Title:
METHOD AND PHARMACEUTICAL COMBINATION FOR PREVENTING CANCER RECURRENCE
Document Type and Number:
WIPO Patent Application WO/2022/156733
Kind Code:
A1
Abstract:
The present disclosure relates to the field of biomedicine, and specifically provides a method for preventing cancer recurrence. The method comprises: administering an interferon-based therapeutic agent to a subject in need thereof, preferably intermittently administering the interferon-based therapeutic agent, and optionally administering an additional anti-cancer agent. Further provided is a pharmaceutical combination for use in the method.
Inventors:
LIAO XIAOJIN (CN)
WU HANZHOU (CN)
CHU HONGRAN (CN)
ZHU PEIJUAN (CN)
XIAO QINGJIANG (CN)
WU HANZHOU (CN)
CHU HONGRAN (CN)
ZHU PEIJUAN (CN)
XIAO QINGJIANG (CN)
Application Number:
PCT/CN2022/072921
Publication Date:
July 28, 2022
Filing Date:
January 20, 2022
Export Citation:
Assignee:
XIAMEN AMOYTOP BIOTECH CO LTD (CN)
BIOSTEED GENE TRANSF TECH CO LTD (CN)
BIOSTEED GENE TRANSF TECH CO LTD (CN)
International Classes:
A61K38/21; A61K45/06; A61P31/14; A61P31/20; A61P31/22; A61P35/00
Domestic Patent References:
| WO2021013204A1 | 2021-01-28 | |||
| WO2019112243A1 | 2019-06-13 | |||
| WO2013028233A1 | 2013-02-28 |
Foreign References:
| CN112245570A | 2021-01-22 | |||
| US20100196320A1 | 2010-08-05 | |||
| US20180051085A1 | 2018-02-22 | |||
| US8454947B1 | 2013-06-04 |
Other References:
KUBO SHOJI, NISHIGUCHI SHUHEI, HIROHASHI KAZUHIRO, TANAKA HIROMU, TSUKAMOTO TADASHI, SHUTO TAICHI, TAKEMURA SHIGEKAZU, YAMAMOTO TA: "Influence of Previous Interferon Therapy on Recurrence after Resection of Hepatitis C Virus-related Hepatocellular Carcinoma", JAPANESE JOURNAL OF CANCER RESEARCH, JAPANESE CANCER ASSOCIATION, TOKYO, JP, vol. 92, no. 1, 1 January 2001 (2001-01-01), JP , pages 59 - 66, XP055952670, ISSN: 0910-5050, DOI: 10.1111/j.1349-7006.2001.tb01048.x
BAOMING YU: "Progress and evaluation of adjuvant chemotherapy for colorectal cancer", JOURNAL OF ABDOMINAL SURGERY, vol. 14, no. 1, 1 February 2001 (2001-02-01), pages 10 - 12, XP055952672, ISSN: 1003-5591
RONGNAN SHEN: "The value and prospect of interferon in cancer therapy", SHIYONG ZHONGLIU ZAZHI = JOURNAL OF PRACTICAL ONCOLOGY, ZHEJIANG DAXUE YIXUEYUAN * FUSHU DI-2 YIYUAN, CN, vol. 6, no. 2, 1 January 1991 (1991-01-01), CN , pages 79 - 79, XP055952674, ISSN: 1001-1692, DOI: 10.13267/j.cnki.syzlzz.1991.02.008
GANE EJ: "The oral toll-like receptor-7 agonist GS-9620 in patients with chronic hepatitis B virus infection.", J HEPATOL., vol. 63, no. 2, August 2015 (2015-08-01), pages 320 - 8
JANSSEN HLA: "Safety, efficacy and pharmacodynamics of vesatolimod (GS-9620) in virally suppressed patients with chronic hepatitis B.", J HEPATOL., vol. 68, no. 3, March 2018 (2018-03-01), pages 431 - 440
AGARWAL K: "Safety and efficacy of vesatolimod (GS-9620) in patients with chronic hepatitis B who are not currently on antiviral treatment.", JOURNAL OF VIRAL HEPATITIS, vol. 25, no. 11, August 2018 (2018-08-01), pages 1331 - 1340
LOPATIN U: "afety, pharmacokinetics and pharmacodynamics of GS-9620, an oral Toll-like receptor 7 agonist.", ANTIVIR THER., vol. 18, no. 3, 2013, pages 409 - 18
EDWARD J. GANE: "TLR7 agonist R07020531 triggers immune activation after multiple doses in chronic hepatitis B patients Reported by Jules Levin.", AASLD, November 2018 (2018-11-01), pages 9 - 13
EBRAHIM M: "Are RIG-1 and MDA5 Expressions Associated with Chronic HBV Infection?", VIRAL IMMUNOL., vol. 28, no. 9, November 2015 (2015-11-01), pages 504 - 8
MA Z: "Contribution of Toll-like receptors to the control of hepatitis B virus infection by initiating antiviral innate responses and promoting specific adaptive immune responses.", CELL MOL IMMUNOL., vol. 12, no. 3, May 2015 (2015-05-01), pages 273 - 82
JONES M: "SB 9200, a novel agonist of innate immunity, shows potent antiviral activity against resistant HCV variants.", J MED VIROL., vol. 89, no. 9, September 2017 (2017-09-01), pages 1620 - 1628
XU CL: "Upregulation of toll-like receptor 4 on T cells in PBMCs is associated with disease aggravation of HBV-related acute-on-chronic liver failure.", J HUAZHONG UNIV SCI TECHNOLOG MED SCI., vol. 35, no. 6, December 2015 (2015-12-01), pages 910 - 915, XP035715536, DOI: 10.1007/s11596-015-1527-x
KATO H: "RIG-I-Like Receptors and Type I Interferonopathies", J INTERFERON CYTOKINE RES., vol. 37, no. 5, May 2017 (2017-05-01), pages 207 - 213
LI L: "Anti-HBV response to toll-like receptor 7 agonist GS-9620 is associated with intrahepatic aggregates of T cells and B cells.", J HEPATOL., vol. 68, no. 5, May 2018 (2018-05-01), pages 912 - 921, XP085372145, DOI: 10.1016/j.jhep.2017.12.008
HARRINGTON: "LBA15Preliminary results of the first-in-human (FIH) study of MK-1454, an agonist of stimulator of interferon genes (STING), as monotherapy or in combination with pembrolizumab (pembro) in patients with advanced solid tumors or lymphomas.", ANNALS OF ONCOLOGY., vol. 29, no. 8, October 2018 (2018-10-01), pages 712 - 712
CEMERSKISASO: "Preclinical characterization of a novel STING agonist, MK-1454.", JOURNAL FOR IMMUNOTHERAPY OF CANCER., vol. 5, no. 2, November 2017 (2017-11-01), pages 16
RAMANJULU JM: "Design of amidobenzimidazole STING receptor agonists with systemic activity.", NATURE., vol. 564, no. 7736, December 2018 (2018-12-01), pages 439 - 443, XP093006969, DOI: 10.1038/s41586-018-0705-y
LARA PN JR: "Randomized phase III placebo-controlled trial of carboplatin and paclitaxel with or without the vascular disrupting agent vadimezan (ASA404) in advanced non-small-cell lung cancer.", J CLIN ONCOL., vol. 29, no. 22, 1 August 2011 (2011-08-01), pages 2965 - 71
YUEN, M. F: "Dose response and safety of the daily, oral RIG-I agonist Inarigivir (SB 9200) in treatment naive patients with chronic hepatitis B: results from the 25mg and 50mg cohorts in the ACHIEVE trial.", JOURNAL OF HEPATOLOGY., vol. 68, no. 1, April 2018 (2018-04-01), pages S509 - S510
MA Z: "Interaction between Hepatitis B Virus and Toll-Like Receptors: Current Status and Potential Therapeutic Use for Chronic Hepatitis B.", VACCINES (BASEL)., vol. 16, no. 6, January 2018 (2018-01-01), pages 1
WALSH, R.: "Effects of SB9200 (Inarigivir) therapy on immune responses in patients with chronic hepatitis B.", JOURNAL OF HEPATOLOGY., vol. 8, no. 1, 6 April 2018 (2018-04-06), pages S89 - S89
NIU C: "Toll-like receptor 7 agonist GS-9620 induces prolonged inhibition of HBV via a type I interferon-dependent mechanism.", J HEPATOL., vol. 68, no. 5, May 2018 (2018-05-01), pages 922 - 931, XP085372144, DOI: 10.1016/j.jhep.2017.12.007
YUEN, MF: "Ascending dose cohort study of inarigivir - A novel RIG I agonist in chronic HBV patients: Final results of the ACHIEVE trial.", JOURNAL OF HEPATOLOGY., vol. 70, no. 1, April 2019 (2019-04-01), pages E47 - E48
BOURQUIN C: "Harnessing the immune system to fight cancer with Toll-like receptor and RIG-I-like receptor agonists.", PHARMACOL RES., 2 March 2019 (2019-03-02), pages S1043 - 6618
ZENG Y: "Toll-like receptors, long non-coding RNA NEAT1, and RIG-I expression are associated with HBeAg-positive chronic hepatitis B patients in the active phase.", J CLIN LAB ANAL., vol. 33, no. 5, June 2019 (2019-06-01), pages e22886
WANG JIAWEN ET AL.: "Research progress of Toll-like receptors and their agonists.", ADVANCES IN PHYSIOLOGICAL SCIENCE, vol. 49, no. 4, 2018, pages 289 - 292
TAO ZEYU ET AL.: "Research progress of drugs for the treatment of chronic hepatitis B virus infection.", FOREIGN MEDICINE AND ANTIBIOTICS VOLUME, vol. 39, no. 4, July 2018 (2018-07-01), pages 308 - 319
XU QUN ET AL.: "Research progress of immunomodulators targeting Toll-like receptors.", ADVANCES IN PHARMACY, vol. 40, no. 1, 2016, pages 42 - 55
LIU QIUMING ET AL.: "New Advances in Anti-HBV Drug Research", JOURNAL OF VIROLOGY., vol. 32, no. 5, September 2016 (2016-09-01), pages 650 - 658
MU NA ET AL.: "Expression levels of pattern recognition receptors TLR3, RIG-I and MDA5 in peripheral blood of patients with chronic hepatitis B.", CHINESE JOURNAL OF IMMUNOLOGY., vol. 05, 2016, pages 715 - 719
HEINZ GISSLINGER: "Ropeginterferon alfa-2b, a novel IFNa-2b, induces high response rates with low toxicity in patients with polycythemia vera.", BLOOD., vol. 126, no. 15, 8 October 2015 (2015-10-08), pages 1762 - 1769, XP055483671, DOI: 10.1182/blood-2015-04-637280
MONKARSH SP: "Positional isomers of monopegylated interferon alpha-2a: isolation, characterization, and biological activity.", ANAL BIOCHEM., vol. 247, no. 2, 1 May 1997 (1997-05-01), pages 434 - 40, XP002092303, DOI: 10.1006/abio.1997.2128
GRACE M: "Structural and biologic characterization of pegylated recombinant IFN-alpha2b.", J INTERFERON CYTOKINE RES., vol. 21, no. 12, pages 1103 - 15, XP002425931, DOI: 10.1089/107999001317205240
FOSER S: "Isolation, structural characterization, and antiviral activity of positional isomers of monopegylated interferon alpha-2a (PEGASYS).", PROTEIN EXPR PURIF., vol. 30, no. 1, July 2003 (2003-07-01), pages 78 - 87, XP002364173
WANG JUNZHI.: "Biotechnology drug research and development and quality control.", 2007, SCIENCE PRESS, pages: 540
BAOMING YU: "Progress and evaluation of adjuvant chemotherapy for colorectal cancer", JOURNAL OF ABDOMINAL SURGERY, vol. 14, no. 1, 1 February 2001 (2001-02-01), pages 10 - 12, XP055952672, ISSN: 1003-5591
RONGNAN SHEN: "The value and prospect of interferon in cancer therapy", SHIYONG ZHONGLIU ZAZHI = JOURNAL OF PRACTICAL ONCOLOGY, ZHEJIANG DAXUE YIXUEYUAN * FUSHU DI-2 YIYUAN, CN, vol. 6, no. 2, 1 January 1991 (1991-01-01), CN , pages 79 - 79, XP055952674, ISSN: 1001-1692, DOI: 10.13267/j.cnki.syzlzz.1991.02.008
GANE EJ: "The oral toll-like receptor-7 agonist GS-9620 in patients with chronic hepatitis B virus infection.", J HEPATOL., vol. 63, no. 2, August 2015 (2015-08-01), pages 320 - 8
JANSSEN HLA: "Safety, efficacy and pharmacodynamics of vesatolimod (GS-9620) in virally suppressed patients with chronic hepatitis B.", J HEPATOL., vol. 68, no. 3, March 2018 (2018-03-01), pages 431 - 440
AGARWAL K: "Safety and efficacy of vesatolimod (GS-9620) in patients with chronic hepatitis B who are not currently on antiviral treatment.", JOURNAL OF VIRAL HEPATITIS, vol. 25, no. 11, August 2018 (2018-08-01), pages 1331 - 1340
LOPATIN U: "afety, pharmacokinetics and pharmacodynamics of GS-9620, an oral Toll-like receptor 7 agonist.", ANTIVIR THER., vol. 18, no. 3, 2013, pages 409 - 18
EDWARD J. GANE: "TLR7 agonist R07020531 triggers immune activation after multiple doses in chronic hepatitis B patients Reported by Jules Levin.", AASLD, November 2018 (2018-11-01), pages 9 - 13
EBRAHIM M: "Are RIG-1 and MDA5 Expressions Associated with Chronic HBV Infection?", VIRAL IMMUNOL., vol. 28, no. 9, November 2015 (2015-11-01), pages 504 - 8
MA Z: "Contribution of Toll-like receptors to the control of hepatitis B virus infection by initiating antiviral innate responses and promoting specific adaptive immune responses.", CELL MOL IMMUNOL., vol. 12, no. 3, May 2015 (2015-05-01), pages 273 - 82
JONES M: "SB 9200, a novel agonist of innate immunity, shows potent antiviral activity against resistant HCV variants.", J MED VIROL., vol. 89, no. 9, September 2017 (2017-09-01), pages 1620 - 1628
XU CL: "Upregulation of toll-like receptor 4 on T cells in PBMCs is associated with disease aggravation of HBV-related acute-on-chronic liver failure.", J HUAZHONG UNIV SCI TECHNOLOG MED SCI., vol. 35, no. 6, December 2015 (2015-12-01), pages 910 - 915, XP035715536, DOI: 10.1007/s11596-015-1527-x
KATO H: "RIG-I-Like Receptors and Type I Interferonopathies", J INTERFERON CYTOKINE RES., vol. 37, no. 5, May 2017 (2017-05-01), pages 207 - 213
LI L: "Anti-HBV response to toll-like receptor 7 agonist GS-9620 is associated with intrahepatic aggregates of T cells and B cells.", J HEPATOL., vol. 68, no. 5, May 2018 (2018-05-01), pages 912 - 921, XP085372145, DOI: 10.1016/j.jhep.2017.12.008
HARRINGTON: "LBA15Preliminary results of the first-in-human (FIH) study of MK-1454, an agonist of stimulator of interferon genes (STING), as monotherapy or in combination with pembrolizumab (pembro) in patients with advanced solid tumors or lymphomas.", ANNALS OF ONCOLOGY., vol. 29, no. 8, October 2018 (2018-10-01), pages 712 - 712
CEMERSKISASO: "Preclinical characterization of a novel STING agonist, MK-1454.", JOURNAL FOR IMMUNOTHERAPY OF CANCER., vol. 5, no. 2, November 2017 (2017-11-01), pages 16
RAMANJULU JM: "Design of amidobenzimidazole STING receptor agonists with systemic activity.", NATURE., vol. 564, no. 7736, December 2018 (2018-12-01), pages 439 - 443, XP093006969, DOI: 10.1038/s41586-018-0705-y
LARA PN JR: "Randomized phase III placebo-controlled trial of carboplatin and paclitaxel with or without the vascular disrupting agent vadimezan (ASA404) in advanced non-small-cell lung cancer.", J CLIN ONCOL., vol. 29, no. 22, 1 August 2011 (2011-08-01), pages 2965 - 71
YUEN, M. F: "Dose response and safety of the daily, oral RIG-I agonist Inarigivir (SB 9200) in treatment naive patients with chronic hepatitis B: results from the 25mg and 50mg cohorts in the ACHIEVE trial.", JOURNAL OF HEPATOLOGY., vol. 68, no. 1, April 2018 (2018-04-01), pages S509 - S510
MA Z: "Interaction between Hepatitis B Virus and Toll-Like Receptors: Current Status and Potential Therapeutic Use for Chronic Hepatitis B.", VACCINES (BASEL)., vol. 16, no. 6, January 2018 (2018-01-01), pages 1
WALSH, R.: "Effects of SB9200 (Inarigivir) therapy on immune responses in patients with chronic hepatitis B.", JOURNAL OF HEPATOLOGY., vol. 8, no. 1, 6 April 2018 (2018-04-06), pages S89 - S89
NIU C: "Toll-like receptor 7 agonist GS-9620 induces prolonged inhibition of HBV via a type I interferon-dependent mechanism.", J HEPATOL., vol. 68, no. 5, May 2018 (2018-05-01), pages 922 - 931, XP085372144, DOI: 10.1016/j.jhep.2017.12.007
YUEN, MF: "Ascending dose cohort study of inarigivir - A novel RIG I agonist in chronic HBV patients: Final results of the ACHIEVE trial.", JOURNAL OF HEPATOLOGY., vol. 70, no. 1, April 2019 (2019-04-01), pages E47 - E48
BOURQUIN C: "Harnessing the immune system to fight cancer with Toll-like receptor and RIG-I-like receptor agonists.", PHARMACOL RES., 2 March 2019 (2019-03-02), pages S1043 - 6618
ZENG Y: "Toll-like receptors, long non-coding RNA NEAT1, and RIG-I expression are associated with HBeAg-positive chronic hepatitis B patients in the active phase.", J CLIN LAB ANAL., vol. 33, no. 5, June 2019 (2019-06-01), pages e22886
WANG JIAWEN ET AL.: "Research progress of Toll-like receptors and their agonists.", ADVANCES IN PHYSIOLOGICAL SCIENCE, vol. 49, no. 4, 2018, pages 289 - 292
TAO ZEYU ET AL.: "Research progress of drugs for the treatment of chronic hepatitis B virus infection.", FOREIGN MEDICINE AND ANTIBIOTICS VOLUME, vol. 39, no. 4, July 2018 (2018-07-01), pages 308 - 319
XU QUN ET AL.: "Research progress of immunomodulators targeting Toll-like receptors.", ADVANCES IN PHARMACY, vol. 40, no. 1, 2016, pages 42 - 55
LIU QIUMING ET AL.: "New Advances in Anti-HBV Drug Research", JOURNAL OF VIROLOGY., vol. 32, no. 5, September 2016 (2016-09-01), pages 650 - 658
MU NA ET AL.: "Expression levels of pattern recognition receptors TLR3, RIG-I and MDA5 in peripheral blood of patients with chronic hepatitis B.", CHINESE JOURNAL OF IMMUNOLOGY., vol. 05, 2016, pages 715 - 719
HEINZ GISSLINGER: "Ropeginterferon alfa-2b, a novel IFNa-2b, induces high response rates with low toxicity in patients with polycythemia vera.", BLOOD., vol. 126, no. 15, 8 October 2015 (2015-10-08), pages 1762 - 1769, XP055483671, DOI: 10.1182/blood-2015-04-637280
MONKARSH SP: "Positional isomers of monopegylated interferon alpha-2a: isolation, characterization, and biological activity.", ANAL BIOCHEM., vol. 247, no. 2, 1 May 1997 (1997-05-01), pages 434 - 40, XP002092303, DOI: 10.1006/abio.1997.2128
GRACE M: "Structural and biologic characterization of pegylated recombinant IFN-alpha2b.", J INTERFERON CYTOKINE RES., vol. 21, no. 12, pages 1103 - 15, XP002425931, DOI: 10.1089/107999001317205240
FOSER S: "Isolation, structural characterization, and antiviral activity of positional isomers of monopegylated interferon alpha-2a (PEGASYS).", PROTEIN EXPR PURIF., vol. 30, no. 1, July 2003 (2003-07-01), pages 78 - 87, XP002364173
WANG JUNZHI.: "Biotechnology drug research and development and quality control.", 2007, SCIENCE PRESS, pages: 540
Attorney, Agent or Firm:
NTD UNIVATION INTELLECTUAL PROPERTY AGENCY LTD. (CN)
Download PDF: