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HUE062719T2 - Ultra-hosszú hatású inzulin-FC fúziós fehérjék és az alkalmazási eljárások - Google Patents

Ultra-hosszú hatású inzulin-FC fúziós fehérjék és az alkalmazási eljárások

Info

Publication number
HUE062719T2
HUE062719T2 HUE21207279A HUE21207279A HUE062719T2 HU E062719 T2 HUE062719 T2 HU E062719T2 HU E21207279 A HUE21207279 A HU E21207279A HU E21207279 A HUE21207279 A HU E21207279A HU E062719 T2 HUE062719 T2 HU E062719T2
Authority
HU
Hungary
Prior art keywords
ultra
methods
fusion proteins
long acting
acting insulin
Prior art date
Application number
HUE21207279A
Other languages
English (en)
Inventor
Thomas M Lancaster
Todd C Zion
Original Assignee
Akston Biosciences Corp
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 Akston Biosciences Corp filed Critical Akston Biosciences Corp
Publication of HUE062719T2 publication Critical patent/HUE062719T2/hu

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • C07K14/575Hormones
    • C07K14/62Insulins
    • 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
    • A61K47/65Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers
    • 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
    • A61K47/68Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61K9/0012Galenical 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
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07HSUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • C07H21/04Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2869Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against hormone receptors
    • 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
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/62DNA sequences coding for fusion proteins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • 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)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Biophysics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Toxicology (AREA)
  • General Engineering & Computer Science (AREA)
  • Wood Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Neurology (AREA)
  • Plant Pathology (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
HUE21207279A 2018-06-29 2019-06-28 Ultra-hosszú hatású inzulin-FC fúziós fehérjék és az alkalmazási eljárások HUE062719T2 (hu)

Applications Claiming Priority (15)

Application Number Priority Date Filing Date Title
US201862692507P 2018-06-29 2018-06-29
US201862692498P 2018-06-29 2018-06-29
US201862693814P 2018-07-03 2018-07-03
US201862696645P 2018-07-11 2018-07-11
US201862698648P 2018-07-16 2018-07-16
US201862702167P 2018-07-23 2018-07-23
US201862719347P 2018-08-17 2018-08-17
US201862740735P 2018-10-03 2018-10-03
US201862743358P 2018-10-09 2018-10-09
US201862774682P 2018-12-03 2018-12-03
US201862781378P 2018-12-18 2018-12-18
US201862781368P 2018-12-18 2018-12-18
US201962824176P 2019-03-26 2019-03-26
US201962827809P 2019-04-01 2019-04-01
US201962837188P 2019-04-22 2019-04-22

Publications (1)

Publication Number Publication Date
HUE062719T2 true HUE062719T2 (hu) 2023-11-28

Family

ID=68985236

Family Applications (4)

Application Number Title Priority Date Filing Date
HUE22203969A HUE065725T2 (hu) 2018-06-29 2019-06-28 Ultra-hosszú hatású inzulin-FC fúziós fehérjék és alkalmazási eljárások
HUE21164434A HUE060471T2 (hu) 2018-06-29 2019-06-28 Ultra-hosszú hatású inzulin-FC fúziós fehérjék és alkalmazási módszerek
HUE21207279A HUE062719T2 (hu) 2018-06-29 2019-06-28 Ultra-hosszú hatású inzulin-FC fúziós fehérjék és az alkalmazási eljárások
HUE19826154A HUE058005T2 (hu) 2018-06-29 2019-06-28 Ultra hosszan ható inzulin Fc fehérjék, és alkalmazási eljárások

Family Applications Before (2)

Application Number Title Priority Date Filing Date
HUE22203969A HUE065725T2 (hu) 2018-06-29 2019-06-28 Ultra-hosszú hatású inzulin-FC fúziós fehérjék és alkalmazási eljárások
HUE21164434A HUE060471T2 (hu) 2018-06-29 2019-06-28 Ultra-hosszú hatású inzulin-FC fúziós fehérjék és alkalmazási módszerek

Family Applications After (1)

Application Number Title Priority Date Filing Date
HUE19826154A HUE058005T2 (hu) 2018-06-29 2019-06-28 Ultra hosszan ható inzulin Fc fehérjék, és alkalmazási eljárások

Country Status (15)

Country Link
US (8) US10961294B2 (hu)
EP (5) EP4344738A3 (hu)
JP (2) JP7417277B2 (hu)
KR (1) KR20210029210A (hu)
CN (1) CN113038964B (hu)
AU (2) AU2019291945B2 (hu)
BR (1) BR112020026777A2 (hu)
CA (1) CA3104144A1 (hu)
DK (4) DK4011908T5 (hu)
FI (2) FI4011908T3 (hu)
HR (4) HRP20240408T1 (hu)
HU (4) HUE065725T2 (hu)
LT (4) LT3655006T (hu)
SI (4) SI3892628T1 (hu)
WO (1) WO2020006529A1 (hu)

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EP3655006A1 (en) 2020-05-27
FI4186920T3 (fi) 2024-03-20
BR112020026777A2 (pt) 2021-03-30
US20200157171A1 (en) 2020-05-21
US20220017590A1 (en) 2022-01-20
FI4011908T3 (fi) 2023-08-04
LT3892628T (lt) 2022-12-12
US10947292B2 (en) 2021-03-16
US20200407413A1 (en) 2020-12-31
SI3892628T1 (sl) 2023-01-31
EP4344738A3 (en) 2024-05-22
EP4344738A2 (en) 2024-04-03
AU2019291945B2 (en) 2024-11-14
HUE060471T2 (hu) 2023-03-28
LT4011908T (lt) 2023-09-11
US10961294B2 (en) 2021-03-30
HRP20240408T1 (hr) 2024-06-07
US20220009990A1 (en) 2022-01-13
DK4186920T5 (da) 2024-07-22
HUE058005T2 (hu) 2022-06-28
US11261229B2 (en) 2022-03-01
HRP20221418T1 (hr) 2023-01-06
EP3655006B1 (en) 2021-11-17
EP3655006A4 (en) 2021-01-13
HRP20230991T1 (hr) 2023-12-08
EP4186920A1 (en) 2023-05-31
JP7417277B2 (ja) 2024-01-18
US20200157170A1 (en) 2020-05-21
US20200157169A1 (en) 2020-05-21
KR20210029210A (ko) 2021-03-15
CA3104144A1 (en) 2020-01-02
US20240101635A1 (en) 2024-03-28
US11673934B2 (en) 2023-06-13
JP2021530210A (ja) 2021-11-11
US20200231646A1 (en) 2020-07-23
SI3655006T1 (sl) 2022-04-29
US10870686B2 (en) 2020-12-22
SI4011908T1 (sl) 2023-10-30
AU2019291945A1 (en) 2021-01-14
AU2024287186A1 (en) 2025-01-23
DK4186920T3 (da) 2024-03-25
HUE065725T2 (hu) 2024-06-28
EP4011908A1 (en) 2022-06-15
US11773151B2 (en) 2023-10-03
EP4011908B1 (en) 2023-06-07
CN113038964A (zh) 2021-06-25
CN113038964B (zh) 2025-05-27
US10851147B2 (en) 2020-12-01
DK3892628T3 (da) 2022-11-14
DK4011908T5 (da) 2024-08-12
EP3892628B1 (en) 2022-09-07
JP2024045117A (ja) 2024-04-02
SI4186920T1 (sl) 2024-05-31
LT3655006T (lt) 2022-03-10
LT4186920T (lt) 2024-04-25
DK3655006T3 (da) 2022-02-21
DK4011908T3 (da) 2023-08-07
JP7510728B2 (ja) 2024-07-04
WO2020006529A1 (en) 2020-01-02
EP4186920B1 (en) 2024-01-03
EP3892628A1 (en) 2021-10-13
HRP20220091T1 (hr) 2022-04-15

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