HRP20191020T1 - Produljeni rekombinantni polipeptidi i sastavi koji ih sadrže - Google Patents
Produljeni rekombinantni polipeptidi i sastavi koji ih sadrže Download PDFInfo
- Publication number
- HRP20191020T1 HRP20191020T1 HRP20191020TT HRP20191020T HRP20191020T1 HR P20191020 T1 HRP20191020 T1 HR P20191020T1 HR P20191020T T HRP20191020T T HR P20191020TT HR P20191020 T HRP20191020 T HR P20191020T HR P20191020 T1 HRP20191020 T1 HR P20191020T1
- Authority
- HR
- Croatia
- Prior art keywords
- seq
- fusion protein
- sequence
- xten
- biologically active
- Prior art date
Links
- 108090000765 processed proteins & peptides Proteins 0.000 title claims 4
- 229920001184 polypeptide Polymers 0.000 title claims 2
- 102000004196 processed proteins & peptides Human genes 0.000 title claims 2
- 239000000203 mixture Substances 0.000 title 1
- 108020001507 fusion proteins Proteins 0.000 claims 14
- 102000037865 fusion proteins Human genes 0.000 claims 14
- 102000004169 proteins and genes Human genes 0.000 claims 11
- 108090000623 proteins and genes Proteins 0.000 claims 11
- 102000040430 polynucleotide Human genes 0.000 claims 5
- 108091033319 polynucleotide Proteins 0.000 claims 5
- 239000002157 polynucleotide Substances 0.000 claims 3
- 108010039209 Blood Coagulation Factors Proteins 0.000 claims 2
- 102000015081 Blood Coagulation Factors Human genes 0.000 claims 2
- 125000000539 amino acid group Chemical group 0.000 claims 2
- 150000001413 amino acids Chemical group 0.000 claims 2
- 239000003114 blood coagulation factor Substances 0.000 claims 2
- 239000013604 expression vector Substances 0.000 claims 2
- 230000002503 metabolic effect Effects 0.000 claims 2
- 239000000692 natriuretic peptide Substances 0.000 claims 2
- 102000012421 C-Type Natriuretic Peptide Human genes 0.000 claims 1
- 101800000060 C-type natriuretic peptide Proteins 0.000 claims 1
- 102100022641 Coagulation factor IX Human genes 0.000 claims 1
- 102100023804 Coagulation factor VII Human genes 0.000 claims 1
- 241000588724 Escherichia coli Species 0.000 claims 1
- 108010011459 Exenatide Proteins 0.000 claims 1
- 108010076282 Factor IX Proteins 0.000 claims 1
- 108010023321 Factor VII Proteins 0.000 claims 1
- 108010054265 Factor VIIa Proteins 0.000 claims 1
- 102000003974 Fibroblast growth factor 2 Human genes 0.000 claims 1
- 108090000379 Fibroblast growth factor 2 Proteins 0.000 claims 1
- 101710198884 GATA-type zinc finger protein 1 Proteins 0.000 claims 1
- 102400000321 Glucagon Human genes 0.000 claims 1
- 108060003199 Glucagon Proteins 0.000 claims 1
- DTHNMHAUYICORS-KTKZVXAJSA-N Glucagon-like peptide 1 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 DTHNMHAUYICORS-KTKZVXAJSA-N 0.000 claims 1
- 102400000326 Glucagon-like peptide 2 Human genes 0.000 claims 1
- 101800000221 Glucagon-like peptide 2 Proteins 0.000 claims 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 1
- 101001076407 Homo sapiens Interleukin-1 receptor antagonist protein Proteins 0.000 claims 1
- 102100040918 Pro-glucagon Human genes 0.000 claims 1
- 108060008683 Tumor Necrosis Factor Receptor Proteins 0.000 claims 1
- 230000004071 biological effect Effects 0.000 claims 1
- 230000036765 blood level Effects 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- JUFFVKRROAPVBI-PVOYSMBESA-N chembl1210015 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(=O)N[C@H]1[C@@H]([C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO[C@]3(O[C@@H](C[C@H](O)[C@H](O)CO)[C@H](NC(C)=O)[C@@H](O)C3)C(O)=O)O2)O)[C@@H](CO)O1)NC(C)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 JUFFVKRROAPVBI-PVOYSMBESA-N 0.000 claims 1
- 230000000052 comparative effect Effects 0.000 claims 1
- 230000000295 complement effect Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 229960001519 exenatide Drugs 0.000 claims 1
- 229960004222 factor ix Drugs 0.000 claims 1
- 229940012413 factor vii Drugs 0.000 claims 1
- 229940012414 factor viia Drugs 0.000 claims 1
- MASNOZXLGMXCHN-ZLPAWPGGSA-N glucagon Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C1=CC=CC=C1 MASNOZXLGMXCHN-ZLPAWPGGSA-N 0.000 claims 1
- 229960004666 glucagon Drugs 0.000 claims 1
- TWSALRJGPBVBQU-PKQQPRCHSA-N glucagon-like peptide 2 Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(O)=O)C(O)=O)[C@@H](C)CC)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)CC)C1=CC=CC=C1 TWSALRJGPBVBQU-PKQQPRCHSA-N 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000004962 physiological condition Effects 0.000 claims 1
- 230000003252 repetitive effect Effects 0.000 claims 1
- 102000003298 tumor necrosis factor receptor Human genes 0.000 claims 1
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
-
- 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
- C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
-
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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
- C07K14/001—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof by chemical synthesis
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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
-
- 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]
- C07K14/545—IL-1
-
- 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
- C07K14/605—Glucagons
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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
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- C07K14/575—Hormones
- C07K14/61—Growth hormone [GH], i.e. somatotropin
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- C—CHEMISTRY; METALLURGY
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Claims (16)
1. Izolirani produljeni rekombinantni polipeptid (XTEN), naznačen time, da
ne obuhvaća ponavljajuću sekvencu s više od 100 do 3000 aminokiselinskih ostataka, pri čemu se najmanje 95%, ili najmanje 96%, ili najmanje 97%, ili najmanje 98%, ili najmanje 99% do oko 100% sekvence sastoji od većeg broja jedinica s dva ili više nepreklapajućih motiva sekvence koji su odabrani od aminokiselinskih sekvenci iz Tablice 1, gdje se sekvenca od bilo koja dva neposredno dodirna aminokiselinska ostatka u bilo kojem od motiva, ne ponavlja više od dva puta u motivu sekvence.
2. XTEN prema zahtjevu 1, naznačen time, da su dva ili više motiva sekvence odabrana od AE-porodice motiva sekvenci SEQ ID NO: 186, SEQ ID NO: 187 i SEQ ID NO: 188 iz Tablice 1.
3. XTEN prema zahtjevu 1 ili zahtjevu 2, naznačen time, da XTEN ima najmanje 95%, ili najmanje 96%, ili najmanje 97%, ili najmanje 98%, ili najmanje 99% ili 100% identiteta sekvence prema sekvenci odabranoj iz Tablice 2.
4. XTEN prema zahtjevu 1 ili zahtjevu 2, naznačen time, da XTEN obuhvaća aminokiselinsku sekvencu odabranu od sljedećih brojeva sljedova SEQ ID NO: 204, 206, 210, 213, 217, 218 i 219.
5. Izolirani fuzijski protein, naznačen time, da obuhvaća izolirani XTEN u skladu s bilo kojim od prethodnih zahtjeva i jedan biološki aktivan protein, pri čemu je XTEN povezan s biološki aktivnim proteinom i pritom fuzijski protein zadržava barem dio biološkog aktiviteta odgovarajućeg biološki aktivnog proteina.
6. Izolirani fuzijski protein prema zahtjevu 5, naznačen time, da biološki aktivan protein je peptid koji regulira glukozu, metabolički protein ili jedan koagulacijski faktor.
7. Izolirani fuzijski protein prema zahtjevu 5 ili zahtjevu 6, naznačen time, da fuzijski protein ima terminalni poluživot koji je barem dva puta dulji kada se uspoređuje s biološki aktivnim proteinom koji nije povezan s XTEN-om.
8. Izolirani fuzijski protein prema jednom od zahtjeva 5 do 7, naznačen time, da fuzijski protein pokazuje očigledan faktor molekularne mase pod fiziološkim uvjetima, koji je veći od 6.
9. Izolirani fuzijski protein prema jednom od zahtjeva 5 do 8, naznačen time, da fuzijski protein zahtijeva doziranje s manjom učestalošću ili smanjenu usporedivu dozu, u svrhu postizanja ili održavanja cirkulacijske razine krvi kod pojedinca, u usporedbi prema biološki aktivnom proteinu koji nije povezan s XTEN-om, koja će se primjenjivati kod pojedinca na usporedbeni način.
10. Izolirani fuzijski protein prema jednom od zahtjeva 5 do 9, naznačen time, da biološki aktivan protein ima najmanje 95%, ili najmanje 96%, ili najmanje 97%, ili najmanje 98%, ili najmanje 99% ili 100% identiteta sekvence prema peptidu koji regulira glukozu, i odabran je iz skupine koja se sastoji od GLP-1 (SEQ ID NO: 20), GLP-2 (SEQ ID NO: 24), eksendin-4 (SEQ ID NO: 12), i glukagon (SEQ ID NO: 19).
11. Izolirani fuzijski protein prema jednom od zahtjeva 5 do 9, naznačen time, da biološki aktivan protein ima najmanje 95%, ili najmanje 96%, ili najmanje 97%, ili najmanje 98%, ili najmanje 99% ili 100% identiteta sekvence prema faktoru koagulacije odabranom iz skupine koja se sastoji od faktora IX (SEQ ID NO: 1735-1746), faktora VIIa, ili faktora VII (SEQ ID NO: 1747).
12. Izolirani fuzijski protein prema jednom od zahtjeva 5 do 9, naznačen time, da biološki aktivan protein ima najmanje 95%, ili najmanje 96%, ili najmanje 97%, ili najmanje 98%, ili najmanje 99% ili 100% identiteta sekvence prema sekvenci metaboličkog proteina odabranom iz skupine koja se sastoji od ljudskog IL-1ra (SEQ ID NO: 1723), α-natriuretičkog peptida (SEQ ID NO: 1729), β-natriuretičkog peptida (SEQ ID NO: 1730), natriuretičkog peptida tipa C (SEQ ID NO: 1732), fibroblastnog faktora rasta 2 (SEQ ID NO: 1733), i TNF-receptora (SEQ ID NO: 1734).
13. Farmaceutski sastav, naznačen time, da obuhvaća fuzijski protein prema bilo kojem od zahtjeva 5 do 12, i najmanje jedan farmaceutski prihvatljiv nosač.
14. Izolirana polinukleinska kiselina, naznačena time, da obuhvaća sekvencu polinukleotida odabranu od (a) jednog polinukleotida koji kodira XTEN prema zahtjevu 1 ili fuzijski protein prema bilo kojem od zahtjeva 5 do 12, ili (b) komplement polinukleotida iz (a).
15. Vektor ekspresije, naznačen time, da obuhvaća sekvencu polinukleinske kiseline u skladu sa zahtjevom 14.
16. E.coli stanica domaćina, naznačena time, da obuhvaća vektor ekspresije u skladu sa zahtjevom 15.
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EP16189957.0A EP3178835B1 (en) | 2009-02-03 | 2010-02-03 | Extended recombinant polypeptides and compositions comprising same |
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