モノクローナル抗体

5月 2日 (金)

8:00 am - 4:30 pm Registration Open

知的財産権の保護
PROTECTING IP

8:30 am Chairperson's Remarks

8:35 Patentability of Antibodies in the United States 
Thomas Kowalski, Partner, Biotechnology, Frommer Lawrence & Haug LLP
Recent US case law attempts to further clarify the written description, novelty and non-obviousness requirements as they apply to antibodies. In view of the recent upsurge of litigations surrounding antibody patents and applications, applicants must be vigilant when preparing their applications.

ダウンストリームへの着目
KEEPING AN EYE DOWNSTREAM

9:05 Efforts to Better Understand and Optimize Antibody Pharmacokinetics 
Bernie Scallon, Ph.D., Senior Research Fellow, Discovery Research, Centocor R&D
Optimizing the pharmacokinetics and biodistribution of therapeutic antibodies is an area of increasing interest to manufacturers as they seek to maximize safety, reduce costs, and enhance convenience to patients. Although there is still a sizable black box that remains regarding our understanding of what determines the in vivo fate of antibodies, encouraging progress is being made towards prolonging circulating half-life. This talk will review factors that may influence the circulating half-life of antibodies, and will share some of our observations made while studying the half-life of human antibodies in mouse models.

9:35 Application of Taguchi Experiment in Process Optimization 
Robin Ng, Scientist, Process Development, Goodwin Biotechnology
Implementation of statistical design of experiment (DOE) has proven to be a powerful and effective tool in both industrial and academic research. With proper planning, implementation and analysis, valid and objective conclusions can be obtained. When data are subjected to experimental errors, statistical analysis it the only objective approach. We will be presenting a case study where DOE has been applied to yield optimization of IgG production, covering both the design of the study and the analysis of the data. The application has not only shortened the experiment time, but also resulted in a robust performance. It is an efficient and scientific approach to problem solving that involves experimental data.

10:05 Coffee Break in the Exhibit Hall

将来展望: 抗体による改善と置き換え
LOOKING AHEAD: ANTIBODY IMPROVEMENTS AND REPLACEMENTS

11:05 Aptamers - An Antibody Alternative
Anthony Keefe, Ph.D, Senior Principal Investigator, Aptamer Discovery, Archemix Corp.
Therapeutic aptamers are discovered using a genetic selection technique and function by binding to and inhibiting extracellular protein targets. In these respects they can be considered highly analogous to therapeutic antibodies. However, because they are ultimately chemically synthesized and do not elicit an immune response they also offer some profound advantages over antibodies. Currently there are several aptamers in the clinic for oncology and cardiovascular indications. Additionally, an anti-VEGF therapeutic aptamer has been approved by the FDA for macular degeneration. A broad overview of the discovery and optimization process will be given along with an update of progress in the clinic with this technology.

11:35 Next Generation Antibodies with Enhanced Effector Functions 
Ekkehard Mössner, Ph.D, Senior Scientist, Antibody Engineering, Glycart Biotechnology
This talk will describe the application of antibody engineering for the development of a new generation of humanized antibodies with enhanced effector functions such as antibody-dependent cellular cytotoxicity achieved through Fc glycoengineering and enhanced apoptosis induction.

12:05 pm Luncheon Workshop (Sponsorship Available) or Lunch on Your Own

1:05 Break

成功例の検証
SUCCESS STORIES: CASE STUDIES

1:25 Chairperson's Remarks 

1:30 Neuro-Targeting Antibody Applications
Peter Hudson, FTSE, Ph.D., Theme Leader, Neuro-Degenerative Disease, Mental Disorders and Brain Health, CSIRO Preventative Health Flagship
Antibodies are providing novel blood and CSF diagnostics for Alzheimer Disease and, most recently, antibodies have been formulated both for systemic and brain-targeted therapeutics. In diagnostics, we have evaluated antibodies on a unique cohort (AIBL) of progressing Alzheimer's disease by correlating neuroimaging and blood-based biomarker diagnosis together with clinical and neuropsychological measures to monitor disease progression over 18 months. AIBL (a $10 million Australian multi-site, multi-Institute study 2006-2009) is a large-scale longitudinal analysis of neurodegeneration in a cohort of 1000 volunteers over the age of 60, leading to AD. AIBL is currently the largest study that correlates PIB-PET and MRI neuroimaging techniques to measure amyloid deposition and initial results suggest PET scans using Pittsburgh Compound-B (PIB) is the earliest available marker for onset of AD. Neuroimaging, together with new antibody-based blood biomarker diagnostic panels can potentially bring forward AD diagnosis by up to 18 months. Recently, antibodies, in addition to their direct application for diagnosis and therapy, have been redesigned to penetrate the blood brain barrier and can potentially target nanostructured materials as drug delivery vehicles into the brain. Our latest results in this emerging field will be presented. 

2:00 Angciocept (CT-322): A Novel Adnectin-Based Biologic
Eric Furfine, Ph.D., Senior Vice President, Research & Preclinical Development, Adnexus, a Bristol-Myers Squibb R&D Company
Adnexus has demonstrated clear leadership in the field of biologics through the company's advancement of Adnectins, a novel, proprietary class of targeted biologics that are derived from a well-characterized protein, fibronectin, that is prevalent throughout the human body. Adnectin-based products offer various potential advantages as compared to traditional protein therapeutics, including high affinity, specific binding to a therapeutic target with only a single Adnectin domain; greater potential to specifically modulate multiple therapeutic targets for multiple therapeutic effects in a single drug molecule ; creating Adnectins to many target types, including targets that are hard to drug by antibodies or small molecules; and manufacturing in E. coli. Angiocept (CT-322) is an inhibitor of VEGFR-2, and is the first Adnectin in clinical trials. Angiocept Phase I clinical data demonstrate the potential of Adnectins as a viable new product class to address important unmet medical needs. The presentation outlines progress in developing this class of therapeutics.

2:30 FcabTM: Fc Fragments with Engineered Antigen Binding Sites 
Geert C. Mudde, CSO, f-star Biotechnologische Forschungs- und Entwicklungsges.m.b.H. 
f-star's Modular Antibody Technology can be used to engineer additional binding sites into antibodies without changing the natural antibody format. Thus it provides a source for next generation antibodies. We have developed large surface display libraries of immunoglobulin domains randomized in non-CDR-loop positions. Fc fragments with engineered antigen binding sites (Fcab™), may be used both as stand-alone therapeutic entities and as building blocks to improve specificity, avidity, effector functions and pharmacokinetics of monoclonal antibodies.

3:00 Networking Refreshment Break 

3:30 Development of LBY135: A Novel Anti-DR5 Agonistic Antibody Induces Tumor-Cell Specific Cytotoxic Activity in Human Colon Tumor Cell Lines and Xenografts
Jing Li, Ph.D., Laboratory Head, Oncology, Novartis
We'll discuss the development of this therapeutic Ab, its unique characteristics including ADCC, CDC, internalization and epitope. We'll also present some preclinical data of this therapeutic Ab.

4:00 Rational Optimization of Therapeutic Bispecific and Tetravalent Antibodies 
Alexey Lugovskoy, Ph.D., Head, Molecular Modeling / Senior Scientist, Drug Discovery, Biogen Idec Inc.
Engineered bispecific and tetravalent antibodies that can engage multiple target epitopes represent promising new classes of therapeutic agents. Typically a single chain variable (scFv) fragment, which is linked to a monoclonal antibody to achieve multispecificity, displays low intrinsic stability and high aggregation propensity. To address these limitations we applied rational design to increase the stability of two therapeutic scFvs without compromising their affinity towards antigen. Further, we demonstrated that incorporation of these stabilized scFvs into a full-length bispecific and tetravalent molecules led to molecules with markedly improved properties. 

4:30 End of Monoclonal Antibodies Conference