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Title:
COMBINATION THERAPY USING T CELL REDIRECTION ANTIGEN BINDING MOLECULE AGAINST CELL HAVING IMMUNOSUPPRESSING FUNCTION
Document Type and Number:
WIPO Patent Application WO/2017/086367
Kind Code:
A1
Abstract:
It is found that an antigen binding molecule, which contains (1) a domain capable of binding to a molecule expressed on the surface of a cell having a function of suppressing an immune response and (2) a domain capable of binding to a T cell receptor complex, can crosslink a cell having a function of suppressing an immune response to a T cell to induce the damage of the cell having a function of suppressing an immune response, thereby exhibiting a superior anti-tumor effect compared with the conventional antigen binding molecules. It is also found that an anti-tumor effect can be further improved by using the antigen binding molecule in combination with another anti-cancer agent.

Inventors:
TSUNENARI TOSHIAKI (JP)
MATSUDA YUTAKA (JP)
MIYAZAKI TARO (JP)
TANIGUCHI KENJI (JP)
Application Number:
PCT/JP2016/084027
Publication Date:
May 26, 2017
Filing Date:
November 17, 2016
Export Citation:
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Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
International Classes:
A61K39/395; A61K31/7068; A61K33/243; A61K45/00; A61P35/00; A61P35/02; A61P37/04; A61P43/00
Domestic Patent References:
WO2015124715A12015-08-27
WO2015156268A12015-10-15
WO2015174439A12015-11-19
WO2009011941A22009-01-22
WO1994011523A21994-05-26
WO1996002576A11996-02-01
WO1993012227A11993-06-24
WO1992003918A11992-03-19
WO1994002602A11994-02-03
WO1994025585A11994-11-10
WO1996034096A11996-10-31
WO1996033735A11996-10-31
WO1992001047A11992-01-23
WO1992020791A11992-11-26
WO1993006213A11993-04-01
WO1993011236A11993-06-10
WO1993019172A11993-09-30
WO1995001438A11995-01-12
WO1995015388A11995-06-08
WO1993011161A11993-06-10
WO1988001649A11988-03-10
WO2006132352A12006-12-14
WO2006106905A12006-10-12
WO1996027011A11996-09-06
WO2011028952A12011-03-10
WO2014018572A22014-01-30
WO2008119353A12008-10-09
WO2011131746A22011-10-27
WO2012058768A12012-05-10
WO2013063702A12013-05-10
WO2012023053A22012-02-23
WO2015046467A12015-04-02
WO2007114325A12007-10-11
WO1998050431A21998-11-12
WO1995033844A11995-12-14
WO2004065611A12004-08-05
WO2015156268A12015-10-15
WO2012073985A12012-06-07
WO2009080251A12009-07-02
WO2009080252A12009-07-02
WO2009080253A12009-07-02
WO2013065708A12013-05-10
Foreign References:
EP0239400A21987-09-30
EP0404097A21990-12-27
US4946778A1990-08-07
US5260203A1993-11-09
US20130336973A12013-12-19
US3773719A1973-11-20
EP0058481A11982-08-25
EP0133988A21985-03-13
Other References:
JANICE M REICHERT; CLARK J ROSENSWEIG; LAURA B FADEN; MATTHEW C DEWITZ: "Monoclonal antibody successes in the clinic", NAT. BIOTECHNOL., 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, 2005, pages 389 - 396, XP025317626, DOI: doi:10.1016/j.ejpb.2004.11.007
WEINER LM; SURANA R; WANG S: "Monoclonal antibodies: versatile platforms for cancer immunotherapy", NAT REV IMMUNOL., vol. 10, no. 5, May 2010 (2010-05-01), pages 317 - 27, XP055217481, DOI: doi:10.1038/nri2744
THOMAS F GAJEWSKI; HANS SCHREIBER; YANG-XIN FU: "Innate and adaptive immune cells in the tumor microenvironment", NATURE IMMUNOLOGY, vol. 14, 2013, pages 1014 - 1022, XP055333410, DOI: doi:10.1038/ni.2703
TOSTI G; COCOROCCHIO E; PENNACCHIOLI E: "Anti-cytotoxic T lymphocyte antigen-4 antibodies in melanoma", CLIN COSMET INVESTIG DERMATOL, vol. 6, 17 October 2013 (2013-10-17), pages 245 - 56
MCDERMOTT DF; ATKINS MB: "PD-1 as a potential target in cancer therapy", CANCER MED., vol. 2, no. 5, October 2013 (2013-10-01), pages 662 - 73
CHARLES G. DRAKE: "Combined Immune Checkpoint Blockade", SEMIN ONCOL., vol. 42, no. 4, August 2015 (2015-08-01), pages 656 - 62, XP009195396, DOI: doi:10.1053/j.seminoncol.2015.05.002
TROELS H. BORCH; MARCO DONIA; MADS H. ANDERSEN; INGE M. SVANE: "Reorienting the immune system in the treatment of cancer by using anti-PD-1 and anti-PD-Ll antibodies", DRUG DISCOV TODAY, vol. 20, no. 9, September 2015 (2015-09-01), pages 1127 - 34
POSTOW MA; CHESNEY J; PAVLICK AC; ROBERT C; GROSSMANN K; MCDERMOTT D; LINETTE GP; MEYER N; GIGUERE JK; AGARWALA SS: "Nivolumab and ipilimumab versus ipilimumab in untreated melanoma", N ENGL J MED., vol. 372, no. 21, 21 May 2015 (2015-05-21), pages 2006 - 17, XP002761464, DOI: doi:10.1056/NEJMoa1414428
JURE-KUNKEL M; MASTERS G; GIRIT E; DITO G; LEE F; HUNT JT; HUMPHREY R: "Synergy between chemotherapeutic agents and CTLA-4 blockade in preclinical tumor models", CANCER IMMUNOL IMMUNOTHER, vol. 62, no. 9, September 2013 (2013-09-01), pages 1533 - 45, XP055129217, DOI: doi:10.1007/s00262-013-1451-5
E JOHN WHERRY: "T cell exhaustion", NATURE IMMUNOLOGY, vol. 12, no. 6, June 2011 (2011-06-01), pages 492 - 499, XP055445573, DOI: doi:10.1038/ni.2035
SIMPSON TR1; LI F; MONTALVO-ORTIZ W; SEPULVEDA MA; BERGERHOFF K; ARCE F; RODDIE C; HENRY JY; YAGITA H; WOLCHOK JD: "Fc-dependent depletion of tumor-infiltrating regulatory T cells co-defines the efficacy of anti-CTLA-4 therapy against melanoma", J EXP MED., vol. 210, no. 9, 26 August 2013 (2013-08-26), pages 1695 - 710, XP009176006, DOI: doi:10.1084/jem.20130579
MARK J. SELBY; JOHN J. ENGELHARDT; MICHAEL QUIGLEY; KARLA A. HENNING; TIMOTHY CHEN; MOHAN SRINIVASAN; ALAN J. KORMAN: "Anti-CTLA-4 Antibodies of IgG2a Isotype Enhance Antitumor Activity through Reduction of Intratumoral Regulatory T Cells", CANCER IMMUNOL RES, vol. 1, no. 1, pages 1 - 11
ZALEVSKY J; LEUNG IW; KARKI S; CHU SY; ZHUKOVSKY EA; DESJARLAIS JR; CARMICHAEL DF; LAWRENCE CE: "The impact of Fc engineering on an anti-CD19 antibody: increased Fcgamma receptor affinity enhances B-cell clearing in nonhuman primates", BLOOD, vol. 113, no. 16, 16 April 2009 (2009-04-16), pages 3735 - 43, XP002685051, DOI: doi:10.1182/BLOOD-2008-10-182048
CURIEL, T. J. ET AL.: "Specific recruitment of regulatory T cells in ovarian carcinoma fosters immune privilege and predicts reduced survival", NATURE MEDICINE, vol. 10, 2004, pages 942 - 949, XP002523105, DOI: doi:10.1038/nm1093
SATO, E. ET AL.: "Intraepithelial CD8+ tumor-infiltrating lymphocytes and a high CD8+/regulatory T cell ratio are associated with favorable prognosis in ovarian cancer", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, vol. 102, 2005, pages 18538 - 18543, XP002687398, DOI: doi:10.1073/PNAS.0509182102
KAWAIDA, H. ET AL.: "Distribution of CD4÷CD25high regulatory T-cells in tumor-draining lymph nodes in patients with gastric cancer", THE JOURNAL OF SURGICAL RESEARCH, vol. 124, 2005, pages 151 - 157, XP004801703, DOI: doi:10.1016/j.jss.2004.10.004
KONO, K. ET AL.: "CD4÷CD25high regulatory T cells increase with tumor stage in patients with gastric and esophageal cancers", CANCER IMMUNOLOGY, IMMUNOTHERAPY : CII, vol. 55, 2006, pages 1064 - 1071, XP019422481
HIRAOKA, N.; ONOZATO, K.; KOSUGE, T.; HIROHASHI, S.: "Prevalence of FOXP3+ regulatory T cells increases during the progression of pancreatic ductal adenocarcinoma and its premalignant lesions", CLINICAL CANCER RESEARCH : AN OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH, vol. 12, 2006, pages 5423 - 5434
LIOTTA, F ET AL.: "Frequency of regulatory T cells in peripheral blood and in tumour-infiltrating lymphocytes correlates with poor prognosis in renal cell carcinoma", BJU INTERNATIONAL, vol. 107, 2011, pages 1500 - 1506
KOBAYASHI, N. ET AL.: "FOXP3+ regulatory T cells affect the development and progression of hepatocarcinogenesis", CLINICAL CANCER RESEARCH : AN OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH, vol. 13, 2007, pages 902 - 911
GOBERT, M. ET AL.: "Regulatory T cells recruited through CCL22/CCR4 are selectively activated in lymphoid infiltrates surrounding primary breast tumors and lead to an adverse clinical outcome", CANCER RESEARCH, vol. 69, 2009, pages 2000 - 2009, XP055101309, DOI: doi:10.1158/0008-5472.CAN-08-2360
BATES, G. J. ET AL.: "Quantification of regulatory T cells enables the identification of high-risk breast cancer patients and those at risk of late relapse", JOURNAL OF CLINICAL ONCOLOGY : OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY, vol. 24, 2006, pages 5373 - 5380
GERBER, A. L. ET AL.: "High expression of FOXP3 in primary melanoma is associated with tumour progression", THE BRITISH JOURNAL OF DERMATOLOGY, vol. 170, 2014, pages 103 - 109
WANG, Y. Y.; HE, X. Y.; CAI, Y. Y.; WANG, Z. J.; LU, S. H.: "The variation of CD4+CD25+ regulatory T cells in the periphery blood and tumor microenvironment of non-small cell lung cancer patients and the downregulation effects induced by CpG ODN", TARGETED ONCOLOGY, vol. 6, 2011, pages 147 - 154, XP019943800, DOI: doi:10.1007/s11523-011-0182-9
DE VOS VAN STEENWIJK, P. J. ET AL.: "Tumor-infiltrating CD14-positive myeloid cells and CD8-positive T-cells prolong survival in patients with cervical carcinoma. International journal of cancer", JOURNAL INTERNATIONAL DU CANCER, vol. 133, 2013, pages 2884 - 2894
WAINWRIGHT, D. A.; DEY, M.; CHANG, A.; LESNIAK, M. S.: "Targeting Tregs in Malignant Brain Cancer: Overcoming IDO", FRONTIERS IN IMMUNOLOGY, vol. 4, 2013, pages 116, XP055211742, DOI: doi:10.3389/fimmu.2013.00116
YU, P. ET AL.: "Simultaneous inhibition of two regulatory T-cell subsets enhanced Interleukin-15 efficacy in a prostate tumor model", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, vol. 109, 2012, pages 6187 - 6192, XP055147800, DOI: doi:10.1073/pnas.1203479109
ZHENG, J.; LIU, P.; YANG, X.: "YB-1 immunization combined with regulatory T-cell depletion induces specific T-cell responses that protect against neuroblastoma in the early stage", ACTA BIOCHIMICA ET BIOPHYSICA SINICA, vol. 44, 2012, pages 1006 - 1014
D'ARENA, G. ET AL.: "Regulatory T-cell number is increased in chronic lymphocytic leukemia patients and correlates with progressive disease", LEUKEMIA RESEARCH, vol. 35, 2011, pages 363 - 368
FRENCH, J. D. ET AL.: "Tumor-associated lymphocytes and increased FoxP3+ regulatory T cell frequency correlate with more aggressive papillary thyroid cancer", THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM, vol. 95, 2010, pages 2325 - 2333
KHAN, A. R.; DOVEDI, S. J.; WILKINSON, R. W.; PRITCHARD, D. I.: "Tumor infiltrating regulatory T cells: tractable targets for immunotherapy", INTERNATIONAL REVIEWS OF IMMUNOLOGY, vol. 29, 2010, pages 461 - 484
YANG, Z. Z.; NOVAK, A. J.; ZIESMER, S. C.; WITZIG, T. E.; ANSELL, S.: "Attenuation of CD8+ T-cell function by CD4+CD25+ regulatory T cells in B-cell non-Hodgkin's lymphoma", CANCER RESEARCH, vol. 66, 2006, pages 10145 - 10152
YANG, Z. Z.; NOVAK, A. J.; STENSON, M. J.; WITZIG, T. E.; ANSELL, S. M.: "Intratumoral CD4+CD25+ regulatory T-cell-mediated suppression of infiltrating CD4+ T cells in B-cell non-Hodgkin lymphoma", BLOOD, vol. 107, 2006, pages 3639 - 3646, XP055406165, DOI: doi:10.1182/blood-2005-08-3376
KABAT: "Sequences of Proteins of Immunological Interest", 1987, NATIONAL INSTITUTE OF HEALTH
"Sequences of Proteins of Immunological Interest", NIH PUBLICATION
J. EXP. MED, vol. 172, 1990, pages 19 - 25
ARTHRITIS. RHEUM., vol. 46, 2002, pages 1242 - 1254
J. CLIN. INVEST., vol. 100, no. 5, 1997, pages 1059 - 1070
J. CLIN. INVEST., vol. 85, 1990, pages 1287 - 1295
PROC. NATL. ACAD. SCI. USA, vol. 103, no. 11, 2006, pages 4005 - 4010
PROC. NATL. ACAD. SCI USA, vol. 103, no. 11, 2006, pages 4005 - 4010
HUM. ANTIBOD. HYBRIDOMAS, vol. 1, no. 1, 1990, pages 47 - 54
BLOOD, vol. 109, 2007, pages 1185 - 1192
PROC NATL ACAD SCI USA., 2009
NATURE, vol. 439, 2006, pages 682 - 687
"Nature Immunology", vol. 12, 2011, YEAR, pages: 492 - 499
PROC. NATL. ACAD. SCI. USA, vol. 77, 1980, pages 4914 - 4917
INT. J. CANCER., vol. 103, no. 4, 2003, pages 455 - 65
NAT. REV. IMMUNOL., vol. 12, 2012, pages 339 - 51
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
BIO/TECHNOLOGY, vol. 12, no. 7, 1994, pages 699 - 702
SATO, K. ET AL., CANCER RES., vol. 53, 1993, pages 851 - 856
NAT BIOTECHNOL., vol. 18, no. 12, December 2000 (2000-12-01), pages 1287 - 92
NUCLEIC ACIDS RES., vol. 34, no. 19, 2006, pages el27
PROC NATL ACAD SCI U S A., vol. 101, no. 9, 2 March 2004 (2004-03-02), pages 2806 - 10
PROC NATL ACAD SCI USA., vol. 101, no. 25, 22 June 2004 (2004-06-22), pages 9193 - 8
PROTEIN ENG DES SEL., vol. 21, no. 4, April 2008 (2008-04-01), pages 247 - 55
PROC NATL ACAD SCI U S A., vol. 97, no. 20, 26 September 2000 (2000-09-26), pages 10701 - 5
MABS., vol. 2, no. 5, September 2010 (2010-09-01), pages 508 - 18
METHODS MOL BIOL., vol. 911, 2012, pages 183 - 98
"Epitope Mapping Protocols in Methods in Molecular Biology", vol. 66, 1996
"Antibodies A Laboratory Manual", 1988, COLD SPRING HARBOR LABORATORY, pages: 359 - 420
HOLLIGER P ET AL., PROC. NATL. ACAD. SCI. USA, vol. 90, 1993, pages 6444 - 6448
PLUCKTHUN: "The Pharmacology of Monoclonal Antibodies", vol. 113, 1994, SPRINGER-VERLAG, pages: 269 - 315
PROC. NATL. ACAD. SCI. U.S.A., vol. 85, no. 16, 1988, pages 5879 - 5883
J IMMUNOL. METHODS, vol. 231, no. 1-2, 1999, pages 177 - 189
JOURNAL OF IMMUNOLOGY, vol. 152, no. 11, 1994, pages 5368 - 5374
SCIENCE, vol. 240, no. 4855, 1988, pages 1038 - 1041
PROTEIN ENGINEERING, vol. 9, no. 3, 1996, pages 299 - 305
RIDGWAY JB ET AL., PROTEIN ENGINEERING, vol. 9, 1996, pages 617 - 621
MERCHANT AM ET AL., NATURE BIOTECHNOLOGY, vol. 16, 1998, pages 677 - 681
PROTEIN ENGINEERING DESIGN & SELECTION, vol. 23, 2010, pages 195 - 202
NAT BIOTECHNOL., vol. 32, no. 2, February 2014 (2014-02-01), pages 191 - 8
CHRISTOPH ET AL., NATURE BIOTECHNOLOGY, vol. 31, 2013, pages 753 - 758
NATURE BIOTECHNOLOGY, vol. 16, 1998, pages 677 - 681
"Remington's Pharmaceutical Science", 1980
J. BIOMED. MATER. RES., vol. 15, 1981, pages 267 - 277
CHEMTECH, vol. 12, 1982, pages 98 - 105
BIOPOLYMERS, vol. 22, 1983, pages 547 - 556
"Remington's Pharmaceutical Science", MARK PUBLISHING COMPANY
"Current protocols in Immunology", 1993, JOHN WILEY & SONS, INC., article "Immunologic studies in humans"
PROTEIN SCIENCE, vol. 4, 1995, pages 2411 - 2423
PROC. NATL. ACAD. SCI., vol. 110, 2013, pages 5145 - 5150
PROC NATL ACAD SCI USA., vol. 108, no. 27, 5 July 2011 (2011-07-05), pages 111 87 - 92
IMMUNITY, vol. 30, no. 6, 2009, pages 899 - 911
See also references of EP 3378487A4
Attorney, Agent or Firm:
HARUNA, Masao et al. (JP)
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