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
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 (en) 2019-03-25 2020-03-24 Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection

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 (en)
EP (1) EP3785701A4 (en)
JP (3) JP7295150B2 (en)
KR (3) KR20230037691A (en)
CN (3) CN117100867A (en)
AU (2) AU2020248612B9 (en)
BR (1) BR112021019076A2 (en)
CA (1) CA3131052A1 (en)
CL (1) CL2021002464A1 (en)
CO (1) CO2021012380A2 (en)
CR (1) CR20210489A (en)
DO (1) DOP2021000197A (en)
EA (1) EA202192588A1 (en)
EC (1) ECSP21070640A (en)
IL (1) IL286539A (en)
JO (1) JOP20210262A1 (en)
MX (1) MX2021011278A (en)
NI (1) NI202100085A (en)
PE (1) PE20220283A1 (en)
SG (1) SG11202110512WA (en)
WO (1) WO2020197230A1 (en)
ZA (2) ZA202108027B (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11201403714TA (en) 2011-12-30 2014-07-30 Halozyme Inc Ph20 polypeptide variants, formulations and uses thereof
WO2018156180A1 (en) 2017-02-24 2018-08-30 Kindred Biosciences, Inc. Anti-il31 antibodies for veterinary use
EP3790532A1 (en) 2018-05-10 2021-03-17 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
WO2020232247A1 (en) 2019-05-14 2020-11-19 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
MX2022008060A (en) * 2020-01-23 2022-07-27 Alteogen Inc Novel hyaluronic acid-hydrolyzing enzyme variant having improved stability and pharmaceutical composition comprising same.
IL303350A (en) 2020-12-04 2023-08-01 Macrogenics Inc Pharmaceutical compositions of a her2/neu antibody and use of the same
EP4267172A1 (en) 2020-12-28 2023-11-01 Bristol-Myers Squibb Company Subcutaneous administration of pd1/pd-l1 antibodies
AU2021411486A1 (en) 2020-12-28 2023-06-29 Bristol-Myers Squibb Company Antibody compositions and methods of use thereof
AU2022322077A1 (en) 2021-08-02 2024-02-08 argenx BV Subcutaneous unit dosage forms
IL311429A (en) 2021-09-14 2024-05-01 Takeda Pharmaceuticals Co Facilitated delivery of concentrated antibody formulations using hyaluronidase
AU2022376750A1 (en) * 2021-10-29 2024-05-16 Alteogen Inc. Pharmaceutical composition comprising human hyaluronidase ph20 and drug
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
WO2023204554A1 (en) * 2022-04-20 2023-10-26 주식회사 알토스바이오로직스 Pharmaceutical composition comprising ocrelizumab and use thereof
WO2023235847A1 (en) 2022-06-02 2023-12-07 Bristol-Myers Squibb Company Antibody compositions and methods of use thereof
TW202405176A (en) * 2022-06-22 2024-02-01 南韓商阿特根公司 N-terminal and/or c-terminal cleaved soluble ph20 polypeptide and use thereof
WO2024005502A1 (en) * 2022-06-29 2024-01-04 주식회사 오디스젠 Hyaluronidase hyal1 variant exhibiting activity in neutral ph
KR20240038901A (en) * 2022-09-16 2024-03-26 (주)피앤피바이오팜 Novel hyaluronidase PH20 mutant and uses thereof
KR102554775B1 (en) * 2023-02-07 2023-07-12 한국코러스 주식회사 Hyaluronidase formulation and which contains stabilizer for hyaluronidase

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SG177008A1 (en) * 2003-03-05 2012-01-30 Halozyme Inc Soluble hyaluronidase glycoprotein (shasegp), process for preparing the same, uses and pharmaceutical compositions comprising thereof
RU2008123518A (en) 2005-11-10 2009-12-20 Ресептор Байолоджикс, Инк. (Us) METHODS FOR PRODUCING ISOFORM OF RECEPTORS AND LIGANDS
TWI489994B (en) * 2008-03-17 2015-07-01 Baxter Healthcare Sa Combinations and methods for subcutaneous administration of immune globulin and hyaluronidase
EP3192525A1 (en) * 2008-04-14 2017-07-19 Halozyme, Inc. Modified hyaluronidases for use in treating hyaluronan-associated diseases and conditions
EP3037529B1 (en) * 2008-12-09 2019-03-27 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
SG11201403714TA (en) * 2011-12-30 2014-07-30 Halozyme Inc Ph20 polypeptide variants, formulations and uses thereof
TW201534726A (en) 2013-07-03 2015-09-16 Halozyme Inc Thermally stable PH20 hyaluronidase variants and uses thereof
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
EP3186281B1 (en) * 2014-08-28 2019-04-10 Halozyme, Inc. Combination therapy with a hyaluronan-degrading enzyme and an immune checkpoint inhibitor
JP2020500863A (en) * 2016-11-30 2020-01-16 メモリアル スローン ケタリング キャンサー センター Inhibitor-functionalized ultra-small nanoparticles and methods thereof
KR20230144110A (en) * 2017-03-02 2023-10-13 제넨테크, 인크. Adjuvant treatment of her2-positive breast cancer
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
EA202192588A1 (en) 2022-03-17
EP3785701A4 (en) 2022-03-16
CO2021012380A2 (en) 2021-10-20
CA3131052A1 (en) 2020-10-01
CN116870164A (en) 2023-10-13
CR20210489A (en) 2021-12-07
EP3785701A1 (en) 2021-03-03
JP2021526542A (en) 2021-10-07
JP2023078146A (en) 2023-06-06
JP7295150B2 (en) 2023-06-20
WO2020197230A1 (en) 2020-10-01
CN112203642A (en) 2021-01-08
CL2021002464A1 (en) 2022-07-22
US20220289864A1 (en) 2022-09-15
CN117100867A (en) 2023-11-24
AU2020248612B2 (en) 2023-11-23
KR20200130451A (en) 2020-11-18
KR20220075238A (en) 2022-06-07
BR112021019076A2 (en) 2021-11-30
ECSP21070640A (en) 2021-11-18
KR102650991B1 (en) 2024-03-27
DOP2021000197A (en) 2021-11-15
KR20230037691A (en) 2023-03-16
IL286539A (en) 2021-10-31
US20210363270A1 (en) 2021-11-25
ZA202108027B (en) 2022-12-21
AU2024201238A1 (en) 2024-03-14
MX2021011278A (en) 2022-03-17
PE20220283A1 (en) 2022-02-25
AU2020248612B9 (en) 2023-11-30
NI202100085A (en) 2021-12-06
JP7166478B2 (en) 2022-11-07
KR102507853B1 (en) 2023-03-10
JOP20210262A1 (en) 2023-01-30
AU2020248612A1 (en) 2021-10-21
JP2022095925A (en) 2022-06-28
ZA202209369B (en) 2023-07-26

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