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DK3072907T3 - Anti-her2- antistof og konjugat deraf - Google Patents

Anti-her2- antistof og konjugat deraf Download PDF

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Publication number
DK3072907T3
DK3072907T3 DK14864053.5T DK14864053T DK3072907T3 DK 3072907 T3 DK3072907 T3 DK 3072907T3 DK 14864053 T DK14864053 T DK 14864053T DK 3072907 T3 DK3072907 T3 DK 3072907T3
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Prior art keywords
antibody
her2
conjugate
linker
cancer
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DK14864053.5T
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English (en)
Inventor
Jianmin Fang
Changjiang Huang
Jing Jiang
Xuejing Yao
Hongwen Li
Qiaoyu Xu
Zhuanglin Li
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Remegen Ltd
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Publication of DK3072907T3 publication Critical patent/DK3072907T3/da

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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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6805—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a vinca alkaloid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6855—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell the tumour determinant being from breast cancer cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Cell Biology (AREA)
  • Oncology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Wood Science & Technology (AREA)
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  • Zoology (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (14)

1. Konjugat, som omfatter et antistof eller funktionelle fragmenter deraf, som specifikt kan binde til HER2, hvor antistoffet eller det funktionelle fragment deraf er konjugeret med et eller flere terapeutiske midler udvalgt blandt MMAE og MMAF, hvor antistoffet omfatter en tungkæde og en letkæde, hvor: (i) tungkæden omfatter tre CDR-regioner, hvor CDR-regionerne har aminosy-resekvenserne som vist i SEQ ID NO: respektivt 1,2 og 3; (ii) letkæden omfatter tre CDR-regioner, hvor CDR-regionerne har aminosyre-sekvenserne som vist i SEQ ID NO: respektivt 4, 5 og 6.
2. Konjugat ifølge krav 1, hvor antistoffet er afledt af et antistof secerneret fra hybridomcellerne, som blev deponeret i China General Microbiological Culture Collection Center den 22. august 2013, med deponeringsnummeret CGMCC No. 8102.
3. Konjugat ifølge krav 1, hvor antistoffet er et humaniseret antistof.
4. Konjugat ifølge krav 3, hvor antistoffet er et antistof secerneret fra CHO-cellerne, som blev deponeret i China Center for Type Culture Collection den 6. november, 2013, med deponeringsnummeret CCTCC C2013170.
5. Konjugat ifølge krav 1, hvor det terapeutiske middel er koblet med antistoffet eller de funktionelle fragmenter deraf gennem en linker.
6. Konjugat ifølge krav 5, hvor linkeren er linket med antistoffet gennem thiol.
7. Konjugat ifølge krav 5, hvor linkeren udvalgt blandt mc-vc-pAB og mc.
8. Konjugat med den almene formel af Ab-(L-U)n, hvor Ab repræsenterer antistoffet eller funktionelle fragmenter deraf ifølge et af kravene 1-4, L repræsenterer en linker, U repræsenterer et terapeutisk middel udvalgt blandt MMAE og MMAF, og n repræsenterer et heltal fra 1 til 8.
9. Konjugat ifølge krav 8, hvor linkeren er udvalgt blandt mc-vc-pAB og mc.
10. Farmaceutisk sammensætning, som omfatter konjugatet ifølge et af kravene 1 -9 og et farmaceutisk acceptabelt bærestof.
11. Konjugat ifølge et af kravene 1 -9 eller den farmaceutiske sammensætning ifølge krav 10 til anvendelse inden for behandlingen eller forebyggelsen af kræft.
12. Konjugat ifølge et af kravene 1-9 eller den farmaceutiske sammensætning ifølge krav 10 til anvendelse inden for behandlingen eller forebyggelsen af HER2-positiv kræft.
13. Konjugat ifølge et af kravene 1-9 eller den farmaceutiske sammensætning ifølge krav 10 til anvendelse inden for behandlingen eller forebyggelsen af brystkræft eller æggestokkræft eller mavekræft.
14. Konjugat ifølge et af kravene 1-9 eller den farmaceutiske sammensætning ifølge krav 10 til anvendelse inden for behandlingen eller forebyggelsen af Lapatinib- og/eller Herceptin-resistent brystkræft, æggestokkræft eller mavekræft.
DK14864053.5T 2013-11-19 2014-11-18 Anti-her2- antistof og konjugat deraf DK3072907T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310586326 2013-11-19
PCT/CN2014/091332 WO2015074528A1 (zh) 2013-11-19 2014-11-18 抗her2抗体及其缀合物

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DK3072907T3 true DK3072907T3 (da) 2019-04-01

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US (1) US10087260B2 (da)
EP (2) EP3072907B1 (da)
JP (2) JP6326137B2 (da)
KR (3) KR101993136B1 (da)
CN (3) CN105008398B (da)
AU (1) AU2014352475B2 (da)
CA (1) CA2919359C (da)
CY (1) CY1124651T1 (da)
DK (2) DK3072907T3 (da)
ES (1) ES2879799T3 (da)
HR (1) HRP20211023T1 (da)
HU (1) HUE055269T2 (da)
LT (1) LT3480215T (da)
PL (1) PL3480215T3 (da)
PT (1) PT3480215T (da)
RS (1) RS62157B1 (da)
RU (1) RU2656161C1 (da)
SI (1) SI3480215T1 (da)
WO (1) WO2015074528A1 (da)

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CN109320612B (zh) 2020-10-27
EP3072907A1 (en) 2016-09-28
EP3480215B8 (en) 2021-07-28
AU2014352475B2 (en) 2017-08-17
KR20190002716A (ko) 2019-01-08
HUE055269T2 (hu) 2021-11-29
HRP20211023T1 (hr) 2021-09-17
EP3072907A4 (en) 2017-06-14
US10087260B2 (en) 2018-10-02
CA2919359A1 (en) 2015-05-28
KR101993136B1 (ko) 2019-06-26
EP3480215B1 (en) 2021-06-23
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