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Day One Tuesday, December 9, 2008 | DAY ONE | DAY TWO | DAY THREE | | |
| 7:00 | Registration, Networking Coffee |
| 7:45 | Announcements |
| Session I: Preclinical Development of Antibody Therapeutics | |
| 7:50 | Chairperson's Opening Remarks Rathin C. Das, Ph.D., Chief Business Officer, President, Affitech AS/Affitech USA, Inc. |
| 8:00 | Challenges in Preclinical Development of Monoclonal Antibodies One of the challenges facing antibody development in oncology is the reactivity of the antibody to target antigens in preclinical models. This presentation focuses on the advantages and disadvantages of different in vitro and in vivo model systems for screening antibodies; using transgenic animals and surrogate antibodies to test antibodies that lack murine cross-reactivity against the target antigen; and the utility of these model systems to understand the mechanism of action as well as pharmacodynamic readouts. Steve Coats, Ph.D., Director of Oncology Research and Development, MedImmune, Inc. |
| 8:30 | Stability-engineered IgG-like Tetravalent Antibody for Inducing Receptor-mediated Death in Leukemia Cells We have developed technology for engineering stable single-chain Fv domains that serve as building blocks for constructing IgG-like bispecific and tetravalent antibodies. A stability-engineered tetravalent antibody targeting receptors expressed on the surface of leukemia cells was developed as a potentially more potent inducer of tumor cell death. Data will be presented characterizing the stability-engineered tetravalent antibodies as well as results from studies examining the effects on tumor cell apoptosis. Scott M. Glaser, Ph.D., Director, Molecular Engineering, Biogen Idec, Inc. |
| 9:00 | Preclinical Development of the Vascular Targeting Antibody, 1N11 Phosphatidylserine (PS) becomes exposed on tumor blood vessels in response to stress conditions in the tumor microenvironment. Anti-PS antibodies have been developed that recruit immune cells that destroy tumor vasculature. The antibodies also enhance anti-tumor immunity by blocking the immunosuppressive action of PS. A chimeric anti-PS antibody, bavituximab, is being used in combination with chemotherapy to treat patients with metastatic breast cancer in Phase II trials. A fully human anti-PS antibody, 1N11, has been developed for further clinical trials. Philip E. Thorpe, Ph.D., Serena S. Simmons Distinguished Chair, University of Texas Southwestern Medical Center |
| 9:30 | Networking Refreshment Break, Exhibit and Poster Viewing |
| 10:15 | Fc-Engineering Increases the In vitro and In vivo Anti-tumor Activity of an Anti-CD19 Antibody CD19 is an excellent target for antibody-based therapies of B cell neoplasms due to its pan-B cell expression profile. To develop a highly cytotoxic anti-CD19 antibody (XmAb®5574) we employed protein engineering and increased the affinity of the Fc domain for Fc(gamma)Rs on immune effector cells. XmAb5574 displayed dramatically increased cytotoxic activity relative to the native unmodified analog in vivo and in vitro and therefore warrants further clinical evaluation. Eugene Zhukovsky, Ph.D., Associate Director, Protein Chemistry/Research, Xencor |
| 10:45 | Preclinical Development of Antibody Combinations and Bispecific Antibodies for Anticancer Therapy Combinations of antitumor antibodies may provide greater efficacy than single antibody without adding significant toxicities. However, the research and development costs of antibodies pose a significant barrier to the use of antibody combinations. An emerging alternative is the use of dual-targeting bispecific antibodies (BsAb) that target simultaneously two tumor-associated antigens, thus providing a means of delivering two therapeutic moieties in one molecule. The rationales and biology of developing antibody combination and BsAb therapies will be discussed. Zhenping Zhu, M.D., Ph.D., Vice President, Antibody Technology and Immunology, ImClone Systems Incorporated |
| 11:15 | Blinatumomab, a CD19-Specific Antibody Engaging T Cells for Treatment of Lymphoma BiTE is a novel antibody format capable of teaching conventional antibodies to recruit cytotoxic T cells, the most potent immune effector cells in the organism. With CD19/CD3-bispecific antibody blinatumomab, we have reached clinical proof of concept. Treatment of lymphoma patients with doses as low as 0.06 mg/square meter/day resulted in regression of tumors, and clearance of infiltrated organs, spleen and peripheral blood from target cells. Patrick A. Baeuerle, Ph.D., Chief Scientific Officer, Micromet Inc. |
| 11:45 | Technology Workshops |
| Therapeutic Antibodies Without Helper T Cell Epitopes Frank J. Carr Ph.D., Director for Biologics Research, Antitope, United Kingdom | |
| PER.C6® Cells: A Highly Efficient Production Platform for Antibodies Marco A. Cacciuttolo, Ph.D., President & Chief Executive Officer, Percivia LLC | |
| The Versatile Role of Bio-Layer Interferometry in Therapeutic Antibody Discovery and Development Arnout F. Gerritsen, Associate Director, Lead Discovery, Genmab bv, The Netherlands | |
| 12:15 | Networking Luncheon, Exhibit and Poster Viewing |
| 1:45 | Technology Workshops |
| Balancing Power and Simplicity in Real Time, Label-Free Characterization/Selection of Antibodies and Development of Biopharmaceuticals: The Added Value of Biosensors Johan Lindberg, Vice President, Sales & Marketing, Attana AB, Sweden | |
| A Combination of Gene Evolution Technologies for Protein Improvement Christian Kranz, Ph.D., Product Manager. Directed Evolution, GENEART AG, Germany | |
| Development of MOR103, a GM-CSF Specific Human Antibody for the Treatment of Inflammatory Diseases Currently Tested in a Phase I Clinical Trial Stefan Steidl, Ph.D., Associate Director, MorphoSys AG, Germany | |
| Session II: Clinical Development of Cancer Therapeutics (1) | |
| 2:15 | Announcements and Chairperson's Opening Remarks Nils Lonberg, Ph.D., Senior Vice President and Scientific Director, Medarex Inc. |
| Keynote Presentation | |
| 2:20 | Monoclonal Antibodies in Cancer Therapy: 30 Years of Progress Hybridoma and recombinant DNA technologies and identification of key ligand-receptor-signal transduction pathways have led to several therapeutic monoclonal antibody products. In the past decade, nine have received regulatory approval for cancer therapy, including six unconjugated, one immunotoxin and two radiolabeled antibody products. They constructs are: one fully human, four humanized, two chimeric, and two murine. These products are now part of standard treatment of a variety of malignancies, especially in combination with chemotherapy. Robert O. Dillman, M.D., Medical & Scientific Director, Grace E. Hoag Director of Cancer Care, Hoag Cancer Center, Clinical Professor of Medicine, University of California, Irvine |
| 3:00 | BMS-663513, a Fully Human Anti-CD137 Agonist MAb: Results from the First-in-Human Study CD137 is a member of the TNFR superfamily and functions as a costimulatory molecule. In mouse tumor models, BMS-469492 (a mouse agonist anti-CD137 MAb) produced anti-tumor immune responses that led to tumor eradication. BMS-663513 is a fully human anti-CD137 agonist MAb. In preclinical studies, BMS-663513 provided costimulation to CD8+ and CD4+ T-cells, leading to enhanced IFNγ production, cytolytic activity, and increased T-cell survival. Results from the first-in-human Phase 1 study are presented. David M. Feltquate, M.D., Ph.D., Director, Oncology Global Clinical Research, Research and Development, Bristol-Myers Squibb Co. |
| 3:30 | Safety and Activity of MDX-1106 (ONO-4538), an Anti-PD-1 Monoclonal Antibody, in Patients Refractory Malignancies or Chronic Viral Infections MDX-1106 is a fully human IgG4 (S228P) MAb to PD-1 that blocks engagement of this receptor by its ligands, and may promote anti-tumor and anti-viral immune responses. A Phase 1 study of MDX-1106 in patients with various malignancies has shown the antibody to be well tolerated, and provided early evidence of anti-tumor activity. An update of the Phase 1 study data and progress in new studies will be presented. Israel Lowy, M.D., Ph.D., Senior Director Clinical Science/Infectious Diseases, Medarex, Inc. |
| 4:00 | Networking Refreshment Break, Exhibit and Poster Viewing |
| 4:45 | SGN-35: Development of a Novel Antibody-Drug Conjugate Targeting CD30 SGN-35 is an antibody-drug conjugate (ADC) that specifically binds CD30 and delivers a potent antimitotic drug, MMAE. A phase 1 clinical trial was conducted to test the safety, PK, and antitumor activity of SGN-35, administered every 3 weeks, in patients with relapsed and refractory CD30+ tumors (Hodgkin lymphoma and ALCL). Partial and complete responses have been observed at doses as low as 0.6 mg/kg and 1.2 mg/kg, respectively. Updated data will be presented. Jonathan G. Drachman, M.D., Vice President, Early Clinical Development, Seattle Genetics |
| 5:15 | Preclinical Properties and Clinical Status of PSMA ADC, an Auristatin-Conjugated, Fully Human Monoclonal Antibody to Prostate-Specific Membrane Antigen Prostate-specific membrane antigen (PSMA) is expressed abundantly on prostate carcinomas and the neovasculature of other solid tumors, and it has limited expression on normal, non-prostatic tissues. PSMA ADC comprises a fully human monoclonal antibody that binds PSMA and is linked to an antimitotic agent, monomethylauristatin E (MMAE). PSMA ADC potently and selectively eliminated PSMA-expressing tumors in preclinical studies and is expected to next enter phase 1 testing in metastatic prostate cancer. William C. Olson, Ph.D., Vice President, Research and Development, Progenics Pharmaceuticals, Inc. |
| 5:45 | GA101: A 3rd Generation Glycoengineered CD20 Antibody with Superior Direct Cell Death Induction and Increased ADCC GA101 is a humanized, glycoengineered type II CD20 antibody. Due to its type II mode of CD20 binding it has strong direct cell death induction compared to classical type I CD20 antibodies, a property enhanced through an engineered elbow hinge. The glycoengineered Fc region binds with high affinity to FcgRIII on immune effector cells leading to increased ADCC. It has demonstrated outstanding efficacy in lymphoma xenograft models and in tissue B-cell depletion in preclinical models. Pablo Umaña, Ph.D., Head of Research, Glycart Biotechnology AG (Roche Group), Switzerland |
| 6:15 | Networking Cocktail Reception, Exhibit and Poster Viewing |
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Day Two Wednesday, December 10, 2008 | DAY ONE | DAY TWO | DAY THREE | | |
| 7:30 | Registration, Networking Coffee |
| Session III: Clinical Development of Cancer Therapeutics (2) | |
| 8:00 | Announcements and Chairperson's Opening Remarks Benjamin P. Chen, Ph.D., Managing Director, Burrill & Company |
| 8:15 | Development of Mapatumumab, a Fully Human Agonistic Monoclonal Antibody which Targets and Activates the Tumor Necrosis Factor Apoptosis-Inducing Ligand (TRAIL) Receptor-1 - An Update Mapatumumab is a fully human monoclonal antibody that targets and activates the TRAIL receptor-1. Pre-clinical experiments demonstrated that mapatumumab binds specifically to TRAIL-R1, efficiently induces apoptosis as a single-agent or in combination in TRAIL-R1 expressing human tumor cell lines, and can induce regressions in xenograft models of human tumors. The administration of mapatumumab has been very well tolerated as a single-agent and in combination with full-dose chemotherapy. Mapatumumab is currently being studied in randomized Phase 2 studies. Gilles Gallant, B.Pharm. Ph.D., Vice President, Clinical Oncology, Human Genome Sciences, Inc. |
| 8:45 | Anaphylactic Reactions to Cetuximab in Patients with IgE antibodies Specific for Galactose alpha 1,3 Galactose Investigation of anaphylactic reactions to the monoclonal antibody cetuximab demonstrated that they were due to pre-existing IgE antibodies to the glycosylation on the antibody. The results challenge the existing view that the glycosylation of recombinant molecules was unlikely to induce reactions. In addition the sugar concerned raises many questions about the reasons why the antibodies are common in this area and also about whether there are other disease associations with these antibodies. Thomas A.E. Platts-Mills, M.D., Ph.D., Head Asthma and Allergic Disease, University of Virginia |
| 9:15 | Mechanisms of Therapeutic Antibodies Against EGF Receptor Zalutumumab (HuMax-EGFr) is a human IgG1 antibody blocking the activation of the Epidermal Growth Factor receptor (EGFr) and efficiently recruiting effector cells for antibody-dependent cell-mediated cytotoxicity (ADCC). We investigated the interaction between zalutumumab and EGFr on cells,. Zalutumumab was found to inhibit receptor activation by spatial mechanisms which efficiently prevented both ligand binding as well as receptor dimerization. Novel insights into the mechanism and role of antibody-mediated effector function in tumor cell killing will be discussed. Paul W.H.I. Parren, Ph.D., Senior Vice President Research and Preclinical Development, Genmab, The Netherlands |
| 9:45 | Networking Refreshment Break, Exhibit and Poster Viewing |
| Keynote Presentation | |
| 10:30 | Therapeutic Antibody Sector Remains Upbeat in Wake of Market Turmoil! The therapeutic antibody sector's report card for the first half of the year continue to contain good grades for its performance on the capital markets, and for partnering and venture capital deal making, despite a very tough financial market. This Keynote will review the 2008 performance of the overall biotech industry and, in greater detail, the therapeutic antibody sector. We will assess the performance of the antibody sector in the context of the life sciences industry as a whole. Benjamin P. Chen, Ph.D., Managing Director, Burrill & Company |
| Panel Discussion | |
| 11:00 | Intellectual Property Issues in Antibody Development The field of antibody therapeutics is evolving at an ever-increasing pace. So too are the legal issues facing companies and research institutions seeking to protect, enforce and/or leverage their proprietary antibody technologies. The strategies used to protect the pioneering antibody technologies of yesterday are not necessarily applicable to today's technologies. Companies must "stay ahead of the curve" by adapting their strategies to keep up with the ever changing legal and technological landscape. Our panel of experienced in-house IP counsel from top antibody companies will share their insights on hot issues in antibody patenting. Moderator: Timothy J. Shea, Jr., Director, Sterne, Kessler, Goldstein & Fox P.L.L.C. Panelists: Michael Braunagel, Ph.D., Director, Strategic Alliances and Licensing, Affitech AS, Norway; Diana Hamlet-Cox, Ph.D., J.D., Vice President and Chief Patent Counsel, Medarex, Inc.; Bernd Hutter, Ph.D., Senior Manager, Licensing & Intellectual Property, MorphoSys AG, Germany; Diane Wilcock, Ph.D., Director, Intellectual Property, Xoma (US) LLC; Jennifer A. Zarutskie, Ph.D., J.D., Director of Intellectual Property, Patent Counsel, Dyax Corp. |
| Technology Workshops | |
| 12:00 | Clinical Trials Using Potelligent® Mabs Masamichi Koike, Ph.D., President and Chief Executive Officer, BioWa, Inc. |
The ADLib® System: The Most Flexible Technology with Alternative Diversity
Chiome's ADLib® System is the only avian cellular antibody-library technology based on a completely proprietary mechanism of antibody diversification. The system provides many different approaches for generating highly specific antibodies against difficult antigens such as trans-membrane and highly homologous proteins. A unique approach for addressing different epitopes on the same target is also available. Chiome is very flexible in structuring partnerships with companies seeking alternative diversity and having complementary technologies and/or novel targets.Hidetaka Seo, Ph.D., Director, Research and Development, Chiome Bioscience, Inc., Japan | |
| Differentiating your Antibody using Xencor's Antibody Platforms for Enhanced Pharmacokinetics and Cytotoxicity | |
| 12:30 | Networking Luncheon, Last Chance for Exhibit and Poster Viewing |
| Session IV: Clinical Development of Non-Cancer Therapeutics (1) | |
| 2:00 | Announcements and Chairperson's Opening Remarks Trudi Veldman, Ph.D., Director, Biologics Generation, Abbott Laboratories |
| Keynote Presentation | |
| 2:05 | Monoclonal Antibody First-In-Man Studies: A Regulatory Perspective and Recommendations Triggered by the TGN1412 catastrophe, procedures and criteria used in the authorization of clinical trials had to be rethought. As a consequence, a new EMEA guideline for First-In-Man studies was published. It outlines requirements for preclinical development and for the clinical protocol with the aim of health risk mitigation for the participants. Clinical trial authorization in the EU is the responsibility of the national competent authorities, in Germany represented by the Paul-Ehrlich-Institute with respect to antibody therapeutics. An overview of current regulatory thinking is given. Petra M. Schmitt, Ph.D., Preclinical and Quality Assessor, Federal Agency for Sera and Vaccines, Division of Immunology, Section 3/2 Monoclonal and Polyclonal Antibodies, Paul-Ehrlich-Institute, Germany |
| 2:45 | Monoclonal Antibodies in Development for the Treatment of Asthma - Anti-IL-13 (CAT-354), Anti-IL-9 (MEDI-528) and Anti-IL-5Rα (MEDI-563) Asthma is an inflammatory disorder of the airways associated with airway remodeling, mucus hypersecretion and reversible airway obstruction. Inflammation in part is mediated cytokines such as IL-5, IL-9 and IL-13, each of which orchestrates different aspects of asthma pathology. We have designed specific monoclonal antibodies that allow for the efficient interference with IL-13, IL-9 and IL5Rα signaling pathways. The relative contribution of inhibiting either pathway for the treatment of asthma will be discussed in detail. Roland Kolbeck, Ph.D., Director Respiratory, Inflammation & Autoimmunity, MedImmune, Inc. |
| 3:15 | Efficacy and Safety of NGF Blocking Antibody, Tanezumab (PF04383119 or RN624), in Treating Moderate to Severe Pain Due to Osteoarthritis Abstract to come. John C. Lin, M.D., Ph.D., Senior Director, Neuroscience, Rinat, Pfizer Inc. |
| 3:45 | Networking Refreshment Break |
| 4:15 | Bapineuzumab for the Potential Treatment of Alzheimer's Disease Abstract to come. Dale B. Schenk, Ph.D., Executive Vice President and Chief Scientific Officer, Elan Pharmaceuticals, Inc. |
| 4:45 | Immunoprophylaxis of RSV Infection: Advancing from RSV-IGIV to Palivizumab and Motavizumab For preventing respiratory syncytial virus (RSV) infection, we have successfully developed two prophylactic antibody products. Palivizumab, a humanized mAb that binds to the RSV F protein, is a potent anti-RSV mAb that is about 50-fold more potent than RSV-IGIV. A more potent second-generation mAb, motavizumab, is currently being investigated in Phase 3 clinical trials. A third generation mAb has been generated with the intent to extend the serum half-life of the mAb in humans. Herren Wu, Ph.D., Vice President, Head, Department of Antibody Discovery and Protein Engineering, and Global Head of Technology, MedImmune, Inc. |
| 5:15 | Certolizumab Pegol (Pegylated Fab' blocking TNFα) Cimzia® The novel, humanized antibody fragment, Cimzia®, binds TNFα univalently with high affinity, and has enhanced pharmacokinetic properties through site-specific attachment of polyethylene glycol. Cimzia was approved by FDA for treatment of Crohn's Disease earlier this year. In Phase lll studies in rheumatoid arthritis, significant reduction in joint destruction and rapid improvement in signs and symptoms of the disease were observed. Tim Bourne, Ph.D., Senior Director, Inflammation Portfolio, UCB, United Kingdom |
| 5:45 | Close of Session |
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Day Three Thursday, December 11, 2008 | DAY ONE | DAY TWO | DAY THREE | | |
| 7:30 | Networking Coffee |
| Session V: Clinical Development of Non-Cancer Therapeutics (2) | |
| 8:35 | Announcements and Chairperson's Opening Remarks Mark R. Alfenito, Ph.D., President, KaloBios Pharmaceuticals Inc. |
| 8:45 | Development of KB001, a Targeted Anti-Bacterial Therapeutic Pseudomonas aeruginosa uses the syringe-like Type Three Secretion System (TTSS) to kill host cells and induce tissue inflammation. KB001, a PEGylated, near germline, "humaneered", Fab' fragment with long half life, low immunogenicity, and resistance to protease degradation, binds with high affinity to the well conserved PcrV protein on the tip of the TTSS, rendering it non-functional. Preclinical and phase 1 results will be presented and clinical trials in cystic fibrosis and mechanically-ventilated patients described. Tillman Pearce, M.D., Chief Medical Officer, KaloBios Pharmaceuticals, Inc. |
| 9:15 | Preclinical and Clinical Development of a Humanized Monoclonal Antibody for Treatment of West Nile Virus Infection Abstract to come. Jeffrey Nordstrom, Ph.D., Director, Product Development, MacroGenics |
| 9:45 | Networking Refreshment Break |
| 10:15 | The Discovery and Development of a Novel Anti-Cytokine Antibody ALD518 Alder Biopharmaceuticals has developed a system that enables the identification of single to double-digit picomolar affinity antibodies that can be quickly humanized with complete potency recovery. Clinical supplies of these molecules are derived from a Pichia pastoris expression system that can provide rapid access to drug supply. The discovery and development of ALD518 will be used to illustrate the capabilities of the system and its agility to quickly move from project inception to first dose in man. John A. Latham, Ph.D., Chief Scientific Officer, Alder Biopharmaceuticals |
| 10:45 | Golimumab, a Human Anti-TNFα Monoclonal Antibody (mAb), for the Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis A Marketing Authorization Application (MAA) was submitted to EMEA in February 2008 and a Biologics License Application (BLA) to the U.S. FDA in June 2008 requesting the approval of Golimumab as a monthly subcutaneous treatment for adults with active forms of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Golimumab is being studied as an every four-week subcutaneous injection and as an intravenous infusion therapy. The improved pharmacokinetic characteristics for golimumab and its exposure-response relationship will be discussed. Zhenhua (Mike) Xu, Ph,D., F.C.P., Associate Director, Clinical Pharmacology, Centocor R&D/Johnson & Johnson |
| 11:15 | PRO 140: A Humanized CCR5 Monoclonal Antibody for HIV-1 Therapy New drugs are needed to manage better the lifelong care of HIV-infected individuals. PRO 140 binds the chemokine receptor CCR5, which most HIV-1 strains use to enter CD4+ cells. Laboratory studies indicate that PRO 140 represents a distinct class of CCR5 inhibitor. Phase 1b monotherapy testing established proof of concept for PRO 140 as a potent antiretroviral agent with extended activity, and phase 2 studies have been initiated to evaluate intravenous and subcutaneous forms of PRO 140. William C. Olson, Ph.D., Vice President, Research and Development, Progenics Pharmaceuticals, Inc. |
| 11:45 | Close of Antibody Therapeutics Meeting; Delegates are Invited to Attend the Afternoon Session of Antibody Engineering |
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