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July 27, 2007

Kyowa Hakko licensed to BioWa (wholly owned subsidiary in US),
a novel antibody engineering technology (COMPLEGENT™)
for the efficacy enhancement of therapeutic antibodies

Kyowa Hakko Kogyo has developed and licensed to BioWa (a wholly owned subsidiary in US), a novel antibody engineering technology for CDC-enhancement (COMPLEGENT™) of therapeutic antibodies, following the POTELLIGENT® technology, an antibody engineering technology for ADCC-enhancement of therapeutic antibodies that was originally established at Kyowa Hakko's Research Lab.

Complement-Dependent Cytotoxicity (CDC) is one of the major pharmacological effects of therapeutic antibodies as well as Antibody-Dependent Cellular Cytotoxicity (ADCC).
Immunoglobulin G molecule has several isotypes which differ in biological effects. We have successfully created an antibody molecule with enhanced CDC by incorporating a part of the amino acid sequence of IgG3 into the sequence of IgG1, standard isotype for therapeutic antibody, in the way the advantages of each isotype are combined together (Isotype Chimerism).
The antibody that is produced by using COMPLEGENT™ technology has CDC activity superior to both isotypes of natural IgG1 and IgG3. In addition, the antibody with enhanced ADCC and CDC can be produced using both COMPLEGENT™ and POTELLIGENT® technology.
(BioWa named this type of antibody with enhanced ADCC and CDC as AccretaMab™.)

We will promote the research and the development of AccretaMab™ with enhanced ADCC and CDC to expand the pipeline of therapeutic antibodies.
BioWa is expected to license POTELLIGENT® and COMPLEGENT™ technology further to pharmaceutical and biotechnology companies around the world.




About POTELLIGENT® technology
POTELLIGENT® technology is an antibody engineering technology for ADCC-enhancement of therapeutic antibodies. POTELLIGENT® technology enables to produce an antibody with reduced fucose in the carbohydrate structure attached to it, resulting in the significant enhancement of ADCC activity and the remarkable efficacy to kill the target cell. Animal study indicates that the antibody produced by this technology shows anti-tumor effects in vivo 100 times more potent than conventional antibodies. The research team of Kyowa Hakko also indicates that this technology will contribute to the creation of novel therapeutic antibody for allergic disease.

About ADCC activity
ADCC activity is the one of the functions of human immune system which enables leukocytes such as natural killer and monocytes to kill the target cell such as cancer cells in the presence of antibody.

About CDC activity
CDC activity is one of the functions of human immune system where activated complement kills the target cell.

About Complement
Complement is a mechanism acquired by multi-cellular organism to defend themselves against foreign organisms. Complement, activated by binding to antigen-antibody complex or pathological microorganisms, supports the functions of antibody, such as phagocytosis or lysis of foreign organisms.

About AccretaMab™
AccretaMab™ is the trademark name of antibody created by combine with POTELLIGENT® and COMPLEGENT™ technology. It is named from "Accretion".



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