AU2019311658B2 - Novel hyaluronidase variants and pharmaceutical composition comprising the same - Google Patents
Novel hyaluronidase variants and pharmaceutical composition comprising the same Download PDFInfo
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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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- 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
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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
- 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
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- 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
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- 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)
- Immunology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Plant Pathology (AREA)
- Reproductive Health (AREA)
- Physics & Mathematics (AREA)
- Cell Biology (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)
Priority Applications (2)
| 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 |
| AU2025275191A AU2025275191A1 (en) | 2018-07-25 | 2025-12-03 | 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 | ||
| KR20190029758 | 2019-03-15 | ||
| KR10-2019-0029758 | 2019-03-15 | ||
| PCT/KR2019/009215 WO2020022791A1 (ko) | 2018-07-25 | 2019-07-25 | 신규 히알루론산 가수분해 효소 변이체 및 이를 포함하는 약제학적 조성물 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2023200324A Division AU2023200324B9 (en) | 2018-07-25 | 2023-01-20 | Novel hyaluoronic acid-hydrolyzing enzyme variant and pharmaceutical composition containing same |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| AU2019311658A1 AU2019311658A1 (en) | 2021-02-11 |
| AU2019311658A8 AU2019311658A8 (en) | 2021-03-25 |
| AU2019311658B2 true AU2019311658B2 (en) | 2022-10-20 |
Family
ID=69182377
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2019311658A Active AU2019311658B2 (en) | 2018-07-25 | 2019-07-25 | Novel hyaluronidase variants and pharmaceutical composition comprising the same |
| AU2023200324A Active AU2023200324B9 (en) | 2018-07-25 | 2023-01-20 | Novel hyaluoronic acid-hydrolyzing enzyme variant and pharmaceutical composition containing same |
| AU2025275191A Pending AU2025275191A1 (en) | 2018-07-25 | 2025-12-03 | Novel hyaluoronic acid-hydrolyzing enzyme variant and pharmaceutical composition containing same |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2023200324A Active AU2023200324B9 (en) | 2018-07-25 | 2023-01-20 | Novel hyaluoronic acid-hydrolyzing enzyme variant and pharmaceutical composition containing same |
| AU2025275191A Pending AU2025275191A1 (en) | 2018-07-25 | 2025-12-03 | Novel hyaluoronic acid-hydrolyzing enzyme variant and pharmaceutical composition containing same |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US12371683B2 (https=) |
| EP (1) | EP3636752A4 (https=) |
| JP (3) | JP7204729B2 (https=) |
| KR (3) | KR20250021616A (https=) |
| CN (5) | CN118755703A (https=) |
| AU (3) | AU2019311658B2 (https=) |
| BR (1) | BR112020019041A2 (https=) |
| CA (1) | CA3093885A1 (https=) |
| MX (1) | MX2020009824A (https=) |
| WO (1) | WO2020022791A1 (https=) |
Families Citing this family (42)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2532399T3 (es) | 2003-03-05 | 2015-03-26 | Halozyme, Inc. | Glicoproteína hialuronidasa soluble (sHASEGP), proceso para prepararla, usos y composiciones farmacéuticas que la comprenden |
| EP3130347B1 (en) | 2011-12-30 | 2019-09-18 | Halozyme, Inc. | Ph20 polypeptide variants, formulations and uses thereof |
| EP3636752A4 (en) | 2018-07-25 | 2021-04-28 | Alteogen, Inc. | NEW HYALURONIC ACID HYDROLYZING ENZYMUTANTS AND THE PHARMACEUTICAL COMPOSITION CONTAINING THIS |
| KR102885113B1 (ko) | 2018-10-18 | 2025-11-13 | 머크 샤프 앤드 돔 엘엘씨 | 항-rsv 항체의 제제 및 그의 사용 방법 |
| CN120842406A (zh) | 2018-10-31 | 2025-10-28 | 默沙东有限责任公司 | 抗人pd-1抗体晶体及其使用方法 |
| CN113316458B (zh) | 2018-11-07 | 2024-08-02 | 默沙东有限责任公司 | 抗lag3抗体和抗pd-1抗体的共制剂 |
| MY204342A (en) * | 2019-03-25 | 2024-08-24 | Alteogen Inc | Pharmaceutical composition, comprising human hyaluronidase ph20 variant and drug, for subcutaneous injection |
| EP3992285A4 (en) | 2020-01-23 | 2023-01-25 | Alteogen, Inc. | NOVEL HYALURONIC HYDROLYZING ENZYME VARIANT WITH IMPROVED STABILITY AND PHARMACEUTICAL COMPOSITION CONTAINING IT |
| JP2023534295A (ja) | 2020-07-17 | 2023-08-08 | ジェロン・コーポレーション | 皮下テロメラーゼ阻害剤組成物及びそれらを使用するための方法 |
| JP7622088B2 (ja) | 2020-08-07 | 2025-01-27 | アルテオジェン・インコーポレイテッド | 組換えヒアルロニダーゼの生産方法 |
| IL301533A (en) | 2020-09-24 | 2023-05-01 | Merck Sharp ַ& Dohme Llc | Stable compositions of programmed death receptor 1 (PD-1) antibodies and hyaluronidase variants and parts thereof and methods of using them |
| SMT202500208T1 (it) | 2020-12-28 | 2025-07-22 | Bristol Myers Squibb Co | Composizioni anticorpali e metodi per il loro uso |
| JP2024501029A (ja) | 2020-12-28 | 2024-01-10 | ブリストル－マイヤーズ スクイブ カンパニー | Ｐｄ１／ｐｄ－ｌ１抗体の皮下投与 |
| TW202305009A (zh) | 2021-04-08 | 2023-02-01 | 美商默沙東有限責任公司 | 以皮下投予抗pd1抗體治療癌症之方法 |
| 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 |
| CA3232451A1 (en) | 2021-09-14 | 2023-03-23 | Takeda Pharmaceutical Company Limited | Facilitated delivery of concentrated antibody formulations using hyaluronidase |
| EP4424301A4 (en) * | 2021-10-29 | 2025-11-19 | Alteogen Inc | Pharmaceutical composition comprising a human PH20 hyaluronidase and a medicinal product |
| US20250099612A1 (en) | 2022-03-01 | 2025-03-27 | Exuma Biotech Corp. | Viral particles with membrane-bound hyaluronidase |
| CN114573715A (zh) * | 2022-03-14 | 2022-06-03 | 江苏雅酶医药科技有限公司 | 一种重组长效人透明质酸酶及其生产方法和应用 |
| JP2025513510A (ja) | 2022-04-20 | 2025-04-24 | アルトス バイオロジックス インク． | オクレリズマブを含む薬学的組成物とその用途 |
| EP4531916A1 (en) | 2022-06-02 | 2025-04-09 | 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 |
| KR102621518B1 (ko) * | 2022-06-29 | 2024-01-10 | 주식회사 오디스젠 | 중성 pH에서 활성을 나타내는 히알루로니다제 Hyal1변이체 |
| WO2024005502A1 (ko) * | 2022-06-29 | 2024-01-04 | 주식회사 오디스젠 | 중성 ph에서 활성을 나타내는 히알루로니다제 hyal1 변이체 |
| 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 |
| KR20250054235A (ko) * | 2022-07-28 | 2025-04-22 | 머크 샤프 앤드 돔 엘엘씨 | 프로그램화된 사멸 수용체 1 (PD-1) 항체 및 rHuPH20 또는 그의 변이체 또는 단편의 제약 조성물 |
| KR20240038901A (ko) * | 2022-09-16 | 2024-03-26 | (주)피앤피바이오팜 | 신규한 히알루로니다제 ph-20 변이체 및 그 용도 |
| IL321611A (en) | 2022-12-22 | 2025-08-01 | Halozyme Inc | High-dose hyaluronidase enzyme formulations |
| CN120936711A (zh) * | 2023-03-23 | 2025-11-11 | 阿特根公司 | 新型透明质酸酶变体及包括其的药物组合物 |
| 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 |
| WO2025168089A1 (zh) | 2024-02-08 | 2025-08-14 | 上海宝济药业股份有限公司 | 用于皮下给药的药物组合及其应用 |
| WO2025264972A1 (en) | 2024-06-21 | 2025-12-26 | Apogee Therapeutics, Inc. | Antibodies that bind il-4r alpha and antibodies that bind |
| WO2025264960A1 (en) | 2024-06-21 | 2025-12-26 | Apogee Therapeutics, Inc. | Antibodies that bind il-13 and antibodies that bind ox40l |
| WO2026001707A1 (zh) * | 2024-06-27 | 2026-01-02 | 上海复宏汉霖生物技术股份有限公司 | 一种新型透明质酸酶变体 |
| WO2026037175A1 (zh) | 2024-08-16 | 2026-02-19 | 上海宝济药业股份有限公司 | 靶向靶细胞的复合物及其应用 |
| 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 |
| CN121737095A (zh) * | 2026-02-28 | 2026-03-27 | 齐鲁制药有限公司 | 透明质酸酶ph20多肽修饰变体、组合物及应用 |
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| CN118853631A (zh) | 2024-10-29 |
| KR20210023798A (ko) | 2021-03-04 |
| AU2025275191A1 (en) | 2026-01-15 |
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| JP2021507676A (ja) | 2021-02-25 |
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| CA3093885A1 (en) | 2020-01-30 |
| KR20250021616A (ko) | 2025-02-13 |
| EP3636752A4 (en) | 2021-04-28 |
| CN111971387A (zh) | 2020-11-20 |
| AU2023200324A1 (en) | 2023-03-02 |
| AU2019311658A8 (en) | 2021-03-25 |
| KR20200017538A (ko) | 2020-02-18 |
| AU2019311658A1 (en) | 2021-02-11 |
| AU2023200324B2 (en) | 2025-09-04 |
| CN118773171B (zh) | 2026-03-13 |
| EP3636752A1 (en) | 2020-04-15 |
| CN118792283A (zh) | 2024-10-18 |
| AU2023200324B9 (en) | 2025-12-04 |
| CN118755703A (zh) | 2024-10-11 |
| US20250368976A1 (en) | 2025-12-04 |
| KR102151388B1 (ko) | 2020-09-04 |
| US12371683B2 (en) | 2025-07-29 |
| WO2020022791A1 (ko) | 2020-01-30 |
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| RU2766680C1 (ru) | 2022-03-15 |
| JP2025004002A (ja) | 2025-01-14 |
| MX2020009824A (es) | 2021-01-15 |
| BR112020019041A2 (pt) | 2021-02-09 |
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