STUTTGART, Germany I April 8, 2013 I Declining R&D productivity associated with increased costs is one of the major problems of the pharmaceutical industry. One strategy to overcome this hurdle, is to focus on biologic drugs such as recombinant proteins and antibodies. They are thought to more likely succeed. In contrast to new chemical entities created by synthetic medicinal chemistry, antibodies can be generated by a variety of systems including in vitro and in vivo antibody generation technologies. Antibodies can be created in vitro by a number of different library systems, but all of them select antibody drug candidates without the selection pressure present in vivo through B-cells. Antibodies can be generated in vivo by conventional immunization of wild-type animals with subsequent humanization to reduce immunogenicity. Newer technologies use transgenic animals for the generation of fully human antibodies.
So far, it has not been investigated whether there is any difference in success between in vitro and in vivo generated antibodies and between different in vitro or in vivo antibody generation technologies.
La Merie Publishing conducted an analysis of clinical attrition rates (failure rates) by identifying the underlying antibody generation technologies of more than 500 naked antibodies which have reached the clinical stage. Results of this industry analysis were published as a full report entitled “Antibody Technologies and Attrition Rates – an industry analysis 2013”. In addition, the study evaluated reasons for failure and the differential probability of success of therapeutic areas. An industry peer analysis was performed describing the preferences of Big Pharma and Biotech companies for antibody generation technologies and their clinical success rate. An extensive compilation of data sheets characterizing the antibodies are added allowing detailed description of the state of the art of antibody generation preferences
- Unique antibody identifiers (drug codes; generic name; brand name)
- Antibody format (full length, Fab, scFv, VH/VL, nanobody, bispecific, cocktail/polyclonal)
- 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)
- Antibody status (active/discontinued)
- Year of failure
- Reason for failure (efficacy, pharmacokinetics/ADME; safety; technical, business, next generation, inactivity)
- Target
- Immunoglobulin class and IgG isotype
- Highest phase
- Therapeutic area of lead indication
- Companies (developer, licensor/originator)
Sample pages of the report “Antibody Technologies and Attrition Rates – an industry analysis 2013 can be downloaded.
SOURCE: La Merie Publishing
Post Views: 103
STUTTGART, Germany I April 8, 2013 I Declining R&D productivity associated with increased costs is one of the major problems of the pharmaceutical industry. One strategy to overcome this hurdle, is to focus on biologic drugs such as recombinant proteins and antibodies. They are thought to more likely succeed. In contrast to new chemical entities created by synthetic medicinal chemistry, antibodies can be generated by a variety of systems including in vitro and in vivo antibody generation technologies. Antibodies can be created in vitro by a number of different library systems, but all of them select antibody drug candidates without the selection pressure present in vivo through B-cells. Antibodies can be generated in vivo by conventional immunization of wild-type animals with subsequent humanization to reduce immunogenicity. Newer technologies use transgenic animals for the generation of fully human antibodies.
So far, it has not been investigated whether there is any difference in success between in vitro and in vivo generated antibodies and between different in vitro or in vivo antibody generation technologies.
La Merie Publishing conducted an analysis of clinical attrition rates (failure rates) by identifying the underlying antibody generation technologies of more than 500 naked antibodies which have reached the clinical stage. Results of this industry analysis were published as a full report entitled “Antibody Technologies and Attrition Rates – an industry analysis 2013”. In addition, the study evaluated reasons for failure and the differential probability of success of therapeutic areas. An industry peer analysis was performed describing the preferences of Big Pharma and Biotech companies for antibody generation technologies and their clinical success rate. An extensive compilation of data sheets characterizing the antibodies are added allowing detailed description of the state of the art of antibody generation preferences
- Unique antibody identifiers (drug codes; generic name; brand name)
- Antibody format (full length, Fab, scFv, VH/VL, nanobody, bispecific, cocktail/polyclonal)
- 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)
- Antibody status (active/discontinued)
- Year of failure
- Reason for failure (efficacy, pharmacokinetics/ADME; safety; technical, business, next generation, inactivity)
- Target
- Immunoglobulin class and IgG isotype
- Highest phase
- Therapeutic area of lead indication
- Companies (developer, licensor/originator)
Sample pages of the report “Antibody Technologies and Attrition Rates – an industry analysis 2013 can be downloaded.
SOURCE: La Merie Publishing
Post Views: 103
