Title:
FULLY HUMAN SINGLE-DOMAIN TANDEM CHIMERIC ANTIGEN RECEPTOR (CAR) TARGETING CD5, AND USE THEREOF
Document Type and Number:
WIPO Patent Application WO/2022/152186
Kind Code:
A1
Abstract:
Provided is a fully human single-domain tandem chimeric antigen receptor (CAR) capable of specifically binding to a CD5 protein, which CAR contains a CD5 binding domain, a transmembrane domain, a co-stimulatory domain, and an intracellular signaling domain. Also provided are engineered immune effector cells, such as T cells, containing the chimeric antigen receptor, and the use of the CAR and the engineered immune effector cells in the treatment of a disease or a condition associated with the expression of CD5.
Inventors:
TAN TAOCHAO (CN)
DAI ZHENYU (CN)
ZHOU JIANFENG (CN)
ZHAO YA (CN)
WEI QIAOE (CN)
JIA XIANGYIN (CN)
LIU JIANWEI (CN)
DAI ZHENYU (CN)
ZHOU JIANFENG (CN)
ZHAO YA (CN)
WEI QIAOE (CN)
JIA XIANGYIN (CN)
LIU JIANWEI (CN)
Application Number:
PCT/CN2022/071677
Publication Date:
July 21, 2022
Filing Date:
January 12, 2022
Export Citation:
Assignee:
NANJING IASO BIOTHERAPEUTICS CO LTD (CN)
International Classes:
C07K19/00; A61K35/17; A61P35/02; C12N5/10; C12N15/62
Domestic Patent References:
| WO2021001356A1 | 2021-01-07 | |||
| WO2020132327A1 | 2020-06-25 | |||
| WO2013154760A1 | 2013-10-17 | |||
| WO2016014789A2 | 2016-01-28 |
Foreign References:
| CN109266667A | 2019-01-25 | |||
| US20180104308A1 | 2018-04-19 | |||
| CN107249602A | 2017-10-13 | |||
| CN111670052A | 2020-09-15 | |||
| US8802374B2 | 2014-08-12 | |||
| US202016650580A |
Other References:
SAMBROOK ET AL., MOLECULAR CLONING: A LABORATORY MANUAL, 2001
SAMBROOK ET AL., MOLECULAR CLONING: A LABORATORY MANUAL, 1989
MANIATIS ET AL., MOLECULAR CLONING: A LABORATORY MANUAL, 1982
AUSUBEL ET AL.: "Current Protocols in Molecular Biology", 1993, JOHN WILEY AND SONS
GLOVER: "Short Protocols in Molecular Biology: A Compendium of Methods from Current Protocols in Molecular Biology", 1985, GREENE PUB. ASSOCIATES
ANAND: "Techniques for the Analysis of Complex Genomes", 1992, ACADEMIC PRESS
TRANSCRIPTION AND TRANSLATION, 1984
PERBAL, A PRACTICAL GUIDE TO MOLECULAR CLONING, 1984
HARLOWLANE: "Antibodies", 1998, COLD SPRING HARBOR LABORATORY PRESS
"Current Protocols in Immunology", 1991
ANNUAL REVIEW OF IMMUNOLOGY
SADELAIN MBRENTJENS RRIVI 'ERE I: "The basicprinciples of chimeric antigen receptor design", CANCER DISCOV, vol. 3, no. 4, 2013, pages 388 - 398
TURTLE CJHUDECEK MJENSEN MCRIDDELL SR: "Engineered T cells for anti-cancer therapy", CURR OPIN IMMUNOL, vol. 24, no. 5, 2012, pages 633 - 639, XP055272888, DOI: 10.1016/j.coi.2012.06.004
DOTTI GGOTTSCHALK SSAVOLDO BBRENNER MK: "Design and development of therapies using chimeric antigen receptor-expressing T cells", IMMUNOL REV, vol. 257, no. 1, 2014, pages 107 - 126, XP055552726, DOI: 10.1111/imr.12131
"GenBank", Database accession no. NM 014207.4
FLATMAN, S. ET AL., J.CHROM.B, vol. 848, 2007, pages 79 - 87
SAMBROOK ET AL.: "Molecular Cloning, A Laboratory Manual", 1989, COLD SPRING HARBOR LABORATORY PRESS
CHEN CHENWAN HAISU: "Lentiviral vectors and their research progress", CHINESE JOURNAL OF LUNG CANCER, vol. 17, no. 12, 2014, pages 870 - 876
CHENG ZHANGJUN LIUJIANG F ZHONG ET AL.: "Engineering CAR-T cells", BIOMARKER RESEARCH, vol. 5, 2017, pages 22, XP055551810, DOI: 10.1186/s40364-017-0102-y
CASTELLA, M. ET AL.: "Development of a Novel Anti-CD19 Chimeric Antigen Receptor: A Paradigm for an Affordable CAR T Cell Production at Academic Institutions", MOLECΜLAR THERAPY, vol. 12, 2019, pages 134 - 144, XP055716791, DOI: 10.1016/j.omtm.2018.11.010
CASTELLA, M. ET AL.: "Point-Of-Care CAR T-Cell Production (AR -0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial", FRONTIERS IN IMMUNOLOGY, vol. 11, 2020, pages 482
ORTIZ-MALDONADO, V ET AL.: "CART19-BE-01 A MµLticenter Trial of ARI-0001 Cell Therapy in Patients with CD19(+) Relapsed/Refractory Malignancies", MOL THER, 2020
GILL, S. ET AL.: "CD19 CAR-T cells combined with ibrutinib to induce complete remission in CLL", JOURNAL OF CLINICAL ONCOLOGY, vol. 35, 2017, pages 7509 - 7509, XP055553631, DOI: 10.1200/JCO.2017.35.15_suppl.7509
NEELAPU, S.S. ET AL.: "Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma", NEW ENGLAND JOURNAL OF MEDICINE, vol. 377, no. 26, 2017, pages 2531 - 2544, XP055547040, DOI: 10.1056/NEJMoa1707447
MAUDE, S.L. ET AL.: "CD19-targeted chimeric antigen receptor T-cell therapy for acute lymphoblastic leukemia", BLOOD, vol. 125, no. 26, 2015, pages 4017, XP055565639, DOI: 10.1182/blood-2014-
JACOBSON, C.A.: "CD19 Chimeric Antigen Receptor Therapy for Refractory Aggressive B-Cell Lymphoma", JOURNAL OF CLINICAL ONCOLOGY, vol. 37, no. 4, 2018, pages 328 - 335
KOCHENDERFER, J. ET AL.: "Anti-CD19 chimeric antigen receptor T cells preceded by low-dose chemotherapy to induce remissions of advanced lymphoma", JOURNAL OF CLINICAL ONCOLOGY, vol. 34, 2016
GRUPP, S.A. ET AL.: "Chimeric Antigen Receptor Modified T Cells for Acute Lymphoid Leukemia", NEW ENGLAND JOURNAL OF MEDICINE, vol. 368, no. 16, 2013, pages 1509 - 1518, XP055169041, DOI: 10.1056/NEJMoa1215134
HIRAYAMA, A.V. ET AL.: "The response to lymphodepletion impacts PFS in aggressive non-Hodgkin lymphoma patients treated with CD19 CAR-T cells", BLOOD, 2019
DAVILA, M.L. ET AL.: "Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia", SCI TRANSL MED, vol. 6, no. 224, 2014, XP055234425, DOI: 10.1126/scitranslmed.3008226
JONES, N.H. ET AL.: "Isolation of complementary DNA clones encoding the human lymphocyte glycoprotein Tl/Leu-1", NATURE, vol. 323, no. 6086, 1986, pages 346 - 349
HUANG, H.J. ET AL.: "MolecuLar cloning of Ly-1, a membrane glycoprotein of mouse T lymphocytes and a subset of B cells: molecµLar homology to its human counterpart Leu-1/T1 (CD5)", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, vol. 84, no. 1, 1987, pages 204 - 208
MAMONKIN, M. ET AL.: "A T-cell-directed chimeric antigen receptor for the selective treatment of T-cell malignancies", BLOOD, vol. 126, no. 8, 2015, pages 983 - 992, XP055325148, DOI: 10.1182/blood-2015-02-629527
HILL, L.C. ET AL.: "Safety and Anti-Tumor Activity of CD5 CAR T-Cells in Patients with Relapsed/Refractory T-Cell Malignancies", BLOOD, vol. 134, 2019, pages 199 - 199, XP086674734, DOI: 10.1182/blood-2019-129559
SAMBROOK ET AL., MOLECULAR CLONING: A LABORATORY MANUAL, 1989
MANIATIS ET AL., MOLECULAR CLONING: A LABORATORY MANUAL, 1982
AUSUBEL ET AL.: "Current Protocols in Molecular Biology", 1993, JOHN WILEY AND SONS
GLOVER: "Short Protocols in Molecular Biology: A Compendium of Methods from Current Protocols in Molecular Biology", 1985, GREENE PUB. ASSOCIATES
ANAND: "Techniques for the Analysis of Complex Genomes", 1992, ACADEMIC PRESS
TRANSCRIPTION AND TRANSLATION, 1984
PERBAL, A PRACTICAL GUIDE TO MOLECULAR CLONING, 1984
HARLOWLANE: "Antibodies", 1998, COLD SPRING HARBOR LABORATORY PRESS
"Current Protocols in Immunology", 1991
ANNUAL REVIEW OF IMMUNOLOGY
SADELAIN MBRENTJENS RRIVI 'ERE I: "The basicprinciples of chimeric antigen receptor design", CANCER DISCOV, vol. 3, no. 4, 2013, pages 388 - 398
TURTLE CJHUDECEK MJENSEN MCRIDDELL SR: "Engineered T cells for anti-cancer therapy", CURR OPIN IMMUNOL, vol. 24, no. 5, 2012, pages 633 - 639, XP055272888, DOI: 10.1016/j.coi.2012.06.004
DOTTI GGOTTSCHALK SSAVOLDO BBRENNER MK: "Design and development of therapies using chimeric antigen receptor-expressing T cells", IMMUNOL REV, vol. 257, no. 1, 2014, pages 107 - 126, XP055552726, DOI: 10.1111/imr.12131
"GenBank", Database accession no. NM 014207.4
FLATMAN, S. ET AL., J.CHROM.B, vol. 848, 2007, pages 79 - 87
SAMBROOK ET AL.: "Molecular Cloning, A Laboratory Manual", 1989, COLD SPRING HARBOR LABORATORY PRESS
CHEN CHENWAN HAISU: "Lentiviral vectors and their research progress", CHINESE JOURNAL OF LUNG CANCER, vol. 17, no. 12, 2014, pages 870 - 876
CHENG ZHANGJUN LIUJIANG F ZHONG ET AL.: "Engineering CAR-T cells", BIOMARKER RESEARCH, vol. 5, 2017, pages 22, XP055551810, DOI: 10.1186/s40364-017-0102-y
CASTELLA, M. ET AL.: "Development of a Novel Anti-CD19 Chimeric Antigen Receptor: A Paradigm for an Affordable CAR T Cell Production at Academic Institutions", MOLECΜLAR THERAPY, vol. 12, 2019, pages 134 - 144, XP055716791, DOI: 10.1016/j.omtm.2018.11.010
CASTELLA, M. ET AL.: "Point-Of-Care CAR T-Cell Production (AR -0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial", FRONTIERS IN IMMUNOLOGY, vol. 11, 2020, pages 482
ORTIZ-MALDONADO, V ET AL.: "CART19-BE-01 A MµLticenter Trial of ARI-0001 Cell Therapy in Patients with CD19(+) Relapsed/Refractory Malignancies", MOL THER, 2020
GILL, S. ET AL.: "CD19 CAR-T cells combined with ibrutinib to induce complete remission in CLL", JOURNAL OF CLINICAL ONCOLOGY, vol. 35, 2017, pages 7509 - 7509, XP055553631, DOI: 10.1200/JCO.2017.35.15_suppl.7509
NEELAPU, S.S. ET AL.: "Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma", NEW ENGLAND JOURNAL OF MEDICINE, vol. 377, no. 26, 2017, pages 2531 - 2544, XP055547040, DOI: 10.1056/NEJMoa1707447
MAUDE, S.L. ET AL.: "CD19-targeted chimeric antigen receptor T-cell therapy for acute lymphoblastic leukemia", BLOOD, vol. 125, no. 26, 2015, pages 4017, XP055565639, DOI: 10.1182/blood-2014-
JACOBSON, C.A.: "CD19 Chimeric Antigen Receptor Therapy for Refractory Aggressive B-Cell Lymphoma", JOURNAL OF CLINICAL ONCOLOGY, vol. 37, no. 4, 2018, pages 328 - 335
KOCHENDERFER, J. ET AL.: "Anti-CD19 chimeric antigen receptor T cells preceded by low-dose chemotherapy to induce remissions of advanced lymphoma", JOURNAL OF CLINICAL ONCOLOGY, vol. 34, 2016
GRUPP, S.A. ET AL.: "Chimeric Antigen Receptor Modified T Cells for Acute Lymphoid Leukemia", NEW ENGLAND JOURNAL OF MEDICINE, vol. 368, no. 16, 2013, pages 1509 - 1518, XP055169041, DOI: 10.1056/NEJMoa1215134
HIRAYAMA, A.V. ET AL.: "The response to lymphodepletion impacts PFS in aggressive non-Hodgkin lymphoma patients treated with CD19 CAR-T cells", BLOOD, 2019
DAVILA, M.L. ET AL.: "Efficacy and toxicity management of 19-28z CAR T cell therapy in B cell acute lymphoblastic leukemia", SCI TRANSL MED, vol. 6, no. 224, 2014, XP055234425, DOI: 10.1126/scitranslmed.3008226
JONES, N.H. ET AL.: "Isolation of complementary DNA clones encoding the human lymphocyte glycoprotein Tl/Leu-1", NATURE, vol. 323, no. 6086, 1986, pages 346 - 349
HUANG, H.J. ET AL.: "MolecuLar cloning of Ly-1, a membrane glycoprotein of mouse T lymphocytes and a subset of B cells: molecµLar homology to its human counterpart Leu-1/T1 (CD5)", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA, vol. 84, no. 1, 1987, pages 204 - 208
MAMONKIN, M. ET AL.: "A T-cell-directed chimeric antigen receptor for the selective treatment of T-cell malignancies", BLOOD, vol. 126, no. 8, 2015, pages 983 - 992, XP055325148, DOI: 10.1182/blood-2015-02-629527
HILL, L.C. ET AL.: "Safety and Anti-Tumor Activity of CD5 CAR T-Cells in Patients with Relapsed/Refractory T-Cell Malignancies", BLOOD, vol. 134, 2019, pages 199 - 199, XP086674734, DOI: 10.1182/blood-2019-129559
Attorney, Agent or Firm:
CHENG & PENG INTELLECTUAL PROPERTY LAW OFFICE (CN)
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