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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

Influence of Antibody Attributes on Clinical Success - A Technology and Coporate Benchmark Analysis
Antibody Technologies and Attrition Rates - an industry analysis 2013
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 

5 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/JandJ) 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 and Biotech companies and overall antibody attrition rates
Table 42          Ranking list of Big Pharma and Biotech companies and in vitro antibody attrition rates
Table 43          Ranking list of Big Pharma and Biotech companies and in vivo antibody attrition rates
Table 44          Ranking list of Big Pharma and Biotech companies and in vivo antibody preference rate
Table 45          Big Pharma and Biotech companies and preferred in vivo antibody technologies: humanization vs. transgenic mice

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