HRP20200503T1 - Fuzijski proteini - Google Patents
Fuzijski proteini Download PDFInfo
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- HRP20200503T1 HRP20200503T1 HRP20200503TT HRP20200503T HRP20200503T1 HR P20200503 T1 HRP20200503 T1 HR P20200503T1 HR P20200503T T HRP20200503T T HR P20200503TT HR P20200503 T HRP20200503 T HR P20200503T HR P20200503 T1 HRP20200503 T1 HR P20200503T1
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- fusion protein
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- amino acid
- insulin
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- 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
- A61K38/28—Insulins
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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
- C07K14/575—Hormones
- C07K14/62—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
-
- 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
- A61K38/26—Glucagons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
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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
-
- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Endocrinology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Toxicology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Peptides Or Proteins (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Crystals, And After-Treatments Of Crystals (AREA)
Claims (23)
1. Fuzijski protein, naznačen time što sadrži:
a) agonist inzulinskog receptora koji ima opću formulu Z1-Z2-Z3, gdje:
i) Z1 je analog inzulinskog lanca B, koji ima aminokiselinski slijed:
X1X2X3QHLCGSHLVEALX4LVCGERGFX5YX6X7X8X9
gdje je X1 F, Q ili A; X2 je V ili G; X3 je N, K, D, G, Q, A ili E; X4 je E, Y, Q, ili H; X5 je H ili F; X6 je G, T, S, H, V ili je odsutan; X7 je G, E, P, K, D, S, H ili je odsutan; X8 je G, E, K, P, Q, D, H ili je odsutan; X9 je G, T, S, E, K, A ili je odsutan, uz uvjet da analog inzulinskog lanca B sadrži najmanje jednu modifikaciju u odnosu na aminokiselinski slijed lanca B molekule ljudskog inzulina na X4, X5, X6, X7, X8 ili X9 (SEQ ID NO:1);
ii) Z2 je prva peptidna spojnica, koja ima 5 do 10 aminokiselina, gdje su najmanje 5 navedenih aminokiselina ostaci G; i
iii) Z3 je analog inzulinskog lanca A, koji ima aminokiselinski slijed:
GIVEQCCTSX1CSLX2QLENYCX3X4
gdje je X1 T ili I; X2 je D, Y, Q ili E; X3 je G, N, S ili A; i X4 je bilo koja prirodna aminokiselina, ili je odsutan, uz uvjet da ako je X3 N, X4 mora biti aminokiselina koja nije G ili N (SEQ ID NO:2);
b) druga peptidna spojnica ima između 10 i 25 aminokiselina, gdje su najmanje 50% navedenih aminokiselina ostaci G; i
c) Fc područje ljudskog IgG;
gdje je C-terminalni ostatak agonista inzulinskog receptora izravno fuzioniran s N-terminalnim ostatkom druge peptidne spojnice, a C-terminalni ostatak druge peptidne spojnice je izravno fuzioniran s N-terminalnim ostatkom Fc područja ljudskog IgG.
2. Fuzijski protein u skladu s patentnim zahtjevom 1, naznačen time:
analog inzulinskog lanca B sadrži najmanje jednu modifikaciju u odnosu na aminokiselinski slijed ljudskog inzulinskog lanca B na X4 ili X5 u SEQ ID NO:1; i
analog inzulinskog lanca A sadrži najmanje jednu modifikaciju u odnosu na aminokiselinski slijed ljudskog inzulinskog lanca A na X1 ili X2 u SEQ ID NO:2.
3. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1 ili 2, naznačen time što:
analog inzulinskog lanca B ima slijed SEQ ID NO:1, gdje: X1 je F; X2 je V; X3 je N ili D; X4 je E; X5 je H; i
analog inzulinskog lanca A ima slijed SEQ ID NO:2, gdje: X1 je I ili T; X2 je D; X3 je G; i X4 je odsutan.
4. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačen time što analog inzulinskog lanca B ima slijed SEQ ID NO:1, gdje je svaki od X6-X9 G.
5. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-4, naznačen time što prva peptidna spojnica ima sljedeći aminokiselinski slijed:
X1GX2GGGG
gdje je X1 G ili je odsutan; i X2 je G, S ili je odsutan (SEQ ID NO:3).
6. Fuzijski protein u skladu s patentnim zahtjevom 5, naznačen time što su X1 i X2 u SEQ ID NO:3 G odnosno S.
7. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-6, naznačen time što agonist inzulinskog receptora ima sljedeći aminokiselinski slijed:
FVNQHLCGSHLVEALELVCGERGFHYGGGGGGSGGGGGIVEQCCTSTCSLDQLENYCG (SEQ ID NO:5).
8. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-7, naznačen time što druga peptidna spojnica sadrži peptid koji ima slijed [GGGGX]n
gdje je X Q, E ili S; i gdje je n 2-5.
9. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-8, naznačen time što druga peptidna spojnica ima sljedeći aminokiselinski slijed:
GGGGX1GGGGX2GGGGX3GGGGX4X5X6
X1 je Q ili E
X2 je Q ili E
X3 je Q ili E
X4 je G, E, Q ili je odsutan
X5 je G ili odsutan; i
X6 je G ili je odsutan
(SEQ ID NO:6).
10. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-9, naznačen time što druga peptidna spojnica ima sljedeći aminokiselinski slijed:
GGGGQGGGGQGGGGQGGGGG (SEQ ID NO:7).
11. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-10, naznačen time što je Fc područje ljudskog IgG Fc područje u IgG1, IgG2 ili IgG4.
12. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-11, naznačen time što Fc područje ljudskog IgG sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO:8, SEQ ID NO:9 i SEQ ID NO:10.
13. Fuzijski protein, naznačen time što ima aminokiselinski slijed SEQ ID NO:12.
14. Homodimer, naznačen time što je homodimer dva fuzijska proteina u skladu s bilo kojim od patentnih zahtjeva 1-13.
15. Farmaceutski pripravak, naznačen time što sadrži bilo fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-13 ili homodimer u skladu s patentnim zahtjevom 14, te najmanje jednu pomoćnu tvar.
16. Farmaceutski pripravak u skladu s patentnim zahtjevom 15, naznačen time što dodatno sadrži citrat, limunsku kiselinu, polisorbat 80, te manitol.
17. Farmaceutski pripravak u skladu s patentnim zahtjevom 15 ili patentnim zahtjevom 16, naznačen time što se pH kreće od otprilike 6,0 do otprilike 6,75.
18. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 15 do 17, naznačen time što dodatno sadrži dulaglutid.
19. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačen time što je namijenjen upotrebi u terapiji.
20. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačen time što je namijenjen upotrebi u liječenju dijabetesa melitusa.
21. Fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-13, naznačen time što je namijenjen upotrebi u istodobnoj, odvojenoj ili uzastopnoj kombinaciji s dulaglutidom, kod liječenja dijabetesa melitusa.
22. Homodimer u skladu s patentnim zahtjevom 14, naznačen time što je namijenjen upotrebi u istodobnoj, odvojenoj ili uzastopnoj kombinaciji s dulaglutidom, kod liječenja dijabetesa melitusa.
23. Polinukleotid, naznačen time što kodira fuzijski protein u skladu s bilo kojim od patentnih zahtjeva 1-13.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562158079P | 2015-05-07 | 2015-05-07 | |
| EP16721605.0A EP3292141B1 (en) | 2015-05-07 | 2016-04-28 | Fusion proteins |
| PCT/US2016/029807 WO2016178905A1 (en) | 2015-05-07 | 2016-04-28 | Fusion proteins |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200503T1 true HRP20200503T1 (hr) | 2020-06-26 |
Family
ID=55953435
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200503TT HRP20200503T1 (hr) | 2015-05-07 | 2016-04-28 | Fuzijski proteini |
Country Status (41)
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