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WO2017055611A3 - Méthodes d'utilisation d'oligonucléotides antisens smad7 sur la base de l'expression de biomarqueurs - Google Patents

Méthodes d'utilisation d'oligonucléotides antisens smad7 sur la base de l'expression de biomarqueurs Download PDF

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Publication number
WO2017055611A3
WO2017055611A3 PCT/EP2016/073518 EP2016073518W WO2017055611A3 WO 2017055611 A3 WO2017055611 A3 WO 2017055611A3 EP 2016073518 W EP2016073518 W EP 2016073518W WO 2017055611 A3 WO2017055611 A3 WO 2017055611A3
Authority
WO
WIPO (PCT)
Prior art keywords
methods
antisense oligonucleotides
smad7 antisense
biomarker expression
oligonucleotides based
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.)
Ceased
Application number
PCT/EP2016/073518
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English (en)
Other versions
WO2017055611A2 (fr
WO2017055611A9 (fr
Inventor
Salvatore Bellinvia
Giovanni Monteleone
Gerald Scott BARDEN HORAN
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.)
Nogra Pharma Ltd
Celgene Corp
Celgene Alpine Investment Co II LLC
Original Assignee
Nogra Pharma Ltd
Celgene Corp
Celgene Alpine Investment Co II LLC
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 Nogra Pharma Ltd, Celgene Corp, Celgene Alpine Investment Co II LLC filed Critical Nogra Pharma Ltd
Priority to JP2018516772A priority Critical patent/JP2018531936A/ja
Priority to EP16778306.7A priority patent/EP3355896A2/fr
Priority to CA3000569A priority patent/CA3000569A1/fr
Priority to US15/764,567 priority patent/US20200237801A1/en
Publication of WO2017055611A2 publication Critical patent/WO2017055611A2/fr
Publication of WO2017055611A9 publication Critical patent/WO2017055611A9/fr
Publication of WO2017055611A3 publication Critical patent/WO2017055611A3/fr
Anticipated expiration legal-status Critical
Ceased 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
    • A61K31/7125—Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
    • 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
    • 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
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • C12N15/1136—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 against growth factors, growth regulators, cytokines, lymphokines or hormones
    • 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
    • C12N2310/33—Chemical structure of the base
    • C12N2310/334—Modified C
    • C12N2310/3341—5-Methylcytosine
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4733—Acute pancreatitis-associated protein
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/5409—IL-5
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52—Assays involving cytokines
    • G01N2333/54—Interleukins [IL]
    • G01N2333/5437—IL-13
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/06—Gastro-intestinal diseases
    • G01N2800/065—Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biochemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Plant Pathology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Endocrinology (AREA)
  • Epidemiology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

L'invention concerne des méthodes de traitement de la maladie inflammatoire chronique de l'intestin (MICI) chez un patient atteint d'une MICI à l'aide d'oligonucléotides antisens SMAD7.
PCT/EP2016/073518 2015-09-30 2016-09-30 Méthodes d'utilisation d'oligonucléotides antisens smad7 sur la base de l'expression de biomarqueurs Ceased WO2017055611A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2018516772A JP2018531936A (ja) 2015-09-30 2016-09-30 バイオマーカー発現に基づいてｓｍａｄ７アンチセンスオリゴヌクレオチドを使用する方法
EP16778306.7A EP3355896A2 (fr) 2015-09-30 2016-09-30 Méthodes d'utilisation d'oligonucléotides antisens smad7 sur la base de l'expression de biomarqueurs
CA3000569A CA3000569A1 (fr) 2015-09-30 2016-09-30 Methodes d'utilisation d'oligonucleotides antisens smad7 sur la base de l'expression de biomarqueurs
US15/764,567 US20200237801A1 (en) 2016-05-12 2016-09-30 Methods of using smad7 antisense oligonucleotides based on biomarker expression

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562235556P 2015-09-30 2015-09-30
US62/235,556 2015-09-30

Publications (3)

Publication Number Publication Date
WO2017055611A2 WO2017055611A2 (fr) 2017-04-06
WO2017055611A9 WO2017055611A9 (fr) 2017-07-27
WO2017055611A3 true WO2017055611A3 (fr) 2017-08-31

Family

ID=57113318

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2016/073518 Ceased WO2017055611A2 (fr) 2015-09-30 2016-09-30 Méthodes d'utilisation d'oligonucléotides antisens smad7 sur la base de l'expression de biomarqueurs

Country Status (4)

Country Link
EP (1) EP3355896A2 (fr)
JP (1) JP2018531936A (fr)
CA (1) CA3000569A1 (fr)
WO (1) WO2017055611A2 (fr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITRM20030149A1 (it) 2003-04-02 2004-10-03 Giuliani Spa Oligonucleotidi (odn) antisenso per smad7 e loro usi in campo medico
RU2739302C2 (ru) 2008-11-13 2020-12-22 Ногра Фарма Лимитед Антисмысловые композиции и способы их получения и применения
EP3165929A3 (fr) 2011-09-15 2017-06-21 Nogra Pharma Limited Procédés permettant de surveiller la réactivité à une thérapie anti-smad7
CN107252492A (zh) 2012-04-18 2017-10-17 诺格尔制药有限公司 治疗糖尿病和/或促进胰岛移植后存活的方法
US10006029B2 (en) 2013-03-15 2018-06-26 Nogra Pharma Limited Methods of treating colorectal cancer
MA39963A (fr) 2014-05-09 2017-03-15 Nogra Pharma Ltd Méthodes de traitement d'une maladie inflammatoire chronique de l'intestin
CA2964667A1 (fr) 2014-10-17 2016-04-21 Nogra Pharma Limited Procedes et compositions pour le traitement d'un sujet au moyen d'un oligonucleotide antisens de smad7
EP3420082A4 (fr) 2016-02-23 2019-10-16 Celgene Alpine Investment Company II, LLC Méthodes de traitement de la fibrose intestinale par inhibition de smad7
EP3658155A4 (fr) * 2017-07-28 2021-06-30 Nogra Pharma Limited Procédé de préparation de composés oligonucléotidiques
WO2020077120A1 (fr) * 2018-10-10 2020-04-16 The Board Of Trustees Of The Leland Stanford Junior University Blocage de rgmb pour traiter une maladie intestinale inflammatoire et une colite
CN113226307A (zh) * 2018-11-30 2021-08-06 艾尼纳制药公司 治疗与s1p1受体有关的病况的方法

Citations (1)

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WO2009083653A1 (fr) * 2007-12-28 2009-07-09 Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä Méthode de surveillance de l'efficacité de traitements par immunomodulateurs

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US20060135610A1 (en) * 2004-12-22 2006-06-22 Bortz Jonathan D Cardiovascular compositions
JP2012507723A (ja) * 2008-11-03 2012-03-29 シェーリング コーポレイション 炎症性腸疾患生物マーカーおよび関連治療方法
RU2739302C2 (ru) * 2008-11-13 2020-12-22 Ногра Фарма Лимитед Антисмысловые композиции и способы их получения и применения
BR112013027867A2 (pt) * 2011-04-29 2016-09-06 Bristol Myers Squibb Co "método de detectar o nível de um anticorpo anti-ip10 em amostra, anticorpo monoclonal isolado ou porção de ligação de antígeno do mesmo, linhagem de célula de hibridoma e kit"
EP3165929A3 (fr) * 2011-09-15 2017-06-21 Nogra Pharma Limited Procédés permettant de surveiller la réactivité à une thérapie anti-smad7

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WO2009083653A1 (fr) * 2007-12-28 2009-07-09 Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä Méthode de surveillance de l'efficacité de traitements par immunomodulateurs

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ANONYMOUS: "NCT02601300 on 2016_08_11: ClinicalTrials.gov Archive", 11 August 2016 (2016-08-11), pages 1 - 8, XP055358835, Retrieved from the Internet <URL:https://clinicaltrials.gov/archive/NCT02601300/2016_08_11> [retrieved on 20170327] *
AVI LEVIN ET AL: "Infliximab in ulcerative colitis", BIOLOGICS: TARGETS & THERAPY, vol. 3, 1 January 2008 (2008-01-01), pages 379 - 388, XP055358816 *
BOIRIVANT ET AL: "Inhibition of Smad7 With a Specific Antisense Oligonucleotide Facilitates TGF-beta1-Mediated Suppression of Colitis", GASTROENTEROLOGY, ELSEVIER, AMSTERDAM, NL, vol. 131, no. 6, 22 December 2006 (2006-12-22), pages 1786 - 1798, XP005750980, ISSN: 0016-5085, DOI: 10.1053/J.GASTRO.2006.09.016 *
FUSS I J ET AL: "Disparate CD4+ lamina propria (LP) lymphokine secretion profiles in inflammatory bowel disease. Crohn's disease LP cells manifest increased secretion of IFN-gamma, whereas ulcerative colitis LP cells manifest increased secretion of IL-5", THE JOURNAL OF IMMUNOLOGY, THE AMERICAN ASSOCIATION OF IMMUNOLOGISTS, US, vol. 157, no. 3, 1 August 1996 (1996-08-01), pages 1261 - 1270, XP002413540, ISSN: 0022-1767 *
GIOVANNI MONTELEONE ET AL: "Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn's Disease", NEW ENGLAND JOURNAL OF MEDICINE, THE - NEJM -, vol. 372, no. 12, 19 March 2015 (2015-03-19), pages 1104 - 1113, XP055357908, ISSN: 0028-4793, DOI: 10.1056/NEJMoa1407250 *
GIOVANNI MONTELEONE ET AL: "Protocol to Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn's Disease", NEW ENGLAND JOURNAL OF MEDICINE, 19 March 2015 (2015-03-19), pages FP1-2,1-64,1-75,FP1-2,1-65,1-18, XP055358051, Retrieved from the Internet <URL:http://www.nejm.org/doi/suppl/10.1056/NEJMoa1407250/suppl_file/nejmoa1407250_protocol.pdf> [retrieved on 20170323], DOI: 10.1056/NEJMoa1407250 *
GIOVANNI MONTELEONE ET AL: "Targets for new immunomodulation strategies in inflammatory bowel disease", AUTOIMMUNITY REVIEWS, vol. 13, no. 1, 1 January 2014 (2014-01-01), NL, pages 11 - 14, XP055358366, ISSN: 1568-9972, DOI: 10.1016/j.autrev.2013.06.003 *
MONTELEONE G ET AL: "BLOCKING SMAD7 RESTORES TGF-BETA1 SIGNALING IN CHRONIC INFLAMMATORY BOWEL DISEASE", JOURNAL OF CLINICAL INVESTIGATION, AMERICAN SOCIETY FOR CLINICAL INVESTIGATION, US, vol. 108, no. 4, 1 August 2001 (2001-08-01), pages 601 - 609, XP001152527, ISSN: 0021-9738, DOI: 10.1172/JCI200112821 *
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Also Published As

Publication number Publication date
JP2018531936A (ja) 2018-11-01
EP3355896A2 (fr) 2018-08-08
CA3000569A1 (fr) 2017-04-06
WO2017055611A2 (fr) 2017-04-06
WO2017055611A9 (fr) 2017-07-27

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