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Next Generation Protein Therapeutics Summit
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Crossing the Barriers Agenda
Crossing the Barriers
Main Conference: Tuesday | Main Conference: Wednesday
7:45
Morning Coffee
8:00
Chairperson's Remarks
H. Kaspar Binz, Ph.D., Vice President Technology and Co-Founder, Molecular Partners, Switzerland
H. Kaspar Binz, Ph.D., Vice President Technology and Co-Founder, Molecular Partners, Switzerland
Engineering Bispecific and Multifunctional Proteins
Keynote Presentation
8:15
Antibody Combinations and Bispecific Antibodies Potently Neutralize Botulinum NeurotoxinsWe have generated human monoclonal antibodies that neutralize botulinum neurotoxins. When individual mAbs are combined, the potency of neutralization increases dramatically. Strategies to capture this potency in a single antibody based molecule will be described.
James D. Marks, M.D., Ph.D., Professor, Department of Anesthesia and Pharmaceutical Chemistry, Member, Comprehensive Cancer Center, University of California, San Francisco
8:45
mAb2: Novel Bispecific Antibodies that are Minimally Changed from IgG
We have developed two novel antibody formats: Fcab, in which antigen-binding sites are introduced into a human Fc fragment and mAb2, in which additional binding sites are engineered into the Fc of an intact antibody. Fcabs allow small therapeutic antibody fragments to be isolated that retain all normal antibody functionalities (antigen binding, effector functions and long half life) while mAb2 represents an elegant way to create bispecific antibodies.
Max Woisetschlager, Ph.D., Director of Target Biology, f-star, Austria
We have developed two novel antibody formats: Fcab, in which antigen-binding sites are introduced into a human Fc fragment and mAb2, in which additional binding sites are engineered into the Fc of an intact antibody. Fcabs allow small therapeutic antibody fragments to be isolated that retain all normal antibody functionalities (antigen binding, effector functions and long half life) while mAb2 represents an elegant way to create bispecific antibodies.
Max Woisetschlager, Ph.D., Director of Target Biology, f-star, Austria
9:10
Bispecific Antibodies: Delivering Combination Therapy in a Single Agent
Abstract not available at time of print.
Scott M. Glaser, Ph.D., Director, Antibody Therapeutics, Biogen Idec, Inc.
Abstract not available at time of print.
Scott M. Glaser, Ph.D., Director, Antibody Therapeutics, Biogen Idec, Inc.
9:35
Surrobodies with Functional Tails
Surrobodies™ are a unique type of antigen-binding protein based on the pre-B cell receptor (pre-BCR). Unlike canonical antibodies, the pre-BCR subunit is a trimer composed of an antibody heavy chain paired with a two subunit surrogate light chain (SLC). The heterodimeric surrogate light chain provides unique opportunities for protein engineering, namely the functional derivatization of their non-immunoglobulin-like tails. Through recent work with both of these novel tails we have recombinantly fused fully active cytokines to generate bifunctional Surrobodies, and similarly fused single chain Fv antibodies to form bispecific Surrobodies. Insights into the utility and combinatorial derivatization of this protein platform will be discussed.
Ramesh Bhatt, Ph.D., Vice President of Research, Sea Lane Biotechnologies
Surrobodies™ are a unique type of antigen-binding protein based on the pre-B cell receptor (pre-BCR). Unlike canonical antibodies, the pre-BCR subunit is a trimer composed of an antibody heavy chain paired with a two subunit surrogate light chain (SLC). The heterodimeric surrogate light chain provides unique opportunities for protein engineering, namely the functional derivatization of their non-immunoglobulin-like tails. Through recent work with both of these novel tails we have recombinantly fused fully active cytokines to generate bifunctional Surrobodies, and similarly fused single chain Fv antibodies to form bispecific Surrobodies. Insights into the utility and combinatorial derivatization of this protein platform will be discussed.
Ramesh Bhatt, Ph.D., Vice President of Research, Sea Lane Biotechnologies
10:00
Networking Refreshment Break and Poster/Exhibit Viewing
Keynote Presentation
10:30
Chemically Programmed Immunity: Antibodies and VaccinesRecently, we invented a new class of immunotherapeutics, Chemically Programmed Antibodies or CovX-bodies, now advancing in numerous clinical trials. This presentation will focus on fundamentals of cpAb technology, its applications, and its ongoing elaboration. Advancing this approach to vaccinology, we show that elements of active and passive immunization can be combined to create an effective chemistry-driven approach to vaccinology in cancer and infectious disease.
Carlos F. Barbas III, Ph.D., Kellogg Professor and Chair, The Skaggs Institute for Chemical Biology and the Departments of Molecular Biology and Chemistry, The Scripps Research Institute
Emerging Preclinical and Clinical Results
11:00
Advancing DARPins to the Clinic
DARPins are a high-affinity, low-immunogenicity-potential protein drugs that combine the advantages of antibodies and small molecule drugs. The favorable properties of DARPins enable the fast generation of a variety of drug candidates for different indications. MP0112, a best-in-class therapeutic program for the treatment of ocular neovascularization diseases will be presented along with other examples for therapeutic applications where DARPins are superior to monoclonal antibodies.
H. Kaspar Binz, Ph.D., Vice President, Technology and Co-Founder, Molecular Partners, Switzerland
DARPins are a high-affinity, low-immunogenicity-potential protein drugs that combine the advantages of antibodies and small molecule drugs. The favorable properties of DARPins enable the fast generation of a variety of drug candidates for different indications. MP0112, a best-in-class therapeutic program for the treatment of ocular neovascularization diseases will be presented along with other examples for therapeutic applications where DARPins are superior to monoclonal antibodies.
H. Kaspar Binz, Ph.D., Vice President, Technology and Co-Founder, Molecular Partners, Switzerland
11:25
Anticalins, A Unique Class of Targeted Protein Therapeutics
Anticalins are modified versions of human lipocalins. Pieris' lead project PRS-050 (VEGF antagonist) is now entering human studies. Unique features of this drug class such as the ability to bind therapeutically relevant hapten targets will be presented, along with their broad formulation and formatting flexibility.
Kristian Jensen, Ph.D., Chief Operating Officer, Pieris AG, Germany
Anticalins are modified versions of human lipocalins. Pieris' lead project PRS-050 (VEGF antagonist) is now entering human studies. Unique features of this drug class such as the ability to bind therapeutically relevant hapten targets will be presented, along with their broad formulation and formatting flexibility.
Kristian Jensen, Ph.D., Chief Operating Officer, Pieris AG, Germany
Featured Presentation
11:50
Monoclonal Antibodies, Next Generation Antibodies, and Antibody Alternatives: An FDA Perspective
The clinical success of therapeutic monoclonal antibodies in the 1990's spurred an increase in the number of these products in the development pipeline. Currently there are over 200 monoclonal antibodies in clinical development including 2nd generation products and novel antibody constructs. The FDA perspective on the regulation of these products, including quality considerations for different routes of administration and how to communicate with the appropriate review divisions will be discussed.
Ruth Cordoba-Rodriguez, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, US FDA
The clinical success of therapeutic monoclonal antibodies in the 1990's spurred an increase in the number of these products in the development pipeline. Currently there are over 200 monoclonal antibodies in clinical development including 2nd generation products and novel antibody constructs. The FDA perspective on the regulation of these products, including quality considerations for different routes of administration and how to communicate with the appropriate review divisions will be discussed.
Ruth Cordoba-Rodriguez, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, US FDA
12:10
Luncheon Discussion & Debate Sessions
(Lunch will be provided)
(Lunch will be provided)
-
Novel scaffolds and scaffold engineering
Discussion Leader: Andreas Plückthun, Ph.D., Professor of Biochemistry, University of Zurich, Switzerland -
Selection and library design
Discussion Leader: Jonathan Davis, Ph.D., Principal Scientist, Protein Design, Adnexus, a Bristol-Myers Squibb Company -
Strategies for plasma half-life extension of biopharmaceuticals
Discussion Leader: Arne Skerra, Ph.D., CEO, XL-protein GmbH, Germany -
De-immunization strategies
Discussion Leader: TBA -
What are the differentiators of next generation biologics in the marketplace?
Discussion Leader: Kristian Jensen, Ph.D., Chief Operating Officer, Pieris AG, Germany -
Blocking multimeric targets with bivalent IgGs; Does immune complex formation pose a safety risk?
Discussion Leader: Volker Schellenberger, Ph.D., Vice President, Drug Discovery, Amunix, Inc. -
Regulatory issues associated with next generation protein therapeutics
Discussion Leaders:
Jack Ragheb, M.D., Ph.D., Principal Investigator and Senior Regulatory Research Officer, Laboratory of Immunology, CDER, US FDA Ruth Cordoba-Rodriguez, Ph.D., Product Quality Reviewer, Division of Monoclonal Antibodies, Office of Biotechnology Products, CDER, US FDA -
Modulating the intracellular undruggable target space
Discussion Leader: Hanjo Hennemann, Ph.D., Executive Director and Head of R&D, Nexigen GmbH, Germany
1:15
Dessert and Exhibit/Poster Viewing
1:45
Chairperson's Remarks
Paul Watt, Ph.D., Chief Scientific Officer and VP, Corporate Development, Phylogica Ltd, Australia
Paul Watt, Ph.D., Chief Scientific Officer and VP, Corporate Development, Phylogica Ltd, Australia
Alternative Delivery
2:00
Novel Technology for Rapid Noninvasive Protein/Peptide Delivery
Technosphere® technology is a formulation/device combination that provides systemic protein/peptide delivery with pharmacokinetics that mimic endogenous hormone secretion. This novel technology will be exemplified in clinical case studies for insulin and GLP-1; and in nonclinical studies for two appetite control peptides, oxyntomodulin, and PYY.
Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corporation
Technosphere® technology is a formulation/device combination that provides systemic protein/peptide delivery with pharmacokinetics that mimic endogenous hormone secretion. This novel technology will be exemplified in clinical case studies for insulin and GLP-1; and in nonclinical studies for two appetite control peptides, oxyntomodulin, and PYY.
Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corporation
2:00
Late-Breaking Presentation
To be considered for a presentation in this session, please contact Michael Keenan at mkeenan@ibcusa.com
To be considered for a presentation in this session, please contact Michael Keenan at mkeenan@ibcusa.com
Attacking Intracellular Targets
3:00
Clinical Application of Cell-Penetrating Peptides to Treat Cardiac Ischemia-Reperfusion Injury and Pain
KAI applies cell-penetrating peptides to selectively modulate intracellular protein:protein interactions. We have applied this approach to discover potent and selective inhibitors and activators for members of the protein kinase C (PKC) family of isozymes. In this presentation we will demonstrate the clinical potential of such molecules to protect heart tissue after ischemia and to provide a novel therapeutic approach to the treatment of pain.
Stephen D. Harrison, Ph.D., Senior Vice President, Research, KAI Pharmaceuticals, Inc.
KAI applies cell-penetrating peptides to selectively modulate intracellular protein:protein interactions. We have applied this approach to discover potent and selective inhibitors and activators for members of the protein kinase C (PKC) family of isozymes. In this presentation we will demonstrate the clinical potential of such molecules to protect heart tissue after ischemia and to provide a novel therapeutic approach to the treatment of pain.
Stephen D. Harrison, Ph.D., Senior Vice President, Research, KAI Pharmaceuticals, Inc.
3:30
Networking Refreshment Break and Exhibit/Poster Viewing
4:00
Targeting Intracellular Pathways with Stapled Peptides
Intracellular protein-protein interactions frequently involve helical peptide molecular recognition to modulate signal transduction, proliferation, survival, metabolism, transcription, translation and other regulatory pathways. Amongst a plethora of therapeutic targets within Aileron's portfolio, this presentation will highlight the design, structure-property and in vivo efficacy studies of promising BH3 stapled helical peptides with respect to identifying a clinical candidate for the treatment of Bcl2-dysregulated cancers. A new therapeutic modality is envisaged to leverage the unique drug properties of stapled helical peptides.
Tomi K. Sawyer, Ph.D., Chief Scientific Officer and Senior Vice President, Aileron Therapeutics
Intracellular protein-protein interactions frequently involve helical peptide molecular recognition to modulate signal transduction, proliferation, survival, metabolism, transcription, translation and other regulatory pathways. Amongst a plethora of therapeutic targets within Aileron's portfolio, this presentation will highlight the design, structure-property and in vivo efficacy studies of promising BH3 stapled helical peptides with respect to identifying a clinical candidate for the treatment of Bcl2-dysregulated cancers. A new therapeutic modality is envisaged to leverage the unique drug properties of stapled helical peptides.
Tomi K. Sawyer, Ph.D., Chief Scientific Officer and Senior Vice President, Aileron Therapeutics
4:30
Cytoplasmic Peptide Therapeutics as an Alternative for siRNA
Until recently peptide therapeutics have been mostly acting on extracellular target proteins. However cell-penetrating peptides and novel methods to select intracellular peptide modulators pave the way to therapeutics which are able to target the so-called undruggable protein space. This novel class of peptide therapeutics is an alternative to siRNA approaches and has the potential to close the gap between small molecule and antibody drugs. The talk will focus on technologies and approaches to develop such peptide drugs.
Hanjo Hennemann, Ph.D., Executive Director and Head of R&D, Nexigen GmbH, Germany
Until recently peptide therapeutics have been mostly acting on extracellular target proteins. However cell-penetrating peptides and novel methods to select intracellular peptide modulators pave the way to therapeutics which are able to target the so-called undruggable protein space. This novel class of peptide therapeutics is an alternative to siRNA approaches and has the potential to close the gap between small molecule and antibody drugs. The talk will focus on technologies and approaches to develop such peptide drugs.
Hanjo Hennemann, Ph.D., Executive Director and Head of R&D, Nexigen GmbH, Germany
5:00
Cell-Penetrating Supramolecular Complexes for Drug Delivery
A drug delivery system should deliver drugs efficiently across biological barriers, yet disintegrate rapidly once this has occurred to avoid safety concerns. Here we describe a supramolecular complex comprising a novel cell-penetrating peptide identified from human lactoferrin and show first applications in organ models and in animals.
Roland Brock, Ph.D., Chair, Biochemistry of Integrated Systems and Head, Department of Biochemistry, Nijmegen Centre for Molecular Life Sciences, Radboud University Nijmegen Medical Centre, The Netherlands
A drug delivery system should deliver drugs efficiently across biological barriers, yet disintegrate rapidly once this has occurred to avoid safety concerns. Here we describe a supramolecular complex comprising a novel cell-penetrating peptide identified from human lactoferrin and show first applications in organ models and in animals.
Roland Brock, Ph.D., Chair, Biochemistry of Integrated Systems and Head, Department of Biochemistry, Nijmegen Centre for Molecular Life Sciences, Radboud University Nijmegen Medical Centre, The Netherlands
5:30
Close of Day One
Main Conference: Tuesday | Main Conference: Wednesday
8:00
Morning Coffee
8:15
Chairperson's Remarks
Mark S. Dennis, Senior Scientist, Antibody Engineering, Genentech, Inc.
Mark S. Dennis, Senior Scientist, Antibody Engineering, Genentech, Inc.
Delivery of Alternative Scaffolds
8:45
Alternative Delivery of Nanobodies®
Llama-derived Nanobodies have inherent biophysical properties, including thermodynamic stability, resistance to pH and protease degradation, which make them ideal candidates for alternative methods of drug delivery. Data will be presented demonstrating that Nanobodies can be delivered via routes other than intravenous injection and retain their function when delivered via skin (SC), oral and pulmonary routes.
Hilde Revets, Ph.D., Senior Director, Technology, Ablynx, Belgium
Llama-derived Nanobodies have inherent biophysical properties, including thermodynamic stability, resistance to pH and protease degradation, which make them ideal candidates for alternative methods of drug delivery. Data will be presented demonstrating that Nanobodies can be delivered via routes other than intravenous injection and retain their function when delivered via skin (SC), oral and pulmonary routes.
Hilde Revets, Ph.D., Senior Director, Technology, Ablynx, Belgium
9:15
Pulmonary Delivered Domain Antibodies: anti-TNFR1 dAb for Lung Diseases
Due to their small size and stability, human domain antibodies (dAbs) can readily be delivered to the respiratory tract. We have demonstrated superior efficacy using low doses of pulmonary delivered dAb against the TNF receptor 1 in mouse models for COPD and acute inflammatory models in non-human primates. This data demonstrates utility of dAbs for pulmonary delivery and highlights the potential of TNFR1 as a target for treatment of pulmonary inflammatory diseases.
Peter J. Morley, Ph.D., Investigator, Discovery, Biopharm R&D, GlaxoSmithkline, United Kingdom
Due to their small size and stability, human domain antibodies (dAbs) can readily be delivered to the respiratory tract. We have demonstrated superior efficacy using low doses of pulmonary delivered dAb against the TNF receptor 1 in mouse models for COPD and acute inflammatory models in non-human primates. This data demonstrates utility of dAbs for pulmonary delivery and highlights the potential of TNFR1 as a target for treatment of pulmonary inflammatory diseases.
Peter J. Morley, Ph.D., Investigator, Discovery, Biopharm R&D, GlaxoSmithkline, United Kingdom
Crossing the Blood-Brain-Barrier
9:45
Delivering Antibodies across the BBB
The vascular and nervous systems form a tight interface in the central nervous system, known as the blood-brain barrier (BBB) that directs the flow of various molecules, including antibodies. We have designed experiments to better understand how the BBB forms and functions, with a particular focus on antibody dynamics at the BBB. This presentation will focus on our efforts to engineer antibodies targeting specific brain endothelial targets to enable receptor-mediated transport as a means to deliver antibodies across the BBB.
Mark S. Dennis, Senior Scientist, Antibody Engineering, Genentech, Inc.
The vascular and nervous systems form a tight interface in the central nervous system, known as the blood-brain barrier (BBB) that directs the flow of various molecules, including antibodies. We have designed experiments to better understand how the BBB forms and functions, with a particular focus on antibody dynamics at the BBB. This presentation will focus on our efforts to engineer antibodies targeting specific brain endothelial targets to enable receptor-mediated transport as a means to deliver antibodies across the BBB.
Mark S. Dennis, Senior Scientist, Antibody Engineering, Genentech, Inc.
10:15
Networking Refreshment Break and Exhibit/Poster Viewing
10:45
Re-Engineering Recombinant Proteins for the Brain with Blood-Brain Barrier Molecular Trojan Horse Technology
Recombinant proteins and monoclonal antibody therapeutics cannot be developed as drugs for the brain, because these large molecules do not cross the blood-brain barrier (BBB). To solve the BBB problem, recombinant proteins are re-engineered as IgG fusion proteins. The IgG is a peptidomimetic monoclonal antibody against the human BBB insulin receptor. The IgG acts as a molecular Trojan horse to ferry the protein pharmaceutical across the BBB via receptor-mediated transport.
William Pardridge, M.D., Chief Scientific Officer, ArmaGen Technologies, Inc.
Recombinant proteins and monoclonal antibody therapeutics cannot be developed as drugs for the brain, because these large molecules do not cross the blood-brain barrier (BBB). To solve the BBB problem, recombinant proteins are re-engineered as IgG fusion proteins. The IgG is a peptidomimetic monoclonal antibody against the human BBB insulin receptor. The IgG acts as a molecular Trojan horse to ferry the protein pharmaceutical across the BBB via receptor-mediated transport.
William Pardridge, M.D., Chief Scientific Officer, ArmaGen Technologies, Inc.
11:15
Screening Phylomer Libraries to Find the Ideal Structures for Particular Targets Inside or Outside Cells
Phylomer peptides can exhibit superior functional hit-rates, when compared to randomly derived peptides, due to evolutionary selection for structure and stability. We have exploited the high functional hit rates from Phylomer libraries, to allow direct screening for particular phenotypes and to identify multiple intracellular targets in vivo. Phylomer libraries can also be used to identify new protein transduction domains for delivery of macromolecules into cells. We will also present ex vivo and in vivo studies of potent blockers of the extracellular target CD40Ligand (CD40L) for inflammatory diseases, including the results of intranasal administration approaches.
Paul Watt, Ph.D., Chief Scientific Officer and VP, Corporate Development, Phylogica Ltd, Australia
Phylomer peptides can exhibit superior functional hit-rates, when compared to randomly derived peptides, due to evolutionary selection for structure and stability. We have exploited the high functional hit rates from Phylomer libraries, to allow direct screening for particular phenotypes and to identify multiple intracellular targets in vivo. Phylomer libraries can also be used to identify new protein transduction domains for delivery of macromolecules into cells. We will also present ex vivo and in vivo studies of potent blockers of the extracellular target CD40Ligand (CD40L) for inflammatory diseases, including the results of intranasal administration approaches.
Paul Watt, Ph.D., Chief Scientific Officer and VP, Corporate Development, Phylogica Ltd, Australia
11:45
Case Study for Intranasal Delivery of a Neuroprotective Peptide
Neuropeptide drug development requires an understanding of the mechanism and kinetics by which peptide gets into the central nervous system, including selection of the route of administration based on pharmacokinetics and pharmacodynamics. Davunetide is a neuroprotective peptide with broad-spectrum preclinical efficacy, currently in clinical development for dementia and cognitive impairment. Examples from the davunetide development program will be used to illustrate how these challenges can be addressed.
Bruce Morimoto, Ph.D., Vice President, Drug Development, Allon Therapeutics, Inc.
Neuropeptide drug development requires an understanding of the mechanism and kinetics by which peptide gets into the central nervous system, including selection of the route of administration based on pharmacokinetics and pharmacodynamics. Davunetide is a neuroprotective peptide with broad-spectrum preclinical efficacy, currently in clinical development for dementia and cognitive impairment. Examples from the davunetide development program will be used to illustrate how these challenges can be addressed.
Bruce Morimoto, Ph.D., Vice President, Drug Development, Allon Therapeutics, Inc.
12:15
Networking Luncheon and Exhibit/Poster Viewing
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