DK2451473T3 - Langtidsvirkende koagulationsfaktorer og fremgangsmåder til fremstilling deraf - Google Patents

Langtidsvirkende koagulationsfaktorer og fremgangsmåder til fremstilling deraf Download PDF

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DK2451473T3
DK2451473T3 DK10796803.4T DK10796803T DK2451473T3 DK 2451473 T3 DK2451473 T3 DK 2451473T3 DK 10796803 T DK10796803 T DK 10796803T DK 2451473 T3 DK2451473 T3 DK 2451473T3
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coagulation factor
ctp
factor
another embodiment
ctps
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DK10796803.4T
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Udi Eyal Fima
Gili Hart
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Opko Biologics Ltd
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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
    • C07K14/475—Growth factors; Growth regulators
    • C07K14/505—Erythropoietin [EPO]
    • 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
    • C07K14/575—Hormones
    • C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • C07K2319/00—Fusion polypeptide
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/90—Fusion polypeptide containing a motif for post-translational modification
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/90—Fusion polypeptide containing a motif for post-translational modification
    • C07K2319/91—Fusion polypeptide containing a motif for post-translational modification containing a motif for glycosylation

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  • 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)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Reproductive Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
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Claims (17)

1. Polypeptid, som består af en koagulationsfaktor og fem carboxyterminale peptider (CTPer) fra humant choriongonadotropin bundet til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor VII eller faktor Vila, eller en koagulationsfaktor og tre CTPer fra humant choriongonadotropin bundet til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor IX, hvor sekvensen af de nævnte CTPer omfatter de første 10 aminosyrer ifølge SEQ ID NO: 4 (dvs. aminosyresekvensen SSSSKAPPPS).
2. Polypeptid ifølge krav 1, hvor sekvensen af mindst ét CTP omfatter en aminosyresekvens valgt blandt SEQ ID NO: 1 og SEQ ID NO: 2.
3. Polypeptid ifølge krav 1 eller 2, hvor mindst ét CTP omfatter mindst ét glycosyleringssted.
4. Polypeptid ifølge et hvilket som helst af kravene 1 til 3, hvor mindst ét CTP er bundet til koagulationsfaktoren via en linker.
5. Polypeptid ifølge krav 4, hvor linkeren er en peptidbinding.
6. Farmaceutisk sammensætning, som omfatter polypeptidet ifølge et hvilket som helst af kravene 1 til 5.
7. Polynukleotid, som omfatter en kodende del, der koder for et polypeptid, som består af en koagulationsfakto og fem carboxyterminale peptider (CTPer) fra humant choriongonadotropin bundet til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor VII eller faktor Vila, eller en kodende del, der koder for et polypeptid, som består af en koagulationsfakto og tre CTPer fra humant choriongonadotropin bundet til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor IX, hvor sekvensen af de nævnte CTPer omfatter de første 10 aminosyrer ifølge SEQ ID NO: 4.
8. Polynukleotid ifølge krav 7, hvor mindst ét CTP omfatter en aminosyre-sekvens valgt blandt SEQ ID NO: 1 og SEQ ID NO: 2.
9. Ekspressionsvektor, som omfatter polynukleotidet ifølge krav 7 eller 8.
10. Celle, som omfatter ekspressionsvektoren ifølge krav 9.
11. Sammensætning, som omfatter ekspressionsvektoren ifølge krav 9.
12. Fremgangsmåde til forlængelse af en koagulationsfaktors biologiske halveringstid, hvilken fremgangsmåde omfatter følgende trin: binding af fem carboxyterminale peptider (CTPer) fra humant choriongonadotropin til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor VII eller faktor Vila, eller binding af tre CTPer fra humant choriongonadotropin til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor IX, hvor sekvensen af de nævnte CTPer omfatter de første 10 aminosyrer ifølge SEQ ID NO: 4, idet koagulationsfaktorens biologiske halveringstid derved forbedres.
13. Fremgangsmåde til forbedring af arealet under kurven (AUC) for en koagulationsfaktor, hvilken fremgangsmåde omfatter følgende trin: binding af fem carboxyterminale peptider (CTPer) fra humant choriongonadotropin til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor VII eller faktor Vila, eller binding af tre CTPer fra humant choriongonadotropin til den carboxyterminale ende af koagulationsfaktoren, hvor koagulationsfaktoren er faktor IX, hvor sekvensen af de nævnte CTP omfatter de første 10 aminosyrer ifølge SEC ID NO: 4, idet AUC for koagulationsfaktoren derved forbedres.
14. Fremgangsmåde ifølge krav 12 eller 13, hvor aminosyresekvensen af mindst ét CTP fra choriongonadotropin er valgt blandt SEQ ID NO: 1 og SEQ IC NO: 2.
15. Polypeptid, som består afen koagulationsfaktor og fem carboxyterminale peptider (CTPer) fra humant choriongonadotropin, hvilke CTPer er bundet til den carboxyterminale ende af koagulationsfaktoren, hvor sekvensen af de nævnte CTPer omfatter de første 10 aminosyrer ifølge SEQ ID NO: 4, til anvendelse ved behandling af hæmofili, hvor koagulationsfaktoren er faktor VII eller faktor Vila.
16. Polypeptid, som består afen koagulationsfaktor og tre carboxyterminale peptider (CTPer) fra humant choriongonadotropin, hvilke CTPer er bundet til den carboxyterminale ende af koagulationsfaktoren, hvor sekvensen af de nævnte CTPer omfatter de første 10 aminosyrer ifølge SEQ ID NO: 4, til anvendelse ved behandling af hæmofili, hvor koagulationsfaktoren er faktor IX.
17. Polypeptid til anvendelse ifølge krav 15 eller 16, hvor aminosyresekvensen af mindst ét CTP fra choriongonadotropin er valgt blandt SEQ ID NO: 1 og SEQ ID NO: 2.
DK10796803.4T 2009-07-09 2010-07-01 Langtidsvirkende koagulationsfaktorer og fremgangsmåder til fremstilling deraf DK2451473T3 (da)

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US22436609P 2009-07-09 2009-07-09
PCT/IL2010/000532 WO2011004361A2 (en) 2009-07-09 2010-07-01 Long-acting coagulation factors and methods of producing same

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CN (2) CN105153314B (da)
AU (1) AU2010269884B2 (da)
CA (1) CA2767503C (da)
CY (1) CY1118733T1 (da)
DK (1) DK2451473T3 (da)
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HR (1) HRP20170051T1 (da)
HU (1) HUE032973T2 (da)
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HUE032973T2 (en) 2017-11-28
CN105153314A (zh) 2015-12-16
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AU2010269884B2 (en) 2015-01-15
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