DK1824988T3 - Stedspecifik modificering af fviii - Google Patents
Stedspecifik modificering af fviii Download PDFInfo
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- DK1824988T3 DK1824988T3 DK05849392.5T DK05849392T DK1824988T3 DK 1824988 T3 DK1824988 T3 DK 1824988T3 DK 05849392 T DK05849392 T DK 05849392T DK 1824988 T3 DK1824988 T3 DK 1824988T3
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- fviii
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Classifications
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- 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
- A61K38/37—Factors VIII
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- 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
- A61K47/56—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
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- 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
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- 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
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- C—CHEMISTRY; METALLURGY
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- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
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- 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)
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K17/00—Carrier-bound or immobilised peptides; Preparation thereof
- C07K17/02—Peptides being immobilised on, or in, an organic carrier
- C07K17/08—Peptides being immobilised on, or in, an organic carrier the carrier being a synthetic polymer
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
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- Chemical Kinetics & Catalysis (AREA)
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- Toxicology (AREA)
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- Communicable Diseases (AREA)
- Oncology (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Materials For Medical Uses (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Other Resins Obtained By Reactions Not Involving Carbon-To-Carbon Unsaturated Bonds (AREA)
Claims (15)
1. Konjugat med faktor VIII-prokoagulantaktivitet, der omfatter et funktionelt faktor VIII-polypeptid, der er muteret, således at mindst én ikke-cysteinrest er erstattet med en cysteinrest, således at der findes en mutant cysteinrest, hvor det funktionelle faktor VIII-polypeptid er kovalent bundet til en biokompatibel polymer i den mutante cysteinrest, hvor den biokompatible polymer er kovalent bundet til polypeptidet i en af faktor VIII-aminosyrepositionerne 81, 129, 377, 378, 468, 487, 491, 504, 556, 570, 1648, 1795, 1796, 1803, 1804, 1808, 1810, 1812, 1813, 1815, 1864, 1911, 2091, 2118 og 2284.
2. Konjugat ifølge krav 1, hvor den biokompatible polymer er polyethylenglycol.
3. Konjugat ifølge krav 1, hvor det funktionelle faktor VIII-polypeptid er B-domænedeleteret faktor VIII.
4. Konjugat ifølge krav 3, hvor den biokompatible polymer er kovalent bundet til B-domænedeleteret faktor VIII i en af aminosyrepositionerne 129, 491, 1804 eller 1808; en biokompatibel polymer er bundet i aminosyreposition 491, og en anden biokompatibel polymer er bundet i aminosyreposition 1808; eller en biokompatibel polymer er bundet i aminosyreposition 491, og en anden biokompatibel polymer er bundet i aminosyreposition 1804.
5. Konjugat ifølge krav 1, hvor det funktionelle faktor VIII-polypeptid har aminosyresekvensen ifølge SEQ ID NO: 4 eller SEQ ID NO: 3.
6. Konjugat ifølge krav 1, hvor det funktionelle faktor VIII-polypeptid har aminosyresekvensen ifølge SEQ ID NO: 3, og den biokompatible polymer er methoxypolyethylenglycol.
7. Konjugat ifølge krav 6, hvor den biokompatible polymer er bundet til polypeptidet i aminosyreposition 1804.
8. Fremgangsmåde til fremstilling af et konjugat ifølge krav 1, der omfatter: mutering af en nukleotidsekvens, der koder for det funktionelle faktor VHI-polypeptid, til substitution af en kodende sekvens for en ikke-cysteinrest med en kodende sekvens for en cysteinrest; ekspression af den muterede nukleotidsekvens til frembringelse af et cysteinforøget mutein; oprensning af muteinet; reaktion af muteinet med den biokompatible polymer, hvor den biokompatible polymer har en reaktiv sulfhydryldel, såsom thiol, triflat, tresylat, aziridin, oxiran, S-pyridyl eller maleimid, der reagerer med polypeptidet i den indførte cysteinrest til frembringelse af konjugatet; og oprensning af konjugatet.
9. Fremgangsmåde ifølge krav 8, hvor den biokompatible polymer er methoxypolyethylenglycol, og muteinet reagerer med en maleimidgruppe på methoxypolyethylenglycolen.
10. Fremgangsmåde ifølge krav 8, hvor ekspressionen af den muterede nukleotidsekvens finder sted i et celledyrkningsmedium, der omfatter sulfhydrylgrupper, der bliver kovalent bundet til den eller de indførte frie cysteingruppe (r) på det cysteinforøgede mutein, hvilken fremgangsmåde yderligere omfatter følgende trin efter ekspression af muteinet og før oprensning af muteinet: (a) etablering af kontakt mellem muteinet og et reduktionsmiddel under betingelser til let reducering muteinet og frigørelse af sulfhydrylgruppen; og (b) fjernelse af den frigjorte sulfhydrylgruppe og reduktionsmidlet fra muteinet; endvidere hvor muteinet reageres med den biokompatible polymer mindst 5 minutter efter fjernelse af reduktionsmidlet.
11. Fremgangsmåde ifølge krav 10, hvor faktor VIII-muteinet er et mutein af B-domænedeleteret faktor VIII.
12. Fremgangsmåde ifølge krav 10, hvor den biokompatible polymer er methoxypolyethylenglycolmaleimid og har en størrelse i intervallet fra 5 kD til 64 kD.
13. Farmaceutisk sammensætning til parenteral administration, der omfatter en terapeutisk effektiv mængde af konjugatet ifølge et af kravene 1 til 7 og et farmaceutisk acceptabelt adjuvans.
14. Anvendelse af konjugatet ifølge et af kravene 1 til 7 til fremstilling af et medikament til behandling af hæmofili.
15. Anvendelse af den farmaceutiske sammensætning ifølge krav 13 til fremstilling af et medikament til behandling af hæmofili.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US62727704P | 2004-11-12 | 2004-11-12 | |
PCT/US2005/041205 WO2006053299A2 (en) | 2004-11-12 | 2005-11-14 | Site-directed modification of fviii |
Publications (1)
Publication Number | Publication Date |
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DK1824988T3 true DK1824988T3 (da) | 2017-08-07 |
Family
ID=36337298
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Application Number | Title | Priority Date | Filing Date |
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DK11153297.4T DK2371856T3 (en) | 2004-11-12 | 2005-11-14 | Site-directed modifikation af FVIII |
DK05849392.5T DK1824988T3 (da) | 2004-11-12 | 2005-11-14 | Stedspecifik modificering af fviii |
DK11153300.6T DK2363414T3 (da) | 2004-11-12 | 2005-11-14 | Stedstyret modifikation af FVIII |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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DK11153297.4T DK2371856T3 (en) | 2004-11-12 | 2005-11-14 | Site-directed modifikation af FVIII |
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Application Number | Title | Priority Date | Filing Date |
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DK11153300.6T DK2363414T3 (da) | 2004-11-12 | 2005-11-14 | Stedstyret modifikation af FVIII |
Country Status (32)
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US (4) | US7632921B2 (da) |
EP (9) | EP3243833B1 (da) |
JP (5) | JP2008524117A (da) |
KR (7) | KR101483917B1 (da) |
CN (6) | CN103102406B (da) |
AU (1) | AU2005304622B2 (da) |
BR (2) | BR122016022033B8 (da) |
CA (1) | CA2586379C (da) |
CY (3) | CY1119292T1 (da) |
DK (3) | DK2371856T3 (da) |
ES (4) | ES2930143T3 (da) |
FR (1) | FR19C1031I2 (da) |
HK (3) | HK1117875A1 (da) |
HN (1) | HN2007015683A (da) |
HR (2) | HRP20180481B1 (da) |
HU (5) | HUE060016T2 (da) |
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