HRP20221531T1 - Pripravci faktora viii i postupci dobivanja i korištenja istih - Google Patents
Pripravci faktora viii i postupci dobivanja i korištenja istih Download PDFInfo
- Publication number
- HRP20221531T1 HRP20221531T1 HRP20221531TT HRP20221531T HRP20221531T1 HR P20221531 T1 HRP20221531 T1 HR P20221531T1 HR P20221531T T HRP20221531T T HR P20221531TT HR P20221531 T HRP20221531 T HR P20221531T HR P20221531 T1 HRP20221531 T1 HR P20221531T1
- Authority
- HR
- Croatia
- Prior art keywords
- fusion protein
- amino acids
- seq
- xten
- fviii
- Prior art date
Links
- 229960000301 factor viii Drugs 0.000 title claims 21
- 238000000034 method Methods 0.000 title claims 3
- 239000000203 mixture Substances 0.000 title 1
- 108010054218 Factor VIII Proteins 0.000 claims 21
- 102000001690 Factor VIII Human genes 0.000 claims 21
- 150000001413 amino acids Chemical class 0.000 claims 16
- 108020001507 fusion proteins Proteins 0.000 claims 15
- 102000037865 fusion proteins Human genes 0.000 claims 15
- 229920001184 polypeptide Polymers 0.000 claims 7
- 102000004196 processed proteins & peptides Human genes 0.000 claims 7
- 108090000765 processed proteins & peptides Proteins 0.000 claims 7
- 210000004027 cell Anatomy 0.000 claims 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims 5
- 125000003275 alpha amino acid group Chemical group 0.000 claims 4
- 239000013598 vector Substances 0.000 claims 4
- 239000013604 expression vector Substances 0.000 claims 3
- 102000039446 nucleic acids Human genes 0.000 claims 3
- 108020004707 nucleic acids Proteins 0.000 claims 3
- 150000007523 nucleic acids Chemical class 0.000 claims 3
- 102000002110 C2 domains Human genes 0.000 claims 1
- 108050009459 C2 domains Proteins 0.000 claims 1
- 102100026735 Coagulation factor VIII Human genes 0.000 claims 1
- 206010053567 Coagulopathies Diseases 0.000 claims 1
- 201000003542 Factor VIII deficiency Diseases 0.000 claims 1
- 108700028146 Genetic Enhancer Elements Proteins 0.000 claims 1
- 108700007698 Genetic Terminator Regions Proteins 0.000 claims 1
- 208000009292 Hemophilia A Diseases 0.000 claims 1
- 208000032843 Hemorrhage Diseases 0.000 claims 1
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 claims 1
- 208000034158 bleeding Diseases 0.000 claims 1
- 230000000740 bleeding effect Effects 0.000 claims 1
- 208000015294 blood coagulation disease Diseases 0.000 claims 1
- 210000004899 c-terminal region Anatomy 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000003623 enhancer Substances 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 239000013612 plasmid Substances 0.000 claims 1
- 230000002947 procoagulating effect Effects 0.000 claims 1
- 230000003362 replicative effect Effects 0.000 claims 1
- 241000701447 unidentified baculovirus Species 0.000 claims 1
- 230000003612 virological effect Effects 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
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
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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
-
- 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
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Hematology (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Gastroenterology & Hepatology (AREA)
- Genetics & Genomics (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Toxicology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Animal Behavior & Ethology (AREA)
- Diabetes (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
Claims (18)
1. Fuzijski protein rekombinantnog faktora VIII (FVIII) koji ima prokoagulantnu aktivnost, koji sadrži polipeptid FVIII kondenziran na najmanje jedan prošireni rekombinantni polipeptid (XTEN), pri čemu polipeptid FVIII sadrži domenu A1 koja sadrži aminokiseline 1-372 iz SEQ ID NO: 1592, A2 domenu koja sadrži aminokiseline 373-740 iz SEQ ID NO: 1592, dio B domene, A3 domenu koja sadrži aminokiseline 1649-2019 iz SEQ ID NO: 1592, C1 domenu koja sadrži aminokiseline 2020-2172 iz SEQ ID NO: 1592, i C2 domenu koja sadrži aminokiseline 2173-2332 iz SEQ ID NO: 1592, pri čemu je najmanje jedan XTEN umetnut u polipeptid FVIII na mjesto koje odgovara aminokiselini 745 sekvence navedene u SEQ ID NO: 1592, i pri čemu rekombinantni FVIII fuzijski protein pokazuje produljeni terminalni poluživot kada se daje subjektu u usporedbi s odgovarajućim FVIII proteinom kojem nedostaje najmanje jedan XTEN.
2. Rekombinantni FVIII fuzijski protein prema zahtjevu 1, naznačen time što je najmanje jedan XTEN umetnut u FVIII polipeptid na mjesto koje odgovara C-terminalnoj strani aminokiseline 745 sekvence navedene u SEQ ID NO: 1592.
3. Rekombinantni FVIII fuzijski protein prema zahtjevu 1 ili 2, naznačen time što rekombinantni FVIII fuzijski protein sadrži jedan, dva, tri, četiri, pet ili šest XTEN-ova, po mogućnosti pri čemu XTEN ima duljinu između 36 aminokiselina i 1000 aminokiselina ili sadrži najmanje 42 aminokiseline, najmanje 72 aminokiseline, najmanje 96 aminokiselina, najmanje 144 aminokiseline ili najmanje 288 aminokiselina.
4. Rekombinantni FVIII fuzijski protein prema bilo kojem od zahtjeva 1 do 3, naznačen time što XTEN sadrži jedan ili više motiva sekvence XTEN, pri čemu motivi sekvence XTEN sadrže jednu ili više sekvenci aminokiselina kako je navedeno u SEQ ID NOs: 23, 24, 25, ili 26.
5. Rekombinantni FVIII fuzijski protein prema bilo kojem od zahtjeva 1 do 4, naznačen time što XTEN sadrži aminokiselinsku sekvencu koja je najmanje 90% ili 100% identična aminokiselinskoj sekvenci kako je navedeno u SEQ ID NOs: 50, 51, 52, 67, ili 78.
6. Rekombinantni FVIII fuzijski protein prema zahtjevu 5, naznačen time što XTEN sadrži aminokiselinsku sekvencu kako je navedeno u SEQ ID NO: 78.
7. Rekombinantni FVIII fuzijski protein prema bilo kojem od zahtjeva 1 do 6, naznačen time što je FVIII polipeptid jednolančani FVIII polipeptid.
8. Rekombinantni FVIII fuzijski protein prema bilo kojem od zahtjeva 1 do 7, naznačen time što dijelu B domene nedostaju aminokiseline koje odgovaraju aminokiselinama 747-1638 sekvence navedene u SEQ ID NO: 1592.
9. Izolirana nukleinska kiselina koja kodira rekombinantni FVIII fuzijski protein prema bilo kojem od zahtjeva 1 do 8.
10. Ekspresijski vektor koji sadrži izoliranu nukleinsku kiselinu prema zahtjevu 9, izborno pri čemu je vektor plazmid, kozmid, virusna čestica, fag, adenovirusni vektor, bakulovirusni vektor ili autonomno replicirajući vektor.
11. Ekspresijski vektor prema zahtjevu 10, naznačen time što je nukleinska kiselina operativno povezana s promotorom, vodećom sekvencom, terminatorom ili pojačivačem.
12. Stanica domaćin naznačena time što sadrži ekspresijski vektor prema zahtjevu 10 ili 11.
13. Stanica domaćin prema zahtjevu 12, naznačena time što je stanica domaćin HEK293 stanica.
14. Postupak za dobivanje rekombinantnog FVIII fuzijskog proteina, naznačen time što postupak obuhvaća uzgoj stanice domaćina prema zahtjevu 12 ili 13 u mediju pod uvjetima prikladnim za dobivanje fuzijskog proteina i ponovno dobivanje fuzijskog proteina.
15. Farmaceutski pripravak naznačen time što sadrži rekombinantni FVIII fuzijski protein prema bilo kojem od zahtjeva 1 do 8 i farmaceutski prihvatljiv nosač.
16. Farmaceutski pripravak prema zahtjevu 15 naznačen time što je za upotrebu u liječenju koagulopatije, po izboru pri čemu se farmaceutski pripravak daje supkutano, intravenski ili intramuskularno.
17. Farmaceutski pripravak prema zahtjevu 15 naznačen time što se koristi u liječenju epizode krvarenja.
18. Farmaceutski pripravak prema zahtjevu 15 naznačen time što se koristi u liječenju hemofilije A.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261599400P | 2012-02-15 | 2012-02-15 | |
EP19165518.2A EP3564260B1 (en) | 2012-02-15 | 2012-07-11 | Factor viii compositions and methods of making and using same |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20221531T1 true HRP20221531T1 (hr) | 2023-02-17 |
Family
ID=48984579
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20221531TT HRP20221531T1 (hr) | 2012-02-15 | 2012-07-11 | Pripravci faktora viii i postupci dobivanja i korištenja istih |
HRP20192314TT HRP20192314T1 (hr) | 2012-02-15 | 2019-12-23 | Pripravci faktora viii i postupci pripreme i njihove uporabe |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20192314TT HRP20192314T1 (hr) | 2012-02-15 | 2019-12-23 | Pripravci faktora viii i postupci pripreme i njihove uporabe |
Country Status (29)
Country | Link |
---|---|
US (3) | US10421798B2 (hr) |
EP (3) | EP4194465A1 (hr) |
JP (6) | JP6256882B2 (hr) |
KR (1) | KR102097263B1 (hr) |
CN (3) | CN111574632A (hr) |
AU (3) | AU2012327217B2 (hr) |
BR (1) | BR112014020694A2 (hr) |
CA (1) | CA2864904C (hr) |
CL (2) | CL2014002166A1 (hr) |
CO (1) | CO7051009A2 (hr) |
CY (1) | CY1122800T1 (hr) |
DK (2) | DK3564260T3 (hr) |
EA (1) | EA201491470A1 (hr) |
ES (2) | ES2771208T3 (hr) |
FI (1) | FI3564260T3 (hr) |
HK (1) | HK1204330A1 (hr) |
HR (2) | HRP20221531T1 (hr) |
HU (2) | HUE046848T2 (hr) |
IL (1) | IL234108B (hr) |
LT (2) | LT2814840T (hr) |
MX (2) | MX369862B (hr) |
MY (1) | MY188897A (hr) |
PH (2) | PH12014501849B1 (hr) |
PL (2) | PL3564260T3 (hr) |
PT (2) | PT3564260T (hr) |
RS (2) | RS63870B1 (hr) |
SG (2) | SG11201404885RA (hr) |
SI (2) | SI2814840T1 (hr) |
WO (1) | WO2013122617A1 (hr) |
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BR112014017165B1 (pt) | 2012-01-12 | 2023-05-02 | Bioverativ Therapeutics Inc | Proteína quimérica compreendendo uma proteína de fator viii, composição farmacêutica, e seus usos |
ES2771208T3 (es) | 2012-02-15 | 2020-07-06 | Bioverativ Therapeutics Inc | Composiciones de factor VIII y métodos de preparación y uso de las mismas |
EP3549953A1 (en) | 2012-02-15 | 2019-10-09 | Bioverativ Therapeutics Inc. | Recombinant factor viii proteins |
MX366864B (es) | 2012-02-27 | 2019-07-26 | Amunix Operating Inc | Composiciones de conjugados de xten y métodos para realizarlas. |
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