DK3645034T5 - 21-dages doseringsregimen for fusionsproteiner omfatten-defaktor ix og human albumin til profylaktisk behandling af hæmofili og fremgangsmåder heraf - Google Patents

21-dages doseringsregimen for fusionsproteiner omfatten-defaktor ix og human albumin til profylaktisk behandling af hæmofili og fremgangsmåder heraf Download PDF

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Publication number
DK3645034T5
DK3645034T5 DK18736860.0T DK18736860T DK3645034T5 DK 3645034 T5 DK3645034 T5 DK 3645034T5 DK 18736860 T DK18736860 T DK 18736860T DK 3645034 T5 DK3645034 T5 DK 3645034T5
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Denmark
Prior art keywords
defactor
hemophilia
prophylaxis
methods
fusion proteins
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DK18736860.0T
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Danish (da)
English (en)
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DK3645034T3 (da
Inventor
Yanyan Li
Debra Bensen-Kennedy
Iris Jacobs
Christine Voigt
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CSL Behring Lengnau AG
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/644Coagulation factor IXa (3.4.21.22)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21022Coagulation factor IXa (3.4.21.22)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/31Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
DK18736860.0T 2017-06-29 2018-06-29 21-dages doseringsregimen for fusionsproteiner omfatten-defaktor ix og human albumin til profylaktisk behandling af hæmofili og fremgangsmåder heraf DK3645034T5 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762526377P 2017-06-29 2017-06-29
PCT/EP2018/067523 WO2019002532A1 (en) 2017-06-29 2018-06-29 21-DAY FUSION PROTEIN DRAFTING COMPRISING IX FACTOR AND HUMAN ALBUMIN FOR THE PROPHYLACTIC TREATMENT OF HEMOPHILIA AND ASSOCIATED METHODS

Publications (2)

Publication Number Publication Date
DK3645034T3 DK3645034T3 (da) 2023-11-20
DK3645034T5 true DK3645034T5 (da) 2024-08-26

Family

ID=62815032

Family Applications (1)

Application Number Title Priority Date Filing Date
DK18736860.0T DK3645034T5 (da) 2017-06-29 2018-06-29 21-dages doseringsregimen for fusionsproteiner omfatten-defaktor ix og human albumin til profylaktisk behandling af hæmofili og fremgangsmåder heraf

Country Status (15)

Country Link
US (1) US20200115436A1 (enExample)
EP (1) EP3645034B1 (enExample)
JP (1) JP2020525498A (enExample)
KR (1) KR102597725B1 (enExample)
CN (1) CN110799209A (enExample)
AU (1) AU2018294517B2 (enExample)
CA (1) CA3068360A1 (enExample)
DK (1) DK3645034T5 (enExample)
ES (1) ES2963665T3 (enExample)
IL (1) IL271160B2 (enExample)
MX (1) MX2019014651A (enExample)
PL (1) PL3645034T3 (enExample)
RU (1) RU2020103424A (enExample)
SG (1) SG10202111032PA (enExample)
WO (1) WO2019002532A1 (enExample)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2001266557A1 (en) 2000-04-12 2001-10-23 Human Genome Sciences, Inc. Albumin fusion proteins
US7939632B2 (en) 2006-06-14 2011-05-10 Csl Behring Gmbh Proteolytically cleavable fusion proteins with high molar specific activity
CA2770609A1 (en) * 2009-08-20 2011-02-24 Csl Behring Gmbh Albumin fused coagulation factors for non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders
AU2011274414B2 (en) * 2010-07-09 2016-10-06 Bioverativ Therapeutics Inc. Factor IX polypeptides and methods of use thereof
HK1213521A1 (zh) * 2012-09-25 2016-07-08 Bioverativ Therapeutics Inc. Fix多肽的應用
KR20160093735A (ko) * 2013-12-23 2016-08-08 시에스엘 리미티드 혈우병의 예방학적 치료를 위한 인자 ix를 포함하는 융합 단백질 및 이의 방법
SG11201608006QA (en) * 2014-04-11 2016-10-28 Csl Ltd Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor

Also Published As

Publication number Publication date
AU2018294517A1 (en) 2020-01-30
PL3645034T3 (pl) 2024-09-02
WO2019002532A1 (en) 2019-01-03
MX2019014651A (es) 2020-02-07
KR20200019749A (ko) 2020-02-24
CN110799209A (zh) 2020-02-14
IL271160B2 (en) 2025-05-01
IL271160A (en) 2020-01-30
US20200115436A1 (en) 2020-04-16
RU2020103424A (ru) 2021-07-29
DK3645034T3 (da) 2023-11-20
AU2018294517B2 (en) 2024-09-26
RU2020103424A3 (enExample) 2021-11-12
JP2020525498A (ja) 2020-08-27
EP3645034B1 (en) 2023-08-30
ES2963665T3 (es) 2024-04-01
IL271160B1 (en) 2025-01-01
CA3068360A1 (en) 2019-01-03
KR102597725B1 (ko) 2023-11-06
SG10202111032PA (en) 2021-11-29
EP3645034A1 (en) 2020-05-06

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