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治験の成功に抗体特性が及ぼす影響:技術・企業のベンチマーク分析

Influence of Antibody Attributes on Clinical Success - A Technology and Coporate Benchmark Analysis

発行 La Merie Publishing 商品コード 290176
出版日 ページ情報 英文 88 Pages
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治験の成功に抗体特性が及ぼす影響:技術・企業のベンチマーク分析 Influence of Antibody Attributes on Clinical Success - A Technology and Coporate Benchmark Analysis
出版日: 2013年03月31日 ページ情報: 英文 88 Pages
概要

当レポートでは、抗体生成技術、親抗体の動物種、抗体フォーマット、免疫グロブリンクラス・アイソタイプ、標的および治療領域を対象に、抗体特性が臨床開発における抗体の成功率に及ぼす影響について評価しており、さらに、失敗の理由と中止された段階や大手製薬企業・バイオテクノロジー企業のベンチマーク分析などをまとめ、概略以下の構成でお届けします。

第1章 エグゼクティブサマリー・議論

第2章 イントロダクション

第3章 調査手法

第4章 結果

  • 抗体技術の利用
  • 摩耗率
  • 失敗理由
  • 抗体生成技術・標的
  • 抗体技術・抗体フォーマット
  • インビボ抗体技術の親動物種
  • 免疫グロブリンクラスおよびアイソタイプvs.抗体技術
  • 抗体技術・治療領域
  • 治療領域における抗体の摩耗率
  • ベンチマーク分析:大手製薬企業・バイオテクノロジー抗体技術の嗜好・摩耗率

図表リスト

目次
Product Code: LMFR0010

How do antibody characteristics impact clinical success?

The analytical report “Influence of Antibody Attributes on Clinical Success - A Technology and Coporate Benchmark Analysis” evaluates the impact of a number of antibody attributes on the success rate of antibodies in clinical development. Among the antibody attributes studied in this investigation are antibody generation technology, animal species of the parental antibody, antibody format, immunoglobulin class and isotype, target, and therapeutic area. Information from more than 500 naked recombinant monoclonal antibodies was used for this research. Antibodies which failed in clinical development were further analyzed for the reason of failure and phase in which they were discontinued. Biotech and pharmaceutical companies with a significant R&D portfolio of therapeutic antibodies were benchmarked for their antibody success rate in development and the underlying antibody attributes contributing to success.

Specific antibody attributes evaluated for their influence on success in clinical development in this research study are:

  • In vitro antibody generation technologies: display technologies from CAT, Dyax, Morphosys, BioInvent, Domantis, Genentech, others;
  • In vivo antibody generation technologies: chimeric, primatized, nanobodies, deimmunized, human engineered, humaneered, humanized, XenoMouse, HuMab mouse, KM mouse, VelocImmune mouse, human B-cell derived;
  • Animal species of parental wild-type antibody: mouse, rat, rabbit, hamster, cynomolgus monkey, camelid;
  • Target;
  • Immunoglobulin (Ig) class;
  • IgG isotype;
  • Therapeutic area of lead indication.

When discovering a new monoclonal antibody, researchers have a number of choices to make regarding antibody generation technologies as well as antibody format and immunoglobulin isotpye among other attributes. One of the basic controversies in selecting the antibody generation technolgoy is the question whether antibodies generated in vitro by display technologies are really equivalent to those generated in vivo by a competent immune system.

Typical questions in antibody R&D are:

  • When selecting an in vivo system for antibody generation, are conventional in vivo systems with an animal immune system and subsequent chimerization or humanization creating the same as “modern” transgenic animals?
  • Are full length antibodies more successful than modern engineered nanobodies, scFv molecules or even domain antibodies?
  • Do companies have different success rates in their antibody development portfolio?
  • And, if yes, are they using different technologies than their peers which could explain the difference?
  • Is there a different success rate of antibodies against the same target based on generation technologies or other attributes?
  • Are there therapeutic areas with higher likelihood of successful development of antibodies than others?
  • What are the main reasons for antibody failure in clinical development?
  • In which phase do antibodies typically fail?

This analytical report will give you answers for many of these questions. The results of the analysis show:

  • whether and how antibody generation technologies differently impact clinical success;
  • why and when antibodies fail;
  • how target selection influences clinical success;
  • if antibody format, class and isotype is relevant for development success;
  • the antibody success rate of therapeutic areas;
  • which companies are the most successful and which antibody attributes they prefer.

Table of Contents

1. Executive Summary and Discussion

2. Introduction

3. Methodology

4. Results

  • 4.1. Use of antibody technologies
  • 4.2. Attrition rates
  • 4.3. Reasons for failure
  • 4.4. Antibody generation technologies and targets
  • 4.5. Antibody technologies and antibody formats
  • 4.6. Parental animal species of in vivo generated antibodies
  • 4.7. Immunoglobulin class and isotype vs. antibody technology
  • 4.8. Antibody technology and therapeutic areas
  • 4.9. Attrition rates of antibodies in therapeutic areas
  • 4.10. Benchmark analysis: big pharma and biotech antibody technology preferences and attrition rates

List of Tables:

  • Table 1: Overall attrition rate of in vitro generated antibodies
  • Table 2: Overall attrition rate of in vivo generated antibodies
  • Table 3: Highest phase of active antibodies generated by in vitro technologies
  • Table 4: Highest phase of active antibodies generated by in vivo technologies
  • Table 5: Year of antibody failure for in vitro generated antibodies
  • Table 6: Year of antibody failure for in vivo generated antibodies
  • Table 7: Attrition rate of in vitro generated antibodies in the period 2006-2013
  • Table 8: Attrition rate of in vivo generated antibodies in the period 2006-2013
  • Table 9: Highest phase of failed antibodies generated by in vitro technologies
  • Table 10: Highest phase of failed antibodies generated by in vivo technologies
  • Tables 11: Reasons for failure of antibodies generated by in vitro technologies
  • Tables 12: Reasons for failure of antibodies generated by in vivo technologies
  • Table 13: Reasons for failure of humanized antibodies per phase
  • Tables 14: Targets of failed in vitro generated antibodies per technology
  • Tables 15: Targets vs. in vitro and in vivo antibody generation technologies
  • Tables 16: Transgenic mouse antibodies and targets
  • Table 17: Antibody technologies and antibody formats
  • Table 18: Parental animal species of in vivo generated antibodies
  • Table 19: Immunoglobulin class and isotype vs antibody technology
  • Table 20: In vitro antibody technology and therapeutic areas
  • Table 21: In vivo antibody technology and therapeutic areas
  • Table 22: Failed antibodies from in vitro technologies vs therapeutic areas
  • Table 23: Failed antibodies from in vivo technologies vs therapeutic areas
  • Table 24: Roche (Genentech(Chugai) use of antibody technologies vs attrition rates
  • Table 25: AstraZeneca (MedImmune/CAT) use of antibody technologies vs attrition rates
  • Table 26: Amgen use of antibody technologies vs attrition rates
  • Table 27: Lilly (ImClone) use of antibody technologies vs attrition rates
  • Table 28: Pfizer (Wyeth) use of antibody technologies vs attrition rates
  • Table 29: Novartis use of antibody technologies vs attrition rates
  • Table 30: GlaxoSmithKline (HGS) use of antibody technologies vs attrition rates
  • Table 31: Sanofi (Genzyme) use of antibody technologies vs attrition rates
  • Table 32: Bristol-Myers Squibb (Medarex) use of antibody technologies vs attrition rates
  • Table 33: Biogen Idec use of antibody technologies vs attrition rates
  • Table 34: Janssen (Centocor/J&J) use of antibody technologies vs attrition rates
  • Table 35: AbbVie (Abbott) use of antibody technologies vs attrition rates
  • Table 36: Kyowa Hakko Kirin Pharma use of antibody technologies vs attrition rates
  • Table 37: Merck (Schering-Plough) use of antibody technologies vs attrition rates
  • Table 38: UCB (Celltech) use of antibody technologies vs attrition rates
  • Table 39: Eisai (Morphotek) use of antibody technologies vs attrition rates
  • Table 40: Novo Nordisk use of antibody technologies vs attrition rates
  • Table 41: Ranking list of Big Pharma & Biotech companies and overall antibody attrition rates
  • Table 42: Ranking list of Big Pharma & Biotech companies and in vitro antibody attrition rates
  • Table 43: Ranking list of Big Pharma & Biotech companies and in vivo antibody attrition rates
  • Table 44: Ranking list of Big Pharma & Biotech companies and in vivo antibody preference rate
  • Table 45: Big Pharma & Biotech companies and preferred in vivo antibody technologies: humanization vs. transgenic mice
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