CO2021012380A2 - Composición farmacéutica para inyección subcutánea que comprende una variante de hialuronidasa humana ph20 y un medicamento - Google Patents

Composición farmacéutica para inyección subcutánea que comprende una variante de hialuronidasa humana ph20 y un medicamento

Info

Publication number
CO2021012380A2
CO2021012380A2 CONC2021/0012380A CO2021012380A CO2021012380A2 CO 2021012380 A2 CO2021012380 A2 CO 2021012380A2 CO 2021012380 A CO2021012380 A CO 2021012380A CO 2021012380 A2 CO2021012380 A2 CO 2021012380A2
Authority
CO
Colombia
Prior art keywords
pharmaceutical composition
human
variant
present disclosure
amino acid
Prior art date
Application number
CONC2021/0012380A
Other languages
English (en)
Inventor
Soon Jae Park
Hye-Shin Chung
Seung Joo Lee
Kyuwan Kim
Minsoo Byun
Ki Seok Nam
Original Assignee
Alteogen 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 Alteogen Inc filed Critical Alteogen Inc
Publication of CO2021012380A2 publication Critical patent/CO2021012380A2/es

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Classifications

    • 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
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2474—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase

Landscapes

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

Abstract

La presente divulgación se refiere a una composición farmacéutica que incluye (a) un medicamento y (b) una variante de PH20 humana. La variante de la PH20 humana incluida en la 5 composición farmacéutica según la presente divulgación incluye sustitución(es) de residuos de aminoácidos en una o más regiones seleccionadas de una región de la hélice alfa 8 (S347 a C381) y una región de enlace (A333 a R346) entre la hélice alfa 7 y la hélice alfa 8 en la PH20 humana de tipo 10 salvaje que tiene la secuencia de aminoácidos de SEC ID NO: 1, en la que el(los) residuo(s) de aminoácidos situado(s) en la N-terminal o la C-terminal se escinde(n) selectivamente. Además, la composición farmacéutica según la presente divulgación puede incluir además un aditivo 15 farmacéuticamente aceptable, en particular un estabilizador. La composición farmacéutica según la presente divulgación puede maximizar el efecto terapéutico de un medicamento utilizado en combinación con la misma, debido al efecto de las variantes humanas de PH20.
CONC2021/0012380A 2019-03-25 2021-09-22 Composición farmacéutica para inyección subcutánea que comprende una variante de hialuronidasa humana ph20 y un medicamento CO2021012380A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20190033880 2019-03-25
PCT/KR2020/003975 WO2020197230A1 (ko) 2019-03-25 2020-03-24 인간 히알루로니다제 ph20의 변이체와 약물을 포함하는 피하투여용 약학 조성물

Publications (1)

Publication Number Publication Date
CO2021012380A2 true CO2021012380A2 (es) 2021-10-20

Family

ID=72611090

Family Applications (1)

Application Number Title Priority Date Filing Date
CONC2021/0012380A CO2021012380A2 (es) 2019-03-25 2021-09-22 Composición farmacéutica para inyección subcutánea que comprende una variante de hialuronidasa humana ph20 y un medicamento

Country Status (22)

Country Link
US (2) US20210363270A1 (es)
EP (1) EP3785701A4 (es)
JP (3) JP7295150B2 (es)
KR (3) KR20230037691A (es)
CN (3) CN112203642A (es)
AU (2) AU2020248612B9 (es)
BR (1) BR112021019076A2 (es)
CA (1) CA3131052A1 (es)
CL (1) CL2021002464A1 (es)
CO (1) CO2021012380A2 (es)
CR (1) CR20210489A (es)
DO (1) DOP2021000197A (es)
EA (1) EA202192588A1 (es)
EC (1) ECSP21070640A (es)
IL (1) IL286539A (es)
JO (1) JOP20210262A1 (es)
MX (1) MX2021011278A (es)
NI (1) NI202100085A (es)
PE (1) PE20220283A1 (es)
SG (1) SG11202110512WA (es)
WO (1) WO2020197230A1 (es)
ZA (2) ZA202108027B (es)

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KR102554775B1 (ko) * 2023-02-07 2023-07-12 한국코러스 주식회사 히알루로니다제의 안정화제 및 이를 포함하는 히알루로니다제 제형

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Also Published As

Publication number Publication date
MX2021011278A (es) 2022-03-17
CN117100867A (zh) 2023-11-24
DOP2021000197A (es) 2021-11-15
AU2020248612B9 (en) 2023-11-30
AU2020248612B2 (en) 2023-11-23
CR20210489A (es) 2021-12-07
EP3785701A1 (en) 2021-03-03
AU2020248612A1 (en) 2021-10-21
SG11202110512WA (en) 2021-10-28
KR20230037691A (ko) 2023-03-16
JOP20210262A1 (ar) 2023-01-30
CN112203642A (zh) 2021-01-08
AU2024201238A1 (en) 2024-03-14
JP2022095925A (ja) 2022-06-28
BR112021019076A2 (pt) 2021-11-30
ECSP21070640A (es) 2021-11-18
JP2021526542A (ja) 2021-10-07
JP2023078146A (ja) 2023-06-06
US20210363270A1 (en) 2021-11-25
NI202100085A (es) 2021-12-06
CA3131052A1 (en) 2020-10-01
WO2020197230A1 (ko) 2020-10-01
IL286539A (en) 2021-10-31
JP7295150B2 (ja) 2023-06-20
EP3785701A4 (en) 2022-03-16
PE20220283A1 (es) 2022-02-25
KR20200130451A (ko) 2020-11-18
KR102507853B1 (ko) 2023-03-10
KR20220075238A (ko) 2022-06-07
CL2021002464A1 (es) 2022-07-22
ZA202209369B (en) 2023-07-26
KR102650991B1 (ko) 2024-03-27
ZA202108027B (en) 2022-12-21
CN116870164A (zh) 2023-10-13
EA202192588A1 (ru) 2022-03-17
JP7166478B2 (ja) 2022-11-07
US20220289864A1 (en) 2022-09-15

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