SG11202110512WA - Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection - Google Patents

Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection

Info

Publication number
SG11202110512WA
SG11202110512WA SG11202110512WA SG11202110512WA SG11202110512WA SG 11202110512W A SG11202110512W A SG 11202110512WA SG 11202110512W A SG11202110512W A SG 11202110512WA SG 11202110512W A SG11202110512W A SG 11202110512WA SG 11202110512W A SG11202110512W A SG 11202110512WA
Authority
SG
Singapore
Prior art keywords
variant
drug
pharmaceutical composition
subcutaneous injection
human hyaluronidase
Prior art date
Application number
SG11202110512WA
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 SG11202110512WA publication Critical patent/SG11202110512WA/en

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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
    • A61K47/26Carbohydrates, 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
    • 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
    • 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)
SG11202110512WA 2019-03-25 2020-03-24 Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection SG11202110512WA (en)

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
SG11202110512WA true SG11202110512WA (en) 2021-10-28

Family

ID=72611090

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11202110512WA SG11202110512WA (en) 2019-03-25 2020-03-24 Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection

Country Status (22)

Country Link
US (2) US20210363270A1 (ko)
EP (1) EP3785701A4 (ko)
JP (3) JP7295150B2 (ko)
KR (3) KR20230037691A (ko)
CN (3) CN116870164A (ko)
AU (2) AU2020248612B9 (ko)
BR (1) BR112021019076A2 (ko)
CA (1) CA3131052A1 (ko)
CL (1) CL2021002464A1 (ko)
CO (1) CO2021012380A2 (ko)
CR (1) CR20210489A (ko)
DO (1) DOP2021000197A (ko)
EA (1) EA202192588A1 (ko)
EC (1) ECSP21070640A (ko)
IL (1) IL286539A (ko)
JO (1) JOP20210262A1 (ko)
MX (1) MX2021011278A (ko)
NI (1) NI202100085A (ko)
PE (1) PE20220283A1 (ko)
SG (1) SG11202110512WA (ko)
WO (1) WO2020197230A1 (ko)
ZA (2) ZA202108027B (ko)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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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DE602004024041D1 (de) * 2003-03-05 2009-12-24 Halozyme Inc Lösliches hyaluronidase-glycoprotein (shasegp), verfahren zu seiner herstellung, verwendungen und dieses enthaltende pharmazeutische zusammensetzungen
EP1945662A2 (en) * 2005-11-10 2008-07-23 Receptor Biologix, Inc. Methods for production of receptor and ligand isoforms
TWI532498B (zh) * 2008-03-17 2016-05-11 巴克斯特保健公司 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法
NZ601248A (en) * 2008-04-14 2014-06-27 Halozyme Inc Modified hyaluronidases and uses in treating hyaluronan-associated diseases and conditions
CA2746181C (en) * 2008-12-09 2016-03-15 Halozyme, Inc. Extended soluble ph20 polypeptides and uses thereof
US9345661B2 (en) * 2009-07-31 2016-05-24 Genentech, Inc. Subcutaneous anti-HER2 antibody formulations and uses thereof
ES2749620T3 (es) * 2011-12-30 2020-03-23 Halozyme Inc Variantes de polipéptidos de PH20, formulaciones y usos de los mismos
TW201534726A (zh) * 2013-07-03 2015-09-16 Halozyme Inc 熱穩定ph20玻尿酸酶變異體及其用途
US20170218382A1 (en) * 2014-07-31 2017-08-03 National University Corporation Kobe University Secretion Signal Peptide, And Protein Secretory Production And Cell Surface Display Using Said Secretion Signal Peptide
ES2727137T3 (es) * 2014-08-28 2019-10-14 Halozyme Inc Terapia combinada con una enzima de degradación de hialuronano y un inhibidor de puntos de control inmunitario
KR20190090394A (ko) * 2016-11-30 2019-08-01 메모리얼 슬로안 케터링 캔서 센터 억제제-작용화된 초소형 나노입자 및 이의 방법
CN116531511A (zh) * 2017-03-02 2023-08-04 豪夫迈·罗氏有限公司 Her2阳性乳腺癌的辅助治疗
AU2019311658B2 (en) * 2018-07-25 2022-10-20 Alteogen, Inc Novel hyaluronidase variants and pharmaceutical composition comprising the same

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
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
NI202100085A (es) 2021-12-06
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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