Title:
ANTIGEN-BINDING MOLECULE FOR ELIMINATING AGGREGATED ANTIGENS
Document Type and Number:
WIPO Patent Application WO/2013/180201
Kind Code:
A1
Abstract:
The inventors of the present invention have discovered that by including, in an antigen-binding molecule that binds to antigens that form an aggregate, the Fc region and antigen-binding domain, wherein binding activity changes with respect to an antigen due to ion concentration conditions, an antigen-binding molecule capable of eliminating protein aggregates within plasma with priority over monomers can be produced. Using this antigen-binding molecule enables various diseases stemming from target tissues to be treated in a target tissue-specific manner. Furthermore, using this antigen-binding molecule enables diseases caused by protein aggregates to be treated.
Inventors:
IGAWA TOMOYUKI (JP)
HIRONIWA NAOKA (JP)
ITO ERIKO (JP)
HIRONIWA NAOKA (JP)
ITO ERIKO (JP)
Application Number:
PCT/JP2013/064979
Publication Date:
December 05, 2013
Filing Date:
May 30, 2013
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
International Classes:
C07K16/18; A61K39/395; A61P43/00; C07K16/42; C12P21/08; G01N33/15; G01N33/50; C12N15/09
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RATHANASWAMI P; ROALSTAD S; ROSKOS L; SU QJ; LACKIE S; BABCOOK J.: "Demonstration of an in vivo generated sub-picomolar affinity fully human monoclonal antibody to interleukin-8.", BIOCHEM. BIOPHYS. RES. COMMUN., vol. 334, no. 4, 2005, pages 1004 - 1013, XP027459137, DOI: doi:10.1016/j.bbrc.2005.07.002
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KUNKEL ET AL., PROC. NATL. ACAD. SCI. USA, vol. 82, 1985, pages 488 - 492
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NATURE, vol. 276, no. 5685, 1978, pages 269 - 270
J. IMMUNOL. METHODS, vol. 35, no. 1-2, 1980, pages 1 - 21
J. EXP. MED., vol. 148, no. 1, 1978, pages 313 - 323
NATURE, vol. 277, no. 5692, 1979, pages 131 - 133
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CURRENT PROTOCOLS IN PROTEIN SCIENCE, May 2001 (2001-05-01)
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CANCER RES., vol. 53, 1993, pages 851 - 856
BERNASCONI ET AL., SCIENCE, vol. 298, 2002, pages 2199 - 2202
"Sequences of Proteins of Immunological Interest", 1987, NATIONAL INSTITUTE OF HEALTH
SPRINGER ET AL., CELL, vol. 102, 2000, pages 275 - 277
KAWASAKI; KRETSINGER, PROTEIN PROF., vol. 2, 1995, pages 305 - 490
MONCRIEF ET AL., J. MOL. EVOL., vol. 30, 1990, pages 522 - 562
CHAUVAUX ET AL., BIOCHEM. J., vol. 265, 1990, pages 261 - 265
BAIROCH; COX, FEBS LETT., vol. 269, 1990, pages 454 - 456
DAVIS, NEW BIOL., vol. 2, 1990, pages 410 - 419
SCHAEFER ET AL., GENOMICS, vol. 25, 1995, pages 638 - 643
ECONOMOU ET AL., EMBO J., vol. 9, 1990, pages 349 - 354
WURZBURG ET AL., STRUCTURE, vol. 14, no. 6, 2006, pages 1049 - 1058
TOMLINSON ET AL., J. MOL. BIOL., vol. 227, 1992, pages 776 - 798
WILLIAMS; WINTER, EUR. J. IMMUNOL., vol. 23, 1993, pages 1456 - 1461
COX ET AL., NAT. GENETICS, vol. 7, 1994, pages 162 - 168
MATSUDA ET AL., J. EXP. MED., vol. 188, 1998, pages 1973 - 1975
KAWASAKI ET AL., EUR. J. IMMUNOL., vol. 31, 2001, pages 1017 - 1028
SCHABLE; ZACHAU, BIOL. CHEM. HOPPE SEYLER, vol. 374, 1993, pages 1001 - 1022
BRENSING-KUPPERS ET AL., GENE, vol. 191, 1997, pages 173 - 181
KAWASAKI ET AL., GENOME RES., vol. 7, 1997, pages 250 - 261
WU ET AL., J. EXP. MED., vol. 132, 1970, pages 211 - 250
KABAT: "Sequences of Proteins of Immunological Interest", 1987, NATIONAL INSTITUTE OF HEALTH BETHESDA MD
LEE; RICHARDS, J. MOL. BIOL., vol. 55, 1971, pages 379 - 400
CONNOLLY, J. APPL. CRYST., vol. 16, 1983, pages 548 - 558
PACIOS, COMPUT. CHEM., vol. 18, no. 4, 1994, pages 377 - 386
J. MOL. MODEL., vol. 1, 1995, pages 46 - 53
GEJIMA ET AL., HUMAN ANTIBODIES, vol. 11, 2002, pages 121 - 129
CARDOSO ET AL., SCAND. J. IMMUNOL., vol. 51, 2000, pages 337 - 344
BIOORG. MED. CHEM., vol. 11, no. 17, 2003, pages 3761 - 3768
GHETIE, IMMUNOL. TODAY, vol. 18, no. 12, 1997, pages 592 - 598
RAGHAVAN ET AL., IMMUNITY, vol. 1, 1994, pages 303 - 315
JOURNAL OF IMMUNOLOGY, vol. 182, 2009, pages 7663 - 7671
CURR. OPIN. BIOTECHNOL., vol. 20, no. 6, 2009, pages 685 - 91
CURR. OPIN. IMMUNOL., vol. 20, no. 4, 2008, pages 460 - 470
PROTEIN ENG. DES. SEL., vol. 23, no. 4, 2010, pages 195 - 202
PROC. NATL. ACAD. SCI. USA, vol. 103, no. 11, 2006, pages 4005 - 4010
WEITZHANDLER ET AL., J. PHARMA. SCIENCES, vol. 83, no. 12, 1994, pages 1670 - 1675
SCHENK ET AL., J. CLIN. INVESTIGATION, vol. 108, no. 11, 2001, pages 1687 - 1695
BIGGE ET AL., ANAL. BIOCHEM., vol. 230, no. 2, 1995, pages 229 - 238
PROTEIN ENGINEERING, vol. 9, no. 3, 1996, pages 299 - 305
EMBO J., vol. 13, 1994, pages 1166 - 75
INT IMMUNOL., vol. 13, no. 12, 2001, pages 1551 - 1559
METHODS MOL BIOL., vol. 602, 2010, pages 93 - 104
CLIN PHARMACOL., vol. 48, no. 4, April 2008 (2008-04-01), pages 406 - 417
PHARM RES., vol. 23, no. 1, January 2006 (2006-01-01), pages 95 - 103
JACKSON LABORATORIES, METHODS MOL BIOL., vol. 602, 2010, pages 93 - 104
YANG ET AL., J. MOL. BIOL., vol. 254, 1995, pages 392 - 403
MARKS ET AL., BIO/TECHNOLOGY, vol. 10, 1992, pages 779 - 783
LOW ET AL., J. MOL. BIOL., vol. 250, 1996, pages 359 - 368
PATTEN ET AL., CURR. OPIN. BIOTECHNOL., vol. 8, 1997, pages 724 - 733
THOMPSON ET AL., J. MOL. BIOL., vol. 256, 1996, pages 77 - 88
CLAMERI ET AL., NATURE, vol. 391, 1998, pages 288 - 291
PROTEIN SCIENCE, vol. 4, 1995, pages 2411 - 2423
See also references of EP 2857419A4
HAMILTON, ROBERT G.: "Molecular engineering: applications to the clinical laboratory.", CLINICAL CHEMISTRY, vol. 39, no. 9, 1993, pages 1988 - 1997, XP055132119
YEUNG, YIK ANDY ET AL.: "Engineering human IgG1 affinity to human neonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates", JOURNAL OF IMMUNOLOGY, vol. 182, no. 12, 2009, pages 7663 - 7671, XP002566420
SHIELDS, ROBERT L. ET AL.: "High resolution mapping of the binding site on human IgG1 for Fc gamma RI, Fc gamma RII, Fc gamma RIII, and FcRn and design of IgG1 variants with improved binding to the Fc gamma R.", THE JOURNAL OF BIOLOGICAL CHEMISTRY, vol. 276, no. 9, 2001, pages 6591 - 6604, XP002495886
PRICKETT, KATHRYN S. ET AL.: "A calcium- dependent antibody for identification and purification of recombinant proteins.", BIOTECHNIQUES, vol. 7, no. 6, 1989, pages 580 - 589, XP008174362
YARMUSH, MARTIN L. ET AL.: "Immunoadsorption: strategies for antigen elution and production of reusable adsorbents.", BIOTECHNOLOGY PROGRESS, vol. 8, no. 3, 1992, pages 168 - 178, XP008143270
JANICE M REICHERT; CLARK J ROSENSWEIG; LAURA B FADEN; MATTHEW C DEWITZ: "Monoclonal antibody successes in the clinic", NATURE BIOTECHNOLOGY, vol. 23, 2005, pages 1073 - 1078, XP002555770, DOI: doi:10.1038/nbt0905-1073
PAVLOU AK; BELSEY MJ.: "The therapeutic antibodies market to 2008.", EUR J PHARM BIOPHARM., vol. 59, no. 3, April 2005 (2005-04-01), pages 389 - 96, XP025317626, DOI: doi:10.1016/j.ejpb.2004.11.007
RAJPAL A; BEYAZ N; HABER L; CAPPUCCILLI G; YEE H; BHATT RR; TAKEUCHI T; LERNER RA; CREA R.: "A general method for greatly improving the affinity of antibodies by using combinatorial libraries.", PROC. NATL. ACAD. SCI. U. S. A., vol. 102, no. 24, 2005, pages 8466 - 8471, XP002392777, DOI: doi:10.1073/pnas.0503543102
RATHANASWAMI P; ROALSTAD S; ROSKOS L; SU QJ; LACKIE S; BABCOOK J.: "Demonstration of an in vivo generated sub-picomolar affinity fully human monoclonal antibody to interleukin-8.", BIOCHEM. BIOPHYS. RES. COMMUN., vol. 334, no. 4, 2005, pages 1004 - 1013, XP027459137, DOI: doi:10.1016/j.bbrc.2005.07.002
IGAWA T: "Antibody recycling by engineered pH-dependent antigen binding improves the duration of antigen neutralization", NAT BIOTECHNOL., vol. 28, 2010, pages 1203, XP009153598, DOI: doi:10.1038/nbt.1691
KUNKEL ET AL., PROC. NATL. ACAD. SCI. USA, vol. 82, 1985, pages 488 - 492
ANNU. REV. BIOPHYS. BIOMOL. STRUCT., vol. 35, 2006, pages 225 - 249
PROC. NATL. ACAD. SCI. U.S.A., vol. 100, no. 11, 2003, pages 6353 - 6357
"Epitope Mapping Protocols in Methods in Molecular Biology", vol. 66, 1996
"Antibodies: A Laboratory Manual", 1988, COLD SPRING HARBOR LABORATORY, pages: 359 - 420
"Sequences of proteins of immunological interest", NIH PUBLICATION NO. 91-3242
J. IMMUNOL., vol. 123, no. 4, 1979, pages 1548 - 1550
CURRENT TOPICS IN MICROBIOLOGY AND IMMUNOLOGY, vol. 81, 1978, pages 1 - 7
C. EUR. J. IMMUNOL., vol. 6, no. 7, 1976, pages 511 - 519
CELL, vol. 8, no. 3, 1976, pages 405 - 415
NATURE, vol. 276, no. 5685, 1978, pages 269 - 270
J. IMMUNOL. METHODS, vol. 35, no. 1-2, 1980, pages 1 - 21
J. EXP. MED., vol. 148, no. 1, 1978, pages 313 - 323
NATURE, vol. 277, no. 5692, 1979, pages 131 - 133
KOHLER; MILSTEIN ET AL., METHODS ENZYMOL., vol. 73, 1981, pages 3 - 46
VANDAMME ET AL., EUR. J. BIOCHEM., vol. 192, no. 3, 1990, pages 767 - 775
BIOCHEMISTRY, vol. 18, no. 24, 1979, pages 5294 - 5299
ANAL. BIOCHEM., vol. 162, no. 1, 1987, pages 156 - 159
PROC. NATL. ACAD. SCI. USA, vol. 85, no. 23, 1988, pages 8998 - 9002
NUCLEIC ACIDS RES., vol. 17, no. 8, 1989, pages 2919 - 2932
CURRENT PROTOCOLS IN PROTEIN SCIENCE, May 2001 (2001-05-01)
EBERT, K. M., BIO/TECHNOLOGY, vol. 12, no. 7, 1994, pages 699 - 702
CANCER RES., vol. 53, 1993, pages 851 - 856
BERNASCONI ET AL., SCIENCE, vol. 298, 2002, pages 2199 - 2202
"Sequences of Proteins of Immunological Interest", 1987, NATIONAL INSTITUTE OF HEALTH
SPRINGER ET AL., CELL, vol. 102, 2000, pages 275 - 277
KAWASAKI; KRETSINGER, PROTEIN PROF., vol. 2, 1995, pages 305 - 490
MONCRIEF ET AL., J. MOL. EVOL., vol. 30, 1990, pages 522 - 562
CHAUVAUX ET AL., BIOCHEM. J., vol. 265, 1990, pages 261 - 265
BAIROCH; COX, FEBS LETT., vol. 269, 1990, pages 454 - 456
DAVIS, NEW BIOL., vol. 2, 1990, pages 410 - 419
SCHAEFER ET AL., GENOMICS, vol. 25, 1995, pages 638 - 643
ECONOMOU ET AL., EMBO J., vol. 9, 1990, pages 349 - 354
WURZBURG ET AL., STRUCTURE, vol. 14, no. 6, 2006, pages 1049 - 1058
TOMLINSON ET AL., J. MOL. BIOL., vol. 227, 1992, pages 776 - 798
WILLIAMS; WINTER, EUR. J. IMMUNOL., vol. 23, 1993, pages 1456 - 1461
COX ET AL., NAT. GENETICS, vol. 7, 1994, pages 162 - 168
MATSUDA ET AL., J. EXP. MED., vol. 188, 1998, pages 1973 - 1975
KAWASAKI ET AL., EUR. J. IMMUNOL., vol. 31, 2001, pages 1017 - 1028
SCHABLE; ZACHAU, BIOL. CHEM. HOPPE SEYLER, vol. 374, 1993, pages 1001 - 1022
BRENSING-KUPPERS ET AL., GENE, vol. 191, 1997, pages 173 - 181
KAWASAKI ET AL., GENOME RES., vol. 7, 1997, pages 250 - 261
WU ET AL., J. EXP. MED., vol. 132, 1970, pages 211 - 250
KABAT: "Sequences of Proteins of Immunological Interest", 1987, NATIONAL INSTITUTE OF HEALTH BETHESDA MD
LEE; RICHARDS, J. MOL. BIOL., vol. 55, 1971, pages 379 - 400
CONNOLLY, J. APPL. CRYST., vol. 16, 1983, pages 548 - 558
PACIOS, COMPUT. CHEM., vol. 18, no. 4, 1994, pages 377 - 386
J. MOL. MODEL., vol. 1, 1995, pages 46 - 53
GEJIMA ET AL., HUMAN ANTIBODIES, vol. 11, 2002, pages 121 - 129
CARDOSO ET AL., SCAND. J. IMMUNOL., vol. 51, 2000, pages 337 - 344
BIOORG. MED. CHEM., vol. 11, no. 17, 2003, pages 3761 - 3768
GHETIE, IMMUNOL. TODAY, vol. 18, no. 12, 1997, pages 592 - 598
RAGHAVAN ET AL., IMMUNITY, vol. 1, 1994, pages 303 - 315
JOURNAL OF IMMUNOLOGY, vol. 182, 2009, pages 7663 - 7671
CURR. OPIN. BIOTECHNOL., vol. 20, no. 6, 2009, pages 685 - 91
CURR. OPIN. IMMUNOL., vol. 20, no. 4, 2008, pages 460 - 470
PROTEIN ENG. DES. SEL., vol. 23, no. 4, 2010, pages 195 - 202
PROC. NATL. ACAD. SCI. USA, vol. 103, no. 11, 2006, pages 4005 - 4010
WEITZHANDLER ET AL., J. PHARMA. SCIENCES, vol. 83, no. 12, 1994, pages 1670 - 1675
SCHENK ET AL., J. CLIN. INVESTIGATION, vol. 108, no. 11, 2001, pages 1687 - 1695
BIGGE ET AL., ANAL. BIOCHEM., vol. 230, no. 2, 1995, pages 229 - 238
PROTEIN ENGINEERING, vol. 9, no. 3, 1996, pages 299 - 305
EMBO J., vol. 13, 1994, pages 1166 - 75
INT IMMUNOL., vol. 13, no. 12, 2001, pages 1551 - 1559
METHODS MOL BIOL., vol. 602, 2010, pages 93 - 104
CLIN PHARMACOL., vol. 48, no. 4, April 2008 (2008-04-01), pages 406 - 417
PHARM RES., vol. 23, no. 1, January 2006 (2006-01-01), pages 95 - 103
JACKSON LABORATORIES, METHODS MOL BIOL., vol. 602, 2010, pages 93 - 104
YANG ET AL., J. MOL. BIOL., vol. 254, 1995, pages 392 - 403
MARKS ET AL., BIO/TECHNOLOGY, vol. 10, 1992, pages 779 - 783
LOW ET AL., J. MOL. BIOL., vol. 250, 1996, pages 359 - 368
PATTEN ET AL., CURR. OPIN. BIOTECHNOL., vol. 8, 1997, pages 724 - 733
THOMPSON ET AL., J. MOL. BIOL., vol. 256, 1996, pages 77 - 88
CLAMERI ET AL., NATURE, vol. 391, 1998, pages 288 - 291
PROTEIN SCIENCE, vol. 4, 1995, pages 2411 - 2423
See also references of EP 2857419A4
Attorney, Agent or Firm:
HARUNA, Masao et al. (JP)
Masao Haruna (JP)
Masao Haruna (JP)
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