Title:
IMPROVED ANTIBODY MOLECULE
Document Type and Number:
WIPO Patent Application WO/2010/035769
Kind Code:
A1
Abstract:
The amino acid sequences for a variable region and a constant region in TOCILIZUMAB, which is a humanized anti-IL-6 receptor IgG1 antibody, are modified so as to improve the pharmacokinetics of TOCILIZUMAB while enhancing the antigen-neutralizing ability of TOCILIZUMAB. In this manner, it becomes possible to produce a second-generation molecule which can be administered at reduced frequency, can exhibit its therapeutic effect sustainably, has improved immunogenicity, safeness and physical properties (stability and uniformity), and is therefore superior to TOCILIZUMAB. Thus, disclosed is a pharmaceutical composition comprising the molecule. Also disclosed is a method for producing the pharmaceutical composition.
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Inventors:
IGAWA TOMOYUKI (JP)
ISHII SHINYA (JP)
MAEDA ATSUHIKO (JP)
SAKURAI MIKA (JP)
KOJIMA TETSUO (JP)
TACHIBANA TATSUHIKO (JP)
SHIRAIWA HIROTAKE (JP)
TSUNODA HIROYUKI (JP)
HIGUCHI YOSHINOBU (JP)
ISHII SHINYA (JP)
MAEDA ATSUHIKO (JP)
SAKURAI MIKA (JP)
KOJIMA TETSUO (JP)
TACHIBANA TATSUHIKO (JP)
SHIRAIWA HIROTAKE (JP)
TSUNODA HIROYUKI (JP)
HIGUCHI YOSHINOBU (JP)
Application Number:
PCT/JP2009/066590
Publication Date:
April 01, 2010
Filing Date:
September 25, 2009
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
IGAWA TOMOYUKI (JP)
ISHII SHINYA (JP)
MAEDA ATSUHIKO (JP)
SAKURAI MIKA (JP)
KOJIMA TETSUO (JP)
TACHIBANA TATSUHIKO (JP)
SHIRAIWA HIROTAKE (JP)
TSUNODA HIROYUKI (JP)
HIGUCHI YOSHINOBU (JP)
IGAWA TOMOYUKI (JP)
ISHII SHINYA (JP)
MAEDA ATSUHIKO (JP)
SAKURAI MIKA (JP)
KOJIMA TETSUO (JP)
TACHIBANA TATSUHIKO (JP)
SHIRAIWA HIROTAKE (JP)
TSUNODA HIROYUKI (JP)
HIGUCHI YOSHINOBU (JP)
International Classes:
C12N15/09; A61K39/395; A61P1/04; A61P1/16; A61P3/10; A61P7/06; A61P9/00; A61P9/10; A61P11/00; A61P11/06; A61P13/12; A61P15/08; A61P17/00; A61P17/06; A61P19/02; A61P19/10; A61P21/00; A61P25/00; A61P27/02; A61P29/00; A61P35/00; A61P37/02; A61P37/08; C07K16/28; C12N1/15; C12N1/19; C12N1/21; C12N5/10; C12P21/08
Domestic Patent References:
| WO2007143168A2 | 2007-12-13 |
Foreign References:
| JPH02163096A | 1990-06-22 |
Other References:
YOSHIYUKI OSUGI: "Kotai Iyakuhin no Genzai Shinkokei -Kaihatsu.Seisan Gijutsu.Tokkyo Han'i- Seizo Hanbai Shonin o Eta Kaihatsu Hinmoku no Success Story Nipponhatsu Saisho no Kotai Iyaku 'Hito-ka Ko-hito-interleukin-6 Juyotai Kotai (Tocilizumab)' no Kenkyu Kaihatsu Keii -Kiso Kenkyu, Tansaku Kenkyu kara Soyaku Kenkyu,", GEKKAN PHARM STAGE, vol. 7, no. 5, 2007, pages 13 - 18, XP008143206
RAJPAL, A. ET AL.: "A general method for greatly improving the affinity of antibodies by using combinatorial libraries.", PROC.NATL.ACAD.SCI.USA, vol. 102, no. 24, 2005, pages 8466 - 8471, XP002392777
ONDA, M. ET AL.: "Lowering the Isoelectric Point of the Fv Portion of Recombinant Immunotoxins Leads to Decreased Nonspecific Animal Toxicity without Affecting Antitumor Activity.", CANCER RES., vol. 61, 2001, pages 5070 - 5077, XP002359466
ITO, W. ET AL.: "The His-probe method: effects of histidine residues introduced into the complementary-determining regions of antibodies on antigen-antibody interactions at different pH values.", FEBS LETT., vol. 309, no. 1, 1992, pages 85 - 88, XP008123385
CHIRINO, A.J. ET AL.: "Minimizing the immunogenicity of protein therapeutics.", DRUG DISCOVERY TODAY, vol. 9, no. 2, 2004, pages 82 - 90, XP002395255
See also references of EP 2330193A4
RAJPAL, A. ET AL.: "A general method for greatly improving the affinity of antibodies by using combinatorial libraries.", PROC.NATL.ACAD.SCI.USA, vol. 102, no. 24, 2005, pages 8466 - 8471, XP002392777
ONDA, M. ET AL.: "Lowering the Isoelectric Point of the Fv Portion of Recombinant Immunotoxins Leads to Decreased Nonspecific Animal Toxicity without Affecting Antitumor Activity.", CANCER RES., vol. 61, 2001, pages 5070 - 5077, XP002359466
ITO, W. ET AL.: "The His-probe method: effects of histidine residues introduced into the complementary-determining regions of antibodies on antigen-antibody interactions at different pH values.", FEBS LETT., vol. 309, no. 1, 1992, pages 85 - 88, XP008123385
CHIRINO, A.J. ET AL.: "Minimizing the immunogenicity of protein therapeutics.", DRUG DISCOVERY TODAY, vol. 9, no. 2, 2004, pages 82 - 90, XP002395255
See also references of EP 2330193A4
Attorney, Agent or Firm:
SHIMIZU, Hatsushi et al. (JP)
Spring water Original aim (JP)
Spring water Original aim (JP)
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