HRP20100264T1 - Varijante gla domene faktora vii ili viia - Google Patents
Varijante gla domene faktora vii ili viia Download PDFInfo
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- HRP20100264T1 HRP20100264T1 HR20100264T HRP20100264T HRP20100264T1 HR P20100264 T1 HRP20100264 T1 HR P20100264T1 HR 20100264 T HR20100264 T HR 20100264T HR P20100264 T HRP20100264 T HR P20100264T HR P20100264 T1 HRP20100264 T1 HR P20100264T1
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- 229940012414 factor viia Drugs 0.000 title claims abstract 7
- 229940012413 factor vii Drugs 0.000 title claims 3
- 238000006467 substitution reaction Methods 0.000 claims abstract 32
- 125000000539 amino acid group Chemical group 0.000 claims abstract 8
- 108010054265 Factor VIIa Proteins 0.000 claims abstract 6
- 125000003275 alpha amino acid group Chemical group 0.000 claims abstract 5
- 229940099816 human factor vii Drugs 0.000 claims abstract 4
- 208000014674 injury Diseases 0.000 claims abstract 3
- 230000008733 trauma Effects 0.000 claims abstract 3
- 230000002209 hydrophobic effect Effects 0.000 claims abstract 2
- 102220494690 Small vasohibin-binding protein_K32E_mutation Human genes 0.000 claims 18
- 102220494687 Small vasohibin-binding protein_R36E_mutation Human genes 0.000 claims 18
- 102220595361 Anamorsin_A34E_mutation Human genes 0.000 claims 9
- 208000032843 Hemorrhage Diseases 0.000 claims 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 8
- 208000034158 bleeding Diseases 0.000 claims 6
- 230000000740 bleeding effect Effects 0.000 claims 6
- 201000010099 disease Diseases 0.000 claims 4
- 208000035475 disorder Diseases 0.000 claims 4
- 230000037431 insertion Effects 0.000 claims 4
- 238000003780 insertion Methods 0.000 claims 4
- 230000004988 N-glycosylation Effects 0.000 claims 3
- 238000001727 in vivo Methods 0.000 claims 3
- 239000002773 nucleotide Substances 0.000 claims 3
- 125000003729 nucleotide group Chemical group 0.000 claims 3
- 229920001184 polypeptide Polymers 0.000 claims 3
- 102000004196 processed proteins & peptides Human genes 0.000 claims 3
- 108090000765 processed proteins & peptides Proteins 0.000 claims 3
- 102100023804 Coagulation factor VII Human genes 0.000 claims 2
- 108010023321 Factor VII Proteins 0.000 claims 2
- 208000031220 Hemophilia Diseases 0.000 claims 2
- 208000009292 Hemophilia A Diseases 0.000 claims 2
- 208000008574 Intracranial Hemorrhages Diseases 0.000 claims 2
- 230000035602 clotting Effects 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000013604 expression vector Substances 0.000 claims 2
- 238000002271 resection Methods 0.000 claims 2
- 238000002054 transplantation Methods 0.000 claims 2
- 230000004913 activation Effects 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 206010008111 Cerebral haemorrhage Diseases 0.000 abstract 2
- 150000001413 amino acids Chemical class 0.000 abstract 1
- 238000012986 modification Methods 0.000 abstract 1
- 230000004048 modification Effects 0.000 abstract 1
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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
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- 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)
-
- 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
- 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
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- 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
- C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
- C12N15/52—Genes encoding for enzymes or proenzymes
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- 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
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- 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
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- 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)
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- Hematology (AREA)
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- Gastroenterology & Hepatology (AREA)
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- General Chemical & Material Sciences (AREA)
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Abstract
Polipeptidna varijanta Faktora VII (FVII) ili Faktora VIIa (FVIIa), naznačena time, da ima amino kiselinsku sekvencu koja se razlikuje u 1-15 amino kiselinskih ostataka u odnosu prema amino kiselinskoj sekvenci humanog Faktora VII (hFVII) ili humanog Faktora VIIa (hFVIIa) koja je prikazana u SEQ ID NO: 1, pri čemu je negativno nabijeni amino kiselinski ostatak bio uveden supstitucijom u položaju 36 te pri čemu navedena polipeptidna varijanta u svojem aktiviranom obliku ima povećanu FX aktivacijsku aktivnost kada se usporedi sa rekombinantnim humanim Faktorom VIIa. Patent sadrži još 44 patentna zahtjeva.
Claims (45)
1. Polipeptidna varijanta Faktora VII (FVII) ili Faktora VIIa (FVIIa), naznačena time, da ima amino kiselinsku sekvencu koja se razlikuje u 1-15 amino kiselinskih ostataka u odnosu prema amino kiselinskoj sekvenci humanog Faktora VII (hFVII) ili humanog Faktora VIIa (hFVIIa) koja je prikazana u SEQ ID NO: 1, pri čemu je negativno nabijeni amino kiselinski ostatak bio uveden supstitucijom u položaju 36 te pri čemu navedena polipeptidna varijanta u svojem aktiviranom obliku ima povećanu FX aktivacijsku aktivnost kada se usporedi sa rekombinantnim humanim Faktorom VIIa.
2. Varijanta iz zahtjeva 1, naznačena time, da navedena supstitucija je R36D.
3. Varijanta iz zahtjeva 1, naznačena time, da navedena supstitucija je R36E.
4. Varijanta iz bilo kojeg zahtjeva 1-3, naznačena time, da nadalje sadrži amino kiselinsku supstituciju u položaju 34.
5. Varijanta iz zahtjeva 4, naznačena time, da je negativno nabijen amino kiselinski ostatak bio uveden supstitucijom u položaju 34.
6. Varijanta iz zahtjeva 5, naznačena time, da sadrži supstitucije A34E+R36E.
7. Varijanta iz bilo kojeg prethodnog zahtjeva, naznačena time, da nadalje sadrži amino kiselinsku supstituciju u položaju 10 i/ili 32.
8. Varijanta iz zahtjeva 7, naznačena time, da sadrži supstituciju K32E.
9. Varijanta iz zahtjeva 7, naznačena time, da sadrži supstituciju P10Q.
10. Varijanta iz zahtjeva 7, naznačena time, da sadrži supstitucije P10Q+K32E.
11. Varijanta iz zahtjeva 10, naznačena time, da sadrži supstitucije P10Q+K32E+A34E+R36E.
12. Varijanta iz zahtjeva 10, naznačena time, da sadrži supstitucije P10Q+K32E+A34L+R36E.
13. Varijanta iz bilo kojeg prethodnog zahtjeva, naznačena time, da je najmanje jedan amino kiselinski ostatak koji sadrži vezujuću skupinu za ne-polipeptidni udio bio uveden u položaj smješten izvan Gla domene.
14. Varijanta iz zahtjeva 13, naznačena time, da navedena vezujuća skupina je in vivo N-glikozilacijsko mjesto uvedeno supstitucijom.
15. Varijanta iz zahtjeva 14, naznačena time, da navedeno in vivo N-glikozilacijsko mjesto uvedeno supstitucijom je izabrano iz skupine koju čine A51N, G58N, T106N, K109N, G124N, K143N+N145T, A175T, I205S, I205T, V253N, T267N, T267N+S269T, S314N+K316S, S314N+K316T, R315N+V317S, R315N+V317T, K316N+G318S, K316N+G318T, G318N, D334N i njihove kombinacije.
16. Varijanta iz zahtjeva 15, naznačena time, da sadrži najmanje jednu supstituciju izabranu iz skupine koju čine T106N, I205T i V253N.
17. Varijanta iz zahtjeva 16, naznačena time, da sadrži dva in vivo N-glikozilacijska mjesta uvedena supstitucijom izabrana iz skupine koju čine T106N+I205T, T106+V253N i I205T+V253N.
18. Varijanta iz zahtjeva 17, naznačena time, da sadrži supstitucije P10Q+K32E+A34E+R36E+T106N+I205T.
19. Varijanta iz zahtjeva 17, naznačena time, da sadrži supstitucije P10Q+K32E+A34E+R36E+T106N+V253N.
20. Varijanta iz zahtjeva 17, naznačena time, da sadrži supstitucije P10Q+K32E+A34E+R36E+I205T+V253N.
21. Varijanta iz zahtjeva 17, naznačena time, da sadrži supstitucije P10Q+K32E+A34L+R36E+T106N+I205T.
22. Varijanta iz zahtjeva 17, naznačena time, da sadrži supstitucije P10Q+K32E+A34L+R36E+T106N+V253N.
23. Varijanta iz zahtjeva 17, naznačena time, da sadrži supstitucije P10Q+K32E+A34L+R36E+I205T+V253N.
24. Varijanta iz bilo kojeg prethodnog zahtjeva, naznačena time, da nadalje sadrži umetanje najmanje jednog amino kiselinskog ostatka između položaja 3 i 4.
25. Varijanta iz zahtjeva 24, naznačena time, da sadrži umetanje jednog amino kiselinskog ostatka između položaja 3 i 4.
26. Varijanta iz zahtjeva 25, naznačena time, da je hidrofobni amino kiselinski ostatak umetnut između položaja 3 i 4.
27. Varijanta iz zahtjeva 26, naznačena time, da navedeni umetak je A3AY.
28. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34E+R36E.
29. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34L+R36E.
30. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34E+R36E+ T106N+I205T.
31. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34E+R36E+T106N+V253N.
32. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34E+R36E+I205T+V253N.
33. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34L+R36E+T106N+I205T.
34. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34L+R36E+T106N+V253N.
35. Varijanta iz zahtjeva 27, naznačena time, da sadrži umetak A3AY i supstitucije P10Q+K32E+A34L+R36E+I205T+V253N.
36. Varijanta iz bilo kojeg prethdnog zahtjeva, naznačena time, da je navedena varijanta u aktiviranom obliku.
37. Nukleotidna sekvenca, naznačena time, da kodira varijantu kakva je određena u bilo kojem od zahtjeva 1- 36.
38. Ekspresijski vektor, naznačen time, da sadrži nukleotidnu sekvencu iz zahtjeva 37.
39. Stanica domaćina, naznačena time, da sadrži nukleotidnu sekvencu iz zahtjeva 37 i ekspresijski vektor iz zahtjeva 38.
40. Pripravak, naznačen time, da sadrži varijantu kakva je određena u bilo kojem od zahtjeva 1-36 i najmanje jednu farmaceutski prihvatljivu podlogu ili pomoćno sredstvo.
41. Varijanta kakva je određena u bilo kojem od zahtjeva 1-36, ili pripravak kakav je određen u zahtjevu 40, naznačen time, da je za uporabu kao lijek.
42. Uporaba varijante kakva je određena u bilo kojem od zahtjeva 1-36, naznačena time, da se koristi za izradu lijeku za liječenje oboljenja ili poremećaja kod kojih je poželjno formiranje ugruška.
43. Uporaba u skladu sa zahtjevom 42, naznačena time, da je navedo oboljenje ili poremećaj izabran iz skupine koju čine hemoragije, uključujući hemoragije mozga, snažna nekontrolirana krvarenja poput trauma, krvarenja kod pacijenata prilikom transplatacija ili resekcija, krvarenja kod varičela i hemofilija.
44. Varijanta kakva je određena u bilo kojem od zahtjeva 1-36, naznačena time, da je za uporabu u liječenju oboljenja ili poremećaja kod kojih je poželjno formiranje ugruška.
45. Varijanta kakva je određena u bilo kojem od zahtjeva 1-36, naznačena time, da je za uporabu u liječenju oboljenja ili poremećaja izabranog iz skupine koju čine hemoragije, uključujući hemoragije mozga, snažna nekontrolirana krvarenja poput trauma, krvarenja kod pacijenata prilikom transplatacija ili resekcija, krvarenja kod varičela i hemofilija.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US47978003P | 2003-06-19 | 2003-06-19 | |
| DKPA200400930 | 2004-06-15 | ||
| PCT/DK2004/000428 WO2004111242A1 (en) | 2003-06-19 | 2004-06-18 | FACTOR VII OR VIIa GLA DOMAIN VARIANTS |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20100264T1 true HRP20100264T1 (hr) | 2010-08-31 |
Family
ID=33553697
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20100264T HRP20100264T1 (hr) | 2003-06-19 | 2010-05-12 | Varijante gla domene faktora vii ili viia |
Country Status (24)
| Country | Link |
|---|---|
| US (5) | US20050164932A1 (hr) |
| EP (1) | EP1644504B8 (hr) |
| JP (2) | JP4915918B2 (hr) |
| KR (1) | KR101191779B1 (hr) |
| CN (1) | CN1839203B (hr) |
| AT (1) | ATE458057T1 (hr) |
| AU (2) | AU2004247799B2 (hr) |
| BR (1) | BRPI0411650A (hr) |
| CA (1) | CA2529828C (hr) |
| CY (1) | CY1109984T1 (hr) |
| DE (1) | DE602004025576D1 (hr) |
| DK (1) | DK1644504T3 (hr) |
| ES (1) | ES2338425T3 (hr) |
| HK (1) | HK1095357A1 (hr) |
| HR (1) | HRP20100264T1 (hr) |
| IL (1) | IL172364A (hr) |
| MX (1) | MXPA05013769A (hr) |
| NZ (2) | NZ544728A (hr) |
| PL (1) | PL1644504T3 (hr) |
| PT (1) | PT1644504E (hr) |
| RU (1) | RU2373282C2 (hr) |
| SI (1) | SI1644504T1 (hr) |
| WO (1) | WO2004111242A1 (hr) |
| ZA (1) | ZA200600539B (hr) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE428445T1 (de) * | 2000-02-11 | 2009-05-15 | Bayer Healthcare Llc | Gerinnungsfaktor vii oder viia konjugate |
| CA2483478A1 (en) * | 2002-04-30 | 2003-11-13 | Maxygen Holdings Ltd. | Factor vii or viia polypeptide variants |
| US7771996B2 (en) * | 2003-03-20 | 2010-08-10 | Bayer Healthcare Llc | FVII or FVIIa variants |
| DK1644504T3 (da) * | 2003-06-19 | 2010-05-25 | Bayer Healthcare Llc | Faktor VII- eller -VIIA-Gla-domænevarianter |
| KR20070043051A (ko) | 2004-08-17 | 2007-04-24 | 쳇엘베 베링 게엠베하 | 변형된 비타민 ｋ 의존적 폴리펩타이드 |
| US20080188400A1 (en) * | 2005-04-26 | 2008-08-07 | Maxygen Holdings Ltd. | Methods For Treating Bleeding |
| EP1893632B1 (en) | 2005-06-17 | 2015-08-12 | Novo Nordisk Health Care AG | Selective reduction and derivatization of engineered factor vii proteins comprising at least one non-native cysteine |
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