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
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WO
WIPO (PCT)
Prior art keywords
methods
antisense oligonucleotides
smad7 antisense
biomarker expression
oligonucleotides based
Prior art date
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PCT/EP2016/073518
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English (en)
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WO2017055611A2 (fr
WO2017055611A9 (fr
Inventor
Salvatore Bellinvia
Giovanni Monteleone
Gerald Scott BARDEN HORAN
Original Assignee
Nogra Pharma Limited
Celgene Corporation
Celgene Alpine Investment Company Ii, Llc
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Publication date
Application filed by Nogra Pharma Limited, Celgene Corporation, Celgene Alpine Investment Company Ii, Llc filed Critical Nogra Pharma Limited
Priority to EP16778306.7A priority Critical patent/EP3355896A2/fr
Priority to US15/764,567 priority patent/US20200237801A1/en
Priority to CA3000569A priority patent/CA3000569A1/fr
Priority to JP2018516772A priority patent/JP2018531936A/ja
Publication of WO2017055611A2 publication Critical patent/WO2017055611A2/fr
Publication of WO2017055611A9 publication Critical patent/WO2017055611A9/fr
Publication of WO2017055611A3 publication Critical patent/WO2017055611A3/fr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088Compounds having three or more nucleosides or nucleotides
    • A61K31/7125Nucleic acids or oligonucleotides having modified internucleoside linkage, i.e. other than 3'-5' phosphodiesters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/11DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113Non-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
    • C12N15/1136Non-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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/10Type of nucleic acid
    • C12N2310/11Antisense
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/30Chemical structure
    • C12N2310/31Chemical structure of the backbone
    • C12N2310/315Phosphorothioates
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2310/00Structure or type of the nucleic acid
    • C12N2310/30Chemical structure
    • C12N2310/33Chemical structure of the base
    • C12N2310/334Modified C
    • C12N2310/33415-Methylcytosine
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701Details
    • G01N2333/4733Acute pancreatitis-associated protein
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52Assays involving cytokines
    • G01N2333/54Interleukins [IL]
    • G01N2333/5409IL-5
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52Assays involving cytokines
    • G01N2333/54Interleukins [IL]
    • G01N2333/5437IL-13
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/06Gastro-intestinal diseases
    • G01N2800/065Bowel diseases, e.g. Crohn, ulcerative colitis, IBS
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/52Predicting 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)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (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 WO2017055611A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
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
US15/764,567 US20200237801A1 (en) 2016-05-12 2016-09-30 Methods of using smad7 antisense oligonucleotides based on biomarker expression
CA3000569A CA3000569A1 (fr) 2015-09-30 2016-09-30 Methodes d'utilisation d'oligonucleotides antisens smad7 sur la base de l'expression de biomarqueurs
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

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

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2016/073518 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 (10)

* 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
LT2364360T (lt) 2008-11-13 2017-08-10 Nogra Pharma Limited Priešprasmės kompozicijos ir jų gavimo bei panaudojimo būdai
RU2678450C2 (ru) 2011-09-15 2019-01-29 Ногра Фарма Лимитед Способы контроля восприимчивости анти-smad7 терапии
CN104487574B (zh) 2012-04-18 2017-07-07 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
JP2017515896A (ja) 2014-05-09 2017-06-15 ノグラ ファーマ リミテッド 炎症性腸疾患の処置の方法
MA43331A (fr) 2014-10-17 2017-08-23 Nogra Pharma Ltd Procédés et compositions pour le traitement d'un sujet au moyen d'un oligonucléotide antisens de smad7
JP2019505598A (ja) 2016-02-23 2019-02-28 セルジーン アルパイン インベストメント カンパニー Ii, エルエルシー Smad7の阻害を用いて、腸線維症を治療する方法
US20200392491A1 (en) * 2017-07-28 2020-12-17 Nogra Pharma Limited Method of Preparing Oligonucleotide Compounds
US20220267428A1 (en) * 2018-10-10 2022-08-25 The Board Of Trustees Of The Leland Stanford Junior University BLOCKADE OF RGMb FOR TREATING INFLAMMATORY BOWEL DISEASE AND COLITIS

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009083653A1 (fr) * 2007-12-28 2009-07-09 Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä Méthode de surveillance de l'efficacité de traitements par immunomodulateurs

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060135610A1 (en) * 2004-12-22 2006-06-22 Bortz Jonathan D Cardiovascular compositions
WO2010062663A1 (fr) * 2008-11-03 2010-06-03 Schering Corporation Biomarqueurs de maladie inflammatoire de l'intestin et procédés apparentés du traitement
LT2364360T (lt) * 2008-11-13 2017-08-10 Nogra Pharma Limited Priešprasmės kompozicijos ir jų gavimo bei panaudojimo būdai
CA2834552A1 (fr) * 2011-04-29 2012-11-01 Bristol-Myers Squibb Company Schemas posologiques a doses progressivement croissantes d'anticorps anti-ip-10
RU2678450C2 (ru) * 2011-09-15 2019-01-29 Ногра Фарма Лимитед Способы контроля восприимчивости анти-smad7 терапии

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009083653A1 (fr) * 2007-12-28 2009-07-09 Helsingin Ja Uudenmaan Sairaanhoitopiirin Kuntayhtymä Méthode de surveillance de l'efficacité de traitements par immunomodulateurs

Non-Patent Citations (10)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "NCT02367183 on 2015_09_14: ClinicalTrials.gov Archive", 14 September 2015 (2015-09-14), pages 1 - 7, XP055358198, Retrieved from the Internet <URL:https://clinicaltrials.gov/archive/NCT02367183/2015_09_14> [retrieved on 20170323] *
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 *
R. BALFOUR SARTOUR: "Mechanisms of Disease: Pathogenesis of Crohn's Disease and Ulcerative Colitis", 1 January 2006 (2006-01-01), pages 1 - 24, XP055358347, Retrieved from the Internet <URL:http://www.medscape.com/viewarticle/540142_print> [retrieved on 20170323] *

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

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