HRP20170051T1 - Dugodjelujući faktori koagulacije i postupci za njihovu proizvodnju - Google Patents

Dugodjelujući faktori koagulacije i postupci za njihovu proizvodnju Download PDF

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HRP20170051T1
HRP20170051T1 HRP20170051TT HRP20170051T HRP20170051T1 HR P20170051 T1 HRP20170051 T1 HR P20170051T1 HR P20170051T T HRP20170051T T HR P20170051TT HR P20170051 T HRP20170051 T HR P20170051T HR P20170051 T1 HRP20170051 T1 HR P20170051T1
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factor
coagulation factor
ctps
carboxy terminal
seq
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HRP20170051TT
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English (en)
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Udi Eyal Fima
Gili Hart
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Opko Biologics Ltd.
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475Growth factors; Growth regulators
    • C07K14/505Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/24Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/59Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/31Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/90Fusion polypeptide containing a motif for post-translational modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/90Fusion polypeptide containing a motif for post-translational modification
    • C07K2319/91Fusion 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)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Toxicology (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Reproductive Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicinal Preparation (AREA)
  • Glass Compositions (AREA)

Claims (17)

1. Polipeptid koji sadrži faktor koagulacije i pet ljudskih korionskih gonadotropin karboksi terminalnih peptida (CTP-ova) vezanih na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor VII ili Faktor VIIa, ili faktor koagulacije i tri ljudska korionska gonadotropina CTP-a vezana na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor IX, pri čemu sekvenca navedenih CTP-ova sadrži prvih 10 amino kiselina iz SEQ ID NO: 4 (tj., sekvencu amino kiseline SSSSKAPPPS).
2. Polipeptid prema zahtjevu 1, naznačen time da sekvenca barem jedne CTP sadrži sekvencu amino kiseline odabranu iz SEQ ID NO: 1 i SEQ ID NO: 2.
3. Polipeptid prema zahtjevu 1 ili 2, naznačen time da barem jedan CTP sadrži barem jedno glikozilacijsko mjesto.
4. Polipeptid prema bilo kojem od zahtjeva 1-3, naznačen time da je barem jedan CTP vezan na navedeni faktor koagulacije preko poveznice.
5. Polipeptid prema zahtjevu 4, naznačen time da navedena poveznica je peptidna veza.
6. Farmaceutski pripravak naznačen time da sadrži polipeptid prema bilo kojem od zahtjeva 1-5.
7. Polinukleotid koji sadrži kodirajući dio koji kodira polipeptid koji se sastoji od faktora koagulacije i pet ljudskih korionskih gonadotropinskih karboksi terminalnih peptida (CTP-ova) vezanih na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor VII ili Faktor VIIa, ili kodirajući dio koji kodira polipeptid koji se sastoji od faktora koagulacije i tri ljudska korionska gonadotropinska CTP-a vezana na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor IX, pri čemu sekvenca navedenih CTP-ova sadrži prvih 10 amino kiselina iz SEQ ID NO: 4.
8. Polinukleotid prema zahtjevu 7, naznačen time da barem jedan CTP sadrži sekvencu amino kiseline koja je odabrana od SEQ ID NO: 1 i SEQ ID NO: 2.
9. Ekspresijski vektor naznačen time da sadrži polinukleotid prema zahtjevu 7 ili 8.
10. Stanica naznačena time da sadrži ekspresijski vektor prema zahtjevu 9.
11. Pripravak naznačen time da sadrži ekspresijski vektor prema zahtjevu 9.
12. Postupak za produljenje biološkog poluvijeka faktora koagulacije, naznačen time da sadrži korak priključivanje pet ljudskih korionskih gonadotropin karboksi terminalnih peptida (CTP-ova) na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor VII ili Faktor VIIa, ili priključivanje tri ljudska korionska gonadotropin CTP-a na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor IX, pri čemu sekvenca navedenih CTP-ova sadrži prvih 10 amino kiselina iz SEQ ID NO: 4, čime se poboljšava biološki poluvijek navedenog faktora koagulacije.
13. Postupak za poboljšanje površine pod krivuljom (AUC) faktora koagulacije, naznačen time da sadrži korak priključivanja pet ljudskih korionskih gonadotropina na karboksi terminalne peptide (CTP) na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor VII ili Faktor VIIa, ili priključivanja tri ljudska korionska gonadotropin CTP-a na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu navedeni faktor koagulacije je Faktor IX, pri čemu sekvenca navedenih CTP-ova sadrži prvih 10 amino kiselina iz SEQ ID NO: 4, čime se poboljšava AUC navedenog faktora koagulacije.
14. Postupak prema zahtjevu 12 ili 13, naznačen time da je sekvenca amino kiseline od barem jednog korionskog gonadotropina CTP odabrana od SEQ ID NO: 1 i SEQ ID NO: 2.
15. Polipeptid koji se sastoji od faktora koagulacije i pet ljudskih korionskih gonadotropinskih karboksi terminalnih peptida (CTP) vezana na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu sekvence navedenih CTP-ova sadrže prvih 10 amino kiselina iz SEQ ID NO: 4, naznačen time da je za uporabu za liječenje hemofilije, pri čemu navedeni faktor koagulacije je Faktor VII ili Faktor VIIa.
16. Polipeptid koji se sastoji od faktora koagulacije i tri ljudska korionska gonadotropinskih karboksi terminalnih peptida (CTP) vezana na karboksi terminalni kraj navedenog faktora koagulacije, pri čemu sekvence navedenih CTP-ova sadrže prvih 10 amino kiselina iz SEQ ID NO: 4, naznačen time da je za uporabu za liječenje hemofilije, pri čemu navedeni faktor koagulacije je Faktor IX.
17. Polipeptid za uporabu prema zahtjevu 15 ili 16, naznačen time da je sekvenca amino kiseline barem jednog korionskog gonadotropina CTP odabrana od SEQ ID NO: 1 i SEQ ID NO: 2.
HRP20170051TT 2009-07-09 2017-01-12 Dugodjelujući faktori koagulacije i postupci za njihovu proizvodnju HRP20170051T1 (hr)

Applications Claiming Priority (3)

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US22436609P 2009-07-09 2009-07-09
EP10796803.4A EP2451473B1 (en) 2009-07-09 2010-07-01 Long-acting coagulation factors and methods of producing same
PCT/IL2010/000532 WO2011004361A2 (en) 2009-07-09 2010-07-01 Long-acting coagulation factors and methods of producing same

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US (1) US8476234B2 (hr)
EP (2) EP3130346A1 (hr)
JP (3) JP5823960B2 (hr)
KR (3) KR101802919B1 (hr)
CN (2) CN102639144B (hr)
AU (1) AU2010269884B2 (hr)
CA (1) CA2767503C (hr)
CY (1) CY1118733T1 (hr)
DK (1) DK2451473T3 (hr)
ES (1) ES2618209T3 (hr)
HR (1) HRP20170051T1 (hr)
HU (1) HUE032973T2 (hr)
IL (2) IL235377A (hr)
LT (1) LT2451473T (hr)
MX (3) MX2012000469A (hr)
PL (1) PL2451473T3 (hr)
PT (1) PT2451473T (hr)
SI (1) SI2451473T1 (hr)
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