NI202100085A - 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
NI202100085A
NI202100085A NI202100085A NI202100085A NI202100085A NI 202100085 A NI202100085 A NI 202100085A NI 202100085 A NI202100085 A NI 202100085A NI 202100085 A NI202100085 A NI 202100085A NI 202100085 A NI202100085 A NI 202100085A
Authority
NI
Nicaragua
Prior art keywords
pharmaceutical composition
variant
human
present disclosure
amino acid
Prior art date
Application number
NI202100085A
Other languages
English (en)
Inventor
Jae Park Soon
-Shin Chung Hye
Joo Lee Seung
KIM Kyuwan
Byun Minsoo
Seok NAM Ki
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 NI202100085A publication Critical patent/NI202100085A/es

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Classifications

    • 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
    • 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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/20Organic 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
    • 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
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • 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
    • C07K16/32Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/24Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2474Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y302/00Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01035Hyaluronoglucosaminidase (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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (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 composición farmacéutica según la presente divulgación incluye sustitución(es) de residuos de aminoácidos en una o más regiones seleccionadas de una región de 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 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 C-terminal se escinde(n) selectivamente. Además, la composición farmacéutica según la presente divulgación puede incluir además un aditivo farmacéuticamente aceptable, en particular un estabilizador. La composición farmacéutica según la presente divulgación puede máximizar el efecto terapéutico de un medicamento utilizado en combinación con la misma, debido al efecto de las variantes humanas de PH20.
NI202100085A 2019-03-25 2021-09-22 Composición farmacéutica para inyección subcutánea que comprende una variante de hialuronidasa humana ph20 y un medicamento NI202100085A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR20190033880 2019-03-25

Publications (1)

Publication Number Publication Date
NI202100085A true NI202100085A (es) 2021-12-06

Family

ID=72611090

Family Applications (1)

Application Number Title Priority Date Filing Date
NI202100085A NI202100085A (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) CN116870164A (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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ES2749620T3 (es) 2011-12-30 2020-03-23 Halozyme Inc Variantes de polipéptidos de PH20, formulaciones y usos de los mismos
WO2018156180A1 (en) 2017-02-24 2018-08-30 Kindred Biosciences, Inc. Anti-il31 antibodies for veterinary use
WO2019217927A1 (en) 2018-05-10 2019-11-14 Regeneron Pharmaceuticals, Inc. High concentration vegf receptor fusion protein containing formulations
AU2019311658B2 (en) * 2018-07-25 2022-10-20 Alteogen, Inc Novel hyaluronidase variants and pharmaceutical composition comprising the same
BR112021022682A2 (pt) 2019-05-14 2022-02-22 Provention Bio Inc Métodos e composições para prevenir diabetes do tipo 1
US20230250408A1 (en) * 2020-01-23 2023-08-10 Alteogen Inc. Novel hyaluronidase variants with improved stability and pharmaceutical composition comprising the same
IL303350A (en) 2020-12-04 2023-08-01 Macrogenics Inc Preparations containing an antibody against HER2/NEU and their use
EP4267172A1 (en) 2020-12-28 2023-11-01 Bristol-Myers Squibb Company Subcutaneous administration of pd1/pd-l1 antibodies
PE20240820A1 (es) 2020-12-28 2024-04-18 Bristol Myers Squibb Co Composiciones de anticuerpos y metodos de uso de los mismos
IL310608A (en) 2021-08-02 2024-04-01 argenx BV Dosage forms for subcutaneous administration
KR20240055077A (ko) 2021-09-14 2024-04-26 다케다 야쿠힌 고교 가부시키가이샤 히알루로니데이스를 이용한 농축된 항체 제형의 촉진된 전달
WO2023075506A1 (ko) * 2021-10-29 2023-05-04 (주)알테오젠 인간 히알루로니다제 ph20과 약물을 포함하는 약학 조성물
WO2023168305A1 (en) 2022-03-01 2023-09-07 Exuma Biotech Corp. Viral particles with membrane-bound hyaluronidase
WO2023169986A1 (en) * 2022-03-07 2023-09-14 Mabxience Research, S.L. Stable formulations for antibodies
KR20230150203A (ko) * 2022-04-20 2023-10-30 주식회사 알토스바이오로직스 오크렐리주맙(Ocrelizumab)을 포함하는 약학적 조성물과 그의 용도
WO2023235847A1 (en) 2022-06-02 2023-12-07 Bristol-Myers Squibb Company Antibody compositions and methods of use thereof
WO2023249408A1 (ko) * 2022-06-22 2023-12-28 (주)알테오젠 N-말단 및/또는 c-말단이 절단된 가용성 ph20 폴리펩티드 및 이의 용도
WO2024005502A1 (ko) * 2022-06-29 2024-01-04 주식회사 오디스젠 중성 ph에서 활성을 나타내는 히알루로니다제 hyal1 변이체
KR20240038901A (ko) * 2022-09-16 2024-03-26 (주)피앤피바이오팜 신규한 히알루로니다제 ph-20 변이체 및 그 용도
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
KR102650991B1 (ko) 2024-03-27
IL286539A (en) 2021-10-31
KR102507853B1 (ko) 2023-03-10
KR20200130451A (ko) 2020-11-18
EP3785701A4 (en) 2022-03-16
ECSP21070640A (es) 2021-11-18
AU2020248612A1 (en) 2021-10-21
AU2020248612B2 (en) 2023-11-23
KR20220075238A (ko) 2022-06-07
MX2021011278A (es) 2022-03-17
SG11202110512WA (en) 2021-10-28
US20210363270A1 (en) 2021-11-25
CR20210489A (es) 2021-12-07
ZA202108027B (en) 2022-12-21
JP7166478B2 (ja) 2022-11-07
JP2022095925A (ja) 2022-06-28
CN117100867A (zh) 2023-11-24
CN112203642A (zh) 2021-01-08
WO2020197230A1 (ko) 2020-10-01
CN116870164A (zh) 2023-10-13
PE20220283A1 (es) 2022-02-25
JP2021526542A (ja) 2021-10-07
JP2023078146A (ja) 2023-06-06
EP3785701A1 (en) 2021-03-03
DOP2021000197A (es) 2021-11-15
CO2021012380A2 (es) 2021-10-20
US20220289864A1 (en) 2022-09-15
AU2020248612B9 (en) 2023-11-30
AU2024201238A1 (en) 2024-03-14
JP7295150B2 (ja) 2023-06-20
JOP20210262A1 (ar) 2023-01-30
KR20230037691A (ko) 2023-03-16
CL2021002464A1 (es) 2022-07-22
CA3131052A1 (en) 2020-10-01
BR112021019076A2 (pt) 2021-11-30
EA202192588A1 (ru) 2022-03-17
ZA202209369B (en) 2023-07-26

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