Title:
PHARMACEUTICAL COMPOSITION FOR AMELIORATING ACUTE LUNG INJURY AND ACUTE WORSENING OF PULMONARY FIBROSIS
Document Type and Number:
WIPO Patent Application WO/2022/196816
Kind Code:
A1
Abstract:
Provided are a colicin-fighting monoclonal antibody molecule or a derivative thereof, and a pharmaceutical composition containing the same, for ameliorating acute lung injury and acute worsening of pulmonary fibrosis. The pharmaceutical composition of the present invention contains a monoclonal antibody molecule that fights against colicin, which is a peptide that stores a variety of staphylococcus strains including staphylococcus nepalensis, or a derivative of the monoclonal antibody molecule.
Inventors:
GABAZZA ESTEBAN (JP)
GABAZZA CORINA (JP)
CANN ISAAC (US)
GABAZZA CORINA (JP)
CANN ISAAC (US)
Application Number:
PCT/JP2022/012823
Publication Date:
September 22, 2022
Filing Date:
March 18, 2022
Export Citation:
Assignee:
UNIV MIE (JP)
UNIV ILLINOIS (US)
UNIV ILLINOIS (US)
International Classes:
C07K16/12; A61K38/10; A61K39/00; A61K39/085; A61K39/395; A61P1/16; A61P7/00; A61P11/00; A61P13/12; A61P37/04; A61P43/00; C07K7/06; C07K7/08; C07K16/40; C12N15/13; C12N15/31; C12P21/08; G01N33/53; G01N33/68
Domestic Patent References:
| WO2020157222A1 | 2020-08-06 | |||
| WO2021126957A1 | 2021-06-24 | |||
| WO2021126957A1 | 2021-06-24 |
Foreign References:
| JP2005247868A | 2005-09-15 | |||
| JP2021046301A | 2021-03-25 | |||
| JP2021173381A | 2021-11-01 |
Other References:
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UDO LORENZ, BIRGIT LORENZ, TIM SCHMITTER, KARIN STREKER, CHRISTIAN ERCK, JÜRGEN WEHLAND, JOACHIM NICKEL, BASTIAN ZIMMERMANN5 AND K: "Functional Antibodies Targeting IsaA of Staphylococcus aureus Augment Host Immune Response and Open New Perspectives for Antibacterial Therapy", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, AMERICAN SOCIETY FOR MICROBIOLOGY, US, vol. 55, no. 1, 1 January 2011 (2011-01-01), US , pages 165 - 173, XP002687630, ISSN: 0066-4804, DOI: 10.1128/AAC.01144-10
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MOLYNEAUX, P. L. ET AL.: "Changes in the respiratory microbiome during acute exacerbations of idiopathic pulmonary fibrosis", RESPIR RES, vol. 18, 2017, pages 29
WENG, D. ET AL.: "The Role of Infection in Acute Exacerbation of Idiopathic Pulmonary Fibrosis", MEDIATORS INFLAMM, 2019, pages 5160694
D'ALESSANDRO-GABAZZA, C. N. ET AL.: "A Staphylococcus pro-apoptotic peptide induces acute exacerbation of pulmonary fibrosis", NAT COMMUN, vol. 11, 2020, pages 1539, XP055778258, DOI: 10.1038/s41467-020-15344-3
"Genbank", Database accession no. 99287.1
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URAWA, M. ET AL.: "Protein S is protective in pulmonary fibrosis.", THROMB HAEMOST, vol. 14, 2016, pages 1588 - 1599
DRAKOPANAGIOTAKIS, F.XIFTERI, A.POLYCHRONOPOULOS, V.BOUROS, D.: "Apoptosis in lung injury and fibrosis", EUR RESPIR J32, 2008, pages 1631 - 1638
D'ALESSANDRO-GABAZZA, C. N. ET AL.: "Development and preclinical efficacy of novel transforming growth factor-betal short interfering RNAs for pulmonary fibrosis", AM J RESPIR CELL MOL BIOL46, 2012, pages 397 - 406
UPAGUPTA, C.SHIMBORI, C.ALSILMI, R.KOLB, M.: "Matrix abnormalities in pulmonary fibrosis", EUR RESPIR REV, vol. 27, 2018
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RAGHU, G. ET AL.: "Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline", AM J RESPIR CRIT CARE MED, vol. 198, 2018, pages e44 - e68
KREUTER, M.MAHER, T. M.: "Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis", A CALL TO ARMS. AM J RESPIR CRIT CARE MED, vol. 201, 2020, pages 1030 - 1032
COLLARD, H. R. ET AL.: "Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials", RESPIR RES, vol. 14, 2013, pages 73, XP021156083, DOI: 10.1186/1465-9921-14-73
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KOEDIJK DENNIS G. A. M., PASTRANA FRANCISCO ROMERO, HOEKSTRA HEDZER, BERG SANNE VAN DEN, BACK JAAP WILLEM, KERSTHOLT CAROLIEN, PRI: "Differential epitope recognition in the immunodominant staphylococcal antigen A of Staphylococcus aureus by mouse versus human IgG antibodies", SCIENTIFIC REPORTS, vol. 7, no. 1, 1 December 2017 (2017-12-01), XP055779130, DOI: 10.1038/s41598-017-08182-9
UDO LORENZ, BIRGIT LORENZ, TIM SCHMITTER, KARIN STREKER, CHRISTIAN ERCK, JÜRGEN WEHLAND, JOACHIM NICKEL, BASTIAN ZIMMERMANN5 AND K: "Functional Antibodies Targeting IsaA of Staphylococcus aureus Augment Host Immune Response and Open New Perspectives for Antibacterial Therapy", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, AMERICAN SOCIETY FOR MICROBIOLOGY, US, vol. 55, no. 1, 1 January 2011 (2011-01-01), US , pages 165 - 173, XP002687630, ISSN: 0066-4804, DOI: 10.1128/AAC.01144-10
KING, T. E., JR.PARDO, A.SELMAN, M.: "Idiopathic pulmonary fibrosis", LANCET, vol. 378, 2011, pages 1949 - 1961, XP055227094, DOI: 10.1016/S0140-6736(11)60052-4
RICHELDI, L. ET AL.: "Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis", N ENGL J MED370, 2014, pages 2071 - 2082, XP055753710, DOI: 10.1056/NEJMoa1402584
KING, T. E., JR.NOBLE, P. W.BRADFORD, W. Z.: "Treatments for idiopathic pulmonary fibrosis", N ENGL J MED, vol. 371, 2014, pages 783 - 784
KING, T. E., JR. ET AL.: "A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis", N ENGL J MED, vol. 370, 2014, pages 2083 - 2092
LEDERER, D. J.MARTINEZ, F. J.: "Idiopathic Pulmonary Fibrosis", N ENGL J MED, vol. 378, 2018, pages 1811 - 1823
SGALLA, G.BIFFI, A.RICHELDI, L.: "Idiopathic pulmonary fibrosis: Diagnosis, epidemiology and natural history", RESPIROLOGY, vol. 21, 2016, pages 427 - 437
KREUTER, M. ET AL.: "Acute exacerbation of idiopathic pulmonary fibrosis: international survey and call for harmonisation", EUR RESPIR J, vol. 55, 2020
COLLARD, H. R. ET AL.: "Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report", AM J RESPIR CRIT CARE MED, vol. 194, 2016, pages 265 - 275
NATSUIZAKA, M. ET AL.: "Epidemiologic survey of Japanese patients with idiopathic pulmonary fibrosis and investigation of ethnic differences", AM J RESPIR CRIT CARE MED, vol. 190, 2014, pages 773 - 779
LEY, B.COLLARD, H. R.KING, T. E., JR.: "Clinical course and prediction of survival in idiopathic pulmonary fibrosis", AM J RESPIR CRIT CARE MED, vol. 183, 2011, pages 431 - 440, XP055963952, DOI: 10.1164/rccm.201006-0894CI
DICKSON, R. P. ET AL.: "Radiographic Honeycombing and Altered Lung Microbiota in Patients with Idiopathic Pulmonary Fibrosis", AM J RESPIR CRIT CARE MED200, 2019, pages 1544 - 1547
HAN, M. K. ET AL.: "Lung microbiome and disease progression in idiopathic pulmonary fibrosis: an analysis of the COMET study", LANCET RESPIR MED, vol. 2, 2014, pages 548 - 556
HUANG, Y. ET AL.: "Microbes Are Associated with Host Innate Immune Response in Idiopathic Pulmonary Fibrosis", AM J RESPIR CRIT CARE MED, vol. 196, 2017, pages 208 - 219
MOLYNEAUX, P. L. ET AL.: "Host-Microbial Interactions in Idiopathic Pulmonary Fibrosis", AM J RESPIR CRIT CARE MED, vol. 195, 2017, pages 1640 - 1650
TAKAHASHI, Y. ET AL.: "Impaired diversity of the lung microbiome predicts progression of idiopathic pulmonary fibrosis", RESPIR RESL9, vol. 34, 2018
WANG, J. ET AL.: "Lung microbiome and host immune tone in subjects with idiopathic pulmonary fibrosis treated with inhaled interferon-gamma", ERJ OPEN RES, vol. 3, 2017
MOLYNEAUX, P. L. ET AL.: "Changes in the respiratory microbiome during acute exacerbations of idiopathic pulmonary fibrosis", RESPIR RES, vol. 18, 2017, pages 29
WENG, D. ET AL.: "The Role of Infection in Acute Exacerbation of Idiopathic Pulmonary Fibrosis", MEDIATORS INFLAMM, 2019, pages 5160694
D'ALESSANDRO-GABAZZA, C. N. ET AL.: "A Staphylococcus pro-apoptotic peptide induces acute exacerbation of pulmonary fibrosis", NAT COMMUN, vol. 11, 2020, pages 1539, XP055778258, DOI: 10.1038/s41467-020-15344-3
"Genbank", Database accession no. 99287.1
ARGEMI, X.HANSMANN, Y.PROLA, K.PREVOST, G.: "Coagulase-Negative Staphylococci Pathogenomics", INT JMOL SCI20, 2019
CZEKAJ, T.CISZEWSKI, M.SZEWCZYK, E. M.: "Staphylococcus haemolyticus - an emerging threat in the twilight of the antibiotics age", MICROBIOLOGY (READING, vol. 161, 2015, pages 2061 - 2068
YIN, Y. ET AL.: "A hybrid sub-lineage of Listeria monocytogenes comprising hypervirulent isolates", NAT COMMUN, vol. 10, 2019, pages 4283
JOHANSEN, M. D.HERRMANN, J. L.KREMER, L.: "Non-tuberculous mycobacteria and the rise of Mycobacterium abscessus", NAT REV MICROBIOL, vol. 18, 2020, pages 392 - 407
FUSCO, V. ET AL.: "The genus Weissella: taxonomy, ecology and biotechnological potential", FRONT MICROBIOL, vol. 6, 2015, pages 155
BEDOUI, S.HEROLD, M. J.STRASSER, A.: "Emerging connectivity of programmed cell death pathways and its physiological implications", NAT REV MOL CELL BIOL, vol. 21, 2020, pages 678 - 695, XP037274454, DOI: 10.1038/s41580-020-0270-8
BATANDIER, C.LEVERVE, X.FONTAINE, E.: "Opening of the mitochondrial permeability transition pore induces reactive oxygen species production at the level of the respiratory chain complex I", J BIOL CHEM, vol. 279, 2004, pages 17197 - 17204
DU, C.FANG, M.LI, Y.LI, L.WANG, X.: "Smac, a mitochondrial protein that promotes cytochrome c-dependent caspase activation by eliminating IAP inhibition", CELL, vol. 102, 2000, pages 33 - 42, XP002175396, DOI: 10.1016/S0092-8674(00)00008-8
JENKINS, R. G.: " An Official American Thoracic Society Workshop Report: Use of Animal Models for the Preclinical Assessment of Potential Therapies for Pulmonary Fibrosis.", AM J RESPIR CELL MOL BIOL, vol. 56, 2017, pages 667 - 679
URAWA, M. ET AL.: "Protein S is protective in pulmonary fibrosis.", THROMB HAEMOST, vol. 14, 2016, pages 1588 - 1599
DRAKOPANAGIOTAKIS, F.XIFTERI, A.POLYCHRONOPOULOS, V.BOUROS, D.: "Apoptosis in lung injury and fibrosis", EUR RESPIR J32, 2008, pages 1631 - 1638
D'ALESSANDRO-GABAZZA, C. N. ET AL.: "Development and preclinical efficacy of novel transforming growth factor-betal short interfering RNAs for pulmonary fibrosis", AM J RESPIR CELL MOL BIOL46, 2012, pages 397 - 406
UPAGUPTA, C.SHIMBORI, C.ALSILMI, R.KOLB, M.: "Matrix abnormalities in pulmonary fibrosis", EUR RESPIR REV, vol. 27, 2018
RYERSON, C. J.COTTIN, V.BROWN, K. K.COLLARD, H. R.: "Acute exacerbation of idiopathic pulmonary fibrosis: shifting the paradigm", EUR RESPIR J, vol. 46, 2015, pages 512 - 520
JEON, K. ET AL.: "Prognostic factors and causes of death in Korean patients with idiopathic pulmonary fibrosis", RESPIRMEDLOO, 2006, pages 451 - 457, XP005285314, DOI: 10.1016/j.rmed.2005.06.013
KONDOH, Y. ET AL.: "Risk factors of acute exacerbation of idiopathic pulmonary fibrosis", SARCOIDOSIS VASE DIFFUSE LUNG DIS, vol. 27, 2010, pages 103 - 110
RAGHU, G. ET AL.: "Diagnosis of Idiopathic Pulmonary Fibrosis. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline", AM J RESPIR CRIT CARE MED, vol. 198, 2018, pages e44 - e68
KREUTER, M.MAHER, T. M.: "Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis", A CALL TO ARMS. AM J RESPIR CRIT CARE MED, vol. 201, 2020, pages 1030 - 1032
COLLARD, H. R. ET AL.: "Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials", RESPIR RES, vol. 14, 2013, pages 73, XP021156083, DOI: 10.1186/1465-9921-14-73
BARBAS-FILHO, J. V. ET AL.: "Evidence of type II pneumocyte apoptosis in the pathogenesis of idiopathic pulmonary fibrosis (IFP)/usual interstitial pneumonia (UIP", J CLIN PATHOL54, 2001, pages 132 - 138
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