Title:
METHOD FOR MEASURING INTERNALISATION OF MOLECULE INTO CELL
Document Type and Number:
WIPO Patent Application WO/2019/078357
Kind Code:
A1
Abstract:
The present invention provides a method for measuring the amount of a molecule that is internalised into a cell, said method comprising: (i) a step for adding said molecule to a cell population derived from an internal organ, and incubating the same; (ii) a step for screening said cell population derived from an organ on the basis of the expression levels of CD31 and CD45; and (iii) a step for measuring, after steps (i) and (ii), the amount of said molecule that is internalised into the cell population screened in (ii), wherein the molecule is internalised within a cell via a receptor present on the cell surface.
Inventors:
NOGUCHI YUKI (JP)
NAMBU TAKERU (JP)
OZEKI KAZUHISA (JP)
OHMINATO NORIAKI (JP)
NAKAGAWA TOSHITO (JP)
NAOI SOTARO (JP)
NAMBU TAKERU (JP)
OZEKI KAZUHISA (JP)
OHMINATO NORIAKI (JP)
NAKAGAWA TOSHITO (JP)
NAOI SOTARO (JP)
Application Number:
PCT/JP2018/039005
Publication Date:
April 25, 2019
Filing Date:
October 19, 2018
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
International Classes:
G01N33/53; C12N5/077; G01N33/15; G01N33/48; G01N33/483; G01N33/50
Domestic Patent References:
| WO2009037839A1 | 2009-03-26 | |||
| WO2016148216A1 | 2016-09-22 | |||
| WO2012132067A1 | 2012-10-04 | |||
| WO2013081143A1 | 2013-06-06 | |||
| WO2014113510A1 | 2014-07-24 | |||
| WO2016117346A1 | 2016-07-28 | |||
| WO2016098357A1 | 2016-06-23 | |||
| WO2013081143A1 | 2013-06-06 | |||
| WO2016098357A1 | 2016-06-23 |
Foreign References:
| JP2013537403A | 2013-10-03 | |||
| JP2011144125A | 2011-07-28 | |||
| JP2001289851A | 2001-10-19 | |||
| US5208020A | 1993-05-04 | |||
| US5416064A | 1995-05-16 | |||
| EP0425235B1 | 1996-09-25 | |||
| US5635483A | 1997-06-03 | |||
| US5780588A | 1998-07-14 | |||
| US7498298B2 | 2009-03-03 | |||
| US5712374A | 1998-01-27 | |||
| US5714586A | 1998-02-03 | |||
| US5739116A | 1998-04-14 | |||
| US5767285A | 1998-06-16 | |||
| US5770701A | 1998-06-23 | |||
| US5770710A | 1998-06-23 | |||
| US5773001A | 1998-06-30 | |||
| US5877296A | 1999-03-02 | |||
| US6630579B2 | 2003-10-07 |
Other References:
MARKS, K. M. ET AL.: "Chemical labeling strategies for cell biology", NATURE METHODS, vol. 3, no. 8, August 2006 (2006-08-01), pages 591 - 596, XP009162404, DOI: doi:10.1038/nmeth906
BENACERRAF, B.M. SEBESTYENN.S. COOPER: "The clearance of antigen antibody complexes from the blood by the reticuloendothelial system", J IMMUNOL, vol. 82, no. 2, 1959, pages 131 - 7
TAKAI, T.: "Roles of Fc receptors in autoimmunity", NAT REV IMMUNOL, vol. 2, no. 8, 2002, pages 580 - 92, XP037115088, DOI: 10.1038/nri856
SCHWAB, IF. NIMMERJAHN: "Intravenous immunoglobulin therapy: how does IgG modulate the immune system?", NAT REV IMMUNOL, vol. 13, no. 3, 2013, pages 176 - 89, XP055234901, DOI: 10.1038/nri3401
AREND, W.P.J.C. STURGE: "Composition and biologic properties of soluble IgG-anti-IgG immune complexes: effects of variations in the specificity of rabbit antibodies to different structural components of human IgG", J IMMUNOL, vol. 123, no. 1, 1979, pages 447 - 54
FINBLOOM, D.S.P.H. PLOTZ: "Studies of reticuloendothelial function in the mouse with model immune complexes. I. Serum clearance and tissue uptake in normal C3H mice", J IMMUNOL, vol. 123, no. 4, 1979, pages 1594 - 9
KURLANDER, R.J.D.M. ELLISONJ. HALL: "The blockade of Fc receptor-mediated clearance of immune complexes in vivo by a monoclonal antibody (2.4G2) directed against Fc receptors on murine leukocytes", J IMMUNOL, vol. 133, no. 2, 1984, pages 855 - 62
MOUSAVI, S.A. ET AL.: "Receptor-mediated endocytosis of immune complexes in rat liver sinusoidal endothelial cells is mediated by FcgammaRIIb2", HEPATOLOGY, vol. 46, no. 3, 2007, pages 871 - 84, XP055312018, DOI: 10.1002/hep.21748
IWAYANAGI, Y. ET AL.: "Inhibitory FcgammaRIIb-Mediated Soluble Antigen Clearance from Plasma by a pH-Dependent Antigen-Binding Antibody and Its Enhancement by Fc Engineering", J IMMUNOL, vol. 195, no. 7, 2015, pages 3198 - 205
IGAWA, T.K. HARAYAK. HATTORI: "Sweeping antibody as a novel therapeutic antibody modality capable of eliminating soluble antigens from circulation", IMMUNOL REV, vol. 270, no. 1, 2016, pages 132 - 51, XP055585172, DOI: 10.1111/imr.12392
GANESAN, L.P. ET AL.: "FcgammaRIIb on liver sinusoidal endothelium clears small immune complexes", J IMMUNOL, vol. 189, no. 10, 2012, pages 4981 - 8, XP002724347, DOI: 10.4049/jimmunol.1202017
LOVDAL, T. ET AL.: "Fc receptor mediated endocytosis of small soluble immunoglobulin G immune complexes in Kupffer and endothelial cells from rat liver", J CELL SCI, vol. 113, 2000, pages 3255 - 66
ROJAS, J.R. ET AL.: "Formation, distribution, and elimination of infliximab and anti-infliximab immune complexes in cynomolgus monkeys", J PHARMACOL EXP THER, vol. 313, no. 2, 2005, pages 578 - 85, XP008070606, DOI: 10.1124/jpet.104.079277
MARCH, S. ET AL.: "Microenvironmental regulation of the sinusoidal endothelial cell phenotype in vitro", HEPATOLOGY, vol. 50, no. 3, 2009, pages 920 - 8, XP055065048, DOI: 10.1002/hep.23085
FILALI, E.E. ET AL.: "Human liver endothelial cells, but not macrovascular or microvascular endothelial cells, engraft in the mouse liver", CELL TRANSPLANT, vol. 22, no. 10, 2013, pages 1801 - 11
BRUHNS, P. ET AL.: "Specificity and affinity of human Fcgamma receptors and their polymorphic variants for human IgG subclasses", BLOOD, vol. 113, no. 16, 2009, pages 3716 - 25, XP055077761, DOI: 10.1182/blood-2008-09-179754
QIAO, S.W. ET AL.: "Dependence of antibody-mediated presentation of antigen on FcRn", PROC NATL ACAD SCI USA, vol. 105, no. 27, 2008, pages 9337 - 42, XP055046753, DOI: 10.1073/pnas.0801717105
WEFLEN, A.W. ET AL.: "Multivalent immune complexes divert FcRn to lysosomes by exclusion from recycling sorting tubules", MOL BIOL CELL, vol. 24, no. 15, 2013, pages 2398 - 405
OITATE, M. ET AL.: "Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data", DRUG METAB PHARMACOKINET, vol. 26, no. 4, 2011, pages 423 - 30
SINGH, A.P. ET AL.: "Quantitative prediction of human pharmacokinetics for mAbs exhibiting target-mediated disposition", AAPS J, vol. 17, no. 2, 2015, pages 389 - 99, XP035473686, DOI: 10.1208/s12248-014-9690-8
LUU, K.T. ET AL.: "A model-based approach to predicting the human pharmacokinetics of a monoclonal antibody exhibiting target-mediated drug disposition", J PHARMACOL EXP THER, vol. 341, no. 3, 2012, pages 702 - 8
MELLMAN, 1.H. PLUTNERP. UKKONEN: "Internalization and rapid recycling of macrophage Fc receptors tagged with monovalent antireceptor antibody: possible role of a prelysosomal compartment", J CELL BIOL, vol. 98, no. 4, 1984, pages 1163 - 9, XP055057764, DOI: 10.1083/jcb.98.4.1163
PFEIFFER, E. ET AL.: "Featured Article: Isolation, characterization, and cultivation of human hepatocytes and non-parenchymal liver cells", EXP BIOL MED, vol. 240, no. 5, 2015, pages 645 - 56
J BIOMATER SCI POLYM ED., vol. 20, no. 1, 2009, pages 83 - 97
MILLER CM. ET AL.: "Stabilin-1 and Stabilin-2 are specific receptors for the cellular internalization of phosphorothioate-modified antisense oligonucleotides (ASOs) in the liver", NUCLEIC ACIDS RES., vol. 44, no. 6, 2016, pages 2782 - 94, XP055647950, DOI: 10.1093/nar/gkw112
MARTIN-ARMAS M. ET AL.: "Toll-like receptor 9 (TLR9) is present in murine liver sinusoidal endothelial cells (LSECs) and mediates the effect of CpG-oligonucleotides", J HEPATOL., vol. 44, no. 5, 2006, pages 939 - 46, XP025054263, DOI: 10.1016/j.jhep.2005.09.020
NUCLEIC ACIDS RES., vol. 25, no. 16, 15 August 1997 (1997-08-15), pages 3290 - 6
BIOCHEM PHARMACOL., vol. 62, no. 3, 1 August 2001 (2001-08-01), pages 297 - 306
DELEVE, L.D., J CLIN INVEST., vol. 123, no. 5, 2013, pages 1861 - 6
J HEPATOL., vol. 66, no. 1, January 2017 (2017-01-01), pages 212 - 227
MULLBERG ET AL., J. IMMUNOL., vol. 152, no. 10, 1994, pages 4958 - 4968
ORGAN BIOLOGY, vol. 24, no. 1, 2017, pages 54 - 60
CELL TISSUE RES., vol. 242, no. 3, 1985, pages 505 - 10
J PHARM SCI., vol. 102, no. 9, September 2013 (2013-09-01), pages 3119 - 27
HEPATOLOGY, vol. 48, no. 6, December 2008 (2008-12-01), pages 2007 - 15
HINMAN ET AL., CANCER RES., vol. 53, 1993, pages 3336 - 3342
LODE ET AL., CANCER RES., vol. 58, 1998, pages 2925 - 2928
KRATZ ET AL., CURRENT MED. CHEM., vol. 13, 2006, pages 477 - 523
JEFFREY ET AL., BIOORGANIC & MED. CHEM. LETTERS, vol. 16, 2006, pages 358 - 362
TORGOV ET AL., BIOCONJ. CHEM., vol. 16, 2005, pages 717 - 721
NAGY ET AL., PROC. NATL. ACAD. SCI. USA, vol. 97, 2000, pages 829 - 834
DUBOWCHIK ET AL., BIOORG. & MED. CHEM. LETTERS, vol. 12, 2002, pages 1529 - 1532
KING ET AL., J. MED. CHEM., vol. 45, 2002, pages 4336 - 4343
ADV BIOMED RES., vol. 1, 2012, pages 27
METHODS MOL BIOL., vol. 726, 2011, pages 207 - 221
NANOTHERANOSTICS, vol. 1, no. 4, 2017, pages 415 - 429
PLOS PATHOG, vol. 7, no. 9, 2011, pages e1002281
HEPATOLOGY, vol. 34, no. 4, 2001, pages 803 - 8
ORGAN BIOLOGY, vol. 16, no. 3, 2009, pages 361 - 370
HISTOPATHOLOGY, vol. 12, no. 5, May 1988 (1988-05-01), pages 461 - 80
WOODFIN A. ET AL.: "PECAM-1: a multi-functional molecule in inflammation and vascular biology", ARTERIOSCLER THROMB VASC BIOL, vol. 27, no. 12, 2007, pages 2514 - 23, XP002515392, DOI: 10.1161/ATVBAHA.107.15.151456
PENNINGER JM. ET AL.: "CD45: new jobs for an old acquaintance", NAT IMMUNOL, vol. 2, no. 5, 2001, pages 389 - 96
"Molecular Cloning : A Laboratory Manual", 1989, COLD SPRING HARBOR LABORATORY
"Current Protocols in Molecular Biology", 2003, JOHN WILEY & SONS INC.
PHARMACOKINETICS, vol. 8, no. 3, 1993, pages 99 - 109
ORGAN BIOLOGY VOL., vol. 16, no. 3, 2009, pages 361 - 370
J HEPATOL., vol. 44, no. 5, 2006, pages 939 - 46
BENACERRAF, B.M. SEBESTYENN.S. COOPER: "The clearance of antigen antibody complexes from the blood by the reticuloendothelial system", J IMMUNOL, vol. 82, no. 2, 1959, pages 131 - 7
TAKAI, T.: "Roles of Fc receptors in autoimmunity", NAT REV IMMUNOL, vol. 2, no. 8, 2002, pages 580 - 92, XP037115088, DOI: 10.1038/nri856
SCHWAB, IF. NIMMERJAHN: "Intravenous immunoglobulin therapy: how does IgG modulate the immune system?", NAT REV IMMUNOL, vol. 13, no. 3, 2013, pages 176 - 89, XP055234901, DOI: 10.1038/nri3401
AREND, W.P.J.C. STURGE: "Composition and biologic properties of soluble IgG-anti-IgG immune complexes: effects of variations in the specificity of rabbit antibodies to different structural components of human IgG", J IMMUNOL, vol. 123, no. 1, 1979, pages 447 - 54
FINBLOOM, D.S.P.H. PLOTZ: "Studies of reticuloendothelial function in the mouse with model immune complexes. I. Serum clearance and tissue uptake in normal C3H mice", J IMMUNOL, vol. 123, no. 4, 1979, pages 1594 - 9
KURLANDER, R.J.D.M. ELLISONJ. HALL: "The blockade of Fc receptor-mediated clearance of immune complexes in vivo by a monoclonal antibody (2.4G2) directed against Fc receptors on murine leukocytes", J IMMUNOL, vol. 133, no. 2, 1984, pages 855 - 62
MOUSAVI, S.A. ET AL.: "Receptor-mediated endocytosis of immune complexes in rat liver sinusoidal endothelial cells is mediated by FcgammaRIIb2", HEPATOLOGY, vol. 46, no. 3, 2007, pages 871 - 84, XP055312018, DOI: 10.1002/hep.21748
IWAYANAGI, Y. ET AL.: "Inhibitory FcgammaRIIb-Mediated Soluble Antigen Clearance from Plasma by a pH-Dependent Antigen-Binding Antibody and Its Enhancement by Fc Engineering", J IMMUNOL, vol. 195, no. 7, 2015, pages 3198 - 205
IGAWA, T.K. HARAYAK. HATTORI: "Sweeping antibody as a novel therapeutic antibody modality capable of eliminating soluble antigens from circulation", IMMUNOL REV, vol. 270, no. 1, 2016, pages 132 - 51, XP055585172, DOI: 10.1111/imr.12392
GANESAN, L.P. ET AL.: "FcgammaRIIb on liver sinusoidal endothelium clears small immune complexes", J IMMUNOL, vol. 189, no. 10, 2012, pages 4981 - 8, XP002724347, DOI: 10.4049/jimmunol.1202017
LOVDAL, T. ET AL.: "Fc receptor mediated endocytosis of small soluble immunoglobulin G immune complexes in Kupffer and endothelial cells from rat liver", J CELL SCI, vol. 113, 2000, pages 3255 - 66
ROJAS, J.R. ET AL.: "Formation, distribution, and elimination of infliximab and anti-infliximab immune complexes in cynomolgus monkeys", J PHARMACOL EXP THER, vol. 313, no. 2, 2005, pages 578 - 85, XP008070606, DOI: 10.1124/jpet.104.079277
MARCH, S. ET AL.: "Microenvironmental regulation of the sinusoidal endothelial cell phenotype in vitro", HEPATOLOGY, vol. 50, no. 3, 2009, pages 920 - 8, XP055065048, DOI: 10.1002/hep.23085
FILALI, E.E. ET AL.: "Human liver endothelial cells, but not macrovascular or microvascular endothelial cells, engraft in the mouse liver", CELL TRANSPLANT, vol. 22, no. 10, 2013, pages 1801 - 11
BRUHNS, P. ET AL.: "Specificity and affinity of human Fcgamma receptors and their polymorphic variants for human IgG subclasses", BLOOD, vol. 113, no. 16, 2009, pages 3716 - 25, XP055077761, DOI: 10.1182/blood-2008-09-179754
QIAO, S.W. ET AL.: "Dependence of antibody-mediated presentation of antigen on FcRn", PROC NATL ACAD SCI USA, vol. 105, no. 27, 2008, pages 9337 - 42, XP055046753, DOI: 10.1073/pnas.0801717105
WEFLEN, A.W. ET AL.: "Multivalent immune complexes divert FcRn to lysosomes by exclusion from recycling sorting tubules", MOL BIOL CELL, vol. 24, no. 15, 2013, pages 2398 - 405
OITATE, M. ET AL.: "Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data", DRUG METAB PHARMACOKINET, vol. 26, no. 4, 2011, pages 423 - 30
SINGH, A.P. ET AL.: "Quantitative prediction of human pharmacokinetics for mAbs exhibiting target-mediated disposition", AAPS J, vol. 17, no. 2, 2015, pages 389 - 99, XP035473686, DOI: 10.1208/s12248-014-9690-8
LUU, K.T. ET AL.: "A model-based approach to predicting the human pharmacokinetics of a monoclonal antibody exhibiting target-mediated drug disposition", J PHARMACOL EXP THER, vol. 341, no. 3, 2012, pages 702 - 8
MELLMAN, 1.H. PLUTNERP. UKKONEN: "Internalization and rapid recycling of macrophage Fc receptors tagged with monovalent antireceptor antibody: possible role of a prelysosomal compartment", J CELL BIOL, vol. 98, no. 4, 1984, pages 1163 - 9, XP055057764, DOI: 10.1083/jcb.98.4.1163
PFEIFFER, E. ET AL.: "Featured Article: Isolation, characterization, and cultivation of human hepatocytes and non-parenchymal liver cells", EXP BIOL MED, vol. 240, no. 5, 2015, pages 645 - 56
J BIOMATER SCI POLYM ED., vol. 20, no. 1, 2009, pages 83 - 97
MILLER CM. ET AL.: "Stabilin-1 and Stabilin-2 are specific receptors for the cellular internalization of phosphorothioate-modified antisense oligonucleotides (ASOs) in the liver", NUCLEIC ACIDS RES., vol. 44, no. 6, 2016, pages 2782 - 94, XP055647950, DOI: 10.1093/nar/gkw112
MARTIN-ARMAS M. ET AL.: "Toll-like receptor 9 (TLR9) is present in murine liver sinusoidal endothelial cells (LSECs) and mediates the effect of CpG-oligonucleotides", J HEPATOL., vol. 44, no. 5, 2006, pages 939 - 46, XP025054263, DOI: 10.1016/j.jhep.2005.09.020
NUCLEIC ACIDS RES., vol. 25, no. 16, 15 August 1997 (1997-08-15), pages 3290 - 6
BIOCHEM PHARMACOL., vol. 62, no. 3, 1 August 2001 (2001-08-01), pages 297 - 306
DELEVE, L.D., J CLIN INVEST., vol. 123, no. 5, 2013, pages 1861 - 6
J HEPATOL., vol. 66, no. 1, January 2017 (2017-01-01), pages 212 - 227
MULLBERG ET AL., J. IMMUNOL., vol. 152, no. 10, 1994, pages 4958 - 4968
ORGAN BIOLOGY, vol. 24, no. 1, 2017, pages 54 - 60
CELL TISSUE RES., vol. 242, no. 3, 1985, pages 505 - 10
J PHARM SCI., vol. 102, no. 9, September 2013 (2013-09-01), pages 3119 - 27
HEPATOLOGY, vol. 48, no. 6, December 2008 (2008-12-01), pages 2007 - 15
HINMAN ET AL., CANCER RES., vol. 53, 1993, pages 3336 - 3342
LODE ET AL., CANCER RES., vol. 58, 1998, pages 2925 - 2928
KRATZ ET AL., CURRENT MED. CHEM., vol. 13, 2006, pages 477 - 523
JEFFREY ET AL., BIOORGANIC & MED. CHEM. LETTERS, vol. 16, 2006, pages 358 - 362
TORGOV ET AL., BIOCONJ. CHEM., vol. 16, 2005, pages 717 - 721
NAGY ET AL., PROC. NATL. ACAD. SCI. USA, vol. 97, 2000, pages 829 - 834
DUBOWCHIK ET AL., BIOORG. & MED. CHEM. LETTERS, vol. 12, 2002, pages 1529 - 1532
KING ET AL., J. MED. CHEM., vol. 45, 2002, pages 4336 - 4343
ADV BIOMED RES., vol. 1, 2012, pages 27
METHODS MOL BIOL., vol. 726, 2011, pages 207 - 221
NANOTHERANOSTICS, vol. 1, no. 4, 2017, pages 415 - 429
PLOS PATHOG, vol. 7, no. 9, 2011, pages e1002281
HEPATOLOGY, vol. 34, no. 4, 2001, pages 803 - 8
ORGAN BIOLOGY, vol. 16, no. 3, 2009, pages 361 - 370
HISTOPATHOLOGY, vol. 12, no. 5, May 1988 (1988-05-01), pages 461 - 80
WOODFIN A. ET AL.: "PECAM-1: a multi-functional molecule in inflammation and vascular biology", ARTERIOSCLER THROMB VASC BIOL, vol. 27, no. 12, 2007, pages 2514 - 23, XP002515392, DOI: 10.1161/ATVBAHA.107.15.151456
PENNINGER JM. ET AL.: "CD45: new jobs for an old acquaintance", NAT IMMUNOL, vol. 2, no. 5, 2001, pages 389 - 96
"Molecular Cloning : A Laboratory Manual", 1989, COLD SPRING HARBOR LABORATORY
"Current Protocols in Molecular Biology", 2003, JOHN WILEY & SONS INC.
PHARMACOKINETICS, vol. 8, no. 3, 1993, pages 99 - 109
ORGAN BIOLOGY VOL., vol. 16, no. 3, 2009, pages 361 - 370
J HEPATOL., vol. 44, no. 5, 2006, pages 939 - 46
Attorney, Agent or Firm:
ONO, Shinjiro et al. (JP)
Download PDF: