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目錄下載(PDF)
產業會議彙總曆
CSS
7:00
Registration, Networking Coffee
7:45
Announcements
Session I: 治療抗體25年的過程：過去的經驗和今後的課題
7:50
Chairperson's Opening Remarks
Rathin C. Das, Ph.D., Chief Executive Officer, Synergys Biotherapeutics, Inc.
Rathin C. Das, Ph.D., Chief Executive Officer, Synergys Biotherapeutics, Inc.
Keynote Presentions
8:00
Angiogenesis, Avastin and Beyond
This abstract was not available at the time of printing the brochure.
Napoleone Ferrara, Ph.D., Genentech Fellow, Tumor Biology and Angiogenesis, Genentech, Inc.
This abstract was not available at the time of printing the brochure.
Napoleone Ferrara, Ph.D., Genentech Fellow, Tumor Biology and Angiogenesis, Genentech, Inc.
8:45
From Mouse Embryos to Antibody Therapies
Human antibody expression from mice engineered with germline configuration human immunoglobulin transgenes was reported at the 1991 IBC Antibody Engineering conference. In the intervening 20 years, the FDA has approved seven therapeutic antibodies derived from transgenic mice. These approved drugs are indicated for a variety of disease areas including rheumatology, bone metabolism, and cancer. The history of this drug discovery platform will be reviewed, and new applications discussed.
Nils Lonberg, Ph.D., Senior Vice President, Bristol-Myers Squibb
Human antibody expression from mice engineered with germline configuration human immunoglobulin transgenes was reported at the 1991 IBC Antibody Engineering conference. In the intervening 20 years, the FDA has approved seven therapeutic antibodies derived from transgenic mice. These approved drugs are indicated for a variety of disease areas including rheumatology, bone metabolism, and cancer. The history of this drug discovery platform will be reviewed, and new applications discussed.
Nils Lonberg, Ph.D., Senior Vice President, Bristol-Myers Squibb
9:30
Networking Refreshment Break, Exhibit and Poster Viewing
10:15
Maytansinoid Antibody Conjugates
Conjugation of antibodies to highly potent cytotoxic payloads to create ADCs offers a strategy for developing anti-cancer drugs of great promise. Several antibody-maytansinoid conjugates have shown encouraging activity in clinical trials. The presentation will focus on considerations in designing highly effective, well-tolerated ADCs, from target selection to factors influencing the selection of each ADC component. Examples will be drawn from the newest AMCs in early development.
John Lambert, Ph.D., Executive Vice President, and Chief Scientific Officer, ImmunoGen, Inc.
Conjugation of antibodies to highly potent cytotoxic payloads to create ADCs offers a strategy for developing anti-cancer drugs of great promise. Several antibody-maytansinoid conjugates have shown encouraging activity in clinical trials. The presentation will focus on considerations in designing highly effective, well-tolerated ADCs, from target selection to factors influencing the selection of each ADC component. Examples will be drawn from the newest AMCs in early development.
John Lambert, Ph.D., Executive Vice President, and Chief Scientific Officer, ImmunoGen, Inc.
10:45
CD20 Antibody Therapy: Learning from the Past for an Improved Future
CD20 arguably represents the strongest validated target for immunotherapy. While standard rituximab immunotherapy continues to have a major impact on the lives of patients with B-cell malignancies and autoimmune disease, novel CD20 antibodies with enhanced or distinct mechanisms of action are being developed to achieve even higher and broader efficacy. Examples include ofatumumab, displaying improved CD20 binding, CDC and ADCC, and afutuzumab, which instead relies on ADCC and apoptosis induction. Novel developments drawing from past experience will be discussed.
Paul Parren, Ph.D., Senior Vice President and Scientific Director, Genmab, The Netherlands
CD20 arguably represents the strongest validated target for immunotherapy. While standard rituximab immunotherapy continues to have a major impact on the lives of patients with B-cell malignancies and autoimmune disease, novel CD20 antibodies with enhanced or distinct mechanisms of action are being developed to achieve even higher and broader efficacy. Examples include ofatumumab, displaying improved CD20 binding, CDC and ADCC, and afutuzumab, which instead relies on ADCC and apoptosis induction. Novel developments drawing from past experience will be discussed.
Paul Parren, Ph.D., Senior Vice President and Scientific Director, Genmab, The Netherlands
11:15
The Antibody as a Therapeutic: Once and Future King?
With global sales reaching $50 billion, antibodies are clearly successful as therapeutics. Innovation in biological engineering in the 2000s led to the creation of a wide variety of antibody formats, but whether these new formats will be as successful as classical IgGs remains to be seen. Dr. Reichert will discuss lessons learned and the challenges ahead for generating clinically successful antibodies. The outlook and strategies for next-generation antibodies, including those for non-traditional indications such as CNS disorders, will be presented.
Janice Reichert, Ph.D., Research Assistant Professor and Senior Research Fellow, Tufts Center for the Study of Drug Development
With global sales reaching $50 billion, antibodies are clearly successful as therapeutics. Innovation in biological engineering in the 2000s led to the creation of a wide variety of antibody formats, but whether these new formats will be as successful as classical IgGs remains to be seen. Dr. Reichert will discuss lessons learned and the challenges ahead for generating clinically successful antibodies. The outlook and strategies for next-generation antibodies, including those for non-traditional indications such as CNS disorders, will be presented.
Janice Reichert, Ph.D., Research Assistant Professor and Senior Research Fellow, Tufts Center for the Study of Drug Development
Technology Workshops
11:45
Data from clinical studies show that one of the major issues with the use of therapeutic antibodies is the development of an anti-therapeutic antibody response. Such responses have been observed in many patients treated with anti-TNFα and α4β7-integrin antibodies for RA and IBS, as well as with antibodies and conjugates for various cancers. Data will be presented providing evidence linking the presence of T cell epitopes in the sequences of therapeutic antibodies with immunogenicity observed in patients as well as how antibodies can be engineered to avoid T cell epitopes.
Matthew Baker, Ph.D., Chief Scientific Officer, Co-Founder, Antitope Ltd
Fynomers represent a new class of binding molecules based on the human Fyn SH3 domain. We will provide examples of the broad applicability of the Fynomer technology, show novel Fynomer formats and present in vitro and in vivo data from our IL-17 program.
Speaker TBA, Covagen AG, Switzerland
Open Monoclonal Technology, Inc. ("OMT") is a private, California-based biotechnology company, that developed a fully human monoclonal antibody (mAb) platform based on transgenic rats. This new technology is the result of breakthroughs in the understanding of B-cell development and a novel approach to the inactivation of endogenous antibody expression. OMT's antibody platform has broad freedom to operate and uses technology protected by a new patent application.
Roland Buelow, Ph.D., Chief Executive Officer, Open Monoclonal Technology, Inc.
12:15
Networking Luncheon, Exhibit and Poster Viewing and NEW Antibody Platform Showcase
Technology Workshops
1:45
The ability to identify high affinity antibodies from Dyax's antibody phage display libraries has been demonstrated in over 70 selection campaigns, including dozens of therapeutic programs. The selection and screening of the library can be completed in days and the output of binders characterized in weeks. Here we will present a case study from Dyax's internal discovery pipeline that illustrates selection strategies and potency of the identified antibodies.
Andrew E. Nixon, Ph.D., Vice President, Lead Discovery & Biochemistry, Dyax
During antibody development, generation of high quality binding interaction data is essential for identifying antibodies with potential therapeutic use. However, many challenges can occur throughout the screening and characterization phase of development. Such challenges include the analyses of target antigen proteins with a propensity for nonspecific binding and the analyses of large numbers of unpurified antibody supernatant samples. Here, we will discuss how different label-free interaction analysis platforms are used to overcome these various challenges and how they can facilitate the identification and characterization of potential therapeutic antibodies.
Matthew C. Blome, Ph.D., Scientist, Therapeutic Proteins, Regeneron Pharmaceuticals, Inc.
κλ-Bodies are unmodified fully human bispecific IgGs. In contrast to existing engineered formats, κλ -Bodies are unique in offering the typical functional and biochemical characteristics of a human antibody. A streamlined platform approach for the identification, production and characterization of κλ -Bodies will be demonstrated.
Greg Elson, Head of Manufacturing, Novimmune SA, Switzerland
2:15
Announcements
Session II: 抗體治療前臨床及初期階段的開發
2:20
Chairperson's Opening Remarks
Benjamin P. Chen, Ph.D., International Director, Burrill & Company
Benjamin P. Chen, Ph.D., International Director, Burrill & Company
2:30
Development of Tanibirumab™, Anti-KDR Neutralizing Fully Human Antibody and Next Generation DIG-bodies™ and PIG-bodies™
I will present our preclinical data of anti-KDR neutralizing fully human IgG1, Tanibirumab, which has cross-species cross reactivity, and discuss our recent progress with dual target neutralizing multifunctional Ig like next generation protein therapeutics, DIG-KT (KDR & Tie2) from the DIG-bodies platform, and PIG-KM (KDR & cMET) from the PIG-bodies platform.
Jin-San Yoo, Ph.D., Chief Executive Officer and President, PharmAbcine, Inc., Korea
I will present our preclinical data of anti-KDR neutralizing fully human IgG1, Tanibirumab, which has cross-species cross reactivity, and discuss our recent progress with dual target neutralizing multifunctional Ig like next generation protein therapeutics, DIG-KT (KDR & Tie2) from the DIG-bodies platform, and PIG-KM (KDR & cMET) from the PIG-bodies platform.
Jin-San Yoo, Ph.D., Chief Executive Officer and President, PharmAbcine, Inc., Korea
3:00
Leveraging the Human Immune System to Combat Infectious Diseases
The human immune repertoire contains an immense untapped supply of therapeutically useful antibodies. Best in class antibodies are rare and hard to find. We have examined tens of millions of individual non-transformed B cells using a microscopic multiplexed assay and discovered picomolar affinity native mAbs with exquisite specificity and potency. Clinical lead antibodies for three infectious disease targets including RSV, CMV and Influenza will be highlighted in this talk.
Bill Usinger, Ph.D., Vice President Research & Development, Trellis Bioscience, Inc.
The human immune repertoire contains an immense untapped supply of therapeutically useful antibodies. Best in class antibodies are rare and hard to find. We have examined tens of millions of individual non-transformed B cells using a microscopic multiplexed assay and discovered picomolar affinity native mAbs with exquisite specificity and potency. Clinical lead antibodies for three infectious disease targets including RSV, CMV and Influenza will be highlighted in this talk.
Bill Usinger, Ph.D., Vice President Research & Development, Trellis Bioscience, Inc.
3:30
Sensitizing Insulin Receptor Antibody Potentiates Insulin Activity and Restores Glycemic Control in Murine Models of Diabetes
This abstract was not available at the time of printing the brochure.
John Corbin, Ph.D., Associate Director, Preclinical Research, XOMA (US) LLC
This abstract was not available at the time of printing the brochure.
John Corbin, Ph.D., Associate Director, Preclinical Research, XOMA (US) LLC
4:00
Networking Refreshment Break, Exhibit and Poster Viewing
4:45
Preclinical and Clinical Developments of Targeted Therapeutics in Malignant, Autoimmune, and Infectious Diseases
The Dock-and-Lock (DNL) platform enables the design and generation of targetable therapeutics that are multivalent, multispecific and multifunctional. Since its invention in 2005, the versatility of the DNL approach has been validated in a variety of novel agents that include trivalent and hexavalent bispecific antibodies, PEGylated dimeric interferon-α2b, immunocytokines, and immunoRNases, all of which display the properties desirable for pharmaceutical applications. The advances of select DNL products currently in development will be presented.
Ken Chang, Ph.D., Vice President, Research & Development, Immunomedics, Inc.
The Dock-and-Lock (DNL) platform enables the design and generation of targetable therapeutics that are multivalent, multispecific and multifunctional. Since its invention in 2005, the versatility of the DNL approach has been validated in a variety of novel agents that include trivalent and hexavalent bispecific antibodies, PEGylated dimeric interferon-α2b, immunocytokines, and immunoRNases, all of which display the properties desirable for pharmaceutical applications. The advances of select DNL products currently in development will be presented.
Ken Chang, Ph.D., Vice President, Research & Development, Immunomedics, Inc.
5:15
Characterizing the Activity and Safety of Probody™ Therapeutics in Animal Models of Disease
CytomX Therapeutics has devised a novel approach to address the toxicity of antibodies that recognize target antigens in both diseased and normal tissues. The antigen-combining site of a conventional antibody is blocked with a masking peptide, which can be released by the action of endogenous proteases that are preferentially localized or overexpressed in diseased tissue. By virtue of their protease-regulated antigen binding, these molecules have the potential for reduced mechanism-based toxicities, improved pharmacokinetics and increased therapeutic indices.
Henry Lowman, Ph.D., Vice President, Research, CytomX Therapeutics, Inc.
CytomX Therapeutics has devised a novel approach to address the toxicity of antibodies that recognize target antigens in both diseased and normal tissues. The antigen-combining site of a conventional antibody is blocked with a masking peptide, which can be released by the action of endogenous proteases that are preferentially localized or overexpressed in diseased tissue. By virtue of their protease-regulated antigen binding, these molecules have the potential for reduced mechanism-based toxicities, improved pharmacokinetics and increased therapeutic indices.
Henry Lowman, Ph.D., Vice President, Research, CytomX Therapeutics, Inc.
5:45
Discovery by SLAM Technology and Characterization of XMAb55, a Fully Human mAb as a Potential Cancer Therapeutic
This abstract was not available at the time of printing the brochure.
Josh Xiao, Ph.D., Principal Scientist, Oncology Research, Amgen, Inc.
This abstract was not available at the time of printing the brochure.
Josh Xiao, Ph.D., Principal Scientist, Oncology Research, Amgen, Inc.
6:15
Networking Cocktail Reception, Exhibit and Poster Viewing
7:30
Registration, Networking Coffee
8:00
Announcements
Session III: 下一代抗血管新生治療
8:05
Chairperson's Opening Remarks
Philip E. Thorpe, Ph.D., Professor of Pharmacology and The Serena S. Simmons Distinguished Chair, University of Texas Southwestern
Philip E. Thorpe, Ph.D., Professor of Pharmacology and The Serena S. Simmons Distinguished Chair, University of Texas Southwestern
8:15
Ramucirumab: The Next Avastin?
Attempts to inhibit angiogenesis have been a hallmark in the age of biologic anticancer therapies. Vascular endothelial growth factor receptor-2 (VEGFR-2) is the premier receptor responsible for many of the cancer-driven vascular endothelial growth factor induced modifications of blood vessel structure and function. Unlike all clinically approved angiogenesis inhibitors, ramucirumab specifically and potently inhibits VEGFR-2. Early clinical trials have shown safety across a range of ramucirumab doses with impressive anticancer activity. The clinical development of ramucirumab and ongoing trial data will be presented.
Jennifer Spratlin, Ph.D., Assistant Professor, Medical Oncology, Cross Cancer Institute, Canada
Attempts to inhibit angiogenesis have been a hallmark in the age of biologic anticancer therapies. Vascular endothelial growth factor receptor-2 (VEGFR-2) is the premier receptor responsible for many of the cancer-driven vascular endothelial growth factor induced modifications of blood vessel structure and function. Unlike all clinically approved angiogenesis inhibitors, ramucirumab specifically and potently inhibits VEGFR-2. Early clinical trials have shown safety across a range of ramucirumab doses with impressive anticancer activity. The clinical development of ramucirumab and ongoing trial data will be presented.
Jennifer Spratlin, Ph.D., Assistant Professor, Medical Oncology, Cross Cancer Institute, Canada
8:45
Clinical Development of an Antibody to Sema4D, a Multifunctional Target in Cancer and Multiple Sclerosis
Semaphorin 4D (SEMA4D/CD100) regulates cell migration in multiple tissues including activation of endothelial cells for neo-vascularization and of epithelial cells to promote tumor invasion and metastasis. In neuronal tissues, SEMA4D negatively regulates the survival and migration of neuronal precursors and of pre-myelinating oligodendrocytes while promoting activation of neuroinflammatory microglia. Vaccinex initiated a Phase I clinical trial in patients with advanced solid tumors in February 2011 and plans to submit an IND for a second trial in MS patients in early 2012.
Maurice Zauderer, Ph.D., President & Chief Executive Officer, Vaccinex, Inc
Semaphorin 4D (SEMA4D/CD100) regulates cell migration in multiple tissues including activation of endothelial cells for neo-vascularization and of epithelial cells to promote tumor invasion and metastasis. In neuronal tissues, SEMA4D negatively regulates the survival and migration of neuronal precursors and of pre-myelinating oligodendrocytes while promoting activation of neuroinflammatory microglia. Vaccinex initiated a Phase I clinical trial in patients with advanced solid tumors in February 2011 and plans to submit an IND for a second trial in MS patients in early 2012.
Maurice Zauderer, Ph.D., President & Chief Executive Officer, Vaccinex, Inc
9:15
Targeting the Extracellular Matrix of Angiogenic Vasculature
Antibodies can be used to deliver bioactive molecules to the tumor environment, thus sparing normal tissues. The targeting of tumour neo-vasculature is particularly attractive, because of the dependence of cancer on new blood vessels and because of the accessibility of these structures from the bloodstream. In this lecture, I will present recent clinical results, obtained in collaboration with the Philogen group, using derivatives of three human monoclonal antibodies, specific to components of the sub-endothelial extracellular matrix of angiogenic vasculature in cancer and in arthritis.
Dario Neri, Ph.D., Professor, Chemistry and Applied Biosciences, ETH Zurich, Switzerland
Antibodies can be used to deliver bioactive molecules to the tumor environment, thus sparing normal tissues. The targeting of tumour neo-vasculature is particularly attractive, because of the dependence of cancer on new blood vessels and because of the accessibility of these structures from the bloodstream. In this lecture, I will present recent clinical results, obtained in collaboration with the Philogen group, using derivatives of three human monoclonal antibodies, specific to components of the sub-endothelial extracellular matrix of angiogenic vasculature in cancer and in arthritis.
Dario Neri, Ph.D., Professor, Chemistry and Applied Biosciences, ETH Zurich, Switzerland
9:45
Networking Refreshment Break, Exhibit and Poster Viewing
10:30
Targeting Tumor Vasculature and Reactivating Tumor Immunity with Bavituximab: Preclinical and Clinical Studies
Bavituximab is a therapeutic monoclonal antibody that is in randomized clinical trials in lung cancer and pancreatic cancer patients. It targets the immunosuppressive lipid, phosphatidylserine, which becomes exposed on tumor blood vessels and tumor cells. Bavituximab causes MDSCs to differentiate into tumoricidal M1 macrophages that destroy the tumor vasculature and tumor cells by ADCC. It also causes immature dendritic cells in tumors to mature and present tumor antigens, resulting in the generation of tumor-specific cytotoxic T-cells.
Philip E. Thorpe, Ph.D., Professor of Pharmacology and The Serena S. Simmons Distinguished Chair, University of Texas Southwestern
Bavituximab is a therapeutic monoclonal antibody that is in randomized clinical trials in lung cancer and pancreatic cancer patients. It targets the immunosuppressive lipid, phosphatidylserine, which becomes exposed on tumor blood vessels and tumor cells. Bavituximab causes MDSCs to differentiate into tumoricidal M1 macrophages that destroy the tumor vasculature and tumor cells by ADCC. It also causes immature dendritic cells in tumors to mature and present tumor antigens, resulting in the generation of tumor-specific cytotoxic T-cells.
Philip E. Thorpe, Ph.D., Professor of Pharmacology and The Serena S. Simmons Distinguished Chair, University of Texas Southwestern
11:00
Identification of Pathways Involved in Resistance to Antibody Mediated Inhibition of VEGF in Murine Models of Cancer
Neutralizing antibodies to VEGF-A augment the activity of standard therapy in multiple tumor types. However, the variability in the response of different tumors to anti-VEGF therapy suggests that the mechanism of anti-VEGF action is complex and that resistance commonly develops. We have evaluated the response of 12 NSCLC xenografts to the anti-VEGF mAbs, bevacizumab and r84 (AT001), and have identified responder and non-responder cell lines. The biology has been interrogated through mRNA and protein profiling techniques linking particular genes/proteins to the resistance phenotype.
Rolf A. Brekken, Ph.D., Associate Professor of Surgery & Pharmacology, University of Texas Southwestern Medical Center
Neutralizing antibodies to VEGF-A augment the activity of standard therapy in multiple tumor types. However, the variability in the response of different tumors to anti-VEGF therapy suggests that the mechanism of anti-VEGF action is complex and that resistance commonly develops. We have evaluated the response of 12 NSCLC xenografts to the anti-VEGF mAbs, bevacizumab and r84 (AT001), and have identified responder and non-responder cell lines. The biology has been interrogated through mRNA and protein profiling techniques linking particular genes/proteins to the resistance phenotype.
Rolf A. Brekken, Ph.D., Associate Professor of Surgery & Pharmacology, University of Texas Southwestern Medical Center
11:30
Antibody-Endostatin Fusion Proteins for Treatment of Solid Tumors
We have developed anti-HER2 antibody-endostatin fusion proteins with greater anti-tumor activity due to longer half-life, endostatin presentation as a dimer and improved tumor targeting compared to anti-HER2 antibody or endostatin alone or in combination. We have generated two anti-HER2 human endostatin fusion proteins by fusing wild type or mutant human forms of endostatin with enhanced anti-angiogenic properties fused to a humanized anti-HER2 IgG3 antibody. We plan to initiate GMP production of a candidate fusion protein to permit toxicology testing and Phase I clinical trials in man.
Joseph D. Rosenblatt, M.D., William Harrington Professor of Medicine, Microbiology and Immunology, University of Miami School of Medicine
We have developed anti-HER2 antibody-endostatin fusion proteins with greater anti-tumor activity due to longer half-life, endostatin presentation as a dimer and improved tumor targeting compared to anti-HER2 antibody or endostatin alone or in combination. We have generated two anti-HER2 human endostatin fusion proteins by fusing wild type or mutant human forms of endostatin with enhanced anti-angiogenic properties fused to a humanized anti-HER2 IgG3 antibody. We plan to initiate GMP production of a candidate fusion protein to permit toxicology testing and Phase I clinical trials in man.
Joseph D. Rosenblatt, M.D., William Harrington Professor of Medicine, Microbiology and Immunology, University of Miami School of Medicine
Technology Workshop
12:00
This abstract was not available at the time of printing the brochure.
Speaker TBA
12:30
Networking Luncheon, Last Chance for Exhibit and Poster Viewing
2:00
Announcements
Session VI: 臨床階段抗體治療的最新資訊
2:05
Chairperson's Opening Remarks
Mark R. Alfenito, Ph.D., President & CEO, EnGen Bio, Inc.
Mark R. Alfenito, Ph.D., President & CEO, EnGen Bio, Inc.
2:15
BiTE Antibody Blinatumomab for the Treatment of Acute Lymphocytic Leukemia
Blinatumomab is a CD19/CD3-bispecific BiTE antibody construct capable of engaging patients' T cells for lysis of CD19-expressing target cells. Exceptional response rates and encouraging response durations have been observed in patients with relapsed/refractory ALL and minimal residual ALL following single-agent treatment with the BiTE antibody. An update on the development of blinatumomab will be given.
Patrick A. Baeuerle, Ph.D., Senior Vice President and Chief Scientific Officer, Micromet, Inc.
Blinatumomab is a CD19/CD3-bispecific BiTE antibody construct capable of engaging patients' T cells for lysis of CD19-expressing target cells. Exceptional response rates and encouraging response durations have been observed in patients with relapsed/refractory ALL and minimal residual ALL following single-agent treatment with the BiTE antibody. An update on the development of blinatumomab will be given.
Patrick A. Baeuerle, Ph.D., Senior Vice President and Chief Scientific Officer, Micromet, Inc.
2:45
Encapsulated Cell Technology: A New Therapy for Biologics Delivery
Encapsulated Cell Technology (ECT) implants are miniature bioreactors that continuously secrete biologics into the patient. ECT implants can produce a variety of biologics such as Mab, Fab, ScFv, Fc-proteins and cytokines. When implanted into the eye, ECT biologics are secreted at therapeutic levels for up to two years. Phase 2 data will be presented summarizing clinical outcomes involving ECT treatment of patients with dry AMD and Retinitis Pigmentosa.
Vincent Ling, Ph.D., Head of Biological Sciences, Neurotech
Encapsulated Cell Technology (ECT) implants are miniature bioreactors that continuously secrete biologics into the patient. ECT implants can produce a variety of biologics such as Mab, Fab, ScFv, Fc-proteins and cytokines. When implanted into the eye, ECT biologics are secreted at therapeutic levels for up to two years. Phase 2 data will be presented summarizing clinical outcomes involving ECT treatment of patients with dry AMD and Retinitis Pigmentosa.
Vincent Ling, Ph.D., Head of Biological Sciences, Neurotech
3:15
Olokizumab (CDP6038) - A Highly Potent Anti-IL-6 Inhibitor with a Novel Mechanism of Action
Olokizumab is an anti-IL-6 monoclonal antibody currently in Phase 2b clinical development in inflammatory arthritis. Olokizumab binds to IL-6 with high affinity and it is the first in a new class of IL-6 inhibitors that selectively blocks the final assembly of the IL-6 signaling complex. This talk will focus on the mode of action of olokizumab, with emphasis on the results of studies performed in whole blood assays in vitro, in pre-clinical models in vivo, and from Phase 1 clinical studies.
Roger Palframan Ph.D., Global Project Leader, UCB, United Kingdom
Olokizumab is an anti-IL-6 monoclonal antibody currently in Phase 2b clinical development in inflammatory arthritis. Olokizumab binds to IL-6 with high affinity and it is the first in a new class of IL-6 inhibitors that selectively blocks the final assembly of the IL-6 signaling complex. This talk will focus on the mode of action of olokizumab, with emphasis on the results of studies performed in whole blood assays in vitro, in pre-clinical models in vivo, and from Phase 1 clinical studies.
Roger Palframan Ph.D., Global Project Leader, UCB, United Kingdom
3:45
Networking Refreshment Break
4:15
MLN0264, an Investigational Antibody Drug Conjugate (ADC) for the Treatment of Colorectal Cancer
MLN0264 is an investigational ADC targeting guanylyl cyclase C (GCC) a protein expressed on normal and malignant intestinal epithelial cells. The drug consists of a selective fully human mAb to GCC conjugated to the cytotoxic agent MMAE via a cleavable linker. MLN0264 targets malignant colon tumor cells but not normal GCC expressing tissues. MLN0264 is a promising new drug for the treatment of mCRC and other GCC expressing malignancies.
Petter Veiby, Ph.D., Director, Molecular and Cellular Oncology, Millennium Pharmaceuticals
MLN0264 is an investigational ADC targeting guanylyl cyclase C (GCC) a protein expressed on normal and malignant intestinal epithelial cells. The drug consists of a selective fully human mAb to GCC conjugated to the cytotoxic agent MMAE via a cleavable linker. MLN0264 targets malignant colon tumor cells but not normal GCC expressing tissues. MLN0264 is a promising new drug for the treatment of mCRC and other GCC expressing malignancies.
Petter Veiby, Ph.D., Director, Molecular and Cellular Oncology, Millennium Pharmaceuticals
4:45
Exploiting the Mechanistic Advantages of Antibody Mixtures to Develop Novel Cancer Drugs
Mixtures of antibodies with non-overlapping epitopes offer a number of mechanistic advantages over mAbs including improved receptor downregulation, more efficient blocking of ligand-receptor interaction and increased activation of cdc. In addition, mAb mixtures have the ability to address multiple cell surface receptors and/or ligands. Historical evidence as well as results from Symphogen pre-clinical and clinical stage antibody mixtures will be highlighted in this talk to demonstrate mechanistic advantages of mAb mixtures. Discussed targets will include EGFR, HER2 and CD5.
Mikkel Pedersen, Ph.D., Principal Scientist and Project Manager, Antibody Pharmacology, Symphogen, Denmark
Mixtures of antibodies with non-overlapping epitopes offer a number of mechanistic advantages over mAbs including improved receptor downregulation, more efficient blocking of ligand-receptor interaction and increased activation of cdc. In addition, mAb mixtures have the ability to address multiple cell surface receptors and/or ligands. Historical evidence as well as results from Symphogen pre-clinical and clinical stage antibody mixtures will be highlighted in this talk to demonstrate mechanistic advantages of mAb mixtures. Discussed targets will include EGFR, HER2 and CD5.
Mikkel Pedersen, Ph.D., Principal Scientist and Project Manager, Antibody Pharmacology, Symphogen, Denmark
5:15
Clinical Development of SGN-35
This abstract was not available at the time of printing the brochure.
Naomi Hunder, M.D., Medical Director, Seattle Genetics
This abstract was not available at the time of printing the brochure.
Naomi Hunder, M.D., Medical Director, Seattle Genetics
5:45
Close of Session
7:30
Networking Coffee
8:00
Announcements
Session V: 藥物複合體和雙重特異性抗體
8:05
Chairperson's Opening Remarks
Trudi Veldman, Ph.D., Director, Biologics Generation, Abbott Bioresearch Center
Trudi Veldman, Ph.D., Director, Biologics Generation, Abbott Bioresearch Center
8:15
Translational Studies of PSMA ADC, a Fully Human Anti-PSMA Monoclonal Antibody Linked to vcMMAE
Prostate-specific membrane antigen (PSMA) exhibits a unique pattern of expression that is dependent upon the cancer type. In prostate cancer, PSMA is expressed on neoplastic cells but not on the neovasculature, while in several non-prostatic cancers, PSMA is expressed on the neovasculature but not on neoplastic cells. Here we describe translational studies of PSMA ADC, including preclinical efficacy studies and preliminary tolerability and efficacy findings from an ongoing phase 1 dose-escalation study in advanced prostate cancer.
William C. Olson, Ph.D., Senior Vice President, Research & Development, Progenics Pharmaceuticals, Inc.
Prostate-specific membrane antigen (PSMA) exhibits a unique pattern of expression that is dependent upon the cancer type. In prostate cancer, PSMA is expressed on neoplastic cells but not on the neovasculature, while in several non-prostatic cancers, PSMA is expressed on the neovasculature but not on neoplastic cells. Here we describe translational studies of PSMA ADC, including preclinical efficacy studies and preliminary tolerability and efficacy findings from an ongoing phase 1 dose-escalation study in advanced prostate cancer.
William C. Olson, Ph.D., Senior Vice President, Research & Development, Progenics Pharmaceuticals, Inc.
8:45
Clinical Development of CDX-011, an Antibody-Drug Conjugate Targeting Glycoprotein NMB (GPNMB) for the Treatment of Metastatic Breast Cancer and Advanced Melanoma
CDX-011 is an ADC comprised of a human IgG2 antibody conjugated to MMAE that targets a novel cell surface protein GPNMB. GPNMB is expressed on an assortment of malignancies including breast cancer, glioma, melanoma and hematologic malignancies. It is associated with invasion and immune evasion. Initial clinical studies have defined a tolerable phase 2 dose and shown significant disease control with tumor shrinkage in a majority of patients with heavily pretreated breast cancer and melanoma. Objective responses have been seen in GPNMB expressing disease including triple negative BRCA. A randomized phase 2 study in breast cancer is ongoing.
Tom Davis, M.D., Chief Medical Officer, Senior Vice President of Clinical Development, Celldex Therapeutics
CDX-011 is an ADC comprised of a human IgG2 antibody conjugated to MMAE that targets a novel cell surface protein GPNMB. GPNMB is expressed on an assortment of malignancies including breast cancer, glioma, melanoma and hematologic malignancies. It is associated with invasion and immune evasion. Initial clinical studies have defined a tolerable phase 2 dose and shown significant disease control with tumor shrinkage in a majority of patients with heavily pretreated breast cancer and melanoma. Objective responses have been seen in GPNMB expressing disease including triple negative BRCA. A randomized phase 2 study in breast cancer is ongoing.
Tom Davis, M.D., Chief Medical Officer, Senior Vice President of Clinical Development, Celldex Therapeutics
9:15
Preclinical Updates for BAY 94-9343, a Mesothelin-Targeting ADC, and BAY 79-4620, a CA9-Targeted ADC
This presentation summarizes comprehensive preclinical data sets on two novel antibody drug conjugates both consisting of fully human monoclonal antibodies coupled to microtubule-targeting toxophores. BAY 79-4620, currently in Phase I clinical development, is directed against carbonic anhydrase IX (CA9), a hypoxia-inducible protein whose expression correlates with poor prognosis in multiple cancers. BAY 94-9343 is targeting Mesothelin, which is found overexpressed in all mesotheliomas as well as in ovarian and pancreatic cancers.
Bertolt Kreft, Ph.D., Director, Targeted Biological Therapeutics, Oncology Research, Bayer Schering Pharma AG, Germany
This presentation summarizes comprehensive preclinical data sets on two novel antibody drug conjugates both consisting of fully human monoclonal antibodies coupled to microtubule-targeting toxophores. BAY 79-4620, currently in Phase I clinical development, is directed against carbonic anhydrase IX (CA9), a hypoxia-inducible protein whose expression correlates with poor prognosis in multiple cancers. BAY 94-9343 is targeting Mesothelin, which is found overexpressed in all mesotheliomas as well as in ovarian and pancreatic cancers.
Bertolt Kreft, Ph.D., Director, Targeted Biological Therapeutics, Oncology Research, Bayer Schering Pharma AG, Germany
9:45
Networking Refreshment Break
10:15
Rethinking Therapy of HER2-positive Cancers: MM-111 and MM-302
We have designed two novel experimental therapeutics for HER2-positive cancers to be effective also in patients refractory to current therapies. One is a bispecific antibody inhibitor of ErbB3 (MM-111); the other an ErbB2-directed nanotherapeutic (MM-302) that delivers doxorubicin directly into tumor cells. We will discuss our experience with these molecules from discovery through currently ongoing Phase 1/2 clinical trials.
Ulrik Nielsen, Ph.D., Chief Scientific Officer, Merrimack Pharmaceuticals
We have designed two novel experimental therapeutics for HER2-positive cancers to be effective also in patients refractory to current therapies. One is a bispecific antibody inhibitor of ErbB3 (MM-111); the other an ErbB2-directed nanotherapeutic (MM-302) that delivers doxorubicin directly into tumor cells. We will discuss our experience with these molecules from discovery through currently ongoing Phase 1/2 clinical trials.
Ulrik Nielsen, Ph.D., Chief Scientific Officer, Merrimack Pharmaceuticals
10:45
A Bispecific Antibody Effectively Inhibits Tumor Growth and Metastasis by Simultaneous Blocking Vascular Endothelial Growth Factor A and Osteopontin
We engineered a bispicific antibody(VEGF/OPN-BsAb) using the humanized anti-VEGF antibody bevacizumab and the humanized anti-OPN antibody hu1A12. Compared with either hu1A12 or bevacizumab alone, VEGF/OPN-BsAb was significantly more effective in inhibiting tumor angiogenesis in a highly metastatic human hepatocellular carcinoma nude mouse model. Further study demonstrated that it could effectively suppress primary tumor growth and metastasis to lungs, suggesting that it might be a promising therapeutic agent for treatment of metastatic cancer.
Yajun Guo M.D., Ph.D., Professor and Director, SMMU Cancer Institute, China
We engineered a bispicific antibody(VEGF/OPN-BsAb) using the humanized anti-VEGF antibody bevacizumab and the humanized anti-OPN antibody hu1A12. Compared with either hu1A12 or bevacizumab alone, VEGF/OPN-BsAb was significantly more effective in inhibiting tumor angiogenesis in a highly metastatic human hepatocellular carcinoma nude mouse model. Further study demonstrated that it could effectively suppress primary tumor growth and metastasis to lungs, suggesting that it might be a promising therapeutic agent for treatment of metastatic cancer.
Yajun Guo M.D., Ph.D., Professor and Director, SMMU Cancer Institute, China
11:15
Modulation of the Interkeukin-1 Axis for arthritis using DVD-Ig™ Technology
IL-1α and IL-1β play a critical role in the pathogenesis of rheumatoid arthritis (RA) and osteoarthritis (OA). Neutralization of both IL-1α and IL-1β either with a combination of IL-1α and IL-1β mAbs or murine IL-1α/β DVD-Ig™ is required for optimal efficacy in rodent models of arthritis. Based on preclinical studies, human IL-1α/β DVD-Igs™ with drug-like properties were constructed and characterized in vitro and in vivo.
Susan Lacy, Ph.D., Associate Director, Biologics, Abbott Bioresearch Center
IL-1α and IL-1β play a critical role in the pathogenesis of rheumatoid arthritis (RA) and osteoarthritis (OA). Neutralization of both IL-1α and IL-1β either with a combination of IL-1α and IL-1β mAbs or murine IL-1α/β DVD-Ig™ is required for optimal efficacy in rodent models of arthritis. Based on preclinical studies, human IL-1α/β DVD-Igs™ with drug-like properties were constructed and characterized in vitro and in vivo.
Susan Lacy, Ph.D., Associate Director, Biologics, Abbott Bioresearch Center
11:45
Close of Antibody Therapeutics Meeting; Delegates are Invited to Attend the Afternoon Session of Antibody Engineering
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