WO2019009684A3 - 신규 치료학적 효소 융합단백질 및 이의 용도 - Google Patents

신규 치료학적 효소 융합단백질 및 이의 용도 Download PDF

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Publication number
WO2019009684A3
WO2019009684A3 PCT/KR2018/007754 KR2018007754W WO2019009684A3 WO 2019009684 A3 WO2019009684 A3 WO 2019009684A3 KR 2018007754 W KR2018007754 W KR 2018007754W WO 2019009684 A3 WO2019009684 A3 WO 2019009684A3
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WO
WIPO (PCT)
Prior art keywords
fusion protein
novel therapeutic
therapeutic enzyme
enzyme fusion
same
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PCT/KR2018/007754
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English (en)
French (fr)
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WO2019009684A2 (ko
Inventor
허용호
김진영
최인영
정성엽
Original Assignee
한미약품 주식회사
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.)
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Publication date
Priority to EA202090084A priority Critical patent/EA202090084A1/ru
Priority to SG11202000115SA priority patent/SG11202000115SA/en
Application filed by 한미약품 주식회사 filed Critical 한미약품 주식회사
Priority to JP2020500616A priority patent/JP2020530283A/ja
Priority to MX2020000037A priority patent/MX2020000037A/es
Priority to US16/628,722 priority patent/US20200157172A1/en
Priority to IL271837A priority patent/IL271837B2/en
Priority to CA3069119A priority patent/CA3069119A1/en
Priority to AU2018295994A priority patent/AU2018295994A1/en
Priority to BR112020000273-9A priority patent/BR112020000273A2/pt
Priority to EP18827529.1A priority patent/EP3650539A4/en
Priority to CN201880057908.2A priority patent/CN111094559A/zh
Publication of WO2019009684A2 publication Critical patent/WO2019009684A2/ko
Publication of WO2019009684A3 publication Critical patent/WO2019009684A3/ko
Priority to PH12020500054A priority patent/PH12020500054A1/en
Priority to ZA2020/00595A priority patent/ZA202000595B/en
Priority to JP2023061129A priority patent/JP2023085445A/ja

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • 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)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • 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)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • 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)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/528—CH4 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06001—Arylsulfatase (3.1.6.1)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06012—N-Acetylgalactosamine-4-sulfatase (3.1.6.12)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/06—Sulfuric ester hydrolases (3.1.6)
    • C12Y301/06013—Iduronate-2-sulfatase (3.1.6.13)

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Cell Biology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

본 발명은 치료학적 효소와 면역글로불린 Fc 영역의 융합단백질, 이의 제조 방법, 및 이를 포함하는 조성물에 관한 것이다.
PCT/KR2018/007754 2017-07-07 2018-07-09 신규 치료학적 효소 융합단백질 및 이의 용도 WO2019009684A2 (ko)

Priority Applications (14)

Application Number Priority Date Filing Date Title
BR112020000273-9A BR112020000273A2 (pt) 2017-07-07 2018-07-09 proteína de fusão de enzima e seu método de preparação, composição farmacêutica, polinucleotídeo que codifica a proteína de fusão de enzima, vetor de expressão, transformante
AU2018295994A AU2018295994A1 (en) 2017-07-07 2018-07-09 Novel therapeutic enzyme fusion protein and use thereof
JP2020500616A JP2020530283A (ja) 2017-07-07 2018-07-09 新規治療学的酵素融合タンパク質及びその用途
SG11202000115SA SG11202000115SA (en) 2017-07-07 2018-07-09 Novel therapeutic enzyme fusion protein and use thereof
US16/628,722 US20200157172A1 (en) 2017-07-07 2018-07-09 Novel therapeutic enzyme fusion protein and use thereof
IL271837A IL271837B2 (en) 2017-07-07 2018-07-09 A new medical fusion protein with an enzyme and its uses
EP18827529.1A EP3650539A4 (en) 2017-07-07 2018-07-09 NEW THERAPEUTIC ENZYMATIC FUSION PROTEIN AND ASSOCIATED USE
EA202090084A EA202090084A1 (ru) 2017-07-07 2018-07-09 Новый терапевтический ферментный слитый белок и его применение
MX2020000037A MX2020000037A (es) 2017-07-07 2018-07-09 Novedosa proteína terapéutica de fusión enzimática y uso de la misma.
CA3069119A CA3069119A1 (en) 2017-07-07 2018-07-09 Novel therapeutic enzyme fusion protein and use thereof
CN201880057908.2A CN111094559A (zh) 2017-07-07 2018-07-09 新型治疗酶融合蛋白及其用途
PH12020500054A PH12020500054A1 (en) 2017-07-07 2020-01-06 Novel therapeutic enzyme fusion protein and use thereof
ZA2020/00595A ZA202000595B (en) 2017-07-07 2020-01-29 Novel therapeutic enzyme fusion protein and use thereof
JP2023061129A JP2023085445A (ja) 2017-07-07 2023-04-05 新規治療学的酵素融合タンパク質及びその用途

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20170086594 2017-07-07
KR10-2017-0086594 2017-07-07

Publications (2)

Publication Number Publication Date
WO2019009684A2 WO2019009684A2 (ko) 2019-01-10
WO2019009684A3 true WO2019009684A3 (ko) 2019-03-28

Family

ID=64950229

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2018/007754 WO2019009684A2 (ko) 2017-07-07 2018-07-09 신규 치료학적 효소 융합단백질 및 이의 용도

Country Status (17)

Country Link
US (1) US20200157172A1 (ko)
EP (1) EP3650539A4 (ko)
JP (2) JP2020530283A (ko)
KR (2) KR102413686B1 (ko)
CN (1) CN111094559A (ko)
AR (1) AR112755A1 (ko)
AU (1) AU2018295994A1 (ko)
BR (1) BR112020000273A2 (ko)
CA (1) CA3069119A1 (ko)
EA (1) EA202090084A1 (ko)
IL (1) IL271837B2 (ko)
MX (1) MX2020000037A (ko)
PH (1) PH12020500054A1 (ko)
SG (1) SG11202000115SA (ko)
TW (1) TWI832818B (ko)
WO (1) WO2019009684A2 (ko)
ZA (1) ZA202000595B (ko)

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JP2021500857A (ja) 2017-10-02 2021-01-14 デナリ セラピューティクス インコーポレイテッドＤｅｎａｌｉ Ｔｈｅｒａｐｅｕｔｉｃｓ Ｉｎｃ． 酵素補充療法用酵素を含む融合タンパク質
EA202091239A1 (ru) * 2017-12-22 2020-09-09 Ханми Фарм. Ко., Лтд. Слитый белок на основе терапевтического фермента, имеющий новую структуру, и его применение
WO2022081765A1 (en) 2020-10-14 2022-04-21 Denali Therapeutics Inc. Fusion proteins comprising sulfoglucosamine sulfohydrolase enzymes and methods thereof
JP2023549323A (ja) * 2020-11-13 2023-11-24 ハンミ ファーマシューティカル カンパニー リミテッド 治療学的酵素融合タンパク質のファブリー病に起因する又は伴う腎臓疾患の予防及び治療用途
CN116419759A (zh) * 2020-11-13 2023-07-11 韩美药品株式会社 治疗酶融合蛋白在预防和治疗由法布里病引起或伴有法布里病的神经病中的用途

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WO2015009052A1 (ko) * 2013-07-16 2015-01-22 일동제약 주식회사 하이브리드 면역글로불린 fc와 효소의 융합단백질
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JP2004525621A (ja) * 2001-01-18 2004-08-26 メルク　パテント　ゲゼルシャフト　ミット　ベシュレンクテル　ハフトング グルコセレブロシダーゼ活性を有する二機能性融合タンパク質
KR20150136514A (ko) * 2013-04-02 2015-12-07 추가이 세이야쿠 가부시키가이샤 Ｆｃ영역 개변체
WO2014193173A1 (ko) * 2013-05-31 2014-12-04 한미약품 주식회사 변이된 힌지 영역을 포함하는 igg4 fc 단편
WO2015009052A1 (ko) * 2013-07-16 2015-01-22 일동제약 주식회사 하이브리드 면역글로불린 fc와 효소의 융합단백질
WO2017100467A2 (en) * 2015-12-08 2017-06-15 Regeneron Pharmaceuticals, Inc. Compositions and methods for internalizing enzymes
KR20170091056A (ko) * 2016-01-29 2017-08-08 한미약품 주식회사 치료학적 효소류의 결합체

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Publication number Publication date
WO2019009684A2 (ko) 2019-01-10
PH12020500054A1 (en) 2020-09-21
CN111094559A (zh) 2020-05-01
EA202090084A1 (ru) 2020-06-19
KR20220098092A (ko) 2022-07-11
US20200157172A1 (en) 2020-05-21
CA3069119A1 (en) 2019-01-10
TWI832818B (zh) 2024-02-21
IL271837B1 (en) 2023-09-01
SG11202000115SA (en) 2020-02-27
BR112020000273A2 (pt) 2020-07-14
EP3650539A4 (en) 2021-08-18
KR20190005803A (ko) 2019-01-16
KR102413686B1 (ko) 2022-06-28
MX2020000037A (es) 2020-08-06
JP2020530283A (ja) 2020-10-22
AU2018295994A1 (en) 2020-02-06
JP2023085445A (ja) 2023-06-20
EP3650539A2 (en) 2020-05-13
KR102556411B1 (ko) 2023-07-18
IL271837A (en) 2020-02-27
IL271837B2 (en) 2024-01-01
AR112755A1 (es) 2019-12-11
TW201906872A (zh) 2019-02-16
ZA202000595B (en) 2021-04-28

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