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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WIPO (PCT)
Prior art keywords
fusion protein
novel therapeutic
therapeutic enzyme
enzyme fusion
same
Prior art date
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PCT/KR2018/007754
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English (en)
French (fr)
Other versions
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.)
Filing date
Publication date
Priority to NZ760918A priority Critical patent/NZ760918A/en
Priority to BR112020000273-9A priority patent/BR112020000273A2/pt
Priority to JP2020500616A priority patent/JP2020530283A/ja
Priority to MX2020000037A priority patent/MX2020000037A/es
Priority to AU2018295994A priority patent/AU2018295994A1/en
Priority to CN201880057908.2A priority patent/CN111094559A/zh
Priority to EA202090084A priority patent/EA202090084A1/ru
Priority to CA3069119A priority patent/CA3069119A1/en
Application filed by 한미약품 주식회사 filed Critical 한미약품 주식회사
Priority to US16/628,722 priority patent/US20200157172A1/en
Priority to EP18827529.1A priority patent/EP3650539A4/en
Priority to IL271837A priority patent/IL271837B2/en
Priority to SG11202000115SA priority patent/SG11202000115SA/en
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)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (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)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Neurology (AREA)
  • Neurosurgery (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 (15)

Application Number Priority Date Filing Date Title
US16/628,722 US20200157172A1 (en) 2017-07-07 2018-07-09 Novel therapeutic enzyme fusion protein and use thereof
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
EP18827529.1A EP3650539A4 (en) 2017-07-07 2018-07-09 NEW THERAPEUTIC ENZYMATIC FUSION PROTEIN AND ASSOCIATED USE
AU2018295994A AU2018295994A1 (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
EA202090084A EA202090084A1 (ru) 2017-07-07 2018-07-09 Новый терапевтический ферментный слитый белок и его применение
CA3069119A CA3069119A1 (en) 2017-07-07 2018-07-09 Novel therapeutic enzyme fusion protein and use thereof
NZ760918A NZ760918A (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
MX2020000037A MX2020000037A (es) 2017-07-07 2018-07-09 Novedosa proteína terapéutica de fusión enzimática y uso de la misma.
IL271837A IL271837B2 (en) 2017-07-07 2018-07-09 A new medical fusion protein with an enzyme and its uses
SG11202000115SA SG11202000115SA (en) 2017-07-07 2018-07-09 Novel therapeutic enzyme fusion protein and use thereof
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
KR10-2017-0086594 2017-07-07
KR20170086594 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 (18)

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)
NZ (1) NZ760918A (ko)
PH (1) PH12020500054A1 (ko)
SG (1) SG11202000115SA (ko)
TW (1) TWI832818B (ko)
WO (1) WO2019009684A2 (ko)
ZA (1) ZA202000595B (ko)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CR20200129A (es) 2017-10-02 2020-08-22 Denali Therapeutics Inc Proteínas de fusión que comprenden enzimas de terapia de reemplazo de enzimas
CN111511910A (zh) * 2017-12-22 2020-08-07 韩美药品株式会社 具有新颖结构的治疗酶融合蛋白及其用途
EP4229192A1 (en) 2020-10-14 2023-08-23 Denali Therapeutics Inc. Fusion proteins comprising sulfoglucosamine sulfohydrolase enzymes and methods thereof
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
KR20220065719A (ko) * 2020-11-13 2022-05-20 한미약품 주식회사 치료학적 효소 융합단백질의 파브리병에 기인하거나 동반되는 신장질환 예방 및 치료 용도

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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
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
KR20150136514A (ko) * 2013-04-02 2015-12-07 추가이 세이야쿠 가부시키가이샤 Ｆｃ영역 개변체
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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US6096871A (en) 1995-04-14 2000-08-01 Genentech, Inc. Polypeptides altered to contain an epitope from the Fc region of an IgG molecule for increased half-life
AU728657B2 (en) 1996-03-18 2001-01-18 Board Of Regents, The University Of Texas System Immunoglobulin-like domains with increased half-lives
MXPA03008031A (es) * 2001-03-07 2003-12-04 Merck Patent Gmbh Tecnologia de expresion para proteinas que contienen porcion de anticuerpo isotipo hibrida.
ATE509954T1 (de) * 2005-12-30 2011-06-15 Merck Patent Gmbh Anti-cd19-antikörper mit reduzierter immunogenität
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Publication number Priority date Publication date Assignee Title
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
KR20190005803A (ko) 2019-01-16
NZ760918A (en) 2024-07-26
KR20220098092A (ko) 2022-07-11
KR102413686B1 (ko) 2022-06-28
PH12020500054A1 (en) 2020-09-21
EP3650539A4 (en) 2021-08-18
TW201906872A (zh) 2019-02-16
TWI832818B (zh) 2024-02-21
US20200157172A1 (en) 2020-05-21
JP2023085445A (ja) 2023-06-20
MX2020000037A (es) 2020-08-06
BR112020000273A2 (pt) 2020-07-14
EP3650539A2 (en) 2020-05-13
JP2020530283A (ja) 2020-10-22
AR112755A1 (es) 2019-12-11
AU2018295994A1 (en) 2020-02-06
CA3069119A1 (en) 2019-01-10
WO2019009684A2 (ko) 2019-01-10
CN111094559A (zh) 2020-05-01
IL271837B1 (en) 2023-09-01
EA202090084A1 (ru) 2020-06-19
IL271837B2 (en) 2024-01-01
KR102556411B1 (ko) 2023-07-18
SG11202000115SA (en) 2020-02-27
IL271837A (en) 2020-02-27
ZA202000595B (en) 2021-04-28

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