WO2017088974A3 - Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders - Google Patents

Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders Download PDF

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Publication number
WO2017088974A3
WO2017088974A3 PCT/EP2016/001970 EP2016001970W WO2017088974A3 WO 2017088974 A3 WO2017088974 A3 WO 2017088974A3 EP 2016001970 W EP2016001970 W EP 2016001970W WO 2017088974 A3 WO2017088974 A3 WO 2017088974A3
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WO
WIPO (PCT)
Prior art keywords
fibrosis
alpha
treatment
relates
antibody
Prior art date
Application number
PCT/EP2016/001970
Other languages
French (fr)
Other versions
WO2017088974A2 (en
Inventor
Ilhan Celik
Eike Staub
Miriam URBAN
Sabine RAAB
Eileen Samy
Andrew Bender
Georgianna HIGGINBOTHAM
Yin Wu
Daigen Xu
Original Assignee
Merck Patent Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to CN201680077086.5A priority Critical patent/CN108473582A/en
Application filed by Merck Patent Gmbh filed Critical Merck Patent Gmbh
Priority to CA3005764A priority patent/CA3005764A1/en
Priority to EP16808567.8A priority patent/EP3380520A2/en
Priority to SG11201804243QA priority patent/SG11201804243QA/en
Priority to BR112018010337A priority patent/BR112018010337A2/en
Priority to US15/778,615 priority patent/US20190144547A1/en
Priority to EA201891204A priority patent/EA201891204A1/en
Priority to MX2018006269A priority patent/MX2018006269A/en
Priority to KR1020187017898A priority patent/KR20180081617A/en
Priority to AU2016360661A priority patent/AU2016360661B2/en
Priority to JP2018526688A priority patent/JP7034914B2/en
Priority to NZ742238A priority patent/NZ742238B2/en
Publication of WO2017088974A2 publication Critical patent/WO2017088974A2/en
Publication of WO2017088974A3 publication Critical patent/WO2017088974A3/en
Priority to IL259482A priority patent/IL259482A/en
Priority to HK18113256.2A priority patent/HK1254295A1/en
Priority to US16/541,650 priority patent/US11485786B2/en
Priority to JP2021181951A priority patent/JP2022022217A/en
Priority to US18/050,817 priority patent/US20230322934A1/en

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2839—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
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    • A61P17/00—Drugs for dermatological disorders
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
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    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/25—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving enzymes not classifiable in groups C12Q1/26 - C12Q1/66
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    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12Q3/00—Condition responsive control processes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/158—Expression markers

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  • Heart & Thoracic Surgery (AREA)

Abstract

The invention relates to the prophylaxis and/or treatment of fibrosis and/or fibrotic diseases by means of antibodies. Above all, the invention relates to the administration of an anti-alpha-v integrin (receptor) antibody to patients suffering from fibrosis and/or fibrotic diseases, including but not limited to systemic sclerosis (SSc). More specifically, the instant invention relates to the treatment of fibrotic diseases of the skin, lung, heart, liver and/or kidney by means of said antibody. Even more specifically, the instant invention relates to the administration of a recombinant, de- immunized monoclonal antibody targeting av-integrins patients suffering from systemic sclerosis, including, but not limited to systemic sclerosis of the skin, lung, heart and/or kidney by means of the anti-alpha-v integrin antibody DI17E6 and structural mutants or modifications thereof.
PCT/EP2016/001970 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders WO2017088974A2 (en)

Priority Applications (17)

Application Number Priority Date Filing Date Title
MX2018006269A MX2018006269A (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders.
CA3005764A CA3005764A1 (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
EP16808567.8A EP3380520A2 (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
SG11201804243QA SG11201804243QA (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
BR112018010337A BR112018010337A2 (en) 2015-11-23 2016-11-22 anti-alpha-v integrin antibody for the treatment of fibrosis and / or fibrotic disorders
US15/778,615 US20190144547A1 (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
AU2016360661A AU2016360661B2 (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
KR1020187017898A KR20180081617A (en) 2015-11-23 2016-11-22 Anti-alpha-V integrin antibodies for the treatment of fibrosis and / or fibrotic diseases
EA201891204A EA201891204A1 (en) 2016-04-12 2016-11-22 ANTIBODY AGAINST ALPHA-V INTEGRINE FOR THE TREATMENT OF FIBROSIS AND / OR FIBROUS DISORDERS
CN201680077086.5A CN108473582A (en) 2015-11-23 2016-11-22 Anti- α V integrin antibody for treating fibrosis and/or fibrotic conditions
JP2018526688A JP7034914B2 (en) 2015-11-23 2016-11-22 Anti-α-v integrin antibody for the treatment of fibrosis and / or fibrotic disease
NZ742238A NZ742238B2 (en) 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
IL259482A IL259482A (en) 2015-11-23 2018-05-21 Anti-integrin antibody
HK18113256.2A HK1254295A1 (en) 2015-11-23 2018-10-16 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
US16/541,650 US11485786B2 (en) 2015-11-23 2019-08-15 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
JP2021181951A JP2022022217A (en) 2015-11-23 2021-11-08 ANTI-α-V INTEGRIN ANTIBODY FOR TREATMENT OF FIBROSIS AND/OR FIBROTIC DISORDERS
US18/050,817 US20230322934A1 (en) 2015-11-23 2022-10-28 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562258626P 2015-11-23 2015-11-23
US62/258,626 2015-11-23
EP16164879 2016-04-12
EP16164879.5 2016-04-12

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US15/778,615 A-371-Of-International US20190144547A1 (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders
US16/541,650 Continuation US11485786B2 (en) 2015-11-23 2019-08-15 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders

Publications (2)

Publication Number Publication Date
WO2017088974A2 WO2017088974A2 (en) 2017-06-01
WO2017088974A3 true WO2017088974A3 (en) 2017-07-13

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PCT/EP2016/001970 WO2017088974A2 (en) 2015-11-23 2016-11-22 Anti-alpha-v integrin antibody for the treatment of fibrosis and/or fibrotic disorders

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EP (1) EP3380520A2 (en)
KR (1) KR20180081617A (en)
CN (1) CN108473582A (en)
AU (1) AU2016360661B2 (en)
BR (1) BR112018010337A2 (en)
CA (1) CA3005764A1 (en)
EA (1) EA201891204A1 (en)
MX (1) MX2018006269A (en)
SG (1) SG11201804243QA (en)
TW (1) TW201720843A (en)
WO (1) WO2017088974A2 (en)

Families Citing this family (5)

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Publication number Priority date Publication date Assignee Title
US20210347898A1 (en) * 2018-10-09 2021-11-11 INSERM (Institut National de la Santé et de la Recherche Médicale) Use of alpha-v-integrin (cd51) inhibitors for the treatment of cardiac fibrosis
JP7317379B2 (en) * 2019-01-04 2023-07-31 国立大学法人京都大学 Examination method for ulcerative colitis and primary sclerosing cholangitis
US20220370545A1 (en) * 2019-09-20 2022-11-24 North Carolina State University Integrin receptor alpha v beta 3 and its ligand involved in chronic itch
EP4323401A1 (en) * 2021-04-12 2024-02-21 Syddansk Universitet Mfap4 and treatment of fibrosis
CN116955967B (en) * 2023-09-20 2023-12-08 成都无糖信息技术有限公司 System and method for simulating investigation and adjustment in network target range

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WO2009010290A2 (en) * 2007-07-17 2009-01-22 Merck Patent Gmbh Engineered anti-alpha v- integrin hybrid antibodies
WO2010008543A2 (en) * 2008-07-15 2010-01-21 Trustees Of Dartmouth College Molecular signatures for diagnosing scleroderma
WO2013148232A1 (en) * 2012-03-27 2013-10-03 Genentech, Inc. Methods of prognosing, diagnosing and treating idiopathic pulmonary fibrosis

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BARBARA ULMASOV ET AL: "Inhibitors of Arg-Gly-Asp-Binding Integrins Reduce Development of Pancreatic Fibrosis in Mice", CMGH CELLULAR AND MOLECULAR GASTROENTEROLOGY AND HEPATOLOGY, vol. 2, no. 4, 1 July 2016 (2016-07-01), pages 499 - 518, XP055338304, ISSN: 2352-345X, DOI: 10.1016/j.jcmgh.2016.03.004 *
CONROY KYLIE P ET AL: "[alpha]v integrins: key regulators of tissue fibrosis", CELL AND TISSUE RESEARCH, SPRINGER, DE, vol. 365, no. 3, 2 May 2016 (2016-05-02), pages 511 - 519, XP036047046, ISSN: 0302-766X, [retrieved on 20160502], DOI: 10.1007/S00441-016-2407-9 *
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MONIQUE HINCHCLIFF ET AL: "Molecular Signatures in Skin Associated with Clinical Improvement during Mycophenolate Treatment in Systemic Sclerosis", JOURNAL OF INVESTIGATIVE DERMATOLOGY, vol. 133, no. 8, 1 August 2013 (2013-08-01), US, pages 1979 - 1989, XP055369808, ISSN: 0022-202X, DOI: 10.1038/jid.2013.130 *
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