DK2337849T3 - Faktor ix-polypeptidmutant, anvendelser deraf og fremgangsmåde til fremstiling deraf - Google Patents
Faktor ix-polypeptidmutant, anvendelser deraf og fremgangsmåde til fremstiling deraf Download PDFInfo
- Publication number
- DK2337849T3 DK2337849T3 DK09748260.8T DK09748260T DK2337849T3 DK 2337849 T3 DK2337849 T3 DK 2337849T3 DK 09748260 T DK09748260 T DK 09748260T DK 2337849 T3 DK2337849 T3 DK 2337849T3
- Authority
- DK
- Denmark
- Prior art keywords
- fix
- polypeptide
- glu
- seq
- val
- Prior art date
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- 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
- 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)
- C12N9/644—Coagulation factor IXa (3.4.21.22)
-
- 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)
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21022—Coagulation factor IXa (3.4.21.22)
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Medicinal Chemistry (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Biotechnology (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (9)
1. Modificeret FIX- (faktor IX) polypeptid til anvendelse i en medicinsk behandling i en daglig dosering på mellem 0,1 pg/kg og 400 pg/kg kropsvægt, hvilket modificeret FIX-polypeptid har mindst 70 % identitet med en SEQ ID NO: 1 eller SEQ ID NO: 2; hvor leucin er til stede ved en position svarende til position 338 af et umodificeret maturt FIX-polypeptid som identificeret ved SEQ ID NO: 2.
2. Polypeptid til anvendelse ifølge krav 1, hvor polypeptidet har mindst 90 % identitet med SEQ ID NO: 1 eller SEQ ID NO: 2.
3. Polypeptid til anvendelse ifølge et hvilket som helst af kravene 1-2, hvor behandling er ved oral, parenteral, rektal, inhalations- eller insufflationsadministration.
4. Polypeptid til anvendelse ifølge et hvilket som helst af kravene 1-3, hvor polypeptidet er beregnet til anvendelse i behandlingen af en medfødt eller erhvervet koagulopati, en medfødt eller erhvervet hæmatologisk sygdom, en hæmoragisk forstyrrelse eller en anden kardiovaskulær sygdom.
5. Polypeptid til anvendelse ifølge et hvilket som helst af de foregående krav ved behandling af hæmoragisk gastritis, uterusblødning eller hæmofili.
6. Polypeptid som defineret i et af kravene 1-3 til anvendelse i behandlingen af mindst én koagulopati.
7. Polypeptid til anvendelse ifølge et hvilket som helst af de foregående krav i behandling af hæmofili A eller hæmofili B.
8. Polypeptid til anvendelse ifølge et hvilket som helst af kravene 4 til 7, hvor polypeptidet er tilvejebragt i en farmaceutisk sammensætning, der omfatter polypeptidet og mindst én farmaceutisk acceptabel excipiens; hvilket modificeret FIX-polypeptid er til stede i den farmaceutiske sammensætning i en mængde, der er egnet til administration i en daglig dosering på mellem 0,1 pg/kg og 400 pg/kg kropsvægt.
9. Polypeptid til anvendelse ifølge krav 8, hvor den farmaceutiske sammensætning er formuleret til oral, parenteral, rektal, inhalations- eller insufflationsadministration.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITBO2008A000564A IT1394177B1 (it) | 2008-09-15 | 2008-09-15 | Polipeptide fattore ix modificato, sue utilizzazioni e metodo per la sua produzione |
ITBO2009A000275A IT1395980B1 (it) | 2009-05-06 | 2009-05-06 | Polipeptide fattore ix modificato, sue utilizzazioni e metodo per la sua produzione |
PCT/EP2009/061935 WO2010029178A1 (en) | 2008-09-15 | 2009-09-15 | Factor ix polypeptide mutant, its uses and a method for its production |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2337849T3 true DK2337849T3 (da) | 2018-10-01 |
Family
ID=41397565
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK19174517.3T DK3581650T3 (da) | 2008-09-15 | 2009-09-15 | Faktor ix polypeptidmutant, anvendelse deraf og en fremgangsmåde til fremstilling deraf |
DK09748260.8T DK2337849T3 (da) | 2008-09-15 | 2009-09-15 | Faktor ix-polypeptidmutant, anvendelser deraf og fremgangsmåde til fremstiling deraf |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK19174517.3T DK3581650T3 (da) | 2008-09-15 | 2009-09-15 | Faktor ix polypeptidmutant, anvendelse deraf og en fremgangsmåde til fremstilling deraf |
Country Status (17)
Country | Link |
---|---|
US (11) | US9249405B2 (da) |
EP (5) | EP2337849B1 (da) |
CA (1) | CA2737094C (da) |
CY (2) | CY1125885T1 (da) |
DK (2) | DK3581650T3 (da) |
ES (2) | ES2940323T3 (da) |
FI (2) | FI3581650T3 (da) |
FR (1) | FR23C1028I1 (da) |
HK (1) | HK1244507A1 (da) |
HR (2) | HRP20230259T1 (da) |
HU (2) | HUE061345T2 (da) |
LT (2) | LT3581650T (da) |
PL (2) | PL3581650T3 (da) |
PT (1) | PT3581650T (da) |
SI (1) | SI3581650T1 (da) |
TR (1) | TR201813067T4 (da) |
WO (1) | WO2010029178A1 (da) |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
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FI3581650T3 (fi) * | 2008-09-15 | 2023-03-23 | Uniqure Biopharma B V | IX-tekijän polypeptidimutantti, sen käyttöjä ja menetelmä sen valmistamiseksi |
TWI595004B (zh) | 2010-11-03 | 2017-08-11 | 介控生化科技公司 | 經修飾之第九因子多胜肽及其用途 |
IN2015DN01404A (da) | 2012-07-25 | 2015-07-03 | Catalyst Biosciences Inc | |
FI2956477T4 (fi) | 2013-02-15 | 2024-04-24 | Bioverativ Therapeutics Inc | Optimoitu tekijä viii:n geeni |
EP3160478A4 (en) | 2014-06-30 | 2018-05-16 | Bioverativ Therapeutics Inc. | Optimized factor ix gene |
GB201420139D0 (en) | 2014-11-12 | 2014-12-24 | Ucl Business Plc | Factor IX gene therapy |
EP3313991B1 (en) * | 2015-06-23 | 2024-07-17 | The Children's Hospital of Philadelphia | Modified factor ix, and compositions, methods and uses for gene transfer to cells, organs and tissues |
PL3411478T3 (pl) | 2016-02-01 | 2022-10-03 | Bioverativ Therapeutics Inc. | Geny zoptymalizowanego czynnika VIII |
SG11201811603WA (en) | 2016-07-26 | 2019-02-27 | Biomarin Pharm Inc | Novel adeno-associated virus capsid proteins |
CN106497949A (zh) * | 2016-10-14 | 2017-03-15 | 上海交通大学医学院附属瑞金医院 | 一种高活性凝血因子ix突变体、重组蛋白与融合蛋白的制备与应用 |
KR102386890B1 (ko) | 2017-05-22 | 2022-04-15 | 다케다 야쿠힌 고교 가부시키가이샤 | B형 혈우병 유전자 요법을 위한 증가된 발현을 가지는 재조합 fix 변이체를 암호화하는 바이러스 벡터 |
EA202090260A1 (ru) | 2017-07-10 | 2020-05-08 | ЮНИКЬЮРЕ АйПи Б.В. | Средства и способы для генотерапии aav у человека |
US11491212B1 (en) | 2017-09-27 | 2022-11-08 | Catalyst Biosciences, Inc. | Subcutaneous administration of modified factor IX polypeptides and treatment of hemophilia B |
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TW202005978A (zh) | 2018-05-14 | 2020-02-01 | 美商拜奧馬林製藥公司 | 新穎肝靶向腺相關病毒載體 |
KR20210008491A (ko) | 2018-05-14 | 2021-01-22 | 바이오마린 파머수티컬 인크. | 청소년 대상체에서 aav 벡터의 안정한 발현 |
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US10842885B2 (en) | 2018-08-20 | 2020-11-24 | Ucl Business Ltd | Factor IX encoding nucleotides |
UY38389A (es) * | 2018-09-27 | 2020-04-30 | Sigilon Therapeutics Inc | Dispositivos implantables para terapia celular y métodos relacionados |
WO2021154414A2 (en) | 2020-01-29 | 2021-08-05 | Catalyst Biosciences, Inc. | Gene therapy for hemophilia b with a chimeric aav capsid vector encoding modified factor ix polypeptides |
US20240293516A1 (en) * | 2021-07-01 | 2024-09-05 | CSL Behring Lengnau AG | Factor ix subcutaneous administration with enhanced safety |
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2009
- 2009-09-15 FI FIEP19174517.3T patent/FI3581650T3/fi active
- 2009-09-15 CA CA2737094A patent/CA2737094C/en active Active
- 2009-09-15 EP EP09748260.8A patent/EP2337849B1/en not_active Revoked
- 2009-09-15 EP EP21200005.3A patent/EP4032979B1/en active Active
- 2009-09-15 LT LTEP19174517.3T patent/LT3581650T/lt unknown
- 2009-09-15 EP EP19174517.3A patent/EP3581650B1/en active Active
- 2009-09-15 ES ES19174517T patent/ES2940323T3/es active Active
- 2009-09-15 EP EP22214327.3A patent/EP4219547A3/en active Pending
- 2009-09-15 EP EP17175191.0A patent/EP3252157A1/en not_active Ceased
- 2009-09-15 ES ES09748260.8T patent/ES2687038T3/es active Active
- 2009-09-15 HU HUE19174517A patent/HUE061345T2/hu unknown
- 2009-09-15 HR HRP20230259TT patent/HRP20230259T1/hr unknown
- 2009-09-15 PL PL19174517.3T patent/PL3581650T3/pl unknown
- 2009-09-15 DK DK19174517.3T patent/DK3581650T3/da active
- 2009-09-15 PT PT191745173T patent/PT3581650T/pt unknown
- 2009-09-15 TR TR2018/13067T patent/TR201813067T4/tr unknown
- 2009-09-15 DK DK09748260.8T patent/DK2337849T3/da active
- 2009-09-15 WO PCT/EP2009/061935 patent/WO2010029178A1/en active Application Filing
- 2009-09-15 PL PL09748260T patent/PL2337849T3/pl unknown
- 2009-09-15 SI SI200932179T patent/SI3581650T1/sl unknown
- 2009-09-15 US US13/063,898 patent/US9249405B2/en active Active
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2015
- 2015-12-29 US US14/981,981 patent/US20160122740A1/en not_active Abandoned
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2017
- 2017-07-14 US US15/650,070 patent/US9982248B2/en active Active
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2018
- 2018-03-21 HK HK18103924.5A patent/HK1244507A1/zh unknown
- 2018-05-25 US US15/989,665 patent/US10465180B2/en active Active
- 2018-09-10 HR HRP20181442TT patent/HRP20181442T1/hr unknown
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2019
- 2019-10-01 US US16/589,851 patent/US20200231958A1/en not_active Abandoned
- 2019-12-09 US US16/707,414 patent/US20200190498A1/en not_active Abandoned
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2020
- 2020-02-11 US US16/787,456 patent/US20200199564A1/en not_active Abandoned
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2021
- 2021-03-26 US US17/213,897 patent/US20210214704A1/en active Pending
- 2021-03-26 US US17/213,848 patent/US20210238573A1/en active Pending
- 2021-09-10 US US17/447,372 patent/US20220002702A1/en not_active Abandoned
- 2021-12-08 US US17/643,326 patent/US20220090042A1/en not_active Abandoned
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2023
- 2023-03-14 CY CY20231100138T patent/CY1125885T1/el unknown
- 2023-07-25 HU HUS2300024C patent/HUS2300024I1/hu unknown
- 2023-07-25 FI FIC20230026C patent/FIC20230026I1/fi unknown
- 2023-07-26 FR FR23C1028C patent/FR23C1028I1/fr active Active
- 2023-07-27 LT LTPA2023521C patent/LTPA2023521I1/lt unknown
- 2023-07-27 CY CY2023016C patent/CY2023016I2/el unknown
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