CA2944174A1 - Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor - Google Patents

Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor Download PDF

Info

Publication number
CA2944174A1
CA2944174A1 CA2944174A CA2944174A CA2944174A1 CA 2944174 A1 CA2944174 A1 CA 2944174A1 CA 2944174 A CA2944174 A CA 2944174A CA 2944174 A CA2944174 A CA 2944174A CA 2944174 A1 CA2944174 A1 CA 2944174A1
Authority
CA
Canada
Prior art keywords
fviia
life extended
dose
life
protein
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA2944174A
Other languages
English (en)
French (fr)
Inventor
Debra BENSEN-KENNEDY
Alex VELDMAN
Sabine ZOLLNER
Eva HERZOG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CSL Ltd
Original Assignee
CSL Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CSL Ltd filed Critical CSL Ltd
Publication of CA2944174A1 publication Critical patent/CA2944174A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • 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
    • A61K38/38—Albumins
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/56—Medicinal 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 an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal 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 an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal 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 an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/62—Medicinal 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
    • A61K47/64—Drug-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
    • A61K47/643—Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • 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)
    • C12Y304/21021—Coagulation factor VIIa (3.4.21.21)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Dermatology (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)
  • Medicinal Preparation (AREA)
CA2944174A 2014-04-11 2015-03-30 Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor Abandoned CA2944174A1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201461978218P 2014-04-11 2014-04-11
US61/978,218 2014-04-11
EP14167612.2 2014-05-09
EP14167612 2014-05-09
EP14168389.6 2014-05-15
EP14168389 2014-05-15
PCT/AU2015/050137 WO2015154139A1 (en) 2014-04-11 2015-03-30 Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor

Publications (1)

Publication Number Publication Date
CA2944174A1 true CA2944174A1 (en) 2015-10-15

Family

ID=54287020

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2944174A Abandoned CA2944174A1 (en) 2014-04-11 2015-03-30 Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor

Country Status (12)

Country Link
US (1) US20170042981A1 (cg-RX-API-DMAC10.html)
EP (1) EP3129408A4 (cg-RX-API-DMAC10.html)
JP (1) JP2017513831A (cg-RX-API-DMAC10.html)
KR (1) KR20160143820A (cg-RX-API-DMAC10.html)
CN (1) CN106164097A (cg-RX-API-DMAC10.html)
AU (1) AU2015245941A1 (cg-RX-API-DMAC10.html)
BR (1) BR112016023158A2 (cg-RX-API-DMAC10.html)
CA (1) CA2944174A1 (cg-RX-API-DMAC10.html)
MX (1) MX2016013281A (cg-RX-API-DMAC10.html)
RU (1) RU2016144159A (cg-RX-API-DMAC10.html)
SG (1) SG11201608006QA (cg-RX-API-DMAC10.html)
WO (1) WO2015154139A1 (cg-RX-API-DMAC10.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2963665T3 (es) * 2017-06-29 2024-04-01 CSL Behring Lengnau AG Régimen de dosificación de 21 días para proteínas de fusión que comprenden factor ix y albúmina humana para el tratamiento profiláctico de la hemofilia y procedimientos para ello

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9458444B2 (en) * 2006-02-03 2016-10-04 Opko Biologics Ltd. Long-acting coagulation factors and methods of producing same
EP1816201A1 (en) * 2006-02-06 2007-08-08 CSL Behring GmbH Modified coagulation factor VIIa with extended half-life
DK2101821T3 (da) * 2006-12-15 2014-10-06 Baxter Healthcare Sa Faktor VIIA-(poly)sialinsyre-konjugat med forlænget halveringstid in vivo
EP2467166A2 (en) * 2009-08-20 2012-06-27 CSL Behring GmbH Albumin fused coagulation factors for non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders
KR20120002129A (ko) * 2010-06-30 2012-01-05 한미홀딩스 주식회사 면역글로불린 단편을 이용한 제７인자（Ｆａｃｔｏｒ Ⅶａ）약물 결합체

Also Published As

Publication number Publication date
WO2015154139A1 (en) 2015-10-15
KR20160143820A (ko) 2016-12-14
JP2017513831A (ja) 2017-06-01
MX2016013281A (es) 2017-01-18
US20170042981A1 (en) 2017-02-16
SG11201608006QA (en) 2016-10-28
BR112016023158A2 (pt) 2017-10-17
RU2016144159A (ru) 2018-05-11
EP3129408A1 (en) 2017-02-15
AU2015245941A1 (en) 2016-11-17
CN106164097A (zh) 2016-11-23
RU2016144159A3 (cg-RX-API-DMAC10.html) 2018-11-26
EP3129408A4 (en) 2018-04-25

Similar Documents

Publication Publication Date Title
CA2704974C (en) Extracellular histones as biomarkers for prognosis and molecular targets for therapy
RU2311923C2 (ru) Комбинированное применение полипептидов фактора vii и полипептидов фактора viii
KR101567762B1 (ko) Ｆｖⅲ 농축물을 포함하는 프로트롬빈 복합체 농축물의 상승적 치료 용도
KR102186924B1 (ko) 출혈 장애를 치료하기 위한 변형된 세르핀
KR20160070163A (ko) 출혈 또는 응고성 저하와 관련된 상태의 치료 또는 예방용 요법
JP2017114889A (ja) 再構成後の精製第ｖｉｉｉ因子の安定性を改善するための方法
US20160346366A1 (en) Fusion proteins comprising factor ix for prophylactic treatment of hemophilia and methods thereof
HUP0400976A2 (hu) VII-es faktor polipeptideket és XI-es faktor polipeptideket tartalmazó gyógyszerészeti összetételek
WO2023246680A1 (en) Activators of coagulation factor x and formulations thereof for treating bleeding disorders
US20170042981A1 (en) Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor
AU2017294555B2 (en) Subcutaneous administration of long-acting factor IX in humans
AU2018294517B2 (en) 21-day dosing regimen for fusion proteins comprising factor IX and human albumin for prophylactic treatment of hemophilia and methods thereof
HK40027732B (en) 21-day dosing regimen for fusion proteins comprising factor ix and human albumin for prophylactic treatment of hemophilia and methods thereof
HK40027732A (en) 21-day dosing regimen for fusion proteins comprising factor ix and human albumin for prophylactic treatment of hemophilia and methods thereof
HUP0401959A2 (hu) A VII-es faktor és PAI-1 polipeptideket tartalmazó gyógyszerészeti összetétel
JP2005510516A (ja) Ｖｉｉ因子ポリペプチドおよびプロテインｓ阻害剤を含む薬学的組成物

Legal Events

Date Code Title Description
FZDE Discontinued

Effective date: 20211123