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Document Title
Antibody Therapeutics Agenda
Antibody Therapeutics Agenda
7:00
Registration, Networking Coffee
7:45
Announcements
7:50
Announcements and Chairperson's Opening Remarks
Rathin C. Das, Ph.D., Senior Vice President, Business Development/President, Affitech AS & Affitech USA, Inc.
Rathin C. Das, Ph.D., Senior Vice President, Business Development/President, Affitech AS & Affitech USA, Inc.
Session I: Preclinical Development of Antibody Therapeutics
8:00
Challenges and Opportunities in the Design of Nonclinical Safety Programs to Support First in Human Dosing
As the development of biotherapeutics becomes a more advanced science-based challenge, the selection of relevant animal models, utility of traditional species and alternatives to traditional safety approaches are becoming more accepted and in fact, necessary. Alternatives to the traditional safety approach include the use of homologous proteins, transgenic animals, and animal models of disease. The opportunities and challenges for these approaches to advance the science of biotechnology drugs will be discussed.
Laura Andrews, Ph.D., DABT, Vice President, Pharmacology and Toxicology, Genzyme Corporation
As the development of biotherapeutics becomes a more advanced science-based challenge, the selection of relevant animal models, utility of traditional species and alternatives to traditional safety approaches are becoming more accepted and in fact, necessary. Alternatives to the traditional safety approach include the use of homologous proteins, transgenic animals, and animal models of disease. The opportunities and challenges for these approaches to advance the science of biotechnology drugs will be discussed.
Laura Andrews, Ph.D., DABT, Vice President, Pharmacology and Toxicology, Genzyme Corporation
8:30
Characterization of the Preclinical Anti-Tumor Effects of r84, a Novel Fully Human Anti-VEGF Antibody
r84, a fully human antibody specific for human and mouse VEGF-A, is a selective inhibitor of VEGF-induced activation of VEGFR2 but does not inhibit VEGF binding or activation of VEGFR1. r84 has been evaluated in orthotopic xenograft models and a mouse chimeric version of r84 has been tested in multiple syngeneic as well as spontaneous transgenic tumor models. The effect of this unique and potent antibody on tumor growth, angiogenesis, and the tumor microenvironment will be discussed.
Rolf A. Brekken, Ph.D., Associate Professor of Surgery & Pharmacology, University of Texas Southwestern Medical Center
r84, a fully human antibody specific for human and mouse VEGF-A, is a selective inhibitor of VEGF-induced activation of VEGFR2 but does not inhibit VEGF binding or activation of VEGFR1. r84 has been evaluated in orthotopic xenograft models and a mouse chimeric version of r84 has been tested in multiple syngeneic as well as spontaneous transgenic tumor models. The effect of this unique and potent antibody on tumor growth, angiogenesis, and the tumor microenvironment will be discussed.
Rolf A. Brekken, Ph.D., Associate Professor of Surgery & Pharmacology, University of Texas Southwestern Medical Center
9:00
Identification and Preclinical Anti-Tumor Activity of Novel Human Antibodies Neutralizing Either Growth Factor or Angiogenic Ligands
The presentation will focus on two preclinical studies that led to the identification of antibodies capable of neutralizing important cancer ligands. First MEDI 573, which targets the IGF1 and IGF2 ligands responsible for growth and survival signalling through the IGFR1 and IRA receptors present on a range of cancers. And second, MEDI3617, which targets the ANG2 ligand that plays a key role in the angiogenic switch that is critical for tumor angiogenesis.
David Blakey, Ph.D., Chief Scientist, Cancer and Infection Research, AstraZeneca, United Kingdom
The presentation will focus on two preclinical studies that led to the identification of antibodies capable of neutralizing important cancer ligands. First MEDI 573, which targets the IGF1 and IGF2 ligands responsible for growth and survival signalling through the IGFR1 and IRA receptors present on a range of cancers. And second, MEDI3617, which targets the ANG2 ligand that plays a key role in the angiogenic switch that is critical for tumor angiogenesis.
David Blakey, Ph.D., Chief Scientist, Cancer and Infection Research, AstraZeneca, United Kingdom
9:30
Networking Refreshment Break, Exhibit and Poster Viewing
10:15
Generation of Dual-Targeting Antibodies and their Preclinical Development
Domain Antibodies (dAbs) are the smallest functional binding fragments of human antibodies. By combining different dAbs, or through fusion of dAbs and mAbs, we are creating a suite of novel bispecific agents that offer enhanced efficacy in a range of indications. We will show that these molecules will provide differentiated, developable biopharmaceuticals, and by virtue of their modular nature offer up a pipeline of further such molecules in the future.
Michael Steward, Ph.D., Manager, Discovery Biopharm R&D, GlaxoSmithKline, United Kingdom
Domain Antibodies (dAbs) are the smallest functional binding fragments of human antibodies. By combining different dAbs, or through fusion of dAbs and mAbs, we are creating a suite of novel bispecific agents that offer enhanced efficacy in a range of indications. We will show that these molecules will provide differentiated, developable biopharmaceuticals, and by virtue of their modular nature offer up a pipeline of further such molecules in the future.
Michael Steward, Ph.D., Manager, Discovery Biopharm R&D, GlaxoSmithKline, United Kingdom
10:45
Anti-TGFß RII Antibody Suppresses Metastasis and Primary Tumor Growth by Multi-Effects on Cancer, Stroma and Immune Cells
Therapeutics capable of controlling metastasis that accounts for most death of cancer patients and elevating weakened antitumor immunity in patients would have desirable clinical outcome. Antibody-directed therapeutics have been primarily focused on targeting a molecule in cancer cells or tumor-associated counterparts. This talk will present a novel approach utilizing a neutralizing anti-TGFß Receptor II antibody to achieve antitumor efficacy through multi-effects on metastasis, angiogenesis, stroma and immunosuppression as well as enhancement of antitumor immunity.
Yan Wu, M.D., Group Leader, Department of Antibody Technology and Immunology, ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company
Therapeutics capable of controlling metastasis that accounts for most death of cancer patients and elevating weakened antitumor immunity in patients would have desirable clinical outcome. Antibody-directed therapeutics have been primarily focused on targeting a molecule in cancer cells or tumor-associated counterparts. This talk will present a novel approach utilizing a neutralizing anti-TGFß Receptor II antibody to achieve antitumor efficacy through multi-effects on metastasis, angiogenesis, stroma and immunosuppression as well as enhancement of antitumor immunity.
Yan Wu, M.D., Group Leader, Department of Antibody Technology and Immunology, ImClone Systems, a wholly owned subsidiary of Eli Lilly and Company
11:15
Engineered Fc Domains for Enhanced Cytotoxicity, Pharmacokinetics, and Immune Modulation: Preclinical Development Challenges for Candidate Antibodies
We have engineered Fc domains for increased affinities to human activating Fc receptors, the inhibitory FcRIIb, and FcRn to improve cytotoxicity, immune cell regulation, or half-life, respectively. In each case, challenges related to imperfect inter-species affinity improvements have arisen. We have therefore utilized a variety of hu-PBL-SCID and transgenic models in combination with nonhuman primates to provide critical information on in vivo pharmocokinetics and pharmacology.
John R. Desjarlais, Ph.D., Vice President, Research, Xencor, Inc.
We have engineered Fc domains for increased affinities to human activating Fc receptors, the inhibitory FcRIIb, and FcRn to improve cytotoxicity, immune cell regulation, or half-life, respectively. In each case, challenges related to imperfect inter-species affinity improvements have arisen. We have therefore utilized a variety of hu-PBL-SCID and transgenic models in combination with nonhuman primates to provide critical information on in vivo pharmocokinetics and pharmacology.
John R. Desjarlais, Ph.D., Vice President, Research, Xencor, Inc.
Technology Workshops
11:45
The clinical immunogenicity of biologics is typically associated with the development of high affinity IgG anti-therapeutic antibodies, indicating the role of CD4+ helper T cell epitopes. We have compared a number of technologies that enable the preclinical prediction of immunogenicity, and using EpiScreen™ technology, we have observed a correlation between T cell responses to biologics and the immunogenicity of protein therapeutics in the clinic. Data will be presented demonstrating our technology in screening for and removing immunogenicity from biologics.
Frank Carr, Ph.D., Director for Biologics Research, Antitope, United Kingdom
Integral Molecular's Lipoparticle technology provides an innovative solution for presenting structurally intact membrane protein antigens, including GPCRs and ion channels, at concentrations 10-100X higher (50-200 pmol/mg) than in cells or membrane preparations. This has enabled us to derive high titer serum responses (>1:500) against membrane proteins of interest. Once MAbs are isolated, our Shotgun Mutagenesis mapping technology has enabled us to rapidly identify both linear and conformationally complex epitopes that distinguish MAb binding sites.
Benjamin Doranz, Ph.D., President and Chief Scientific Officer, Integral Molecular
12:15
Networking Luncheon, Exhibit and Poster Viewing
Technology Workshops
1:45
Antibody-dependent cellular cytotoxicity activity is a critical effector function for many therapeutic antibodies. This activity is dramatically enhanced by a reduction in core-fucose on the antibody. This presentation describes the progress of afucosylated antibodies and the development, in collaboration with Lonza, of Potelligent® CHOK1SV: a cell line from which recombinant cell lines suitable for cGMP manufacture and expressing 100% non-fucosylated antibodies can be generated.
Mitsuo Satoh, Ph.D., Director, Antibody Research Laboratories, Kyowa Hakko Kirin Co., Ltd., Japan
Over the last 10 years, the fully synthetic Human Combinatorial Antibody Library (HuCAL®) evolved from the first scFv format antibody library with two diversified CDRs to Fab format libraries featuring six diversified CDRs and delivering more than 60 therapeutic lead candidates and hundreds of research antibodies. The most advanced member is HuCAL PLATINUM®. Latest results demonstrating the superior performance of HuCAL GOLD and PLATINUM during antibody selections, high throughput screenings, antibody production and in vivo applications will be presented.
Michael Tesar, Ph.D., Associate Director, MorphoSys AG, Germany
Open Monoclonal Technology, Inc. (www.omtinc.net) is developing a human antibody platform using transgenic rats. This technology is based on an improved understanding of B-cell development and a novel approach to inactivating endogenous rat antibody expression. OMT's platform has broad freedom to operate and is protected by a patent application.
Roland Buelow, Ph.D., Chief Executive Officer, OMT Inc.
2:15
Announcements
Session II: Clinical Development: Inflammation
2:15
Announcements and Chairperson's Opening Remarks
Trudi Veldman, Ph.D., Director, Biologics Generation, Abbott Laboratories
Trudi Veldman, Ph.D., Director, Biologics Generation, Abbott Laboratories
2:30
BT-061, a Therapeutic Antibody Targeting Regulatory T Cells
BT-061 is a non-depleting humanized monoclonal antibody that selectively activates naturally occurring regulatory T cells (Tregs). Binding of BT-061 to an unique epitope of CD4 induces signaling events in Tregs resulting in their efficient activation. BT-061 is developed in the lead indications Rheumatoid Arthritis and Psoriasis. Based on blinded analysis from ongoing clinical phase IIa trials, BT-061 was generally well tolerated and first very promising efficacy data showed clear improvement of symptoms in both indications.
Christoph Uherek, Ph.D., Director, Preclinical Development Biotherapeutics, Biotest AG, Germany
BT-061 is a non-depleting humanized monoclonal antibody that selectively activates naturally occurring regulatory T cells (Tregs). Binding of BT-061 to an unique epitope of CD4 induces signaling events in Tregs resulting in their efficient activation. BT-061 is developed in the lead indications Rheumatoid Arthritis and Psoriasis. Based on blinded analysis from ongoing clinical phase IIa trials, BT-061 was generally well tolerated and first very promising efficacy data showed clear improvement of symptoms in both indications.
Christoph Uherek, Ph.D., Director, Preclinical Development Biotherapeutics, Biotest AG, Germany
3:00
ESBA105: an Anti-TNF scFv, Developed for Treatment of Local Inflammatory Diseases
ESBA105 is a 27kDa TNF-alpha inhibitor originating from ESBATech's proprietary scFv platform. The compound has shown unique local biodistribution and pharmacokinetics characteristics. Based on these properties the ESBA105 can be applied locally, leading to high local concentrations in disease relevant tissues combined with low systemic drug exposure. ESBA105, using local delivery routes, is developed for treatment of local inflammatory diseases in which the use of conventional TNF-alpha inhibitors is prohibited for pharmacological or safety reasons.
Peter Lichtlen, M.D., Ph.D., Head of Clinical Research & Development, ESBATech, Switzerland
ESBA105 is a 27kDa TNF-alpha inhibitor originating from ESBATech's proprietary scFv platform. The compound has shown unique local biodistribution and pharmacokinetics characteristics. Based on these properties the ESBA105 can be applied locally, leading to high local concentrations in disease relevant tissues combined with low systemic drug exposure. ESBA105, using local delivery routes, is developed for treatment of local inflammatory diseases in which the use of conventional TNF-alpha inhibitors is prohibited for pharmacological or safety reasons.
Peter Lichtlen, M.D., Ph.D., Head of Clinical Research & Development, ESBATech, Switzerland
3:30
MDX-1100, A Fully Human Anti-CXCL10 (IP-10) Monoclonal Antibody for Inflammatory Diseases
The chemokine CXCL10 (IP10) binds to the cell surface receptor CXCL10 expressed on T cells and monocytes. CXCL10 and CXCR3 are expressed at inflammatory sites, such as in rheumatoid arthritis (RA) synovial membrane and colonic mucosa in ulcerative colitis (UC), and blocking this pathway ameliorates disease manifestations in RA and UC models. MDX-1100 is a fully human monoclonal antibody that neutralizes CXCL10 that has shown activity in RA and is currently in Phase 2 development in UC.
Michael Yellin, M.D., Senior Director, Rheumatology and Immunology, Medarex, Inc.
The chemokine CXCL10 (IP10) binds to the cell surface receptor CXCL10 expressed on T cells and monocytes. CXCL10 and CXCR3 are expressed at inflammatory sites, such as in rheumatoid arthritis (RA) synovial membrane and colonic mucosa in ulcerative colitis (UC), and blocking this pathway ameliorates disease manifestations in RA and UC models. MDX-1100 is a fully human monoclonal antibody that neutralizes CXCL10 that has shown activity in RA and is currently in Phase 2 development in UC.
Michael Yellin, M.D., Senior Director, Rheumatology and Immunology, Medarex, Inc.
4:00
Networking Refreshment Break, Exhibit and Poster Viewing
4:45
The Therapeutic Lure of the Chemokine System: Past, Present and Future
At the time of their discovery over twenty years ago, chemokines and their receptors attracted the immediate attention of drug developers. Consequently, many small molecule and monoclonal antibody antagonists have been developed. Several of these have been tested in clinical trials but the results have been generally disappointing. A better understanding of the complex biology of the chemokine system as well as new targeting strategies will help to fully exploit the therapeutic potential of chemokine inhibition.
William A. Kuziel, Ph.D., Director, External Scientific Affairs, Daiichi Sankyo Research Institute
At the time of their discovery over twenty years ago, chemokines and their receptors attracted the immediate attention of drug developers. Consequently, many small molecule and monoclonal antibody antagonists have been developed. Several of these have been tested in clinical trials but the results have been generally disappointing. A better understanding of the complex biology of the chemokine system as well as new targeting strategies will help to fully exploit the therapeutic potential of chemokine inhibition.
William A. Kuziel, Ph.D., Director, External Scientific Affairs, Daiichi Sankyo Research Institute
5:15
Sclerostin: A Potential New Target for Treating Low Bone Mass Disorders
Individuals suffering from the rare mendelianly inherited condition sclerosteosis have exceptionally high bone mass. We have shown that neutralizing monoclonal antibodies to sclerostin can increase bone formation and bone strength in both rodents and primates. A recently completed human Ph I study in post menopausal women showed that a single dose of an antibody to sclerostin can produce a dose-dependent increase in biomarkers of bone formation and a decrease in a biomarker of bone resorption.
Martyn Robinson, Ph.D., Vice President and Principal Scientist, UCB, United Kingdom
Individuals suffering from the rare mendelianly inherited condition sclerosteosis have exceptionally high bone mass. We have shown that neutralizing monoclonal antibodies to sclerostin can increase bone formation and bone strength in both rodents and primates. A recently completed human Ph I study in post menopausal women showed that a single dose of an antibody to sclerostin can produce a dose-dependent increase in biomarkers of bone formation and a decrease in a biomarker of bone resorption.
Martyn Robinson, Ph.D., Vice President and Principal Scientist, UCB, United Kingdom
5:45
Clinical Development of Antibody for Inflammation
This abstract was not available at the time of printing the brochure.
Speaker TBA, Biocon Limited, India
This abstract was not available at the time of printing the brochure.
Speaker TBA, Biocon Limited, India
6:15
Networking Cocktail Reception, Exhibit and Poster Viewing
7:30
Registration, Networking Coffee
8:00
Announcements and Chairperson's Opening Remarks
Nils Lonberg, Ph.D., Senior Vice President and Scientific Director, Medarex Inc.
Nils Lonberg, Ph.D., Senior Vice President and Scientific Director, Medarex Inc.
Session III: Clinical Development: Cancer
8:15
EpCAM-specific BiTE Antibody MT110 for Treatment of Solid Tumors
MT110 is the second BiTE antibody in clinical trials. The first BiTE antibody, blinatumumab, has shown high response rates in patients with lymphoma and leukemia. The presentation will provide an update on preclinical activity of MT110 against mutated colorectal cancer stem cells, and on clinical data from patients with late-stage gastrointestinal or lung cancers.
Patrick A. Baeuerle, Ph.D., Senior Vice President, Research and Development, Chief Scientific Officer, Micromet AG, Germany
MT110 is the second BiTE antibody in clinical trials. The first BiTE antibody, blinatumumab, has shown high response rates in patients with lymphoma and leukemia. The presentation will provide an update on preclinical activity of MT110 against mutated colorectal cancer stem cells, and on clinical data from patients with late-stage gastrointestinal or lung cancers.
Patrick A. Baeuerle, Ph.D., Senior Vice President, Research and Development, Chief Scientific Officer, Micromet AG, Germany
8:45
PD-1 Pathway Blockade for Cancer Immunotherapy
PD-1 is a negative signaling lymphocyte receptor associated with unresponsive antigen specific T cells. B7-H1, one of two ligands for PD-1, is expressed on many human cancers, and that expression correlates with poor survival. Two different human antibodies that block this pathway—one targeting the receptor and the other targeting the ligand—are in clinical development. Preclinical and clinical data will be presented.
Nils Lonberg, Ph.D., Senior Vice President and Scientific Director, Medarex Inc.
PD-1 is a negative signaling lymphocyte receptor associated with unresponsive antigen specific T cells. B7-H1, one of two ligands for PD-1, is expressed on many human cancers, and that expression correlates with poor survival. Two different human antibodies that block this pathway—one targeting the receptor and the other targeting the ligand—are in clinical development. Preclinical and clinical data will be presented.
Nils Lonberg, Ph.D., Senior Vice President and Scientific Director, Medarex Inc.
9:15
Clinical Development of Dacetuzumab, a Humanized Anti-CD40 Monoclonal Antibody
Dacetuzumab (SGN-40) selectively binds to CD40 and induces tumor cell death through multiple mechanisms. Phase I and II studies of single-agent dacetuzumab have demonstrated objective responses and tolerability in patients with hematologic malignancies. Preclinical data suggest that a novel gene signature may predict single-agent activity in patients with DLBCL. Phase Ib and IIb studies of dacetuzumab in combination with standard chemotherapies in patients with DLBCL, follicular NHL, or multiple myeloma are ongoing.
Nancy C. Whiting, PharmD, BCOP, Associate Medical Director, Translational Medicine, Seattle Genetics, Inc.
Dacetuzumab (SGN-40) selectively binds to CD40 and induces tumor cell death through multiple mechanisms. Phase I and II studies of single-agent dacetuzumab have demonstrated objective responses and tolerability in patients with hematologic malignancies. Preclinical data suggest that a novel gene signature may predict single-agent activity in patients with DLBCL. Phase Ib and IIb studies of dacetuzumab in combination with standard chemotherapies in patients with DLBCL, follicular NHL, or multiple myeloma are ongoing.
Nancy C. Whiting, PharmD, BCOP, Associate Medical Director, Translational Medicine, Seattle Genetics, Inc.
9:45
Networking Refreshment Break, Exhibit and Poster Viewing
10:30
CD22 Antibody Drug Conjugate for NHL
CD22 is a B-cell antigen expressed on >90% of B-lymphoid malignancies and represents an attractive therapeutic target for the treatment of patients with B-cell NHL. Inotuzumab ozogamicin (CMC-544) combines a humanized IgG4 anti-CD22 antibody (G544) with a potent cytotoxic antibiotic (calicheamicin). CMC-544 has demonstrated activity against indolent and aggressive CD22 positive B-cell lymphomas in phase 1 and phase 1/2 trials when used as monotherapy or in combination with rituximab. Its activity and safety profile warrants continued development of this investigational agent.
Patrick Kelly, M.D., Senior Director, Hematology, Clinical Research & Development, Wyeth Research
CD22 is a B-cell antigen expressed on >90% of B-lymphoid malignancies and represents an attractive therapeutic target for the treatment of patients with B-cell NHL. Inotuzumab ozogamicin (CMC-544) combines a humanized IgG4 anti-CD22 antibody (G544) with a potent cytotoxic antibiotic (calicheamicin). CMC-544 has demonstrated activity against indolent and aggressive CD22 positive B-cell lymphomas in phase 1 and phase 1/2 trials when used as monotherapy or in combination with rituximab. Its activity and safety profile warrants continued development of this investigational agent.
Patrick Kelly, M.D., Senior Director, Hematology, Clinical Research & Development, Wyeth Research
11:00
Mechanisms of Action of Daratumumab, a Novel CD38 Therapeutic Antibody for the Treatment of Multiple Myeloma
CD38 is a type II membrane molecule involved in cell signaling which is highly expressed on all malignant Multiple Myeloma (MM) tumor cells. Daratumumab is a human IgG1 antibody generated in human Ig transgenic mice. Daratumumab interferes with CD38 enzyme function and effectively induces killing of fresh MM tumor cells by ADCC, apoptosis and potent CDC. In vivo, daratumumab inhibits the outgrowth of B cell tumors in a SCID mouse tumor model. Daratumumab represents a promising candidate for treatment of MM and is currently evaluated in a Phase I/II safety and dose finding study.
Paul W.H.I. Parren, Ph.D., Senior Vice President Research & Preclinical Development, Genmab, The Netherlands
CD38 is a type II membrane molecule involved in cell signaling which is highly expressed on all malignant Multiple Myeloma (MM) tumor cells. Daratumumab is a human IgG1 antibody generated in human Ig transgenic mice. Daratumumab interferes with CD38 enzyme function and effectively induces killing of fresh MM tumor cells by ADCC, apoptosis and potent CDC. In vivo, daratumumab inhibits the outgrowth of B cell tumors in a SCID mouse tumor model. Daratumumab represents a promising candidate for treatment of MM and is currently evaluated in a Phase I/II safety and dose finding study.
Paul W.H.I. Parren, Ph.D., Senior Vice President Research & Preclinical Development, Genmab, The Netherlands
11:30
Elotuzumab, a Humanized Antibody, for the Potential Treatment of Multiple Myeloma
Elotuzumab is directed against CS1, a cell surface glycoprotein, which is highly and uniformly expressed in multiple myeloma (MM). Elotuzumab is proposed to induce significant antibody-dependent cellular cytotoxicity (ADCC), which is significantly enhanced by combination treatment with either lenalidomide or bortezomib. Elotuzumab is being tested in 3 different phase 1/1b clinical studies, either alone or in combination with standard of care agents. The results from these studies will be discussed at the meeting.
Anil Singhal, Ph.D., Senior Medical Director, Facet Biotech
Elotuzumab is directed against CS1, a cell surface glycoprotein, which is highly and uniformly expressed in multiple myeloma (MM). Elotuzumab is proposed to induce significant antibody-dependent cellular cytotoxicity (ADCC), which is significantly enhanced by combination treatment with either lenalidomide or bortezomib. Elotuzumab is being tested in 3 different phase 1/1b clinical studies, either alone or in combination with standard of care agents. The results from these studies will be discussed at the meeting.
Anil Singhal, Ph.D., Senior Medical Director, Facet Biotech
12:00
Technology Workshops
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For more information on presenting a technology workshop at this meeting, please contact Jennifer McElligott at (508) 614-1672 or jmcelligott@ibcusa.com. Three workshop slots are available in this time slot at the time of printing this brochure.
IBC's Technology Workshops offer supplier and service companies the opportunity to present product and service offers directly to the audience at the conference. For more information on presenting a technology workshop at this meeting, please contact Jennifer McElligott at (508) 614-1672 or jmcelligott@ibcusa.com. Three workshop slots are available in this time slot at the time of printing this brochure.
12:30
Networking Luncheon, Last Chance for Exhibit and Poster Viewing
Session IV: Business, Regulatory and Intellectual Property
2:00
Chairperson's Opening Remarks
Benjamin P. Chen, Ph.D., Managing Director, Burrill & Company
Benjamin P. Chen, Ph.D., Managing Director, Burrill & Company
2:15
Antibodies: A Wall Street Perspective
With the largest consolidation of antibody assets now complete following the Roche/Genentech merger, many investors are wondering where the next wave of growth in the industry will come from. Increasingly, investors are seeing new opportunities in technologies outside of antibodies (vaccines, anti-sense, RNAi, etc.). The presentation will review some of the most exciting clinical data that supports continued interest in antibodies and next generation antibody technologies.
Jason Kantor, Ph.D., Senior Biotechnology Analyst, RBC Capital Markets
With the largest consolidation of antibody assets now complete following the Roche/Genentech merger, many investors are wondering where the next wave of growth in the industry will come from. Increasingly, investors are seeing new opportunities in technologies outside of antibodies (vaccines, anti-sense, RNAi, etc.). The presentation will review some of the most exciting clinical data that supports continued interest in antibodies and next generation antibody technologies.
Jason Kantor, Ph.D., Senior Biotechnology Analyst, RBC Capital Markets
2:45
Investing in Private Antibody Therapeutics Companies: A Venture Capitalist's Viewpoint
Several case studies will be used to highlight market performance and projected trends. Topics to be addressed will include what acquirers want in the way of platforms versus products, when will they want it, and what will they be willing to pay for it. While the viewpoint will be that of a venture capitalist, it will be biased by this VC having formerly been the CEO of an antibody-based company.
Ron Eastman, Managing Director, Essex Woodlands Health Ventures
Several case studies will be used to highlight market performance and projected trends. Topics to be addressed will include what acquirers want in the way of platforms versus products, when will they want it, and what will they be willing to pay for it. While the viewpoint will be that of a venture capitalist, it will be biased by this VC having formerly been the CEO of an antibody-based company.
Ron Eastman, Managing Director, Essex Woodlands Health Ventures
3:15
Recent Changes in the IP Environment: Beware of the Key Changes that will Significantly Alter how Companies and Investors Manage Risk
The Courts continue to change the rules for assessing risk and value of patents. eBay, Seagate, Medimmune, LG, Bilski, KSR, Broadcomm and their progeny have changed the rules of the game for life science and pharmaceutical companies. The impact of these changes is discussed in the context of an economic model. The potential impact of biosimilar legislation and other new legal trends will also be discussed.
Bill Gaede, Partner, McDermott, Will & Emery
The Courts continue to change the rules for assessing risk and value of patents. eBay, Seagate, Medimmune, LG, Bilski, KSR, Broadcomm and their progeny have changed the rules of the game for life science and pharmaceutical companies. The impact of these changes is discussed in the context of an economic model. The potential impact of biosimilar legislation and other new legal trends will also be discussed.
Bill Gaede, Partner, McDermott, Will & Emery
3:45
Networking Refreshment Break
4:15
Is Your Antibody Obvious? A Comparison of US and European Approaches
In order to be patentable, an antibody must be novel and non-obvious. But how do the patent offices decide what is obvious? Recent decisions from the U.S. Supreme Court and U.S. Court of Appeals have dramatically changed the way that obviousness is decided in the United States. This interactive presentation will discuss this new approach and compare it to the way that obviousness is judged in Europe.
Philip Webber, Ph.D., European and UK Patent Attorney, Frank B. Dehn & Co, United Kingdom
In order to be patentable, an antibody must be novel and non-obvious. But how do the patent offices decide what is obvious? Recent decisions from the U.S. Supreme Court and U.S. Court of Appeals have dramatically changed the way that obviousness is decided in the United States. This interactive presentation will discuss this new approach and compare it to the way that obviousness is judged in Europe.
Philip Webber, Ph.D., European and UK Patent Attorney, Frank B. Dehn & Co, United Kingdom
4:45
A Flexible Business Model to Support a Novel Human Antibody Discovery Platform
Big pharma is projecting major growth in the biologics arena in the upcoming decade. Because of the high level of clinical validation, much of this growth is expected to rely on therapeutic antibodies, at a time when many of the existing discovery platform providers for antibodies are encumbered by legacy agreements and gate keeping. We will discuss the main features of Adimab's human antibody discovery platform and how the development of an novel freestanding platform supports a more fluid and flexible business model.
Tillman U. Gerngross, Ph.D., Co-Founder and Chief Executive Officer, Adimab
Big pharma is projecting major growth in the biologics arena in the upcoming decade. Because of the high level of clinical validation, much of this growth is expected to rely on therapeutic antibodies, at a time when many of the existing discovery platform providers for antibodies are encumbered by legacy agreements and gate keeping. We will discuss the main features of Adimab's human antibody discovery platform and how the development of an novel freestanding platform supports a more fluid and flexible business model.
Tillman U. Gerngross, Ph.D., Co-Founder and Chief Executive Officer, Adimab
5:15
Panel Discussion with Session Speakers
5:45
Close of Session
7:30
Networking Coffee
Session V: Clinical Development: Infection and Autoimmune Diseases
8:00
Announcements and Chairperson's Opening Remarks
Mark R. Alfenito, Ph.D., Head of Technology Licensing, KaloBios Pharmaceuticals Inc.
Mark R. Alfenito, Ph.D., Head of Technology Licensing, KaloBios Pharmaceuticals Inc.
8:15
BENLYSTA: A Human Monoclonal Antibody Against BLyS for the Treatment of SLE
Elevated serum levels of soluble B-lymphocyte stimulator (BLyS) protein have been observed in patients with autoimmune disease, including RA, Sjogren's syndrome and SLE. BENLYSTA (belimumab) is a fully human monoclonal Ab (IgG1 l)obtained from a human phage display library, that binds soluble BLyS and inhibits its binding to the 3 receptors TACI, BCMA, and BR3. Preclinical and clinical data, including recent positive Phase 3 data, for this program will be discussed.
Thi-Sau Migone, Ph.D., Senior Director, Clinical Immunology, Human Genome Sciences
Elevated serum levels of soluble B-lymphocyte stimulator (BLyS) protein have been observed in patients with autoimmune disease, including RA, Sjogren's syndrome and SLE. BENLYSTA (belimumab) is a fully human monoclonal Ab (IgG1 l)obtained from a human phage display library, that binds soluble BLyS and inhibits its binding to the 3 receptors TACI, BCMA, and BR3. Preclinical and clinical data, including recent positive Phase 3 data, for this program will be discussed.
Thi-Sau Migone, Ph.D., Senior Director, Clinical Immunology, Human Genome Sciences
8:45
A Neutralizing Human Monoclonal Antibody Therapy for Nipah Virus Infection
Nipah virus is a highly pathogenic zoonotic paramyxovirus that causes severe neurologic and/or respiratory disease in animals and humans. Nipah is a BSL-4 select agent and there are no approved therapies for human use. A ferret model of Nipah-pathogenesis, which mirrors the illness seen in infected humans, was developed and a neutralizing human monoclonal antibody (m102.4) targeting the viral attachment glycoprotein could completely protect ferrets from lethal disease as a post-exposure therapy.
Christopher C. Broder, Ph.D., Professor of Microbiology and Immunology, Director, Emerging Infectious Diseases Graduate Program, Department of Microbiology and Immunology, Uniformed Services University
Nipah virus is a highly pathogenic zoonotic paramyxovirus that causes severe neurologic and/or respiratory disease in animals and humans. Nipah is a BSL-4 select agent and there are no approved therapies for human use. A ferret model of Nipah-pathogenesis, which mirrors the illness seen in infected humans, was developed and a neutralizing human monoclonal antibody (m102.4) targeting the viral attachment glycoprotein could completely protect ferrets from lethal disease as a post-exposure therapy.
Christopher C. Broder, Ph.D., Professor of Microbiology and Immunology, Director, Emerging Infectious Diseases Graduate Program, Department of Microbiology and Immunology, Uniformed Services University
9:15
Recombinant Polyclonal Antibodies, a New Class of Drug for Treatment of Infectious Disease, Autoimmunity and Cancer
Recombinant polyclonal antibodies (pAb) contain several antibody species, thus leveraging multiple mechanisms of action in a single drug. These offer significant advantages in the treatment of complex organism like virus and bacteria as well as in cancer and autoimmunity. Symphogen has developed technologies for the discovery, manufacturing and quality control of pAb enabling their development as well-characterized pharmaceuticals. Examples from the development of rozrolimupab, currently in phase II development for the treatment of ITP, will be provided with examples from Symphogen's anti-infectives development pipeline.
Søren Bregenholt, Ph.D., Chief Operating Officer, Symphogen A/S, Denmark
Recombinant polyclonal antibodies (pAb) contain several antibody species, thus leveraging multiple mechanisms of action in a single drug. These offer significant advantages in the treatment of complex organism like virus and bacteria as well as in cancer and autoimmunity. Symphogen has developed technologies for the discovery, manufacturing and quality control of pAb enabling their development as well-characterized pharmaceuticals. Examples from the development of rozrolimupab, currently in phase II development for the treatment of ITP, will be provided with examples from Symphogen's anti-infectives development pipeline.
Søren Bregenholt, Ph.D., Chief Operating Officer, Symphogen A/S, Denmark
9:45
Networking Refreshment Break
10:15
Type I Interferons in Systemic Autommine Disease
Type I IFNs induce multiple biological effects in the immune system and recent data suggests a potential role of Type-I IFNs in lupus. In animal models, inhibition of interferon signaling prevents skin inflammation. MEDI-545 is a fully humanized anti-IFN-a mAb and patients with lupus inhibited the "Interferon signature" and reduced the expression of a number of genes that are upregulated in the inflamed skin suggesting that targeting Type I IFNs in autoimmune may be a new therapeutic approach.
Anthony J Coyle, Ph.D., Vice President, Respiratory Inflammation and Autoimmunity Department, MedImmune, Inc.
Type I IFNs induce multiple biological effects in the immune system and recent data suggests a potential role of Type-I IFNs in lupus. In animal models, inhibition of interferon signaling prevents skin inflammation. MEDI-545 is a fully humanized anti-IFN-a mAb and patients with lupus inhibited the "Interferon signature" and reduced the expression of a number of genes that are upregulated in the inflamed skin suggesting that targeting Type I IFNs in autoimmune may be a new therapeutic approach.
Anthony J Coyle, Ph.D., Vice President, Respiratory Inflammation and Autoimmunity Department, MedImmune, Inc.
10:45
Targeting TNF-Alpha with ART621 - the First Human Framework Domain Antibody to Hit the Clinic
Domain antibodies (dAbs) offer potential for enhanced stability, production yields, tissue penetration and formatting flexibility, and reduced immunogenicity compared with IgG's. Combinatorial methods were used to develop a potent TNF-alpha-neutralizing dAb that was then formatted into a bivalent Fc-linked construct. A clinical update will be provided on ART621, which displays IgG-like pharmacokinetic behavior in humans, has completed testing in a phase II psoriasis trial and is currently in two phase II rheumatoid arthritis trials.
David S. Wilson, Ph.D., Vice President, Research & Development, Arana Therapeutics Ltd.
Domain antibodies (dAbs) offer potential for enhanced stability, production yields, tissue penetration and formatting flexibility, and reduced immunogenicity compared with IgG's. Combinatorial methods were used to develop a potent TNF-alpha-neutralizing dAb that was then formatted into a bivalent Fc-linked construct. A clinical update will be provided on ART621, which displays IgG-like pharmacokinetic behavior in humans, has completed testing in a phase II psoriasis trial and is currently in two phase II rheumatoid arthritis trials.
David S. Wilson, Ph.D., Vice President, Research & Development, Arana Therapeutics Ltd.
11:15
Antibody for Infectious Disease
This abstract was not available at the time of printing the brochure.
Teresa Parli, M.D., Medical Director, KaloBios Pharmaceuticals Inc.
This abstract was not available at the time of printing the brochure.
Teresa Parli, M.D., Medical Director, KaloBios Pharmaceuticals Inc.
11:45
Close of Antibody Therapeutics Meeting; Delegates are Invited to Attend the Afternoon Session of Antibody Engineering
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