CY1123997T1 - Νεα μεταλλακτικη παραλλαγη αλβουμινης ανθρωπινου ορου - Google Patents

Νεα μεταλλακτικη παραλλαγη αλβουμινης ανθρωπινου ορου

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Publication number
CY1123997T1
CY1123997T1 CY20211100290T CY211100290T CY1123997T1 CY 1123997 T1 CY1123997 T1 CY 1123997T1 CY 20211100290 T CY20211100290 T CY 20211100290T CY 211100290 T CY211100290 T CY 211100290T CY 1123997 T1 CY1123997 T1 CY 1123997T1
Authority
CY
Cyprus
Prior art keywords
amino acid
serum albumin
human serum
mutant variant
acid sequence
Prior art date
Application number
CY20211100290T
Other languages
English (en)
Inventor
Kenichi Takahashi
Aya YOSHIOKA
Hideto Morimoto
Masafumi Kinoshita
Original Assignee
Jcr Pharmaceuticals Co., 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 Jcr Pharmaceuticals Co., Ltd. filed Critical Jcr Pharmaceuticals Co., Ltd.
Publication of CY1123997T1 publication Critical patent/CY1123997T1/el

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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
    • C07K14/76—Albumins
    • C07K14/765—Serum albumin, e.g. HSA
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • 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
    • 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
    • A61K47/65—Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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
    • C07K14/575—Hormones
    • C07K14/61—Growth hormone [GH], i.e. somatotropin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • 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
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/10—Cells modified by introduction of foreign genetic material
    • C12N5/12—Fused cells, e.g. hybridomas
    • C12N5/16—Animal cells
    • 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
    • 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
    • C12N2800/00—Nucleic acids vectors
    • C12N2800/10—Plasmid DNA
    • C12N2800/106—Plasmid DNA for vertebrates
    • C12N2800/107—Plasmid DNA for vertebrates for mammalian

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Toxicology (AREA)
  • General Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Cell Biology (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

Αποκαλυπτόμενη είναι μεταλλακτική παραλλαγή αλβουμίνης ανθρώπινου ορού που μπορεί να συνδέεται φυσιολογικώς δραστική πρωτεΐνη για να αυξάνεται η σταθερότητα της πρωτεΐνης στο αίμα, καθώς επίσης προκύπτουσα πρωτεΐνη που παράγεται με σύνδεση με τη μεταλλακτική παραλλαγή. Η πρωτεΐνη που παράγεται με σύνδεση με τη μεταλλακτική παραλλαγή συνίσταται από μεταλλακτική παραλλαγή αλβουμίνης ανθρώπινου ορού που περιλαμβάνει την αλληλουχία αμινοξέος που εκτίθεται ως SEQ ID NO: 3 ή αλληλουχία αμινοξέος που, εν συγκρίσει με αυτή, έχει έλλειψη όχι περισσότερων από 10 υπολειμμάτων αμινοξέος ή/και έχει όχι περισσότερα από 10 υπολείμματα αμινοξέος αντικατασταθέντα, υπό την προϋπόθεση ότι το υπόλειμμα ασπαραγίνης που προκύπτει στη θέση 318 και η θρεονίνη στη θέση 320 από το Ν-άκρο της αλληλουχίας αμινοξέος που εκτίθεται ως SEQ ID NO: 3 διατηρούνται και συνδέονται με πεπτιδικούς δεσμούς μέσω απλού υπολείμματος αμινοξέος (Χ) εκτός προλίνης τοποθετημένης μεταξύ αυτών των δύο υπολειμμάτων αμινοξέος, και φυσιολογικώς δραστικής πρωτεΐνης που συνδέεται προς τη μεταλλακτική παραλλαγή.
CY20211100290T 2015-09-08 2021-04-05 Νεα μεταλλακτικη παραλλαγη αλβουμινης ανθρωπινου ορου CY1123997T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015177093 2015-09-08
PCT/JP2016/076438 WO2017043569A1 (ja) 2015-09-08 2016-09-08 新規なヒト血清アルブミン変異体

Publications (1)

Publication Number Publication Date
CY1123997T1 true CY1123997T1 (el) 2022-05-27

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US (3) US10654912B2 (el)
EP (3) EP3348635B1 (el)
JP (4) JP6886920B2 (el)
KR (1) KR102360744B1 (el)
CN (2) CN107949638B (el)
AU (3) AU2016319540B2 (el)
CA (2) CA3183289A1 (el)
CY (1) CY1123997T1 (el)
DK (1) DK3348635T3 (el)
ES (1) ES2861059T3 (el)
HK (1) HK1247244A1 (el)
HR (1) HRP20210635T1 (el)
HU (1) HUE053937T2 (el)
PL (1) PL3348635T3 (el)
PT (1) PT3348635T (el)
SI (1) SI3348635T1 (el)
WO (1) WO2017043569A1 (el)

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WO2017159540A1 (ja) 2016-03-14 2017-09-21 Ｊｃｒファーマ株式会社 血清アルブミン－２０ｋ成長ホルモン融合タンパク質
EP3811962A4 (en) * 2018-06-25 2022-03-16 JCR Pharmaceuticals Co., Ltd. PROTEIN AQUEOUS LIQUID FORMULATION
CN109734816A (zh) * 2019-03-12 2019-05-10 王大勇 一种基因重组人促皮质素与白蛋白的融合蛋白及表达方法
KR20220083784A (ko) * 2019-10-17 2022-06-20 제이씨알 파마 가부시키가이샤 혈청 알부민과 성장 호르몬의 융합 단백질의 제조 방법
CN114728043B (zh) * 2019-10-30 2024-04-16 Jcr制药股份有限公司 含有血清白蛋白与生长激素的融合蛋白的水性药物组合物
CN113430227A (zh) * 2020-03-23 2021-09-24 佛山汉腾生物科技有限公司 制备稳定细胞池的方法、蛋白表达方法及试剂盒
CN114133458B (zh) * 2021-12-08 2023-11-14 福州大学 一种在人血清白蛋白内部融合多肽的方法
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Publication number Publication date
JP2021141893A (ja) 2021-09-24
KR20180042432A (ko) 2018-04-25
SI3348635T1 (sl) 2021-08-31
JP6886920B2 (ja) 2021-06-16
US11634474B2 (en) 2023-04-25
EP4374913A2 (en) 2024-05-29
EP3348635B1 (en) 2021-02-17
JPWO2017043569A1 (ja) 2018-06-28
HUE053937T2 (hu) 2021-08-30
AU2021212110B2 (en) 2022-07-14
ES2861059T3 (es) 2021-10-05
CN114591445A (zh) 2022-06-07
US20200247872A1 (en) 2020-08-06
US20180244754A1 (en) 2018-08-30
EP3845644B1 (en) 2024-04-24
CN107949638B (zh) 2022-05-13
US10654912B2 (en) 2020-05-19
AU2016319540A1 (en) 2018-03-22
AU2016319540B2 (en) 2021-08-26
KR102360744B1 (ko) 2022-02-08
CA2996672A1 (en) 2017-03-16
WO2017043569A1 (ja) 2017-03-16
CA2996672C (en) 2023-02-21
HRP20210635T1 (hr) 2021-08-20
HK1247244A1 (zh) 2018-09-21
JP7123216B2 (ja) 2022-08-22
AU2022204463B2 (en) 2024-05-02
JP7403595B2 (ja) 2023-12-22
EP4374913A3 (en) 2024-08-14
EP3845644C0 (en) 2024-04-24
US11046751B2 (en) 2021-06-29
CN114591445B (zh) 2024-04-23
JP2022166098A (ja) 2022-11-01
JP2024037850A (ja) 2024-03-19
AU2022204463A1 (en) 2022-07-14
DK3348635T3 (da) 2021-03-01
CA3183289A1 (en) 2017-03-16
PT3348635T (pt) 2021-03-15
PL3348635T3 (pl) 2021-09-27
EP3845644A1 (en) 2021-07-07
EP3348635A1 (en) 2018-07-18
US20210269507A1 (en) 2021-09-02
AU2021212110A1 (en) 2021-08-26
CN107949638A (zh) 2018-04-20
EP3348635A4 (en) 2019-06-19

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