AU2019311658B2 - Novel hyaluronidase variants and pharmaceutical composition comprising the same - Google Patents

Novel hyaluronidase variants and pharmaceutical composition comprising the same Download PDF

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AU2019311658B2
AU2019311658B2 AU2019311658A AU2019311658A AU2019311658B2 AU 2019311658 B2 AU2019311658 B2 AU 2019311658B2 AU 2019311658 A AU2019311658 A AU 2019311658A AU 2019311658 A AU2019311658 A AU 2019311658A AU 2019311658 B2 AU2019311658 B2 AU 2019311658B2
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AU2019311658A8 (en
AU2019311658A1 (en
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Hye-Shin Chung
Chang Woo Lee
Seung Joo Lee
Soon Jae Park
Hyung-Nam SONG
Sun-Ah YOU
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Alteogen Inc
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    • 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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • 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
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • 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
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0681—Cells of the genital tract; Non-germinal cells from gonads
    • C12N5/0682—Cells of the female genital tract, e.g. endometrium; Non-germinal cells from ovaries, e.g. ovarian follicle cells
    • 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)
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02—Fusion polypeptide containing a localisation/targetting motif containing a signal sequence
    • 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
    • C12N2510/00—Genetically modified cells
    • 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
    • C12N2800/00—Nucleic acids vectors
    • C12N2800/10—Plasmid DNA
    • C12N2800/106—Plasmid DNA for vertebrates
    • C12N2800/107—Plasmid DNA for vertebrates for mammalian

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Cell Biology (AREA)
  • Reproductive Health (AREA)
  • Plant Pathology (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
AU2019311658A 2018-07-25 2019-07-25 Novel hyaluronidase variants and pharmaceutical composition comprising the same Active AU2019311658B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2023200324A AU2023200324B9 (en) 2018-07-25 2023-01-20 Novel hyaluoronic acid-hydrolyzing enzyme variant and pharmaceutical composition containing same

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
KR20180086308 2018-07-25
KR10-2018-0086308 2018-07-25
KR10-2019-0029758 2019-03-15
KR20190029758 2019-03-15
PCT/KR2019/009215 WO2020022791A1 (ko) 2018-07-25 2019-07-25 신규 히알루론산 가수분해 효소 변이체 및 이를 포함하는 약제학적 조성물

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AU2019311658A1 AU2019311658A1 (en) 2021-02-11
AU2019311658A8 AU2019311658A8 (en) 2021-03-25
AU2019311658B2 true AU2019311658B2 (en) 2022-10-20

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US (2) US12371683B2 (OSRAM)
EP (1) EP3636752A4 (OSRAM)
JP (3) JP7204729B2 (OSRAM)
KR (3) KR20210023798A (OSRAM)
CN (5) CN118755703A (OSRAM)
AU (2) AU2019311658B2 (OSRAM)
BR (1) BR112020019041A2 (OSRAM)
CA (1) CA3093885A1 (OSRAM)
MX (1) MX2020009824A (OSRAM)
RU (1) RU2766680C1 (OSRAM)
WO (1) WO2020022791A1 (OSRAM)

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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
PT3130347T (pt) 2011-12-30 2019-12-10 Halozyme Inc Variantes de polipéptidos de ph20, suas formulações e utilizações
CN118755703A (zh) 2018-07-25 2024-10-11 阿特根公司 新型透明质酸水解酶突变体和包含其的药物组合物
BR112021008873A8 (pt) 2018-11-07 2023-04-11 Merck Sharp & Dohme Formulação
KR20230037691A (ko) * 2019-03-25 2023-03-16 (주)알테오젠 인간 히알루로니다제 ph20의 변이체와 약물을 포함하는 피하투여용 약학 조성물
KR102801434B1 (ko) * 2020-01-23 2025-04-30 (주)알테오젠 안정성이 향상된 신규 히알루론산 가수분해 효소 변이체 및 이를 포함하는 약제학적 조성물
MX2023000760A (es) 2020-07-17 2023-02-13 Geron Corp Composiciones subcutaneas del inhibidor de la telomerasa y metodos para su uso.
CN120738156A (zh) * 2020-08-07 2025-10-03 阿特根公司 制备重组玻尿酸酶的方法
KR20230074516A (ko) * 2020-09-24 2023-05-30 머크 샤프 앤드 돔 엘엘씨 프로그램화된 사멸 수용체 1 (pd-1) 항체 및 히알루로니다제 변이체 및 그의 단편의 안정한 제제 및 그의 사용 방법
WO2022146948A1 (en) 2020-12-28 2022-07-07 Bristol-Myers Squibb Company Subcutaneous administration of pd1/pd-l1 antibodies
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CN115671267A (zh) 2021-07-23 2023-02-03 上海宝济药业有限公司 一种皮下抗生素药物组合物
WO2023012515A2 (en) 2021-08-02 2023-02-09 argenx BV Subcutaneous unit dosage forms
KR20240055077A (ko) 2021-09-14 2024-04-26 다케다 야쿠힌 고교 가부시키가이샤 히알루로니데이스를 이용한 농축된 항체 제형의 촉진된 전달
KR20230064559A (ko) * 2021-10-29 2023-05-10 (주)알테오젠 인간 히알루로니다제 ph20과 약물을 포함하는 약학 조성물
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KR20230150203A (ko) 2022-04-20 2023-10-30 주식회사 알토스바이오로직스 오크렐리주맙(Ocrelizumab)을 포함하는 약학적 조성물과 그의 용도
US20250332252A1 (en) 2022-06-02 2025-10-30 Bristol-Myers Squibb Company Antibody compositions and methods of use thereof
KR102774438B1 (ko) * 2022-06-08 2025-02-27 (주)한국비엠아이 히알루로니다제 폴리펩티드 및 이의 용도
WO2023249408A1 (ko) * 2022-06-22 2023-12-28 (주)알테오젠 N-말단 및/또는 c-말단이 절단된 가용성 ph20 폴리펩티드 및 이의 용도
CN119421949A (zh) * 2022-06-29 2025-02-11 奥德斯根株式会社 中性pH中显示活性的透明质酸酶Hyal1变体
KR102621518B1 (ko) * 2022-06-29 2024-01-10 주식회사 오디스젠 중성 pH에서 활성을 나타내는 히알루로니다제 Hyal1변이체
EP4562048A1 (en) * 2022-07-28 2025-06-04 Merck Sharp & Dohme LLC Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and ph20 variants or fragments thereof
WO2024025989A1 (en) * 2022-07-28 2024-02-01 Merck Sharp & Dohme Llc Pharmaceutical compositions of programmed death receptor 1 (pd-1) antibodies and rhuph20 or variants or fragments thereof
KR20240038901A (ko) * 2022-09-16 2024-03-26 (주)피앤피바이오팜 신규한 히알루로니다제 ph-20 변이체 및 그 용도
CN120936341A (zh) 2022-12-22 2025-11-11 海洋酶公司 用于高体积施用的透明质酸酶制剂
KR20250162568A (ko) * 2023-03-23 2025-11-18 (주)알테오젠 신규 히알루론산 가수분해 효소 변이체 및 이를 포함하는 약제학적 조성물
KR20250086876A (ko) * 2023-12-06 2025-06-16 (주)한국비엠아이 히알루로니다제 폴리펩티드와 약물을 포함하는 피하투여용 조성물
KR102896967B1 (ko) * 2023-12-21 2025-12-09 주식회사 오디스젠 개선된 특성을 갖는 히알루로니다제 Hyal2 변이체
WO2025136032A1 (ko) * 2023-12-21 2025-06-26 주식회사 오디스젠 개선된 특성을 갖는 히알루로니다제 hyal2 변이체
KR102875495B1 (ko) * 2023-12-28 2025-10-27 주식회사 오디스젠 히알루로니다제 Hyal1 변이체
CN119776311B (zh) * 2024-12-13 2025-12-19 江南大学 一种透明质酸合酶突变体及其应用

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