EP3389671A4 - Antisense oligomers for treatment of alagille syndrome - Google Patents

Antisense oligomers for treatment of alagille syndrome Download PDF

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Publication number
EP3389671A4
EP3389671A4 EP16876499.1A EP16876499A EP3389671A4 EP 3389671 A4 EP3389671 A4 EP 3389671A4 EP 16876499 A EP16876499 A EP 16876499A EP 3389671 A4 EP3389671 A4 EP 3389671A4
Authority
EP
European Patent Office
Prior art keywords
treatment
antisense oligomers
alagille syndrome
alagille
syndrome
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.)
Withdrawn
Application number
EP16876499.1A
Other languages
German (de)
French (fr)
Other versions
EP3389671A1 (en
Inventor
Isabel AZNAREZ
Huw M. Nash
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.)
Cold Spring Harbor Laboratory
Stoke Therapeutics Inc
Original Assignee
Cold Spring Harbor Laboratory
Stoke Therapeutics 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 Cold Spring Harbor Laboratory, Stoke Therapeutics Inc filed Critical Cold Spring Harbor Laboratory
Publication of EP3389671A1 publication Critical patent/EP3389671A1/en
Publication of EP3389671A4 publication Critical patent/EP3389671A4/en
Withdrawn legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/04—Drugs for disorders of the muscular or neuromuscular system for myasthenia gravis
    • 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
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/111—General methods applicable to biologically active non-coding nucleic acids
    • 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
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6876—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes
    • C12Q1/6883—Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
    • 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
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/11—Antisense
    • 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
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/30—Chemical structure
    • C12N2310/31—Chemical structure of the backbone
    • C12N2310/315—Phosphorothioates
    • 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
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/30—Chemical structure
    • C12N2310/32—Chemical structure of the sugar
    • C12N2310/321—2'-O-R Modification
    • 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
    • C12N2320/00—Applications; Uses
    • C12N2320/30—Special therapeutic applications
    • C12N2320/33—Alteration of splicing
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q2600/00—Oligonucleotides characterized by their use
    • C12Q2600/156—Polymorphic or mutational markers

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Veterinary Medicine (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Plant Pathology (AREA)
  • Immunology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Epidemiology (AREA)
  • Pathology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Saccharide Compounds (AREA)
EP16876499.1A 2015-12-14 2016-12-13 Antisense oligomers for treatment of alagille syndrome Withdrawn EP3389671A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562267210P 2015-12-14 2015-12-14
PCT/US2016/066414 WO2017106210A1 (en) 2015-12-14 2016-12-13 Antisense oligomers for treatment of alagille syndrome

Publications (2)

Publication Number Publication Date
EP3389671A1 EP3389671A1 (en) 2018-10-24
EP3389671A4 true EP3389671A4 (en) 2019-07-17

Family

ID=59057483

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16876499.1A Withdrawn EP3389671A4 (en) 2015-12-14 2016-12-13 Antisense oligomers for treatment of alagille syndrome

Country Status (4)

Country Link
EP (1) EP3389671A4 (en)
JP (2) JP2018538288A (en)
CA (1) CA3005245A1 (en)
WO (1) WO2017106210A1 (en)

Families Citing this family (15)

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Publication number Priority date Publication date Assignee Title
GB201410693D0 (en) 2014-06-16 2014-07-30 Univ Southampton Splicing modulation
CN107109411B (en) 2014-10-03 2022-07-01 冷泉港实验室 Targeted increase in nuclear gene export
AU2016334804B2 (en) 2015-10-09 2022-03-31 University Of Southampton Modulation of gene expression and screening for deregulated protein expression
US11096956B2 (en) 2015-12-14 2021-08-24 Stoke Therapeutics, Inc. Antisense oligomers and uses thereof
CN109312343B (en) 2015-12-14 2022-09-27 冷泉港实验室 Antisense oligomers for the treatment of autosomal dominant mental retardation type 5 and Dravet syndrome
CN110199032A (en) 2017-01-23 2019-09-03 雷杰纳荣制药公司 Hydroxy steroid 17- β dehydrogenase 13 (HSD17B13) variant and application thereof
JP7048574B2 (en) 2017-03-10 2022-04-05 国立研究開発法人国立成育医療研究センター Antisense oligonucleotides and glycogen storage disease type Ia preventive or therapeutic compositions
JP2020516283A (en) 2017-04-11 2020-06-11 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． Assay for screening the activity of modulators of hydroxysteroid (17-beta) dehydrogenase (HSD17B) family members
US11197884B2 (en) 2017-08-18 2021-12-14 Ionis Pharmaceuticals, Inc. Modulation of the notch signaling pathway for treatment of respiratory disorders
SI3673080T1 (en) 2017-08-25 2024-03-29 Stoke Therapeutics, Inc. Antisense oligomers for treatment of conditions and diseases
KR20240125690A (en) 2017-10-11 2024-08-19 리제너론 파마슈티칼스 인코포레이티드 Inhibition of hsd17b13 in the treatment of liver disease in patients expressing the pnpla3 i148m variation
CN115976028A (en) * 2018-03-09 2023-04-18 第一三共株式会社 Remedies for glycogen disease type Ia
US20210238257A1 (en) * 2018-04-27 2021-08-05 The Regents Of The University Of California De Novo Formation of the Biliary System by Hepatocyte Transdifferentiation
US12060558B2 (en) 2018-05-04 2024-08-13 Stoke Therapeutics, Inc. Methods and compositions for treatment of cholesteryl ester storage disease
IL298063A (en) 2020-05-11 2023-01-01 Stoke Therapeutics Inc Opa1 antisense oligomers for treatment of conditions and diseases

Citations (4)

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US20040102401A1 (en) * 2002-11-22 2004-05-27 Isis Pharmaceuticals Inc. Modulation of jagged 1 expression
WO2005049651A2 (en) * 2003-11-14 2005-06-02 The Queen's University Of Belfast Cancer diagnosis and therapy
WO2007048629A2 (en) * 2005-10-28 2007-05-03 MAX-PLANCK-Gesellschaft zur Förderung der Wissenschaften e.V. Modulation of rna silencing efficiency by argonaute proteins
WO2007048628A2 (en) * 2005-10-28 2007-05-03 Max Planck Gesellschaft Structures of active guide rna molecules and method of selection

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US4866042A (en) 1987-11-18 1989-09-12 Neuwelt Edward A Method for the delivery of genetic material across the blood brain barrier
US6294520B1 (en) 1989-03-27 2001-09-25 Albert T. Naito Material for passage through the blood-brain barrier
US5151510A (en) 1990-04-20 1992-09-29 Applied Biosystems, Inc. Method of synethesizing sulfurized oligonucleotide analogs
WO1994008026A1 (en) 1992-09-25 1994-04-14 Rhone-Poulenc Rorer S.A. Adenovirus vectors for the transfer of foreign genes into cells of the central nervous system, particularly in brain
US5656612A (en) 1994-05-31 1997-08-12 Isis Pharmaceuticals, Inc. Antisense oligonucleotide modulation of raf gene expression
FR2727867B1 (en) 1994-12-13 1997-01-31 Rhone Poulenc Rorer Sa GENE TRANSFER IN MEDULLAR MOTONURONES USING ADENOVIRAL VECTORS
US6936589B2 (en) 2001-09-28 2005-08-30 Albert T. Naito Parenteral delivery systems
WO2007047913A2 (en) 2005-10-20 2007-04-26 Isis Pharmaceuticals, Inc Compositions and methods for modulation of lmna expression
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WO2005049651A2 (en) * 2003-11-14 2005-06-02 The Queen's University Of Belfast Cancer diagnosis and therapy
WO2007048629A2 (en) * 2005-10-28 2007-05-03 MAX-PLANCK-Gesellschaft zur Förderung der Wissenschaften e.V. Modulation of rna silencing efficiency by argonaute proteins
WO2007048628A2 (en) * 2005-10-28 2007-05-03 Max Planck Gesellschaft Structures of active guide rna molecules and method of selection

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JANA KRALOVICOVA ET AL: "Optimal antisense target reducing INS intron 1 retention is adjacent to a parallel G quadruplex", NUCLEIC ACIDS RESEARCH, vol. 42, no. 12, 17 June 2014 (2014-06-17), pages 8161 - 8173, XP055211568, ISSN: 0305-1048, DOI: 10.1093/nar/gku507 *
LITING LI ET AL: "JAG1 Mutation Spectrum and Origin in Chinese Children with Clinical Features of Alagille Syndrome", PLOS ONE, vol. 10, no. 6, 15 June 2015 (2015-06-15), pages e0130355, XP055587896, DOI: 10.1371/journal.pone.0130355 *
M. YAMAMOTO ET AL: "Mib-Jag1-Notch signalling regulates patterning and structural roles of the notochord by controlling cell-fate decisions", DEVELOPMENT, vol. 137, no. 15, 23 June 2010 (2010-06-23), GB, pages 2527 - 2537, XP055587656, ISSN: 0950-1991, DOI: 10.1242/dev.051011 *
NANCY B. SPINNER ET AL: "Jagged1 mutations in Alagille syndrome", HUMAN MUTATION, vol. 17, no. 1, 22 December 2000 (2000-12-22), US, pages 18 - 33, XP055587899, ISSN: 1059-7794, DOI: 10.1002/1098-1004(2001)17:1<18::AID-HUMU3>3.0.CO;2-T *
PETER D TURNPENNY ET AL: "Alagille syndrome: pathogenesis, diagnosis and management", EUROPEAN JOURNAL OF HUMAN GENETICS., vol. 20, no. 3, 21 September 2011 (2011-09-21), CH, pages 251 - 257, XP055590188, ISSN: 1018-4813, DOI: 10.1038/ejhg.2011.181 *
RYSZARD KOLE ET AL: "RNA therapeutics: beyond RNA interference and antisense oligonucleotides", NATURE REVIEWS DRUG DISCOVERY, vol. 11, no. 2, 20 January 2012 (2012-01-20), pages 125 - 40, XP055138361, ISSN: 1474-1776, DOI: 10.1038/nrd3625 *
See also references of WO2017106210A1 *

Also Published As

Publication number Publication date
JP2022106803A (en) 2022-07-20
WO2017106210A1 (en) 2017-06-22
JP2018538288A (en) 2018-12-27
CA3005245A1 (en) 2017-06-22
EP3389671A1 (en) 2018-10-24

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