HRP20191305T1 - Preradive jednolančane molekule i polipeptidi izrađeni koristeći iste - Google Patents

Preradive jednolančane molekule i polipeptidi izrađeni koristeći iste Download PDF

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Publication number
HRP20191305T1
HRP20191305T1 HRP20191305TT HRP20191305T HRP20191305T1 HR P20191305 T1 HRP20191305 T1 HR P20191305T1 HR P20191305T T HRP20191305T T HR P20191305TT HR P20191305 T HRP20191305 T HR P20191305T HR P20191305 T1 HRP20191305 T1 HR P20191305T1
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Croatia
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polypeptide according
polypeptide
biologically active
group
active part
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HRP20191305TT
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English (en)
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Joe Salas
Robert Peters
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Bioverativ Therapeutics Inc.
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Publication of HRP20191305T1 publication Critical patent/HRP20191305T1/hr

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    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/644—Coagulation factor IXa (3.4.21.22)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • 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
    • 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
    • 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
    • C07K16/2848—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 against integrin beta3-subunit-containing molecules, e.g. CD41, CD51, CD61
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6432—Coagulation factor Xa (3.4.21.6)
    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6437—Coagulation factor VIIa (3.4.21.21)
    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/647—Blood coagulation factors not provided for in a preceding group or according to more than one of the proceeding groups
    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21021—Coagulation factor VIIa (3.4.21.21)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/33—Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies

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

Claims (16)

1. Polipeptid, koji sadrži (i) barem jedan biološki aktivan dio koji sadrži faktor zgrušavanja, (ii) Fc regiju koja sadrži najmanje dva Fc dijela, i (iii) scFc (cscFc) poveznicu koja se može cijepati umetnutu između dva Fc dijela, pri čemu je cscFc poveznica okružena s mjestom enzimatskog cijepanja i uzvodno i nizvodno od cscFc poveznice, što rezultira cijepanjem cscFc poveznice.
2. Polipeptid prema patentnom zahtjevu 1, naznačen time što sadrži drugi biološki aktivan dio.
3. Polipeptid prema patentnom zahtjevu 2, naznačen time što je drugi biološki aktivan dio odabran iz skupine koja se sastoji od: antigen vezujućeg dijela protutijela, ne-imunoglobulinske vezujuće molekule, veznog dijela liganda, veznog dijela receptora, i faktora zgrušavanja.
4. Polipeptid prema patentnom zahtjevu 2 ili 3, naznačen time što polipeptid ima formulu izabranu iz skupine koja se sastoji od: A-F1-B-P1-L-P2-F2; A-F1-P1-L-P2-B-F2; A-F1-P1-L-P2-F2; i F1-P1-L-P2-B-F2; u linearnoj sekvenci od amino do karboksi terminalnog kraja, i pri čemu A je barem jedan biološki aktivan dio; B je drugi biološki aktivan dio; P1 je prvo mjesto enzimatskog cijepanja; P2 je drugo mjesto enzimatskog cijepanja; L je cscFc poveznica; i F1 i F2 su Fc dijelovi.
5. Polipeptid prema patentnom zahtjevu 4, naznačen time što najmanje jedan od P1 ili P2 sadrži aminokiselinsku sekvencu odabranu iz skupine koju čine: TQSFNDFTR, SVSQTSKLTR, DFLAEGGGVR, TTKIKPR, LVPRG, i ALRPR.
6. Polipeptid prema patentnom zahtjevu 4, naznačen time što najmanje jedan od P1 ili P2 sadrži aminokiselinsku sekvencu odabranu iz skupine koju čine: RRRR, RKRRKR, i RRRRS.
7. Polipeptid prema patentnom zahtjevu 2, naznačen time što: (i) prvi biološki aktivan dio sadrži lagani lanac faktora zgrušavanja; i (ii) drugi biološki aktivan dio sadrži teški lanac faktora zgrušavanja; pri čemu Fc regija sadrži prvi Fc dio i drugi Fc dio; pri čemu je prvi Fc dio vezan na lagani lanac faktora zgrušavanja i drugi Fc dio je vezan na teški lanac faktora zgrušavanja; i pri čemu se lagani lanac i teški lanac vežu tako da tvore enzimatski aktivni faktor zgrušavanja.
8. Polipeptid prema patentnom zahtjevu 3 ili 7, naznačen time što je faktor zgrušavanja odabran iz skupine koja se sastoji od FVII, FVIIa, FIX, FIXa, FX, i FXa.
9. Polipeptid prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time što nadalje sadrži ciljajući dio.
10. Polipeptid prema patentnom zahtjevu 9, naznačen time što se ciljajući dio selektivno veže na mirujuće trombocite ili selektivno veže na aktivirane trombocite.
11. Molekula nukleinske kiseline naznačena time što kodira polipeptid prema bilo kojem od patentnih zahtjeva 1 do 10.
12. Vektor naznačen time što sadrži molekulu nukleinske kiseline prema patentnom zahtjevu 11.
13. Stanica domaćin koja sadrži vektor prema patentnom zahtjevu 12, naznačena time što stanica domaćina eksprimira enzim koji cijepa cscFc poveznicu, pri čemu je enzim endogeni ili egzogeni za stanicu.
14. Postupak za proizvodnju obrađenog, heterodimernog polipeptida koji sadrži dva polipeptidna lanca, naznačen time što obuhvaća kultiviranje stanice domaćina prema zahtjevu 13 u mediju stanične kulture i izoliranje zrelog, heterodimernog polipeptida iz medija kulture.
15. Pripravak naznačen time što sadrži polipeptid prema bilo kojem od patentnih zahtjeva 1 do 10 i farmaceutski prihvatljiv nosač.
16. Pripravak prema patentnom zahtjevu 15, naznačen time što je za uporabu za liječenje ili prevenciju bolesti ili poremećaja kod subjekta.
HRP20191305TT 2010-07-09 2019-07-18 Preradive jednolančane molekule i polipeptidi izrađeni koristeći iste HRP20191305T1 (hr)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US36318310P 2010-07-09 2010-07-09
US36318610P 2010-07-09 2010-07-09
US201161442029P 2011-02-11 2011-02-11
US201161442150P 2011-02-11 2011-02-11
US201161442055P 2011-02-11 2011-02-11
US201161467880P 2011-03-25 2011-03-25
US201161491762P 2011-05-31 2011-05-31
EP11738539.3A EP2591006B1 (en) 2010-07-09 2011-07-11 Processable single chain molecules and polypeptides made using same
PCT/US2011/043599 WO2012006635A1 (en) 2010-07-09 2011-07-11 Processable single chain molecules and polypeptides made using same

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HRP20191305T1 true HRP20191305T1 (hr) 2019-10-18

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US (6) US20130216513A1 (hr)
EP (3) EP2591099B1 (hr)
JP (1) JP2013534427A (hr)
KR (1) KR20140002601A (hr)
CN (1) CN103180439A (hr)
AU (1) AU2011274423B2 (hr)
CA (1) CA2804280A1 (hr)
CY (1) CY1122044T1 (hr)
DK (2) DK2591099T3 (hr)
EA (1) EA201291482A1 (hr)
ES (1) ES2739503T3 (hr)
HR (1) HRP20191305T1 (hr)
HU (1) HUE044419T2 (hr)
LT (1) LT2591006T (hr)
MX (1) MX2013000301A (hr)
NZ (1) NZ605400A (hr)
PL (1) PL2591006T3 (hr)
PT (1) PT2591006T (hr)
SG (2) SG186875A1 (hr)
SI (1) SI2591006T1 (hr)
TW (2) TW201217527A (hr)
WO (2) WO2012006635A1 (hr)

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US20210355473A1 (en) 2021-11-18
US20130216513A1 (en) 2013-08-22
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ES2739503T3 (es) 2020-01-31
US10968442B2 (en) 2021-04-06
AU2011274423B2 (en) 2016-02-11
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PT2591006T (pt) 2019-07-29
US20170044512A1 (en) 2017-02-16
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