CO2023017358A2 - Formulaciones de proteínas quiméricas del factor viii y usos de las mismas - Google Patents

Formulaciones de proteínas quiméricas del factor viii y usos de las mismas

Info

Publication number
CO2023017358A2
CO2023017358A2 CONC2023/0017358A CO2023017358A CO2023017358A2 CO 2023017358 A2 CO2023017358 A2 CO 2023017358A2 CO 2023017358 A CO2023017358 A CO 2023017358A CO 2023017358 A2 CO2023017358 A2 CO 2023017358A2
Authority
CO
Colombia
Prior art keywords
factor viii
formulations
chimeric factor
viii proteins
polypeptide
Prior art date
Application number
CONC2023/0017358A
Other languages
English (en)
Inventor
Tyler Carlage
Randall Mauldin
Loubna Mzaalak Tazi
Timothy R Mccoy
Original Assignee
Bioverativ Therapeutics Inc
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 Bioverativ Therapeutics Inc filed Critical Bioverativ Therapeutics Inc
Publication of CO2023017358A2 publication Critical patent/CO2023017358A2/es

Links

Classifications

    • 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
    • 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
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C07K2319/30Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente divulgación proporciona composiciones farmacéuticas de una proteína quimérica que comprende un polipéptido de factor VIII (FVIII) y un polipéptido de factor von Willebrand (VWF). También se divulgan kits farmacéuticos y métodos para utilizar las composiciones farmacéuticas divulgadas para tratar la hemofilia A.
CONC2023/0017358A 2021-06-23 2023-12-14 Formulaciones de proteínas quiméricas del factor viii y usos de las mismas CO2023017358A2 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163214245P 2021-06-23 2021-06-23
US202163214246P 2021-06-23 2021-06-23
US202163214752P 2021-06-24 2021-06-24
US202163231909P 2021-08-11 2021-08-11
PCT/US2022/034747 WO2022271962A1 (en) 2021-06-23 2022-06-23 Formulations of factor viii chimeric proteins and uses thereof

Publications (1)

Publication Number Publication Date
CO2023017358A2 true CO2023017358A2 (es) 2024-01-15

Family

ID=82656587

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2023/0017358A CO2023017358A2 (es) 2021-06-23 2023-12-14 Formulaciones de proteínas quiméricas del factor viii y usos de las mismas

Country Status (12)

Country Link
US (1) US20240287158A1 (es)
EP (1) EP4358938A1 (es)
JP (1) JP2024522855A (es)
KR (1) KR20240024949A (es)
AU (1) AU2022298798A1 (es)
BR (1) BR112023026782A2 (es)
CA (1) CA3220564A1 (es)
CO (1) CO2023017358A2 (es)
IL (1) IL309309A (es)
MX (1) MX2023015238A (es)
TW (1) TW202317178A (es)
WO (1) WO2022271962A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW202400657A (zh) * 2022-03-08 2024-01-01 美商百歐維拉提夫治療公司 治療a型血友病的方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
BRPI0921429B1 (pt) * 2008-11-07 2022-07-12 Takeda Pharmaceutical Company Limited Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável
SG10201913893XA (en) 2012-07-11 2020-03-30 Bioverativ Therapeutics Inc Factor viii complex with xten and von willebrand factor protein, and uses thereof
CN117106095A (zh) 2014-01-10 2023-11-24 比奥贝拉蒂治疗公司 因子viii嵌合蛋白及其用途
BR112020022164A2 (pt) * 2018-05-18 2021-02-02 Bioverativ Therapeutics Inc. métodos de tratamento de hemofilia a
BR112021025426A2 (pt) * 2019-06-19 2022-06-21 Bioverativ Therapeutics Inc Fator recombinante viii-fc para tratamento de hemofilia e baixa densidade mineral óssea
EP4013389A1 (en) * 2019-08-16 2022-06-22 Octapharma AG Stabilizing buffer for factor viii and vwf

Also Published As

Publication number Publication date
TW202317178A (zh) 2023-05-01
BR112023026782A2 (pt) 2024-03-12
IL309309A (en) 2024-02-01
EP4358938A1 (en) 2024-05-01
WO2022271962A1 (en) 2022-12-29
MX2023015238A (es) 2024-03-08
JP2024522855A (ja) 2024-06-21
AU2022298798A1 (en) 2024-02-08
KR20240024949A (ko) 2024-02-26
US20240287158A1 (en) 2024-08-29
CA3220564A1 (en) 2022-12-29

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