising approach for delivering antibodies to the brain. Bispecific antibodies that target TfR with weak affinity and potently inhibit BACE1, demonstrate substantial brain uptake and dissemination and inhibit the production of Abeta in brain. This talk will focus on TfR affinity optimization and potential safety implications for utilizing TfR to transverse the BBB. Mark S. Dennis, Principal Scientist, Antibody Engineering, Genentech, Inc.
2:00
Brain-Penetrating Recombinant Protein Therapeutics
The CNS drug development of protein therapeutics (neurotrophins, decoy receptors, lysosomal enzymes, and therapeutic antibodies) is limited because these large molecule drugs do not cross the blood-brain barrier (BBB). BBB targeting in humans is made possible with the re-engineering of the protein therapeutic as a molecular Trojan horse fusion protein. William M. Pardridge, M.D., Distinguished Professor of Medicine, UCLA
2:30
Crossing the Plasma Membrane with a Delivery Platform Based on Anthrax Lethal Toxin
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 present a macromolecular delivery platform based on an engineered bacterial transport machine that allows for facile delivery of bioactive peptide variants to the cytosol of cells. We show that the delivered cargo material can disrupt protein-protein interactions in cancer cells and induce apoptosis. Bradley Pentelute, Ph.D., Assistant Professor of Chemistry, Massachusetts Institute of Technology
3:00
Botulinum Neurotoxin Domains as Tools for Engineering Novel Molecules
Botulinum neurotoxins are effective in the treatment of peripheral neuronal hyperactivity. The pharmacological activity underpinning this resides in a multi-domain di-chain protein. Understanding the structure function relationship of the individual domains enables rational design of recombinant proteins that are highly potent with therapeutic potential in a wide range of diseases. Keith Foster, Ph.D., Founder and Chief Scientific Officer, Syntaxin, Ltd., United Kingdom
3:30
Networking Refreshment Break in Exhibit and Poster Hall
Speed Networking Session
Join us during this afternoon's refreshment break for a Speed Networking Session which will introduce you to companies that develop novel tools and technologies or provide research or production services to help advance your next-generation protein therapeutics and bioconjugates programs from discovery to clinic to market. Protein Screening, Selection and Characterization StrategiesUnpublished Data
4:15
Vectors for Expression of Full-length IgG from Clones Selected by Phage Display
A major bottleneck in the discovery of antibodies by phage display is expression of IgG for screening of selected clones. We describe vectors that facilitate the expression of IgG in mammalian cells derived from the sequences of phage display clones that display Fab fragments in bacterial cells. These vectors can be used to streamline the screening of clones in full-length IgG format. Isidro Hotzel, Ph.D., Scientist, Antibody Engineering, Genentech, Inc.
4:45
Rapid, Cost Effective Microbial Strain Development Using BLI
Discarding the traditional linear and iterative approach, Pfenex Expression Technology ™, a Pseudomonas fluorescens-based expression platform, adopts a parallel, high-throughput method for microbial strain development. Thousands of unique host strains and plasmid combinations are seamlessly integrated to enable rapid strain engineering for optimal protein production. For a typical screen, the assessment of both the expression level and the quality of the target protein is needed for each unique expression strain. Here we present case studies outlining how BLI facilitates this high-throughput process. Greg Cantin, Ph.D., Group Leader, Analytical Biochemistry, Pfenex, Inc. Unpublished Data
5:15
Eukaryotic Virus and Cell Display Technology for the Discovery and Optimization of Antibodies
The discovery and optimization of high affinity antibodies to important therapeutic targets could be significantly improved by the availability of a robust, eukaryotic display technology comparable to display on microorganisms that would overcome the protein translation limitations, thereby improving library diversity and seamlessly transition into a large-scale mammalian expression system for clinical production. We present data that demonstrate the replication and polypeptide display characteristics of a eukaryotic retrovirus, Avian Leukosis Virus (ALV), offers such a display system. Mark J. Federspiel, Ph.D., Associate Professor, Department of Molecular Medicine, Mayo Clinic |
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5:45
Networking Wine and Cheese Reception with Exhibit and Poster Viewing
Sponsored by
7:30
Coffee
7:55
Chairman's Remarks
Jochem Gokemeijer, Associate Director, Adnexus, a Bristol-Myers Squibb R&D Company Beyond mAbs: Preclinical and Clinical ProgressClinical Update
8:00
Multi-Specific DARPins Enabling Novel Therapeutic Concepts
The DARPin platform allows the design of powerful drugs combining multiple functionalities. These molecules enable novel therapeutic concepts with improved efficacy and PK, as well as mechanism of action tailored to optimally address diseases with unmet medical needs. We present examples from our clinical and preclinical programs that have the potential to surpass current standards of care or break new therapeutic ground. Daniel Steiner, Associate Director Lead Identification, Molecular Partners AG, Switzerland Clinical Update
8:30
Early Lessons from Clinical Evaluation of Bispecific T cell Engaging Antibodies in Oncology
Bispecific T cell engager (BiTE®) antibodies possess dual specificity for CD3 and a target antigen of therapeutic interest. The most clinically advanced BiTE, blinatumomab, can transiently link CD19-expressing target cells to any cytotoxic T cell by bridging to the invariant CD3 epsilon subunit of the T cell receptor. The engaged T cell is redirected to lyse tumor cells that express the target antigen. BiTEs against other targets including EpCAM, CEA and PSMA are at earlier stages of clinical investigation. The advances of the BiTE platform in the clinic are reviewed. Stanley R. Frankel, M.D., Medical Sciences Executive Medical Director, Amgen Rockville, Inc.
9:00
Peptide Sensors of Angiogenesis
Blocking VEGF has been validated as an effective approach for cancer therapy and overexpression of VEGF in tumors is associated with a poor prognosis. In order to rapidly measure VEGF levels within tumors we undertook the design of two and three helix bundle peptides to recognize VEGF and potentially act as VEGF sensors. Peptide design, optimization via phage display, structures of the VEGF complexes and positron emission tomography (PET) images are presented. Strategies are presented to improve image quality and enhance sensitivity. Kurt Deshayes, Ph.D., Senior Scientist, Early Discovery Biochemistry, Genentech, Inc. Optimizing Protein Therapeutics for "Manufacturability"
9:30
Engineering Developability for the Next Generation of Protein Therapeutics
We describe a new strategic approach for developability assessment and protein optimization based on application of molecular modeling tools in order to gain an understanding of protein aggregation and viscosity with unprecedented detail and accuracy. For aggregation, Spatial-Aggregation Propensity and Developability Index algorithms and for viscosity, Spatial-Charge-Map algorithm can be applied in the discovery phase through the development phase to identify problems early on and address them. We also have related tools for oxidation, deamidation and crystalizability of proteins. Neeraj J Agrawal, Ph.D., Post-Doctoral Associate, Department of Chemical Engineering, Laboratory of Bernhardt Trout, Massachusetts Institute of Technology
10:00
Networking Refreshment Break in Exhibit and Poster Hall
Immunogenicity Prediction and De-immunization StrategiesUnpublished Data
10:45
Computationally Driven De-immunization of Biotherapeutics
Anti-biotherapeutic immune responses can compromise therapeutic efficacy and safety and there exists a growing need for broadly applicable de-immunization strategies. We have developed and tested protein design algorithms that seamlessly integrate computational prediction of immunogenic T cell epitopes and bioinformatics-based assessment of the structural and functional consequences of epitope-deleting mutations. This talk highlights recent experimental results in which we have mapped the Pareto optimal frontier in the dual-objective design space of one target protein. Karl E. Griswold, Ph.D., Assistant Professor, Thayer School of Engineering, Dartmouth
11:15
De-immunizing a Novel Bacterial Enzyme for Potential Use in Autoimmune Disease
The Streptococcus pyogenes enzyme IdeS is a highly specific protease targeting human IgG and could represent a potential treatment for autoimmune diseases. This presentation outlines in silico and in vitro approaches to identify and remove T-cell epitopes from IdeS to address immunogenicity issues. Stacey Chin, Ph.D., Scientist II, MedImmune, LLC, United Kingdom Unpublished Data
11:45
Case
Comprehensive Immunogenicity Prediction Strategy for FnIII Based AdnectinsStudy Therapeutic agents comprising engineered scaffold proteins that incorporate non human sequences have the potential to be immunogenic in humans. The use of library selection strategies combined with immunogenicity prediction strategies can enable more preclinical drug candidate choices with reduced immunogenicity risk. Here we present a three pronged immunogenicity prediction strategy based on in silico, in vitro and in vivo models, including a clinical immunogenicity case study of an albumin binding Adnectin. Jochem Gokemeijer, Associate Director, Adnexus, a Bristol-Myers Squibb R&D Company
12:15
Networking Luncheon in Exhibit and Poster Hall with "Hot Topic" Roundtable Discussions
Moderated by Conference Speakers - Join us during this afternoon's luncheon for informal, moderated hot topic discussions led by your conference speakers. Discuss and debate important industry issues and challenges with other attendees and speakers and make new contacts at the same time. Partial list of discussion topics below. If you would like to suggest a topic for discussion during this session, please contact Michael Keenan at mkeenan@ibcusa.com
Concurrent Tracks |
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1:25
Chairman's Remarks
Keith Foster, Ph.D., Founder and Chief Scientific Officer, Syntaxin, Ltd., United Kingdom Expanding "Druggable" Target Space: Difficult & Intracellular TargetsUnpublished Data
1:30
In Vitro Selection of Binders against Membrane Transporters: Challenges and Opportunities
Integral membrane proteins such as receptors, transporters and channels are major targets for small molecule drugs, but challenging to approach with protein therapeutics. Based on our recent work in selecting DARPins against ABC transporters, opportunities and technical hurdles to target "difficult to handle" proteins with alternative scaffolds are discussed. Markus Seeger, Ph.D., Group Leader, Department of Biochemistry, University of Zurich, Switzerland Unpublished Data
2:00
Humanized Rabbit Antibody Variable Domains as Building Blocks for the Engineering of Innovative Antibody-based Therapeutics
There is an increasing demand for non-standard antibody formats such as bi-specific molecules or fragments with shorter half-lives and improved tissue penetration compared to full-size IgGs. A prerequisite for such approaches is the availability of highly potent and drug-like antibody variable domains that allow for modular assembly of new molecules according to the design goals. David Urech, Ph.D., Chief Scientific Officer and Co-CEO, Numab AG, Switzerland Unpublished Data
2:30
Using Stabilized Receptors (StaRs) to Generate Therapeutic Antibodies and Proteins to GPCR Targets
G-protein coupled receptors (GPCRs) have historically been considered as difficult targets for antibody and protein therapeutic development, but are one of the most important classes of drug targets. Opportunities for targeting GPCRs with antibodies and other proteins with the challenges encountered are outlined. We present a novel approach that utilizes StaRs and has yielded potent agonist antibodies. Catherine Hutchings, Ph.D., Principal Scientist, Antibody Discovery, Heptares Therapeutics Ltd., United Kingdom
3:00
Networking Refreshment Break and Last Chance for Exhibit and Poster Viewing
3:45
Nanobodies: A Robust Platform for the Generation of Innovative Biotherapeutics
Nanobodies are antibody-derived therapeutic proteins containing the unique structural and functional properties of naturally occurring heavy-chain antibodies. The modularity of this technology allows for control over valency, in vivo half life and effector function. Furthermore, Nanobodies provide solutions for difficult targets such as ion channels and GPCRs. Examples are used to illustrate the ease with which these different goals can be met without compromising on manufacturability. Andreas Menrad, Ph.D., Chief Scientific Officer, Ablynx NV, Belgium
4:15
Phylomer Libraries as a Rich Source of Peptides Targeting the Intracellular Space
Phylomers are a new class of peptide, derived from fragments of biodiverse microbial genomes. Phylomer libraries can also be used to identify new cell penetrating peptides for delivery of macromolecules and nanoparticles into cells. Some of these cell penetrating Phylomers are specific for particular cell types. Phylomers themselves can be active against intracellular targets in vivo and can be used to discover and validate new targets using protein interference. Richard Hopkins, Ph.D., Vice President, Research, Phylogica, Ltd., Australia
4:45
Controlling Intracellular Regulatory Networks with Synthetic Binding Proteins
Intracellular regulatory proteins are potentially attractive drug targets, but it is challenging to define their functional roles and to validate them as drug targets, mainly due to a paucity of selective and potent inhibitors. Binding proteins built on a small cysteine-free scaffold, such as the FN3 monobodies, are ideally suited as genetically encoded inhibitors. I describe our recent studies in which we generate, validate and utilize monobody inhibitors to control intracellular regulatory networks and to discover druggable targets. Shohei Koide, Ph.D., Professor, Department of Biochemistry and Molecular Biology, The University of Chicago Unpublished Data
5:15
Targeting Intracellular Antigens Using Engineered T Cell Receptors
Intracellular antigens provide opportunities to expand beyond the limited number of targets used in standard monoclonal antibody therapies of cancer. T-cells and T-cell receptors (TCRs) evolved to target these antigens, as cell-surface complexes with MHC products. Novel strategies to engineer TCRs for adoptive T-cell therapies or soluble therapeutics are presented. David M. Kranz, Ph.D., Phillip A. Sharp Professor of Biochemistry, University of Illinois |
1:25
Chairman's Remarks
Robert Lutz, Ph.D., Vice President, Translational Research and Development, ImmunoGen, Inc. Next-Generation ADCs: Clinical, Chemical and Engineering AdvancesShared Session with IBC's Bioconjugates Conference
1:30
Clinical Update on Antibody-Drug Conjugates from Seattle Genetics
This presentation will highlight the development of new antibody-drug conjugates for the treatment of cancer from Seattle Genetics, and the clinical opportunities available for this versatile and powerful platform. In addition this presentation will address aspects of early phase oncology clinical trial design that can be leveraged to fuel translational research efforts and maximize the potential of this increasingly important class of therapeutics. Samuel C. Blackman, M.D., Ph.D., Executive Director, Head of Translational Medicine, Seattle Genetics, Inc. Spotlight Presentation
2:00
Design and Production of Homogeneous Best-in-Class ADC's by Cell Free Protein Synthesis
Site-specific conjugant variants can be produced and analyzed within days and candidate ADC's advanced to in vivo efficacy and toxicology studies within weeks. Recent advances with non-natural amino acid containing protein expression technology overcome cell-based expression yield limitations and enable faster conjugation kinetics suitable for manufacturing. Trevor Hallam, Ph.D., Chief Scientific Officer, Sutro Biopharma, Inc. 
2:30
Antibody-drug Conjugate Activation with in vivo Chemistry
The use of a bioorthogonal chemical reaction for selective antibody-drug cleavage in vivo would represent a powerful new tool for ADCs, as it would not rely on endogenous activation mechanisms. We have shown earlier that the Diels-Alder conjugation between antibody-bound trans-cyclooctene and a radiolabeled tetrazine occurs effectively in mice at low concentrations. Here we report that a modified reaction can provoke rapid and self-immolative ADC release of model drug doxorubicin in vitro. Marc Robillard, Ph.D., CEO, Tagworks Pharmaceuticals, The Netherlands
3:00
Networking Refreshment Break in Exhibit and Poster Hall
Engineering Next Generation ADCs
3:30
Site Specific ADC Generation Using SMARTag™ Platform.
Redwood Bioscience, Inc. has developed a technology platform that enables precise, programmable, site-selective chemical protein modification. Leveraging the target sequence of Formylglycine Generating Enzyme, termed the SMARTag™, we can engineer homogenous, enhanced biotherapeutics, including ADCs. Additionally, we have developed novel conjugation chemistry where the resulting ADCS have enhanced stability while maintaining the potency of the cytotoxic payload. David Rabuka, Ph.D., Chief Scientific Officer, Redwood Bioscience 
4:00
Producing Better Antibody Drug Conjugates using ThioBridge™ Conjugation
PolyTherics has developed a novel reagent, ThioBridge™, for the site-directed conjugation of cytotoxic drugs to antibodies and antibody fragments. Antibody drug conjugates produced using ThioBridge™ are less heterogeneous, more stable and less prone to aggregation. A toolbox of ThioBridge™ reagents which can be used with a range of payloads is being developed. George O. Badescu, Ph.D., Head of Bioconjugation and Bioanalysis, PolyTherics, Inc., United Kingdom 
4:30
Comparison of Site Specific Conjugation Approach to Conventional Conjugation Relative to Efficacy and Toxicity in Rodents and Non Human Primate Models: Lessons Learned
Homogeneous drug substance enables quantitative analysis for ADC optimization to meet target drug profiles. The site of conjugation impacts biophysical properties and has a significant impact on the plasma stability of cathepsin-cleavable linkers. Site-specific conjugation preserves target binding and minimizes off-target binding. Ambrx ADCs have PK similar to the naked wt-mAb resulting in improved efficacy and Therapeutic Index relative to conventional conjugates. Ho Cho, Ph.D., Chief Technology Officer, Ambrx, Inc. Unpublished Data
5:00
Case
Recombinant Strategies to Engineer Stable Antibody Drug ConjugatesStudy Significant progress has been made most recently in using recombinant strategies to generate stable antibody-drug conjugates (ADCs) with predetermined sites and stoichiometries for drug attachment. Here, I present our recent effort in engineering antibodies with improved potency and stability. The in vitro and in vivo activity of ADCs are also discussed. Changshou Gao, Ph.D., Fellow, Technology, Department of Antibody Discovery & Protein Engineering, MedImmune LLC Unpublished Data
5:30
Activatable Immunoconjugates for Super-specific Cancer Diagnosis and Therapy
In the treatment of cancer, early diagnosis and targeted therapies are assumed to yield the highest cure rates. However, current methods are limited by their sensitivity for diagnosis and their specificity for targeted cell killing. Newly developed activatable immunoconjugates allow the accurate detection of cancer yet also provide the possibility of highly specific, light-mediated treatment with minimal effects on surrounding healthy cells. Hisataka Kobayashi, M.D., Ph.D., Molecular Imaging Program, NCI, NIH |
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6:00-7:00
Happy Hour on the Beach
Join us in the Hotel del Coronado's backyard for Happy Hour on the beach, overlooking the shimmering Pacific Ocean. This networking reception (included in your conference registration fee) is a great opportunity to meet attendees and speakers from both the Next Generation Protein Therapeutics Summit and co-located Bioconjugates conference in a relaxed and informal setting.
Advance RSVP is required when registering.
7:30
Coffee
8:00
Chairman's Remarks
Dimiter Dimitrov, Ph.D., Senior Investigator, Protein Interactions, National Cancer Institute, NIH Keynote Presentation
8:05
FDA Perspective on Novel Monoclonal Antibody Development PathwaysAbstract not available at time of print. Kathleen A. Clouse, Ph.D., Director, Division of Monoclonal Antibodies OBP, CDER, US FDA
8:40
Session Chairman's Remarks
Robert Mabry, Ph.D., Associate Director, Antibody Discovery and Bispecific Engineering, Adimab, Inc. Bispecific and Genetic FusionsUnpublished Data
8:45
FynomAbs: Bispecific Antibodies with Tailored Architecture
Covagen develops bispecific FynomAbs by fusing its fully human Fynomer binding proteins to antibodies generating therapeutics with novel modes-of-action and enhanced efficacy. The ability to fuse Fynomers to multiple sites on an antibody allows Covagen to create FynomAbs with tailored architectures to maximize efficacy. We present new preclinical data of bispecific FynomAbs for the treatment of inflammatory diseases and cancer and how these molecules move towards the clinic. Fabian Buller, Ph.D., Director Discovery Research, Covagen AG, Switzerland Unpublished Data
9:15
Targeting of HER2 Receptor with Bispecific DARPin Agents
Designed Ankyrin Repeat Proteins (DARPins) recognizing the individual subdomains of human HER2 have been used to construct high-affinity tumor targeting vehicles. Particular formats of such bispecific DARPins exhibited strong tumoricidal activity on HER2-addicted breast cancer cell lines both in vitro and in vivo, which was attributable to induction of apoptosis, growth arrest and inhibition of cell motility. On the receptor level, DARPins brought about both inactivation of HER2 homodimers and disintegration of HER2-EGFR/HER3 heterodimers, entailing a potent and sustained inhibition of downstream signaling. Rastislav Tamaskovic, Ph.D., Researcher, Biochemistry, Laboratory of Andreas Pluekthun, University of Zurich, Switzerland
9:45
Leveraging Multi-Specificity and Multi-Valency to Build Novel Cancer Therapeutics
Effective delivery of antagonistic and agonistic signals requires crosslinking of key cell surface receptors. The impact of such crosslinking on tumor growth/survival depends on the biological role of the receptors being targeted and the extent of crosslinking achieved. Data is presented describing two therapeutic opportunities to alter tumor growth through novel multi-specific and multi-valent Zybodies targeting erbB-family receptors and death-domain receptors. David M. Hilbert, Ph.D., CSO and Head R&D, Zyngenia, Inc.
10:15
Networking Refreshment Break
10:45
Case
Ang-2-VEGF CrossMab - A Novel Bispecific Human IgG1 Antibody Blocking VEGF-A and Ang-2 FunctionStudy Roche has applied the CrossMab technology to generate a bispecific human IgG1 antibody targeting VEGF-A and Angiopoietin 2. The Ang-2-VEGFCrossMab binds and blocks the biological function of the two pro-angiogenic factors VEGF-A and Angiopoietin-2 simultaneously. Our data show that the CrossMab possesses a very good stability, an IgG like half-life in Cynomolgus monkey and a favorable safety profile. Additionally it shows favorable efficacy in preclinical tumor cancer models, thereby representing a promising therapeutic agent for the therapy of cancer patients. Joerg T. Regula, Ph.D., Head of Protein Analytics, Pharma Research and Early Development (pRED), Roche Diagnostics, Germany
11:15
Case
Engineering Stable Bispecific Antibodies in the Final Therapeutic FormatStudy With over thirty different constructs currently under investigation, bispecific antibodies have become the focus of many commercial efforts. However, one major obstacle remains to be solved; bispecific molecules assembled from individual components frequently do not retain affinity, structural stability and mammalian expression titers of parental antibodies. We present case studies demonstrating the discovery of IgGs and their conversion to several final bispecific formats on the surface of yeast. Large libraries of full-length bispecific antibody formats were generated to select for significant affinity and biophysical improvements over antibody assembly. Upon expression in mammalian cells these molecules appear to express well and detailed biophysical characterization demonstrates a consistent pattern of generating stable bispecific molecules. Robert Mabry, Ph.D., Associate Director, Antibody Discovery and Bispecific Engineering, Adimab, Inc.
11:45
A Peptide-Antibody Bispecific Genetic Fusion Platform for Novel Peptide Therapeutics
Peptides offer target specificity and affinity advantages over small molecules, but are hampered by pharmacokinetic limitations. We have engineered a bispecific therapeutic by combining a peptide and an antibody using genetic fusion and mammalian expression. A neutralizing peptide directed against interleukin-17A (IL17A) was genetically fused to the N-termini of an anti-IL223,4 antibody, through either the light chain, heavy chain, or both chains. The resulting fusion proteins bound and inhibited IL22 with the same affinity and potency as the unmodified anti-IL22 antibody. The peptide required an N-terminal pyroglutamate to retain binding and neutralization of IL17A. Removal of an unexpected O-linked glycosylation modification at threonine 5 of the anti-IL17A peptide was essential for full binding affinity and neutralization potency for IL17A. These novel findings in biotherapeutics engineering suggest that a peptide-antibody genetic fusion platform is a fast and effective modality allowing the targeting of multiple antigens in a single antibody-like molecule. Xiaotian Zhong, Ph.D., Principal Scientist/ Lab Head, Pfizer Global Biotherapeutics Technologies
12:15
The Affilin® Platform - A Modular Approach to Multifunctional Formats
Scil Proteins offers the development of innovative biotherapeutics based on its proprietary Affilin® technology. Affilin® molecules are based on ubiquitin, a small and highly stable human protein whose sequence is fully conserved across all mammalian species, simplifying preclinical development. Affilin® molecules are amenable to a broad modular approach, e.g. fusion to various effector molecules, half-life modulation, chemical derivatization, bi- and tri-specific formats can be realized. Ulrich Haupts, Ph.D., Chief Scientific Officer, Scil Proteins GmbH, Germany
12:45
Lunch on your own
1:55
Chairman's Remarks
David M. Kranz, Ph.D., Phillip A. Sharp Professor of Biochemistry, University of Illinois Recruiting the Immune System for Cancer TherapyUnpublished Data
2:00
Single Domain Antibody-based Bispecific Antibodies for Cancer Immunotherapy
Llama-derived single domain antibodies (sdAbs) are characterized by a small size (13kDa), high stability and expression yield and targeting of cryptic epitopes. We use these fragments as convenient building blocks to retarget effector cells such as NK cells toward tumor cells. Our latest results obtained with these fragments are discussed. Patrick Chames, Ph.D., Scientist, Cancer Research Center of Marseille (CRCM), INSERM, France
2:30
Case
BiTEs: Engaging the Cytolytic Power of Polyclonal T cells to Eliminate TumorsStudy BiTEs are potent bispecific single-chain antibodies that redirect T cells to kill tumors. They engage a tumor target and a constant region of the T cell receptor to recruit and activate polyclonal T cells to eliminate tumors. They have demonstrated potent efficacy in various pre-clinical tumor models and have now transitioned to clinical studies in both liquid and solid malignancies. Luis Borges, Ph.D., Scientific Director, Therapeutic Innovation Unit, Amgen
3:00
Networking Refreshment Break
Unpublished Data
3:30
Case
MCLA-117: A Biclonics - ENGAGE Bispecific IgG Product Lead Targeting CLEC12A and CD3 in AMLStudy Using the MeMo transgenic mouse platform, MCLA-117, a common light chain T cell-engaging human bispecific antibody (Biclonics - ENGAGE) was discovered that targets CD3 on T cells and CLEC12A on acute myeloid leukemia (AML). Co-incubation of resting patient T cells and AML cells with MCLA-117 results in efficient tumor cell lysis. Clinical application of MCLA-117 potentially provides a therapy in AML that more efficiently eradicates the cancer cells and prevents relapse. Alexander Bakker, Ph.D., Chief Development Officer, Merus, The Netherlands Unpublished Data / Clinical Update
4:00
Case
Exploiting the Immune System for Cancer Cell Killing: Development of Next-Generation Protein TherapeuticsStudy The TandAb technology enables the recruitment of T and NK effector cells and subsequent killing of cancer cells expressing targeted cell-surface antigens. We demonstrate that T- and NK cell-engaging TandAbs are efficacious against tumor cells in vitro and in vivo, possess excellent safety profiles and show activity in the clinic. Kristina Ellwanger, Ph.D., Head of Protein Expression and Cell Engineering, Affimed Therapeutics AG, Germany
4:30
Close of Conference
Featured TutorialOpen to All Conference Attendees
Friday, June 28 · 10:45 am - 12:15 pm
Building Better Libraries: Display Technologies, Selection Methods and Affinity Maturation Strategies for Alternative Scaffolds
John Löfblom, Assistant Professor, Division of Protein Technology, School of Biotechnology, KTH Royal Institute of Technology, Sweden Shohei Koide, Ph.D., Professor, Department of Biochemistry and Molecular Biology, The University of Chicago |
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