Title:
CD16 ANTIBODY AND USE THEREOF
Document Type and Number:
WIPO Patent Application WO/2023/274183
Kind Code:
A1
Abstract:
The present invention relates to a CD16 antibody and the use thereof. Specifically, disclosed are an antibody or an antigen-binding fragment specifically binding CD16, and an encoding nucleic acid, an expression vector and an expression cell thereof, a preparation method therefor, a pharmaceutical composition thereof, and the use thereof for treating diseases, such as the use thereof in the treatment of tumors. The CD16 antibody holds great significance for the development of a CD16 antibody therapeutic drug and a detection reagent.
Inventors:
WANG QIONG (CN)
FU YAYUAN (CN)
YANG CUIQING (CN)
CAO ZHUOXIAO (CN)
TANG RENHONG (CN)
REN JINSHENG (CN)
FU YAYUAN (CN)
YANG CUIQING (CN)
CAO ZHUOXIAO (CN)
TANG RENHONG (CN)
REN JINSHENG (CN)
Application Number:
PCT/CN2022/101713
Publication Date:
January 05, 2023
Filing Date:
June 28, 2022
Export Citation:
Assignee:
JIANGSU SIMCERE PHARM CO LTD (CN)
International Classes:
C07K16/28; A61K39/395; A61P35/00; C07K16/46; C12N1/21; C12N5/10; C12N15/13; C12N15/85; C12R1/19
Domestic Patent References:
| WO2019028027A1 | 2019-02-07 | |||
| WO2018217947A1 | 2018-11-29 | |||
| WO1994004678A1 | 1994-03-03 | |||
| WO1995004079A1 | 1995-02-09 | |||
| WO1996034103A1 | 1996-10-31 | |||
| WO1994025591A1 | 1994-11-10 | |||
| WO1999037681A2 | 1999-07-29 | |||
| WO2000040968A1 | 2000-07-13 | |||
| WO2000043507A1 | 2000-07-27 | |||
| WO2000065057A1 | 2000-11-02 | |||
| WO2001040310A2 | 2001-06-07 | |||
| WO2001044301A1 | 2001-06-21 | |||
| WO2002048193A2 | 2002-06-20 | |||
| WO1997049805A2 | 1997-12-31 | |||
| WO2001021817A1 | 2001-03-29 | |||
| WO2003035694A2 | 2003-05-01 | |||
| WO2003054016A2 | 2003-07-03 | |||
| WO2003055527A2 | 2003-07-10 | |||
| WO2003050531A2 | 2003-06-19 | |||
| WO2001090190A2 | 2001-11-29 | |||
| WO2003025020A1 | 2003-03-27 | |||
| WO2004041867A2 | 2004-05-21 | |||
| WO2004041862A2 | 2004-05-21 | |||
| WO2004041865A2 | 2004-05-21 | |||
| WO2004041863A2 | 2004-05-21 | |||
| WO2004062551A2 | 2004-07-29 | |||
| WO2005044858A1 | 2005-05-19 | |||
| WO2006040153A2 | 2006-04-20 | |||
| WO2006079372A1 | 2006-08-03 | |||
| WO2006122786A2 | 2006-11-23 | |||
| WO2006122787A1 | 2006-11-23 | |||
| WO2006122825A2 | 2006-11-23 | |||
| WO2016177846A1 | 2016-11-10 |
Foreign References:
| CN108101988A | 2018-06-01 | |||
| CN202110732732A | 2021-06-29 | |||
| EP1134231A1 | 2001-09-19 | |||
| US5807715A | 1998-09-15 | |||
| US5821333A | 1998-10-13 | |||
| US20100286374A1 | 2010-11-11 | |||
| CN201110459100A | 2011-12-31 | |||
| EP2101823B1 | 2016-11-23 |
Other References:
GHISLAINE BEHAR, SOPHIE SIBÉRIL, AGNÈS GROULET, PATRICK CHAMES, MARTINE PUGNIÈRE, CHARLOTTE BOIX, CATHERINE SAUTÈS-FRIDMAN, JEAN-L: "Isolation and characterization of anti-Fc[gamma]RIII (CD16) llama single-domain antibodies that activate natural killer cells", PROTEIN ENGINEERING, DESIGN AND SELECTION JANUARY 2008 OXFORD UNIVERSITY PRESS GB, vol. 21, no. 1, 1 January 2008 (2008-01-01), pages 1 - 10, XP002646408, DOI: 10.1093/PROTEIN/GZM064
GONZáLEZ CRISTINA; CHAMES PATRICK; KERFELEC BRIGITTE; BATY DANIEL; ROBERT PHILIPPE; LIMOZIN LAURENT: "Nanobody-CD16 Catch Bond Reveals NK Cell Mechanosensitivity", BIOPHYSICAL JOURNAL, ELSEVIER, AMSTERDAM, NL, vol. 116, no. 8, 1 January 1900 (1900-01-01), AMSTERDAM, NL, pages 1516 - 1526, XP085670553, ISSN: 0006-3495, DOI: 10.1016/j.bpj.2019.03.012
VAN FAASSEN HENK, JO DONG-HYEON, RYAN SHANNON, LOWDEN MICHAEL J., RAPHAEL SHALINI, MACKENZIE C. ROGER, LEE SEUNG-HWAN, HUSSACK GRE: "Incorporation of a Novel CD16-Specific Single-Domain Antibody into Multispecific Natural Killer Cell Engagers With Potent ADCC", MOLECULAR PHARMACEUTICS, AMERICAN CHEMICAL SOCIETY, US, vol. 18, no. 6, 7 June 2021 (2021-06-07), US , pages 2375 - 2384, XP093018471, ISSN: 1543-8384, DOI: 10.1021/acs.molpharmaceut.1c00208
KORNDORFER, I. P.BESTE, G.SKERRA, A., PROTEINS, vol. 53, 2003, pages 121 - 129
ROQUE, A. C. A.LOWE, C. R.TAIPA, M. A.: "Antibodies and genetically engineered related molecules: production and purification", BIOTECHNOL. PROG., vol. 20, 2004, pages 639 - 654
HAMERS-CASTERMAN ET AL., NATURE, vol. 363, 1993, pages 446 - 8
MUYLDERMANS, J BIOTECHNOL., vol. 74, no. 4, June 2001 (2001-06-01), pages 277 - 302
MORRISON: "Transfectomas Provide Novel Chimeric Antibodies", SCIENCE, vol. 229, no. 4719, 1985, pages 1202 - 1207, XP001030113, DOI: 10.1126/science.3929380
GILLIES ET AL., J IMMUNOL METHODS, vol. 125, no. 1-2, 20 December 1989 (1989-12-20), pages 191 - 202
KABAT, E. A., WU, T. T., BILOFSKY, H.: "Unusual distributions of amino acids in complementarity determining (hypervariable) segments of heavy and light chains of immunoglobulins and their possible roles in specificity of antibody-combining sites", JOURNAL OF BIOLOGICAL CHEMISTRY, vol. 252, no. 19, 1977, pages 6609 - 6616
KABAT ET AL.: "Sequences of Proteins of Immunological Interest", 1991, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
CHOTHIA, C.LESK, A. M.: "Canonical structures for the hypervariable regions of immunoglobulins", JOURNAL OF MOLECULAR BIOLOGY, vol. 196, no. 4, 1987, pages 901 - 917, XP024010426, DOI: 10.1016/0022-2836(87)90412-8
AL-LAZIKANI, B.LESK, A. M.CHOTHIA, C.: "Standard conformations for the canonical structures of immunoglobulins", JOURNAL OF MOLECULAR BIOLOGY, vol. 273, no. 4, 1997, pages 927 - 948, XP004461383, DOI: 10.1006/jmbi.1997.1354
MACCALLUM, R. M.MARTIN, A. C.THORNTON, J. M.: "Antibodyantigen interactions: contact analysis and binding site topography", JOURNAL OF MOLECULAR BIOLOGY, vol. 262, no. 5, 1996, pages 732 - 745, XP002242391, DOI: 10.1006/jmbi.1996.0548
ABHINANDAN, K. R.MARTIN, A. C.: "Analysis and improvements to Kabat and structurally correct numbering of antibody variable domains", MOLECULAR IMMUNOLOGY, vol. 45, no. 14, 2008, pages 3832 - 3839, XP023437109, DOI: 10.1016/j.molimm.2008.05.022
LEFRANC, M. P.POMMIE, C.RUIZ, M.GIUDICELLI, V.FOULQUIER, E.TRUONG, L.LEFRANC, G.: "IMGT unique numbering for immunoglobulin and T cell receptor variable domains and Ig superfamily V-like domains", DEVELOPMENTAL & COMPARATIVE IMMUNOLOGY, vol. 27, no. 1, 2003, pages 55 - 77, XP055585227, DOI: 10.1016/S0145-305X(02)00039-3
HONEGGER, A., PLUECKTHUN, A.: "Yet another numbering scheme for immunoglobulin variable domains: an automatic modelling and analysis tool", JOURNAL OF MOLECULAR BIOLOGY, vol. 309, no. 3, 2001, pages 657 - 670, XP004626893, DOI: 10.1006/jmbi.2001.4662
RIDGWAY, J. B.PRESTA, L. G.CARTER, P.: "Knobs-into-holes' engineering of antibody CH3 domains for heavy chain heterodimerization", PROTEIN ENGINEERING, DESIGN AND SELECTION, vol. 9, no. 7, 1996, pages 617 - 621, XP002610995, DOI: 10.1093/protein/9.7.617
DAVIS, J. H.APERLO, C.LI, Y.KUROSAWA, E.LAN, Y.LO, K. M.HUSTON, J. S.: "SEEDbodies: fusion proteins based on strand-exchange engineered domain (SEED) CH3 heterodimers in an Fc analogue platform for asymmetric binders or immunofusions and bispecific antibodies", PROTEIN ENGINEERING, DESIGN & SELECTION, vol. 23, no. 4, 2010, pages 195 - 202, XP055018770, DOI: 10.1093/protein/gzp094
GRAMER, M. J.VAN DEN BREMER, E. T.VAN KAMPEN, M. D.KUNDU, A.KOPFMANN, P.ETTER, E.PARREN, P. W.: "MAbs", vol. 3, November 2011, TAYLOR & FRANCIS, article "Production of stable bispecific IgG1 by controlled Fab-arm exchange: scalability from bench to large-scale manufacturing by application of standard approaches", pages: 546 - 557
ALTSCHUL, S. F.GISH, W.MILLER, W.MYERS, E. W.LIPMAN, D. J.: "Basic local alignment search tool", JOURNAL OF MOLECULAR BIOLOGY, vol. 215, no. 3, 1990, pages 403 - 410, XP002949123, DOI: 10.1006/jmbi.1990.9999
ALTSCHUL, S. F.MADDEN, T. L.SCHAFFER, A. A.ZHANG, J.ZHANG, Z.MILLER, W.LIPMAN, D. J.: "Gapped BLAST and PSI-BLAST: a new generation of protein database search programs", NUCLEIC ACIDS RESEARCH, vol. 25, no. 17, 1997, pages 3389 - 3402, XP002905950, DOI: 10.1093/nar/25.17.3389
STADLER, C. R.BAHR-MAHMUD, H.CELIK, L.HEBICH, B.ROTH, A. S.ROTH, R. P.SAHIN, U.: "Elimination of large tumours in mice by mRNA-encoded bispecific antibodies", NATURE MEDICINE, vol. 23, no. 7, 2017, pages 815 - 817
"Remington's Pharmaceutical Sciences", 1990, MACKPRINTING COMPANY, pages: 1289 - 1329
SAMBROOK, J.FRITSCH, E. F.MANIATIS, T.: "Molecular Cloning: A Laboratory Manual, Second Edition", 1989, COLD SPRING HARBOR LABORATORY PRESS
FLEIT H.B. ET AL., PROC NATL ACAD SCI USA., May 1982 (1982-05-01)
GONZáLEZ CRISTINA; CHAMES PATRICK; KERFELEC BRIGITTE; BATY DANIEL; ROBERT PHILIPPE; LIMOZIN LAURENT: "Nanobody-CD16 Catch Bond Reveals NK Cell Mechanosensitivity", BIOPHYSICAL JOURNAL, ELSEVIER, AMSTERDAM, NL, vol. 116, no. 8, 1 January 1900 (1900-01-01), AMSTERDAM, NL, pages 1516 - 1526, XP085670553, ISSN: 0006-3495, DOI: 10.1016/j.bpj.2019.03.012
VAN FAASSEN HENK, JO DONG-HYEON, RYAN SHANNON, LOWDEN MICHAEL J., RAPHAEL SHALINI, MACKENZIE C. ROGER, LEE SEUNG-HWAN, HUSSACK GRE: "Incorporation of a Novel CD16-Specific Single-Domain Antibody into Multispecific Natural Killer Cell Engagers With Potent ADCC", MOLECULAR PHARMACEUTICS, AMERICAN CHEMICAL SOCIETY, US, vol. 18, no. 6, 7 June 2021 (2021-06-07), US , pages 2375 - 2384, XP093018471, ISSN: 1543-8384, DOI: 10.1021/acs.molpharmaceut.1c00208
KORNDORFER, I. P.BESTE, G.SKERRA, A., PROTEINS, vol. 53, 2003, pages 121 - 129
ROQUE, A. C. A.LOWE, C. R.TAIPA, M. A.: "Antibodies and genetically engineered related molecules: production and purification", BIOTECHNOL. PROG., vol. 20, 2004, pages 639 - 654
HAMERS-CASTERMAN ET AL., NATURE, vol. 363, 1993, pages 446 - 8
MUYLDERMANS, J BIOTECHNOL., vol. 74, no. 4, June 2001 (2001-06-01), pages 277 - 302
MORRISON: "Transfectomas Provide Novel Chimeric Antibodies", SCIENCE, vol. 229, no. 4719, 1985, pages 1202 - 1207, XP001030113, DOI: 10.1126/science.3929380
GILLIES ET AL., J IMMUNOL METHODS, vol. 125, no. 1-2, 20 December 1989 (1989-12-20), pages 191 - 202
KABAT, E. A., WU, T. T., BILOFSKY, H.: "Unusual distributions of amino acids in complementarity determining (hypervariable) segments of heavy and light chains of immunoglobulins and their possible roles in specificity of antibody-combining sites", JOURNAL OF BIOLOGICAL CHEMISTRY, vol. 252, no. 19, 1977, pages 6609 - 6616
KABAT ET AL.: "Sequences of Proteins of Immunological Interest", 1991, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
CHOTHIA, C.LESK, A. M.: "Canonical structures for the hypervariable regions of immunoglobulins", JOURNAL OF MOLECULAR BIOLOGY, vol. 196, no. 4, 1987, pages 901 - 917, XP024010426, DOI: 10.1016/0022-2836(87)90412-8
AL-LAZIKANI, B.LESK, A. M.CHOTHIA, C.: "Standard conformations for the canonical structures of immunoglobulins", JOURNAL OF MOLECULAR BIOLOGY, vol. 273, no. 4, 1997, pages 927 - 948, XP004461383, DOI: 10.1006/jmbi.1997.1354
MACCALLUM, R. M.MARTIN, A. C.THORNTON, J. M.: "Antibodyantigen interactions: contact analysis and binding site topography", JOURNAL OF MOLECULAR BIOLOGY, vol. 262, no. 5, 1996, pages 732 - 745, XP002242391, DOI: 10.1006/jmbi.1996.0548
ABHINANDAN, K. R.MARTIN, A. C.: "Analysis and improvements to Kabat and structurally correct numbering of antibody variable domains", MOLECULAR IMMUNOLOGY, vol. 45, no. 14, 2008, pages 3832 - 3839, XP023437109, DOI: 10.1016/j.molimm.2008.05.022
LEFRANC, M. P.POMMIE, C.RUIZ, M.GIUDICELLI, V.FOULQUIER, E.TRUONG, L.LEFRANC, G.: "IMGT unique numbering for immunoglobulin and T cell receptor variable domains and Ig superfamily V-like domains", DEVELOPMENTAL & COMPARATIVE IMMUNOLOGY, vol. 27, no. 1, 2003, pages 55 - 77, XP055585227, DOI: 10.1016/S0145-305X(02)00039-3
HONEGGER, A., PLUECKTHUN, A.: "Yet another numbering scheme for immunoglobulin variable domains: an automatic modelling and analysis tool", JOURNAL OF MOLECULAR BIOLOGY, vol. 309, no. 3, 2001, pages 657 - 670, XP004626893, DOI: 10.1006/jmbi.2001.4662
RIDGWAY, J. B.PRESTA, L. G.CARTER, P.: "Knobs-into-holes' engineering of antibody CH3 domains for heavy chain heterodimerization", PROTEIN ENGINEERING, DESIGN AND SELECTION, vol. 9, no. 7, 1996, pages 617 - 621, XP002610995, DOI: 10.1093/protein/9.7.617
DAVIS, J. H.APERLO, C.LI, Y.KUROSAWA, E.LAN, Y.LO, K. M.HUSTON, J. S.: "SEEDbodies: fusion proteins based on strand-exchange engineered domain (SEED) CH3 heterodimers in an Fc analogue platform for asymmetric binders or immunofusions and bispecific antibodies", PROTEIN ENGINEERING, DESIGN & SELECTION, vol. 23, no. 4, 2010, pages 195 - 202, XP055018770, DOI: 10.1093/protein/gzp094
GRAMER, M. J.VAN DEN BREMER, E. T.VAN KAMPEN, M. D.KUNDU, A.KOPFMANN, P.ETTER, E.PARREN, P. W.: "MAbs", vol. 3, November 2011, TAYLOR & FRANCIS, article "Production of stable bispecific IgG1 by controlled Fab-arm exchange: scalability from bench to large-scale manufacturing by application of standard approaches", pages: 546 - 557
ALTSCHUL, S. F.GISH, W.MILLER, W.MYERS, E. W.LIPMAN, D. J.: "Basic local alignment search tool", JOURNAL OF MOLECULAR BIOLOGY, vol. 215, no. 3, 1990, pages 403 - 410, XP002949123, DOI: 10.1006/jmbi.1990.9999
ALTSCHUL, S. F.MADDEN, T. L.SCHAFFER, A. A.ZHANG, J.ZHANG, Z.MILLER, W.LIPMAN, D. J.: "Gapped BLAST and PSI-BLAST: a new generation of protein database search programs", NUCLEIC ACIDS RESEARCH, vol. 25, no. 17, 1997, pages 3389 - 3402, XP002905950, DOI: 10.1093/nar/25.17.3389
STADLER, C. R.BAHR-MAHMUD, H.CELIK, L.HEBICH, B.ROTH, A. S.ROTH, R. P.SAHIN, U.: "Elimination of large tumours in mice by mRNA-encoded bispecific antibodies", NATURE MEDICINE, vol. 23, no. 7, 2017, pages 815 - 817
"Remington's Pharmaceutical Sciences", 1990, MACKPRINTING COMPANY, pages: 1289 - 1329
SAMBROOK, J.FRITSCH, E. F.MANIATIS, T.: "Molecular Cloning: A Laboratory Manual, Second Edition", 1989, COLD SPRING HARBOR LABORATORY PRESS
FLEIT H.B. ET AL., PROC NATL ACAD SCI USA., May 1982 (1982-05-01)
Download PDF:
Previous Patent: DATA SENDING AND RECEIVING METHOD AND APPARATUS
Next Patent: DUAL-FUEL INTELLIGENT COMBUSTION SYSTEM AND CONTROL METHOD THEREFOR
Next Patent: DUAL-FUEL INTELLIGENT COMBUSTION SYSTEM AND CONTROL METHOD THEREFOR