Title:
A PHARMACEUTICAL COMPOSITION FOR USE IN THE TREATMENT OR PREVENTION OF A C5-RELATED DISEASE AND A METHOD FOR TREATING OR PREVENTING A C5-RELATED DISEASE
Document Type and Number:
WIPO Patent Application WO/2018/143266
Kind Code:
A1
Abstract:
The present invention relates to pharmaceutical compositions for use in the treatment or prevention of a C5-related disease and methods for treating or preventing a C5-related disease. The present invention further relates to dosages and administrations of anti-C5 antibody or pharmaceutical compositions containing the anti-C5 antibody.
Inventors:
SHINOMIYA KENJI (JP)
YONEYAMA KOICHIRO (JP)
SHIBAHARA NORIHITO (JP)
TSUBOI YOSHINORI (JP)
FUKUZAWA TAKU (SG)
HARAYA KENTA (SG)
SAMPEI ZENJIRO (SG)
BOGMAN KATRIJN (CH)
CHAROIN JEAN ERIC (CH)
YONEYAMA KOICHIRO (JP)
SHIBAHARA NORIHITO (JP)
TSUBOI YOSHINORI (JP)
FUKUZAWA TAKU (SG)
HARAYA KENTA (SG)
SAMPEI ZENJIRO (SG)
BOGMAN KATRIJN (CH)
CHAROIN JEAN ERIC (CH)
Application Number:
PCT/JP2018/003193
Publication Date:
August 09, 2018
Filing Date:
January 31, 2018
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
HOFFMANN LA ROCHE (CH)
HOFFMANN LA ROCHE (CH)
International Classes:
C07K16/18; A61K39/00
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J.E. CELLIS: "Cell Biology: A Laboratory Notebook", 1998, ACADEMIC PRESS
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A. DOYLE ET AL: "Cell and Tissue Culture: Laboratory Procedures", August 1993, J. WILEY AND SONS
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"Monoclonal Antibodies: A Practical Approach", 2000, OXFORD UNIVERSITY PRESS
E. HARLOW; D. LANE: "Using Antibodies: A Laboratory Manual", 1999, COLD SPRING HARBOR LABORATORY PRESS
M. ZANETTI AND J. D. CAPRA: "The Antibodies", 1995, HARWOOD ACADEMIC PUBLISHERS
V.T. DEVITA ET AL: "Cancer: Principles and Practice of Oncology", 1993, J.B. LIPPINCOTT COMPANY
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KABAT ET AL.: "Sequences of Proteins of Immunological Interest", 1991, PUBLIC HEALTH SERVICE, NIH
MACCALLUM ET AL., J. MOL. BIOL., vol. 262, 1996, pages 732 - 745
RAVETCH; KINET, ANNU. REV. IMMUNOL., vol. 9, 1991, pages 457 - 492
HELLSTROM ET AL., PROC. NAT'L ACAD. SCI. USA, vol. 83, 1986, pages 7059 - 7063
HELLSTROM ET AL., PROC. NAT'L ACAD. SCI. USA, vol. 82, 1985, pages 1499 - 1502
BRUGGEMANN ET AL., J. EXP. MED., vol. 166, 1987, pages 1351 - 1361
CLYNES ET AL., PROC. NAT'L ACAD. SCI. USA, vol. 95, 1998, pages 652 - 656
GAZZANO-SANTORO ET AL., J. IMMUNOL. METHODS, vol. 202, 1996, pages 163
CRAGG ET AL., BLOOD, vol. 101, 2003, pages 1045 - 1052
CRAGG ET AL., BLOOD, vol. 103, 2004, pages 2738 - 2743
PETKOVA ET AL., INT'L. IMMUNOL., vol. 18, no. 12, 2006, pages 1759 - 1769
SHIELDS ET AL., J. BIOL. CHEM., vol. 9, no. 2, 2001, pages 6591 - 6604
IDUSOGIE ET AL., J. IMMUNOL., vol. 164, 2000, pages 4178 - 4184
GUYER ET AL., J. IMMUNOL., vol. 117, 1976, pages 587
KIM ET AL., J. IMMUNOL., vol. 24, 1994, pages 249
DUNCAN, NATURE, vol. 322, 1988, pages 738 - 740
YANAN ZHENG ET AL: "Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration", MABS, vol. 4, no. 2, 1 March 2012 (2012-03-01), US, pages 243 - 255, XP055312728, ISSN: 1942-0862, DOI: 10.4161/mabs.4.2.19387
W. F. RICHTER ET AL: "Subcutaneous Absorption of Biotherapeutics: Knowns and Unknowns", DRUG METABOLISM AND DISPOSITION, vol. 42, no. 11, 6 August 2014 (2014-08-06), pages 1881 - 1889, XP055344158, DOI: 10.1124/dmd.114.059238
TAKU FUKUZAWA ET AL: "Long lasting neutralization of C5 by SKY59, a novel recycling antibody, is a potential therapy for complement-mediated diseases", SCIENTIFIC REPORTS, vol. 7, no. 1, 24 April 2017 (2017-04-24), XP055399003, DOI: 10.1038/s41598-017-01087-7
NORI KAWAHATA: "A Subcutaneously Administered Investigational RNAi Therapeutic (ALN-CC5) Targeting Complement C5 for Treatment of PNH and Complement-Mediated Diseases: Interim Phase 1 Study Results", 22 March 2016 (2016-03-22), XP055471916, Retrieved from the Internet
HOLERS ET AL., IMMUNOL. REV., vol. 223, 2008, pages 300 - 316
DMYTRIJUK ET AL., THE ONCOLOGIST, vol. 13, no. 9, 2008, pages 993 - 1000
YEUNG ET AL., J IMMUNOL., vol. 182, no. 12, 2009, pages 7663 - 7671
DATTA-MANNAN ET AL., J BIOL. CHEM., vol. 282, no. 3, 2007, pages 1709 - 1717
DALL'ACQUA ET AL., J. IMMUNOL., vol. 169, no. 9, 2002, pages 5171 - 5180
SAMBROOK ET AL.: "Molecular Cloning: A Laboratory Manual", 2001, COLD SPRING HARBOR LABORATORY PRESS
F.M. AUSUBEL ET AL: "Current Protocols in Molecular Biology", 2003
M.J. MACPHERSON ET AL: "Methods in Enzymology", 1995, ACADEMIC PRESS, INC.
HARLOW AND LANE: "Antibodies, A Laboratory Manual", 1988
R.I. FRESHNEY: "Animal Cell Culture", 1987
M.J. GAIT: "Oligonucleotide Synthesis", 1984
"Methods in Molecular Biology", HUMANA PRESS
J.E. CELLIS: "Cell Biology: A Laboratory Notebook", 1998, ACADEMIC PRESS
J. P. MATHER; P.E. ROBERTS: "Introduction to Cell and Tissue Culture", 1998, PLENUM PRESS
A. DOYLE ET AL: "Cell and Tissue Culture: Laboratory Procedures", August 1993, J. WILEY AND SONS
D.M. WEIR AND C.C. BLACKWELL: "Handbook of Experimental Immunology", 1986
J.M. MILLER AND M.P. CALOS: "Gene Transfer Vectors for Mammalian Cells", 1987
MULLIS ET AL: "PCR: The Polymerase Chain Reaction", 1994
J.E. COLIGAN ET AL: "Current Protocols in Immunology", 1991
"Short Protocols in Molecular Biology", 1999, WILEY AND SONS
C.A. JANEWAY; P. TRAVERS: "Immunobiology", 1997
P. FINCH: "Antibodies", 1997
"Antibodies: A Practical Approach", 1988, IRL PRESS
"Monoclonal Antibodies: A Practical Approach", 2000, OXFORD UNIVERSITY PRESS
E. HARLOW; D. LANE: "Using Antibodies: A Laboratory Manual", 1999, COLD SPRING HARBOR LABORATORY PRESS
M. ZANETTI AND J. D. CAPRA: "The Antibodies", 1995, HARWOOD ACADEMIC PUBLISHERS
V.T. DEVITA ET AL: "Cancer: Principles and Practice of Oncology", 1993, J.B. LIPPINCOTT COMPANY
CC THOMAS: "Experimental Immunochemistry", 1961, SPRINGFIELD, pages: 135 - 139
HILLMEN ET AL., N. ENGL. J. MED., vol. 350, no. 6, 2004, pages 552 - 559
CHOTHIA, J. MOL. BIOL., vol. 196, 1987, pages 901 - 917
KABAT ET AL.: "Sequences of Proteins of Immunological Interest", 1991, PUBLIC HEALTH SERVICE, NIH
MACCALLUM ET AL., J. MOL. BIOL., vol. 262, 1996, pages 732 - 745
RAVETCH; KINET, ANNU. REV. IMMUNOL., vol. 9, 1991, pages 457 - 492
HELLSTROM ET AL., PROC. NAT'L ACAD. SCI. USA, vol. 83, 1986, pages 7059 - 7063
HELLSTROM ET AL., PROC. NAT'L ACAD. SCI. USA, vol. 82, 1985, pages 1499 - 1502
BRUGGEMANN ET AL., J. EXP. MED., vol. 166, 1987, pages 1351 - 1361
CLYNES ET AL., PROC. NAT'L ACAD. SCI. USA, vol. 95, 1998, pages 652 - 656
GAZZANO-SANTORO ET AL., J. IMMUNOL. METHODS, vol. 202, 1996, pages 163
CRAGG ET AL., BLOOD, vol. 101, 2003, pages 1045 - 1052
CRAGG ET AL., BLOOD, vol. 103, 2004, pages 2738 - 2743
PETKOVA ET AL., INT'L. IMMUNOL., vol. 18, no. 12, 2006, pages 1759 - 1769
SHIELDS ET AL., J. BIOL. CHEM., vol. 9, no. 2, 2001, pages 6591 - 6604
IDUSOGIE ET AL., J. IMMUNOL., vol. 164, 2000, pages 4178 - 4184
GUYER ET AL., J. IMMUNOL., vol. 117, 1976, pages 587
KIM ET AL., J. IMMUNOL., vol. 24, 1994, pages 249
DUNCAN, NATURE, vol. 322, 1988, pages 738 - 740
Attorney, Agent or Firm:
HARUNA, Masao et al. (JP)
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