HRP20181090T1 - Polipeptidi il-22 i fuzijski proteini fc il-22 te postupci njihove uporabe - Google Patents
Polipeptidi il-22 i fuzijski proteini fc il-22 te postupci njihove uporabe Download PDFInfo
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- HRP20181090T1 HRP20181090T1 HRP20181090TT HRP20181090T HRP20181090T1 HR P20181090 T1 HRP20181090 T1 HR P20181090T1 HR P20181090T T HRP20181090T T HR P20181090TT HR P20181090 T HRP20181090 T HR P20181090T HR P20181090 T1 HRP20181090 T1 HR P20181090T1
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- 238000000034 method Methods 0.000 title claims 9
- 108091006020 Fc-tagged proteins Proteins 0.000 title claims 2
- 229920001184 polypeptide Polymers 0.000 title 1
- 102000004196 processed proteins & peptides Human genes 0.000 title 1
- 108090000765 processed proteins & peptides Proteins 0.000 title 1
- 108020001507 fusion proteins Proteins 0.000 claims 34
- 102000037865 fusion proteins Human genes 0.000 claims 34
- 239000000825 pharmaceutical preparation Substances 0.000 claims 31
- 125000003275 alpha amino acid group Chemical group 0.000 claims 14
- 210000004027 cell Anatomy 0.000 claims 11
- 206010052428 Wound Diseases 0.000 claims 6
- 208000027418 Wounds and injury Diseases 0.000 claims 6
- 102000039446 nucleic acids Human genes 0.000 claims 6
- 108020004707 nucleic acids Proteins 0.000 claims 6
- 150000007523 nucleic acids Chemical class 0.000 claims 6
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 4
- 208000022559 Inflammatory bowel disease Diseases 0.000 claims 3
- 239000003795 chemical substances by application Substances 0.000 claims 3
- 206010012601 diabetes mellitus Diseases 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 230000000968 intestinal effect Effects 0.000 claims 3
- 229940124597 therapeutic agent Drugs 0.000 claims 3
- 230000029663 wound healing Effects 0.000 claims 3
- 201000001320 Atherosclerosis Diseases 0.000 claims 2
- 208000037260 Atherosclerotic Plaque Diseases 0.000 claims 2
- 241000588724 Escherichia coli Species 0.000 claims 2
- 208000001145 Metabolic Syndrome Diseases 0.000 claims 2
- 201000000690 abdominal obesity-metabolic syndrome Diseases 0.000 claims 2
- 238000004113 cell culture Methods 0.000 claims 2
- 238000012258 culturing Methods 0.000 claims 2
- 230000002526 effect on cardiovascular system Effects 0.000 claims 2
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- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 230000008569 process Effects 0.000 claims 2
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims 1
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims 1
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- 230000010393 epithelial cell migration Effects 0.000 claims 1
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- 210000003527 eukaryotic cell Anatomy 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 210000002175 goblet cell Anatomy 0.000 claims 1
- 239000001963 growth medium Substances 0.000 claims 1
- 229920002674 hyaluronan Polymers 0.000 claims 1
- 229960003160 hyaluronic acid Drugs 0.000 claims 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- 201000001421 hyperglycemia Diseases 0.000 claims 1
- 230000005764 inhibitory process Effects 0.000 claims 1
- 108010027445 interleukin-22 receptor Proteins 0.000 claims 1
- 210000002490 intestinal epithelial cell Anatomy 0.000 claims 1
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- 239000004584 polyacrylic acid Substances 0.000 claims 1
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- 210000001236 prokaryotic cell Anatomy 0.000 claims 1
- 230000000699 topical effect Effects 0.000 claims 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 claims 1
Classifications
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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
- C07K14/52—Cytokines; Lymphokines; Interferons
- C07K14/54—Interleukins [IL]
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- 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
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/20—Interleukins [IL]
-
- A—HUMAN NECESSITIES
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- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- 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
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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Claims (46)
1. Fuzijski protein Fc IL-22 koji se veže na receptor IL-22, naznačen time, da navedeni fuzijski protein Fc IL-22 obuhvaća polipeptid IL-22 povezan na Fc područje preko poveznice, pri čemu Fc područje obuhvaća zglobno područje, IgG domenu CH2 i IgG domenu CH3, gdje fuzijski protein Fc IL-22 sadrži aminokiselinsku sekvencu koja ima najmanje 95% identiteta sekvence prema aminokiselinskoj sekvenci odabranoj iz skupine koja se sastoji od SEQ ID NO:8 i SEQ ID NO:10, dok se ostatak N297 mijenja u Gly ili Ala i pritom se Fc područje ne glikozilira.
2. Fuzijski protein Fc IL-22 prema zahtjevu 1, naznačen time, da aminokiselinska sekvenca ima najmanje 96%, najmanje 97%, najmanje 98%, ili najmanje 99% identiteta sekvence prema aminokiselinskoj sekvenci odabranoj iz skupine koju čine SEQ ID NO:8 i SEQ ID NO:10.
3. Fuzijski protein Fc IL-22 prema zahtjevu 1 ili 2, naznačen time, da poveznica obuhvaća aminokiselinsku sekvencu SKYGPP (SEQ ID NO:43) ili RVESKYGPP (SEQ ID NO:44).
4. Fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 3, naznačen time, da fuzijski protein Fc IL-22 sadrži aminokiselinsku sekvencu od SEQ ID NO:8.
5. Fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 3, naznačen time, da fuzijski protein Fc IL-22 sadrži aminokiselinsku sekvencu od SEQ ID NO:10.
6. Fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 3, naznačen time, da se fuzijski protein Fc IL-22 sastoji od aminokiselinske sekvence od SEQ ID NO:8 ili SEQ ID NO:10.
7. Fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 6, naznačen time, da se fuzijski protein Fc IL-22 proizvodi putem postupka koji obuhvaća korak kultiviranja stanice domaćina koja može izražavati fuzijski protein Fc IL-22, pod uvjetima koji su prikladni za ekspresiju fuzijskog proteina Fc IL-22, pri čemu stanica domaćina sadrži vektor koji obuhvaća nukleinsku kiselinu koja kodira fuzijski protein Fc IL-22, dok, prema potrebi, postupak nadalje obuhvaća korak dobivanja fuzijskog proteina Fc IL-22 iz stanične kulture ili iz medija za kultiviranje.
8. Fuzijski protein Fc IL-22 prema zahtjevu 7, naznačen time, da stanica domaćina je CHO-stanica.
9. Fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 8, naznačen time, da fuzijski protein Fc IL-22 je dimerni fuzijski protein Fc IL-22 ili monomerni fuzijski protein Fc IL-22.
10. Fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 9, naznačen time, da polipeptid IL-22 obuhvaća aminokiselinsku sekvencu od SEQ ID NO:4.
11. Izolirana nukleinska kiselina, naznačena time, da ona kodira fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 10.
12. Izolirana nukleinska kiselina prema zahtjevu 11, naznačena time, da nukleinska kiselina koja kodira fuzijski protein Fc IL-22, obuhvaća ili se sastoji od aminokiselinske sekvence od SEQ ID NO:8 ili SEQ ID NO:10.
13. Izolirana nukleinska kiselina prema zahtjevu 11 ili 12, naznačena time, da ona obuhvaća ili se sastoji od aminokiselinske sekvence od SEQ ID NO:7 ili SEQ ID NO:9.
14. Vektor, naznačen time, da obuhvaća nukleinsku kiselinu prema bilo kojem od zahtjeva 11 do 13.
15. Stanica domaćina, naznačena time, da obuhvaća vektor prema zahtjevu 14.
16. Stanica domaćina prema zahtjevu 15, naznačena time, da stanica domaćina je prokariotska stanica ili eukariotska stanica, ili je stanica E.coli ili je CHO-stanica.
17. Postupak proizvodnje fuzijskog proteina Fc IL-22, naznačen time, da obuhvaća korak kultiviranja stanice domaćina prema zahtjevu 15 ili 16, pod uvjetima koji su prikladni za ekspresiju fuzijskog proteina Fc IL-22.
18. Postupak prema zahtjevu 17, naznačen time, da dodatno obuhvaća korak dobivanja fuzijskog proteina Fc IL-22 iz stanične kulture ili iz medija za kultiviranje.
19. Postupak prema zahtjevu 17 ili 18, naznačen time, da se kod stanice domaćina radi o stanici E.coli.
20. Postupak prema zahtjevu 17 ili 18, naznačen time, da se kod stanice domaćina radi o CHO-stanici.
21. Farmaceutski pripravak, naznačen time, da obuhvaća terapeutski učinkovitu količinu fuzijskog proteina Fc IL-22 prema bilo kojem od zahtjeva 1 do 10, i najmanje jedan farmaceutski prikladan nosač.
22. Farmaceutski pripravak prema zahtjevu 21, naznačen time, da fuzijski protein Fc IL-22 obuhvaća ili se sastoji od aminokiselinske sekvence od SEQ ID NO:8 ili SEQ ID NO:10.
23. Farmaceutski pripravak prema bilo kojem od zahtjeva 21 do 22, naznačen time, da se fuzijski protein Fc IL-22 proizvodi u CHO-stanici.
24. Farmaceutski pripravak prema bilo kojem od zahtjeva 21 do 23, naznačen time, da nadalje obuhvaća dodatno terapeutsko sredstvo.
25. Farmaceutski pripravak prema zahtjevu 21, naznačen time, da se kod farmaceutski prikladnog nosača radi o želatinoznom sredstvu.
26. Farmaceutski pripravak prema zahtjevu 25, naznačen time, da želatinozno sredstvo je (i) polisaharid, (ii) celulozno sredstvo, (iii) metilceluloza, hidroksietilceluloza, karboksimetilceluloza, hidroksipropilceluloza, POE-POP blok polimeri, alginat, hijaluronska kiselina, poliakrilna kiselina, hidroksietilmetilceluloza ili hidroksipropilmetilceluloza, ili (iv) hidroksipropilmetilceluloza.
27. Farmaceutski pripravak prema bilo kojem od zahtjeva 25 do 26, naznačen time, da farmaceutski pripravak služi za topikalnu primjenu.
28. Farmaceutski pripravak koji obuhvaća fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 10, ili farmaceutski pripravak prema bilo kojem od zahtjeva 21 do 24, naznačen time, da se upotrebljava u postupku:
(a) liječenja upalne bolesti crijeva (IBD) kod pojedinca kojemu je to potrebno;
(b) inhibicije mikrobne zaraze u crijevima, očuvanja vrčastih stanica u crijevima za vrijeme mikrobne zaraze, ojačavanja integriteta epitelnih stanica, proliferacije epitelnih stanica, diferencijacije epitelnih stanica, migracije epitelnih stanica ili zacijeljivanja epitelnih rana u crijevima, kod pojedinca kojemu je to potrebno;
(c) liječenja akutne ozljede bubrega ili akutnog pankreatitisa kod pojedinca kojemu je to potrebno;
(d) prevencije ili liječenja kardiovaskularnih stanja, pri čemu ta stanja uključuju patologiju ateroskleroznih tvorbi plaka, kod pojedinca kojemu je to potrebno;
(e) liječenja metaboličkog sindroma kod pojedinca kojemu je to potrebno; ili
(f) liječenja akutne endotoksemije, sepse ili oboje, kod pojedinca kojemu je to potrebno.
29. Farmaceutski pripravak za uporabu prema zahtjevu 28(a), naznačen time, da IBD je ulcerativni kolitis ili Crohnova bolest.
30. Farmaceutski pripravak za uporabu prema zahtjevu 28(b), naznačen time, da epitelna stanica je crijevna epitelna stanica.
31. Farmaceutski pripravak za uporabu prema zahtjevu 28(d), naznačen time, da (i) kardiovaskularno stanje je odabrano iz skupine koju čine koronarna arterijska bolest, koronarna mikrovaskularna bolest, moždani udar, bolest karotidne arterije, periferna arterijska bolest, te kronična bubrežna bolest; (ii) nadalje obuhvaća usporavanje progresije ateroskleroznih tvorbi plaka ili sprečavanje prvih znakova ateroskleroze, pri čemu, opcijski, prvi znakovi ateroskleroze uključuju akumulaciju plaka ili vaskularnu upalu; ili (iii) pri čemu je pojedinac prepoznat kao pacijent s rizikom za razvoj kardiovaskularnog oboljenja.
32. Farmaceutski pripravak za uporabu prema zahtjevu 28(e), naznačen time, da dodatno obuhvaća smanjenje jednog ili više faktora rizika povezanih s metaboličkim sindromom, uključujući jedno ili više od sljedećih stanja: abdominalna pretilost, hiperglikemija, dislipidemija, i hipertenzija.
33. Farmaceutski pripravak za uporabu prema zahtjevu 28(e) ili 32, naznačen time, da dodatno obuhvaća smanjenje razine bakterijskih lipopolisaharida (LPS) kod pojedinca.
34. Farmaceutski pripravak za uporabu prema zahtjevu 28(e) ili (f), 32 ili 33, naznačen time, da pojedincu treba promjena lipidnog profila u HDL/LDL.
35. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 28 do 34, naznačen time, da farmaceutski pripravak obuhvaća fuzijski protein Fc IL-22 koji obuhvaća ili se sastoji od aminokiselinske sekvence od SEQ ID NO:8 ili SEQ ID NO:10.
36. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 28 do 35, naznačen time, da se on pojedincu daje zajedno s primjenom najmanje jednog dodatnog terapeutskog sredstva.
37. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 28 do 36, naznačen time, da se farmaceutski pripravak primjenjuje intravenozno, subkutano ili intraperitonealno.
38. Farmaceutski pripravak koji obuhvaća fuzijski protein Fc IL-22 prema bilo kojem od zahtjeva 1 do 10, ili farmaceutski pripravak prema bilo kojem od zahtjeva 21 do 27, naznačen time, da se upotrebljava u postupku ubrzavanja ili poboljšavanja zacijeljivanja rana kod pojedinca.
39. Farmaceutski pripravak za uporabu prema zahtjevu 38, naznačen time, da se kod rane radi o kroničnoj rani ili inficiranoj rani.
40. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 38 do 39, naznačen time, da se kod pojedinca radi o dijabetičaru, gdje opcijski, dijabetičar ima dijabetes tipa II.
41. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 38 do 40, naznačen time, da se kod rane radi o dijabetičkoj otvorenoj rani stopala.
42. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 38 do 41, naznačen time, da se farmaceutski pripravak primjenjuje sve dok se rana potpuno ne zatvori.
43. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 38 do 42, naznačen time, da fuzijski protein Fc IL-22 obuhvaća ili se sastoji od aminokiselinske sekvence odabrane iz skupine koju čine SEQ ID NO:8 ili SEQ ID NO:10.
44. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 38 do 43, naznačen time, da se on pojedincu daje zajedno s najmanje jednim dodatnim terapeutskim sredstvom za ubrzanje ili poboljšanje zacijeljivanja rana.
45. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 38 do 44, naznačen time, da se farmaceutski pripravak primjenjuje intravenozno, subkutano, intraperitonealno ili topikalno.
46. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 28 do 45, naznačen time, da se kod pojedinca radi o čovjeku.
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