Title:
PROTEIN RECOGNIZING DRUG MOIETY OF ANTIBODY-DRUG CONJUGATE
Document Type and Number:
WIPO Patent Application WO/2020/022475
Kind Code:
A1
Abstract:
A protein that recognizes the drug moiety of an antibody-drug conjugate in which a drug represented by the formula is linked to an antibody via a linker; a method for measuring the concentration of the antibody-drug conjugate in the plasma of a mammal dosed with the antibody-drug conjugate using the protein; and a method for checking the tissue distribution of the antibody-drug conjugate in the mammal using the protein.
Inventors:
SOMA MASAKO (JP)
KUGA HIROSHI (JP)
MASUDA TAKESHI (JP)
KAWAMURA JUNKO (JP)
ISHIBASHI HIROMI (JP)
YASUDA SATORU (JP)
KUGA HIROSHI (JP)
MASUDA TAKESHI (JP)
KAWAMURA JUNKO (JP)
ISHIBASHI HIROMI (JP)
YASUDA SATORU (JP)
Application Number:
PCT/JP2019/029379
Publication Date:
January 30, 2020
Filing Date:
July 26, 2019
Export Citation:
Assignee:
DAIICHI SANKYO CO LTD (JP)
International Classes:
C07K16/44; A61K39/395; A61K47/68; A61P35/00; C07K16/46; C12N1/15; C12N1/19; C12N1/21; C12N5/10; C12N15/13; C12N15/63; C12Q1/00; G01N33/53; C07K17/00
Domestic Patent References:
| WO2017002776A1 | 2017-01-05 | |||
| WO2014057687A1 | 2014-04-17 | |||
| WO2014061277A1 | 2014-04-24 | |||
| WO2015098099A1 | 2015-07-02 | |||
| WO2015115091A1 | 2015-08-06 | |||
| WO2015146132A1 | 2015-10-01 | |||
| WO2015155976A1 | 2015-10-15 | |||
| WO2015155998A1 | 2015-10-15 | |||
| WO2001000245A2 | 2001-01-04 | |||
| WO2007077028A2 | 2007-07-12 | |||
| WO2008100624A2 | 2008-08-21 | |||
| WO2018135501A1 | 2018-07-26 | |||
| WO2018212136A1 | 2018-11-22 | |||
| WO2009048072A1 | 2009-04-16 | |||
| WO2010117011A1 | 2010-10-14 | |||
| WO1990007861A1 | 1990-07-26 | |||
| WO2004061104A2 | 2004-07-22 |
Foreign References:
| US5821337A | 1998-10-13 | |||
| US4946778A | 1990-08-07 | |||
| US5260203A | 1993-11-09 | |||
| US5091513A | 1992-02-25 | |||
| US5455030A | 1995-10-03 | |||
| US5834476A | 1998-11-10 |
Other References:
NAKAYAMA JOJI: "2016 financial results - Management briefing session", 20 September 2019 (2019-09-20), pages 1 - 75, XP009524862, Retrieved from the Internet
AGATSUMA TOSHINORI : "Antibody drugs and antibody-drug conjugates (ADCs) and Daiichi Sankyo's efforts", 29 March 2017 (2017-03-29), pages 28 - 30, XP009524863, Retrieved from the Internet [retrieved on 20190920]
DERE, RANDALL ET AL.: "PK assays for antibody-drug conjugates: case study with ado-trastuzumab emtansine", BIOANALYSIS, vol. 5, 2013, pages 1025 - 1040, XP055763232
STEPHAN, JEAN-PHILIPPE ET AL.: "Anti- CD 22-MCC-DMl and MC -MMAF Conjugates: Impact of Assay Format on Pharmacokinetic Parameters Determination", BIOCONJUGATE CHEM, vol. 19, 2008, pages 1673 - 1683, XP002672616
SANDERSON, RUSSE LL J. ET AL.: "In vivo Drug-Linker stability of an anti- CD 30 Dipeptide-linked auristatin immunoconjugate", CLINICAL CANCER RESEARCH, vol. 11, 2005, pages 843 - 852, XP002631376
DUCRY, L. ET AL., BIOCONJUGATE CHEM, vol. 21, 2010, pages 5 - 13
ALLEY, S. C. ET AL., CURRENT OPINION IN CHEMICAL BIOLOGY, vol. 14, 2010, pages 529 - 537
DAMLE N. K., EXPERT OPIN. BIOL. THER., vol. 4, 2004, pages 1445 - 1452
SENTER P. D. ET AL., NATURE BIOTECHNOLOGY, vol. 30, 2012, pages 631 - 637
HOWARD A. ET AL., J CLIN ONCOL, vol. 29, pages 398 - 405
XIE H. ET AL., J PHARMACOL EXP THER, vol. 308, no. 3, 2004, pages 1073 - 1082
SANDERSON RJ. ET AL., CLINICAL CANCER RESEARCH, vol. 11, 2005, pages 843 - 852
STEPHAN JP ET AL., BIOCONJUGATE CHEM, vol. 19, 2008, pages 1673 - 1683
STEPHAN JP ET AL., BIOANALYSIS, vol. 3, no. 6, 2011, pages 677 - 700
DERE R. ET AL., BIOANALYSIS, vol. 5, no. 9, 2013, pages 1025 - 1040
OGITANI Y. ET AL., CLINICAL CANCER RESEARCH, vol. 22, no. 20, 2016, pages 5097 - 5108
OGITANI Y. ET AL., CANCER SCIENCE, vol. 107, 2016, pages 1039 - 1046
DOI T ET AL., LANCET ONCOL, vol. 18, 2017, pages 1512 - 22
TAKEGAWA N ET AL., INT. J. CANCER, vol. 141, 2017, pages 1682 - 1689
KASPER BINZ H. ET AL., CURRENT OPINION IN BIOTECHNOLOGY, vol. 16, 2005, pages 459 - 469
KASPER BINZ H. ET AL., NATURE BIOTECHNOLOGY, vol. 23, no. 10, 2005, pages 1137 - 1146
SKERRA A., CURRENT OPINION IN BIOTECHNOLOGY, vol. 18, 2007, pages 295 - 304
NYGREN P., FEBS JOURNAL, vol. 275, 2008, pages 2668 - 2676
GRONWALL C. ET AL., JOURNAL OF BIOTECHNOLOGY, vol. 140, 2009, pages 254 - 269
OGITANI Y. ET AL., CLINICAL CANCER RESEARCH, vol. 22, no. 20, 29 March 2016 (2016-03-29), pages 5097 - 5108
KOHLERMILSTEIN, NATURE, vol. 256, 1975, pages 495 - 497
URLAUB, G.CHASIN, L. A., PROC. NATL. ACAD. SCI. U.S.A., vol. 77, 1980, pages 4126 - 4220
"Strategies for Protein Purification and Characterization: A Laboratory Course Manual", 1996, COLD SPRING HARBOR LABORATORY PRESS
HUSTON, J. S. ET AL., PROC. NATL. ACAD. SCI. U.S.A., vol. 85, 1988, pages 5879 - 5883
PROC. NATL. ACAD. SCI. USA, vol. 81, 1984, pages 6851 - 6855
NATURE, vol. 321, 1986, pages 522 - 525
JOURNAL OF CHROMATOGRAPHY A, vol. 705, 1995, pages 129 - 134
ANALYTICAL BIOCHEMISTRY, vol. 360, 2007, pages 75 - 83
NUCL. ACIDS RES., vol. 25, 1997, pages 3389 - 3402
LORI BURTON, PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, vol. 12, 2007, pages 265 - 273
LEE, H-S ET AL., MOLECULAR IMMUNOLOGY, vol. 36, 1999, pages 61 - 71
SHIRRMANN, T. ET AL., MABS, vol. 2, no. 1, 2010, pages 1 - 4
MUYLDEMANS S. ET AL., PROTEIN ENG, vol. 7, no. 9, 1994, pages 1129 - 35
HAMERS-CASTERMAN C. ET AL., NATURE, vol. 363, no. 6428, 1993, pages 446 - 8
GLUZMAN, Y., CELL, vol. 23, 1981, pages 175 - 182
MILLSTEIN ET AL., NATURE, vol. 305, 1983, pages 537 - 539
SUGIMORI M. ET AL., J MED. CHEM., vol. 113, 1994, pages 3033 - 3039
SAMBROOK, J.FRITSCH, E. F.MANIATIS, T.: "Molecular Cloning", 1989, COLD SPRING HARBOR LABORATORY PRESS
ITO M ET AL., BLOOD, vol. 100, no. 9, 2002, pages 3175 - 3182
ATSUMI R. ET AL., ARZNEIMITTEL-FORSCHUNG, 2001, pages 253 - 257
See also references of EP 3831853A4
AGATSUMA TOSHINORI : "Antibody drugs and antibody-drug conjugates (ADCs) and Daiichi Sankyo's efforts", 29 March 2017 (2017-03-29), pages 28 - 30, XP009524863, Retrieved from the Internet
DERE, RANDALL ET AL.: "PK assays for antibody-drug conjugates: case study with ado-trastuzumab emtansine", BIOANALYSIS, vol. 5, 2013, pages 1025 - 1040, XP055763232
STEPHAN, JEAN-PHILIPPE ET AL.: "Anti- CD 22-MCC-DMl and MC -MMAF Conjugates: Impact of Assay Format on Pharmacokinetic Parameters Determination", BIOCONJUGATE CHEM, vol. 19, 2008, pages 1673 - 1683, XP002672616
SANDERSON, RUSSE LL J. ET AL.: "In vivo Drug-Linker stability of an anti- CD 30 Dipeptide-linked auristatin immunoconjugate", CLINICAL CANCER RESEARCH, vol. 11, 2005, pages 843 - 852, XP002631376
DUCRY, L. ET AL., BIOCONJUGATE CHEM, vol. 21, 2010, pages 5 - 13
ALLEY, S. C. ET AL., CURRENT OPINION IN CHEMICAL BIOLOGY, vol. 14, 2010, pages 529 - 537
DAMLE N. K., EXPERT OPIN. BIOL. THER., vol. 4, 2004, pages 1445 - 1452
SENTER P. D. ET AL., NATURE BIOTECHNOLOGY, vol. 30, 2012, pages 631 - 637
HOWARD A. ET AL., J CLIN ONCOL, vol. 29, pages 398 - 405
XIE H. ET AL., J PHARMACOL EXP THER, vol. 308, no. 3, 2004, pages 1073 - 1082
SANDERSON RJ. ET AL., CLINICAL CANCER RESEARCH, vol. 11, 2005, pages 843 - 852
STEPHAN JP ET AL., BIOCONJUGATE CHEM, vol. 19, 2008, pages 1673 - 1683
STEPHAN JP ET AL., BIOANALYSIS, vol. 3, no. 6, 2011, pages 677 - 700
DERE R. ET AL., BIOANALYSIS, vol. 5, no. 9, 2013, pages 1025 - 1040
OGITANI Y. ET AL., CLINICAL CANCER RESEARCH, vol. 22, no. 20, 2016, pages 5097 - 5108
OGITANI Y. ET AL., CANCER SCIENCE, vol. 107, 2016, pages 1039 - 1046
DOI T ET AL., LANCET ONCOL, vol. 18, 2017, pages 1512 - 22
TAKEGAWA N ET AL., INT. J. CANCER, vol. 141, 2017, pages 1682 - 1689
KASPER BINZ H. ET AL., CURRENT OPINION IN BIOTECHNOLOGY, vol. 16, 2005, pages 459 - 469
KASPER BINZ H. ET AL., NATURE BIOTECHNOLOGY, vol. 23, no. 10, 2005, pages 1137 - 1146
SKERRA A., CURRENT OPINION IN BIOTECHNOLOGY, vol. 18, 2007, pages 295 - 304
NYGREN P., FEBS JOURNAL, vol. 275, 2008, pages 2668 - 2676
GRONWALL C. ET AL., JOURNAL OF BIOTECHNOLOGY, vol. 140, 2009, pages 254 - 269
OGITANI Y. ET AL., CLINICAL CANCER RESEARCH, vol. 22, no. 20, 29 March 2016 (2016-03-29), pages 5097 - 5108
KOHLERMILSTEIN, NATURE, vol. 256, 1975, pages 495 - 497
URLAUB, G.CHASIN, L. A., PROC. NATL. ACAD. SCI. U.S.A., vol. 77, 1980, pages 4126 - 4220
"Strategies for Protein Purification and Characterization: A Laboratory Course Manual", 1996, COLD SPRING HARBOR LABORATORY PRESS
HUSTON, J. S. ET AL., PROC. NATL. ACAD. SCI. U.S.A., vol. 85, 1988, pages 5879 - 5883
PROC. NATL. ACAD. SCI. USA, vol. 81, 1984, pages 6851 - 6855
NATURE, vol. 321, 1986, pages 522 - 525
JOURNAL OF CHROMATOGRAPHY A, vol. 705, 1995, pages 129 - 134
ANALYTICAL BIOCHEMISTRY, vol. 360, 2007, pages 75 - 83
NUCL. ACIDS RES., vol. 25, 1997, pages 3389 - 3402
LORI BURTON, PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, vol. 12, 2007, pages 265 - 273
LEE, H-S ET AL., MOLECULAR IMMUNOLOGY, vol. 36, 1999, pages 61 - 71
SHIRRMANN, T. ET AL., MABS, vol. 2, no. 1, 2010, pages 1 - 4
MUYLDEMANS S. ET AL., PROTEIN ENG, vol. 7, no. 9, 1994, pages 1129 - 35
HAMERS-CASTERMAN C. ET AL., NATURE, vol. 363, no. 6428, 1993, pages 446 - 8
GLUZMAN, Y., CELL, vol. 23, 1981, pages 175 - 182
MILLSTEIN ET AL., NATURE, vol. 305, 1983, pages 537 - 539
SUGIMORI M. ET AL., J MED. CHEM., vol. 113, 1994, pages 3033 - 3039
SAMBROOK, J.FRITSCH, E. F.MANIATIS, T.: "Molecular Cloning", 1989, COLD SPRING HARBOR LABORATORY PRESS
ITO M ET AL., BLOOD, vol. 100, no. 9, 2002, pages 3175 - 3182
ATSUMI R. ET AL., ARZNEIMITTEL-FORSCHUNG, 2001, pages 253 - 257
See also references of EP 3831853A4
Attorney, Agent or Firm:
ISHIBASHI Koki et al. (JP)
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