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MULTISPECIFIC ANTIBODY AND METHOD FOR PRODUCING SAME NEW

外国特許コード F210010587
整理番号 (2019-041)
掲載日 2021年11月4日
出願国 世界知的所有権機関(WIPO)
国際出願番号 2021JP012911
国際公開番号 WO 2021200673
国際出願日 令和3年3月26日(2021.3.26)
国際公開日 令和3年10月7日(2021.10.7)
優先権データ
  • 特願2020-063869 (2020.3.31) JP
発明の名称 (英語) MULTISPECIFIC ANTIBODY AND METHOD FOR PRODUCING SAME NEW
発明の概要(英語) The present invention provides a novel antibody format that does not use hetero-association technology and that is theoretically free of by-products having immune activity. This multispecific antibody has a Fab region that includes one polypeptide a chain and two polypeptide b chains. The polypeptide a chain includes a polypeptide in which a variable region Va1, a stationary region Ca1, a peptide linker LL, a variable region Va2 and a stationary region Ca are linked in the stated order. The polypeptide b chain includes a polypeptide in which a variable region Vb is linked to a stationary region Cb, which is linked to the stationary region Ca1 or the stationary region Ca2.
従来技術、競合技術の概要(英語) BACKGROUND ART
Bispecific antibodies are artificial antibodies that have been enhanced by combining two antibodies to target two different antigens. The high functionality of bispecific antibodies results in characteristic mechanisms of action, such as immune cell recycling, inhibition of receptor-mediated signaling, and mediating protein to protein association (NpL 1).
Due to such a characteristic mechanism of action, bispecific antibodies are expected to be present in drawing next-generation antibody pharmaceuticals. Therefore, bispecific antibodies have been studied, and currently 60 or more antibody formats have been reported (NpL 2).
Bispecific antibodies are made essentially by introducing two heavy chain genes and two light chain genes into animal cells and expressing and naturally associating the four polypeptide chains. However, when four expressed polypeptide chains associate to make up an antibody, each polypeptide chain is randomly chosen, thus inevitably resulting in undesired antibodies, including homo-associated antibodies, as a byproduct. In this case, the yield of the target antibody is theoretically 12.5%.
Therefore, in the production of bispecific antibodies, it is an important issue to suppress the generation of byproducts to improve the yield of the desired antibody. Furthermore, research to promote heteroassociation of polypeptide chains has progressed vigorously on such challenges. In such heteroassociation techniques, introduction of various mutations has been proposed, such as a method of introducing a substitution into the CH1 domain and the CL domain (Patent Document 1), a method of introducing mutations into the CH3 domain (Non-Patent Document 3, Patent Document 2), and the like. The accumulation of such a number of heteroassociation techniques has led to a yield of bispecific antibodies of greater than 90% by heteroassociation (NpL 4).
On the other hand, it has been pointed out that by-products generated in the production process of bispecific antibodies cause unexpected activation of immune cells, and may increase the risk of side effects when used as an antibody medicament (Non-Patent Document 5).
  • 出願人(英語)
  • ※2012年7月以前掲載分については米国以外のすべての指定国
  • UNIVERSITY PUBLIC CORPORATION OSAKA
  • 発明者(英語)
  • NAKANISHI, Takeshi
  • KITAMURA, Masaya
  • TACHIBANA, Taro
国際特許分類(IPC)
指定国 National States: AE AG AL AM AO AT AU AZ BA BB BG BH BN BR BW BY BZ CA CH CL CN CO CR CU CZ DE DJ DK DM DO DZ EC EE EG ES FI GB GD GE GH GM GT HN HR HU ID IL IN IR IS IT JO JP KE KG KH KN KP KR KW KZ LA LC LK LR LS LU LY MA MD ME MG MK MN MW MX MY MZ NA NG NI NO NZ OM PA PE PG PH PL PT QA RO RS RU RW SA SC SD SE SG SK SL ST SV SY TH TJ TM TN TR TT TZ UA UG US UZ VC VN WS ZA ZM ZW
ARIPO: BW GH GM KE LR LS MW MZ NA RW SD SL ST SZ TZ UG ZM ZW
EAPO: AM AZ BY KG KZ RU TJ TM
EPO: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
OAPI: BF BJ CF CG CI CM GA GN GQ GW KM ML MR NE SN TD TG

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