CN106102749B - 唾液酸化糖蛋白组合物及其用途 - Google Patents

唾液酸化糖蛋白组合物及其用途 Download PDF

Info

Publication number
CN106102749B
CN106102749B CN201580015886.XA CN201580015886A CN106102749B CN 106102749 B CN106102749 B CN 106102749B CN 201580015886 A CN201580015886 A CN 201580015886A CN 106102749 B CN106102749 B CN 106102749B
Authority
CN
China
Prior art keywords
glucuronidase
recombinant glycoprotein
rhgus
recombinant
composition
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CN201580015886.XA
Other languages
English (en)
Chinese (zh)
Other versions
CN106102749A (zh
Inventor
S·琼格勒斯
G·莫里斯
J·格拉布
M·韦拉德
E·D·卡基斯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ultragenyx Pharmaceutical Inc
Original Assignee
Ultragenyx Pharmaceutical 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 Ultragenyx Pharmaceutical Inc filed Critical Ultragenyx Pharmaceutical Inc
Publication of CN106102749A publication Critical patent/CN106102749A/zh
Application granted granted Critical
Publication of CN106102749B publication Critical patent/CN106102749B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • 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
    • C12N15/67—General methods for enhancing the expression
    • 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)
    • 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)
    • C12N9/2468—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1) acting on beta-galactose-glycoside bonds, e.g. carrageenases (3.2.1.83; 3.2.1.157); beta-agarase (3.2.1.81)
    • 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)
    • C12Y302/01031—Beta-glucuronidase (3.2.1.31)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Plant Pathology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
CN201580015886.XA 2014-03-05 2015-03-05 唾液酸化糖蛋白组合物及其用途 Active CN106102749B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201461948421P 2014-03-05 2014-03-05
US61/948,421 2014-03-05
US201562114313P 2015-02-10 2015-02-10
US62/114,313 2015-02-10
PCT/US2015/018859 WO2015134696A1 (en) 2014-03-05 2015-03-05 Sialylated glycoprotein compositions and uses thereof

Publications (2)

Publication Number Publication Date
CN106102749A CN106102749A (zh) 2016-11-09
CN106102749B true CN106102749B (zh) 2019-07-12

Family

ID=54016314

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201580015886.XA Active CN106102749B (zh) 2014-03-05 2015-03-05 唾液酸化糖蛋白组合物及其用途

Country Status (17)

Country Link
US (9) US9457067B2 (cg-RX-API-DMAC10.html)
EP (1) EP3113781B1 (cg-RX-API-DMAC10.html)
JP (1) JP6581590B2 (cg-RX-API-DMAC10.html)
KR (1) KR102150481B1 (cg-RX-API-DMAC10.html)
CN (1) CN106102749B (cg-RX-API-DMAC10.html)
AU (1) AU2015227137B2 (cg-RX-API-DMAC10.html)
BR (1) BR112016019893B1 (cg-RX-API-DMAC10.html)
CA (1) CA2940318C (cg-RX-API-DMAC10.html)
ES (1) ES2704923T3 (cg-RX-API-DMAC10.html)
IL (1) IL247550B (cg-RX-API-DMAC10.html)
MX (1) MX368972B (cg-RX-API-DMAC10.html)
MY (1) MY188028A (cg-RX-API-DMAC10.html)
PE (1) PE20161417A1 (cg-RX-API-DMAC10.html)
PH (1) PH12016501658A1 (cg-RX-API-DMAC10.html)
RU (1) RU2689119C2 (cg-RX-API-DMAC10.html)
TW (1) TWI702049B (cg-RX-API-DMAC10.html)
WO (1) WO2015134696A1 (cg-RX-API-DMAC10.html)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX368972B (es) 2014-03-05 2019-10-23 Ultragenyx Pharmaceutical Inc Composiciones de glicoproteínas sialiladas y usos de estas.
EP3724314A1 (en) 2017-12-13 2020-10-21 3M Innovative Properties Company Water-reconstitutable culture medium resistant to liquefaction by microorganisms
TWI667252B (zh) * 2018-07-13 2019-08-01 中原大學 阿伐-選擇性唾液酸供體及其於製備唾液酸苷的用途

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6458574B1 (en) 1996-09-12 2002-10-01 Transkaryotic Therapies, Inc. Treatment of a α-galactosidase a deficiency
CA2492267C (en) * 2002-07-15 2013-09-10 Immunex Corporation Methods and media for controlling sialylation of proteins produced by mammalian cells
US20060104968A1 (en) * 2003-03-05 2006-05-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases
EP1699821B1 (en) * 2003-12-31 2012-06-20 Merck Patent GmbH Fc-ERYTHROPOIETIN FUSION PROTEIN WITH IMPROVED PHARMACOKINETICS
EP1818395A1 (en) * 2006-02-08 2007-08-15 Diatos Compositions and methods for treating lysosomal storage diseases
WO2008028686A2 (en) * 2006-09-10 2008-03-13 Glycotope Gmbh Use of human cells of myeloid leukaemia origin for expression of antibodies
WO2008109677A2 (en) * 2007-03-06 2008-09-12 Saint Louis University Modified enzyme and treatment method
WO2011096750A2 (en) * 2010-02-08 2011-08-11 Korea Advanced Institute Of Science And Technology Method for preparing recombinant glycoproteins with high sialic acid content
WO2012101671A1 (en) * 2011-01-25 2012-08-02 Jcr Pharmaceuticals Co., Ltd. Method for production of human recombinant iduronate 2-sulfatase
KR101457514B1 (ko) * 2011-11-21 2014-11-03 한국생명공학연구원 우렁쉥이(멍게) 유래의 시알산 전이효소 및 이를 이용한 시알화 복합당질 합성 방법
US10138474B2 (en) * 2012-08-17 2018-11-27 Research Foundation Of The City University Of New York Scavenger receptor uptake for fabry disease enzyme replacement therapy
MX368972B (es) 2014-03-05 2019-10-23 Ultragenyx Pharmaceutical Inc Composiciones de glicoproteínas sialiladas y usos de estas.

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
A biochemical and pharmacological comparison of enzyme replacement therapies for the glycolipid storage disorder Fabry disease;Karen Lee etal;《glycobiology》;20030401;第13卷(第4期);参见摘要，表3，图4，第309页右栏第1段，第305-313页 *
Overcoming the blood–brain barrier with high-dose enzyme replacement therapy in murine mucopolysaccharidosis VII;Carole Vogler etal;《PNAS》;20051011;第102卷(第41期);参见摘要，第14777-14782页 *

Also Published As

Publication number Publication date
RU2016138790A3 (cg-RX-API-DMAC10.html) 2018-08-23
US20160367646A1 (en) 2016-12-22
CA2940318C (en) 2020-09-22
BR112016019893A2 (pt) 2017-10-24
TWI702049B (zh) 2020-08-21
BR112016019893B1 (pt) 2023-02-14
TW201615210A (zh) 2016-05-01
US20190054153A1 (en) 2019-02-21
US20220202915A1 (en) 2022-06-30
CA2940318A1 (en) 2015-09-11
EP3113781B1 (en) 2018-11-21
US20200282028A1 (en) 2020-09-10
US20260077025A1 (en) 2026-03-19
US9457067B2 (en) 2016-10-04
IL247550A0 (en) 2016-11-30
ES2704923T3 (es) 2019-03-20
EP3113781A4 (en) 2017-08-09
MX368972B (es) 2019-10-23
US20150366951A1 (en) 2015-12-24
CN106102749A (zh) 2016-11-09
US9687532B2 (en) 2017-06-27
US9937243B2 (en) 2018-04-10
MY188028A (en) 2021-11-10
JP2017508455A (ja) 2017-03-30
WO2015134696A1 (en) 2015-09-11
RU2689119C2 (ru) 2019-05-24
US9457068B2 (en) 2016-10-04
PH12016501658A1 (en) 2016-10-03
US20240245759A1 (en) 2024-07-25
EP3113781A1 (en) 2017-01-11
AU2015227137B2 (en) 2019-06-06
JP6581590B2 (ja) 2019-09-25
RU2016138790A (ru) 2018-04-09
IL247550B (en) 2020-10-29
US20150250860A1 (en) 2015-09-10
AU2015227137A1 (en) 2016-09-15
MX2016011416A (es) 2016-12-02
US20170326210A1 (en) 2017-11-16
KR102150481B1 (ko) 2020-09-02
KR20160127124A (ko) 2016-11-02
PE20161417A1 (es) 2017-01-22

Similar Documents

Publication Publication Date Title
JP7436545B2 (ja) 高ｍ６ｐ組換えタンパク質の選択方法
US10512676B2 (en) Formulations comprising recombinant acid alpha-glucosidase
US20260077025A1 (en) Sialylated glycoprotein composition and uses thereof
US20120020951A1 (en) Adverse side-effects associated with administration of anti-hyaluronan agents and methods for ameliorating or preventing the side-effects
US10413597B2 (en) Methods of treating Mucopolysaccharidosis IIIB (MPSIIIB)
EP3436053B1 (en) Formulations comprising recombinant acid alpha-glucosidase
TWI759291B (zh) 用於選擇高m6p重組蛋白之方法
HK1262140A1 (en) Formulations comprising recombinant acid alpha-glucosidase
NZ786386A (en) Formulations comprising recombinant acid alpha-glucosidase

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant