AU2016273343B2 - Adenoassociated virus vectors for the treatment of mucopolysaccharidoses - Google Patents

Adenoassociated virus vectors for the treatment of mucopolysaccharidoses Download PDF

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Publication number
AU2016273343B2
AU2016273343B2 AU2016273343A AU2016273343A AU2016273343B2 AU 2016273343 B2 AU2016273343 B2 AU 2016273343B2 AU 2016273343 A AU2016273343 A AU 2016273343A AU 2016273343 A AU2016273343 A AU 2016273343A AU 2016273343 B2 AU2016273343 B2 AU 2016273343B2
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Prior art keywords
cag
aav9
seq
plasmid
vectors
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Ceased
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AU2016273343A
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AU2016273343A1 (en
Inventor
Maria Fátima BOSCH TUBERT
Virginia Areba Haurigot
Sandra MOTAS MALLOL
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Universitat Autonoma de Barcelona UAB
Esteve Pharmaceuticals SA
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Universitat Autonoma de Barcelona UAB
Esteve Pharmaceuticals SA
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Assigned to UNIVERSITAT AUTÓNOMA DE BARCELONA, ESTEVE PHARMACEUTICALS, S.A. reassignment UNIVERSITAT AUTÓNOMA DE BARCELONA Alteration of Name(s) of Applicant(s) under S113 Assignors: LABORATORIOS DEL DR. ESTEVE, S.A., UNIVERSITAT AUTÓNOMA DE BARCELONA
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0008—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition
    • A61K48/0016—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'non-active' part of the composition delivered, e.g. wherein such 'non-active' part is not delivered simultaneously with the 'active' part of the composition wherein the nucleic acid is delivered as a 'naked' nucleic acid, i.e. not combined with an entity such as a cationic lipid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/005—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered
    • A61K48/0066—Manipulation of the nucleic acid to modify its expression pattern, e.g. enhance its duration of expression, achieved by the presence of particular introns in the delivered nucleic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • A61K48/0075—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy characterised by an aspect of the delivery route, e.g. oral, subcutaneous
    • 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
    • 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
    • C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
    • 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
    • C12N15/86—Viral vectors
    • 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
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/14011—Parvoviridae
    • C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14141—Use of virus, viral particle or viral elements as a vector
    • C12N2750/14143—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • 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
    • C12N2800/22—Vectors comprising a coding region that has been codon optimised for expression in a respective host
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Virology (AREA)
  • Dermatology (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
AU2016273343A 2015-06-05 2016-06-03 Adenoassociated virus vectors for the treatment of mucopolysaccharidoses Ceased AU2016273343B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP15382297.8 2015-06-05
EP15382297.8A EP3101125A1 (en) 2015-06-05 2015-06-05 Adenoassociated virus vectors for the treatment of mucopolysaccharidoses
PCT/EP2016/062655 WO2016193431A1 (en) 2015-06-05 2016-06-03 Adenoassociated virus vectors for the treatment of mucopolysaccharidoses

Publications (2)

Publication Number Publication Date
AU2016273343A1 AU2016273343A1 (en) 2017-12-21
AU2016273343B2 true AU2016273343B2 (en) 2022-04-28

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AU2016273343A Ceased AU2016273343B2 (en) 2015-06-05 2016-06-03 Adenoassociated virus vectors for the treatment of mucopolysaccharidoses

Country Status (21)

Country Link
US (1) US10617771B2 (enExample)
EP (2) EP3101125A1 (enExample)
JP (1) JP6850736B2 (enExample)
KR (1) KR102609858B1 (enExample)
CN (1) CN108138154B (enExample)
AU (1) AU2016273343B2 (enExample)
CA (1) CA2988201C (enExample)
CL (1) CL2017003096A1 (enExample)
CO (1) CO2017012562A2 (enExample)
ES (1) ES2790834T3 (enExample)
IL (1) IL255939B (enExample)
MX (1) MX386615B (enExample)
MY (1) MY184586A (enExample)
NZ (1) NZ738018A (enExample)
PH (1) PH12017502192B1 (enExample)
PT (1) PT3303576T (enExample)
RU (1) RU2744593C2 (enExample)
TN (1) TN2017000506A1 (enExample)
UA (1) UA125373C2 (enExample)
WO (1) WO2016193431A1 (enExample)
ZA (1) ZA201708039B (enExample)

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US9309534B2 (en) 2010-07-12 2016-04-12 Universidad Autonoma De Barcelona Gene therapy composition for use in diabetes treatment
EP2692868A1 (en) 2012-08-02 2014-02-05 Universitat Autònoma De Barcelona Adeno-associated viral (AAV) vectors useful for transducing adipose tissue
US10973931B2 (en) 2014-09-16 2021-04-13 Universitat Autònoma De Barcelona Adeno-associated viral vectors for the gene therapy of metabolic diseases
ES2824457T3 (es) 2014-12-05 2021-05-12 UNIV AUTòNOMA DE BARCELONA Vectores virales para el tratamiento de la diabetes
ES2900973T3 (es) 2015-01-07 2022-03-21 UNIV AUTòNOMA DE BARCELONA Constructo genético de vector individual que comprende genes de insulina y glucoquinasa
WO2017181113A1 (en) * 2016-04-15 2017-10-19 The Trustees Of The University Of Pennsyvania Gene therapy for treating mucopolysaccharidosis type ii
WO2018191666A1 (en) 2017-04-14 2018-10-18 Regenxbio Inc. Treatment of mucopolysaccharidosis ii with recombinant human iduronate-2 sulfatase (ids) produced by human neural or glial cells
TWI835747B (zh) * 2017-09-22 2024-03-21 賓州大學委員會 用於治療黏多醣病 ii 型之基因治療
CN108715867A (zh) * 2018-05-31 2018-10-30 深圳市免疫基因治疗研究院 一种Sanfilippo B综合症慢病毒载体、慢病毒及其制备方法和应用
CN108795985A (zh) * 2018-05-31 2018-11-13 深圳市免疫基因治疗研究院 一种黏多糖贮积症慢病毒载体、慢病毒及其制备方法和应用
BR112021001498A2 (pt) * 2018-07-27 2021-04-27 Regenxbio Inc. vírus adeno-associado recombinante (raav), composição farmacêutica, polinucleotídeo, plasmídeo de raav, célula ex vivo, método de produção de um raav e métodos para tratar um sujeito humano diagnosticado com mucopolissacaridose tipo iva (mps iva)
WO2020099548A1 (en) * 2018-11-15 2020-05-22 Esteve Pharmaceuticals, S.A. Animal model of mucopolysaccharidoses type iva
TW202039856A (zh) * 2019-03-28 2020-11-01 西班牙商艾斯提夫製藥股份有限公司 製造重組病毒載體之方法
WO2021007473A1 (en) 2019-07-10 2021-01-14 Masonic Medical Research Institute Vgll4 with ucp-1 cis-regulatory element and method of use thereof
EP4072595A1 (en) * 2019-12-10 2022-10-19 Takeda Pharmaceutical Company Limited Adeno associated virus vectors for the treatment of hunter disease
CN115484975A (zh) * 2020-04-06 2022-12-16 同源药物公司 用于ids基因转移的腺相关病毒组合物和其使用方法
CN111718947B (zh) * 2020-06-18 2022-08-23 舒泰神（北京）生物制药股份有限公司 用于治疗ⅲa或ⅲb型粘多糖贮积症的腺相关病毒载体及用途
CN114480454B (zh) * 2020-10-27 2024-03-29 华东理工大学 用于治疗粘多糖贮积症ⅱ型的腺相关病毒载体、药物及其应用
CA3209611A1 (en) 2021-02-10 2022-08-18 Regenxbio Inc. Treatment of mucopolysaccharidosis ii with recombinant human iduronate-2-sulfatase (ids)
WO2022221421A2 (en) * 2021-04-13 2022-10-20 Capsida, Inc. Aav compositions with high brain expression for treating mucopolysaccharidosis ii
CN118019768A (zh) * 2021-08-18 2024-05-10 吉尼瑞姆股份公司 治疗酶的靶向递送

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KR20040084881A (ko) * 2004-09-08 2004-10-06 진동규 동물 세포주를 이용한 이듀로네이트-설파타제의 발현 방법및 그 발현을 위한 세포주
WO2011108451A1 (ja) * 2010-03-01 2011-09-09 日本ケミカルリサーチ株式会社 遺伝子ノックアウト細胞を用いた組換え体リソソーム酵素の製造方法
US20140004593A1 (en) * 2012-06-29 2014-01-02 Shire Human Genetic Therapies, Inc. Cells for producing recombinant iduronate-2-sulfatase

Also Published As

Publication number Publication date
CL2017003096A1 (es) 2018-08-10
CA2988201C (en) 2024-01-16
CN108138154A (zh) 2018-06-08
CN108138154B (zh) 2022-01-18
PT3303576T (pt) 2020-05-08
RU2017142006A (ru) 2019-07-09
MX386615B (es) 2025-03-19
US20180169272A1 (en) 2018-06-21
BR112017025892A2 (pt) 2018-08-14
KR102609858B1 (ko) 2023-12-05
PH12017502192A1 (en) 2018-06-11
RU2744593C2 (ru) 2021-03-11
TN2017000506A1 (en) 2019-04-12
JP2018517414A (ja) 2018-07-05
JP6850736B2 (ja) 2021-03-31
PH12017502192B1 (en) 2022-09-02
EP3303576A1 (en) 2018-04-11
WO2016193431A1 (en) 2016-12-08
US10617771B2 (en) 2020-04-14
ES2790834T3 (es) 2020-10-29
CO2017012562A2 (es) 2018-02-28
ZA201708039B (en) 2018-11-28
EP3303576B1 (en) 2020-02-12
NZ738018A (en) 2025-03-28
IL255939B (en) 2021-05-31
KR20180012843A (ko) 2018-02-06
CA2988201A1 (en) 2016-12-08
MX2017015725A (es) 2018-08-15
UA125373C2 (uk) 2022-03-02
MY184586A (en) 2021-04-06
IL255939A (en) 2018-01-31
EP3101125A1 (en) 2016-12-07
RU2017142006A3 (enExample) 2020-02-03
AU2016273343A1 (en) 2017-12-21

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Date Code Title Description
DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS: AMEND THE NAME OF THE INVENTOR TO READ BOSCH TUBERT, MARIA FATIMA; HAURIGOT, VIRGINIA AREBA AND MOTAS MALLOL, SANDRA

HB Alteration of name in register

Owner name: UNIVERSITAT AUTONOMA DE BARCELONA

Free format text: FORMER NAME(S): UNIVERSITAT AUTONOMA DE BARCELONA; LABORATORIOS DEL DR. ESTEVE, S.A.

Owner name: ESTEVE PHARMACEUTICALS, S.A.

Free format text: FORMER NAME(S): UNIVERSITAT AUTONOMA DE BARCELONA; LABORATORIOS DEL DR. ESTEVE, S.A.

FGA Letters patent sealed or granted (standard patent)