DK3174553T3 - Glycokonjugat-vacciner omfattende basisenheder af et molekylekonstrukt, som udtrykker flere integrerede epitoper til formuleringen af en bredspektret vaccine mod infektioner grundet enteropatogene bakterier - Google Patents
Glycokonjugat-vacciner omfattende basisenheder af et molekylekonstrukt, som udtrykker flere integrerede epitoper til formuleringen af en bredspektret vaccine mod infektioner grundet enteropatogene bakterier Download PDFInfo
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- DK3174553T3 DK3174553T3 DK15742232.0T DK15742232T DK3174553T3 DK 3174553 T3 DK3174553 T3 DK 3174553T3 DK 15742232 T DK15742232 T DK 15742232T DK 3174553 T3 DK3174553 T3 DK 3174553T3
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- salmonella
- escherichia coli
- lps
- carbohydrate structures
- enterotoxoid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/107—Vibrio
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/025—Enterobacteriales, e.g. Enterobacter
- A61K39/0258—Escherichia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/025—Enterobacteriales, e.g. Enterobacter
- A61K39/0275—Salmonella
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
- A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
- A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55505—Inorganic adjuvants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
- A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/62—Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier
- A61K2039/627—Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier characterised by the linker
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/70—Multivalent vaccine
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Claims (21)
1. Antigent multivalent molekylekonstrukt bestående af basisenheder omfattende de hjælper-T-afhængige afgiftede bærerproteiner valgt mellem Enterotoxoid A og Cytotoxoid B fra Clostridium difficile kovalent bundet til et minimum af tre kulhydratstrukturer fra enteropatogene bakterier valgt mellem bakterielle polysaccharider eller afgiftede lipopolysaccharider af forskellig serologisk specificitet, hvor hver kulhydratstruktur omfatter mindst en af de gentagende basisepitoper bestående af et minimum af fem til tolv monosaccharidrester, hvor mindst et mol af bærerprotein er bundet til mindst et mol af hver af de mindst tre kulhydratstrukturer eller deres molære sum.
2. Antigent multivalent molekylekonstrukt ifølge krav 1, hvor nævnte Enterotoxoid A eller Cytotoxoid B stammende fra Clostridium difficile er afgiftede ved formalin-behandling eller ved DNA-rekombinant teknologi.
3. Antigent multivalent molekylekonstrukt ifølge et hvilket som helst af de foregående krav 1-2, hvor nævnte bårne kulhydratstrukturer af forskellig serologisk specificitet er valgt blandt kapsulære polysaccharider af Salmonella typhi, Vibrio cholerae, Escherichia coli og Clostridium difficile eller en kombination deraf.
4. Antigent multivalent molekylekonstrukt ifølge et hvilket som helst af de foregående krav 1-2, hvor nævnte afgiftede lipopolysaccharid er et Endotoxoid.
5. Antigent multivalent molekylekonstrukt ifølge krav 1 eller 4, hvor nævnte bårne kulhydratstrukturer af forskellig serologisk specificitet er valgt blandt afgiftede lipopolysaccharider/Endotoxoider af enteropatogene bakterier valgt blandt Salmonella typhi, Escherichia coli, Vibrio cholerae, Salmonella enteritidis, Shigella flexneri, Salmonella paratyphi A, Salmonella dysenteriae, Shigella sonnei og Salmonella cholerasuis eller en kombination deraf.
6. Antigent multivalent molekylekonstrukt ifølge et hvilket som helst af kravene 1-5, valgt mellem: - Enterotoxoid A kovalent bundet til de kapsulære polysaccharider af Salmonella typhi, Vibrio cholerae og Escherichia coli; - Cytotoxoid B kovalent bundet til de kapsulære polysaccharider af Salmonella typhi, Vibrio cholerae og Escherichia coli; - Enterotoxoid A kovalent bundet til de afgiftede lipopolysaccharider/Endotoxoider af Salmonella enteritidis, Salmonella paratyphi A og Salmonella dysenteriae·, - Cytotoxoid B kovalent bundet til de afgiftede lipopolysaccharider/Endotoxoider af Salmonella enteritidis, Salmonella paratyphi A og Salmonella dysenteriae.
7. Antigent multivalent molekylekonstrukt ifølge et hvilket som helst af de foregående krav, til anvendelse i en vaccine til beskyttelsen af et individ mod infektionerne grundet mindst en af de enteropatogene bakterier valgt fra Clostridium difficile, Salmonella typhi, Escherichia coli, Vibrio cholerae, Salmonella enteritidis, Shigella flexneri, Shigella sonnei, Salmonella paratyphi A, Salmonella dysenteriae, Salmonella cholerasuis eller en kombination deraf.
8. Vaccineformulering omfattende mindst et antigent multivalent molekylekonstrukt som defineret ifølge et hvilket som helst af kravene 1-6 i et fysiologisk acceptabelt vehikel, eventuelt sammen med en adjuvans eller excipienser der er farmaceutisk acceptable.
9. Vaccineformulering ifølge krav 8, hvor dosen af hvert bærerantigen og/eller bårne antigener er i området mellem 0,1 til 100 pg, fortrinsvis fra 1 til 10 pg.
10. Vaccineformulering ifølge et hvilket som helst af kravene 8-9, hvor nævnte adjuvans er valgt mellem en mineraladjuvans valgt fra aluminiumphosphat, aluminiumhydroxid, en organisk adjuvans valgt fra squalene-baserede adjuvanser såsom MF59, QF 21, Addavax og en biologisk adjuvans valgt fra monophosphoryl-lipid A og trehalose dicorynomycolat.
11. Vaccineformulering ifølge et hvilket som helst af kravene 8-10, hvor mængden af adjuvans er i området mellem 0,1-1 mg/dosis, fortrinsvis 0,5 mg/dosis.
12. Vaccineformulering ifølge et hvilket som helst af kravene 8-11, hvor nævnte formulering er egnet til administrationen via subkutan, intramuskulær, intrakutan eller transkutan vej.
13. Bredspektret polyvalent vaccineformulering ifølge et hvilket som helst af de foregående krav 8-12, til anvendelse i human- eller veterinærmedicinsk felt til beskyttelsen af et individ mod de systemiske og enteriske infektioner grundet mindst en af de enteropatogene bakterier valgt blandt Clostridium difficile, Salmonella typhi, Escherichia coli, Vibrio cholerae, Salmonella enteritidis, Shigella flexneri, Shigella sonnei, Salmonella paratyphi A, Salmonella dysenteriae, Salmonella cholerasuis, Klebsiella, Enterobacter eIler en kombination deraf.
14. Bredspektret polyvalent vaccineformulering til anvendelse i human- eller veterinærmedicinsk felt ifølge krav 13, hvor nævnte individ hører til den humane population.
15. Bredspektret polyvalent vaccineformulering til anvendelse i medicinsk felt ifølge krav 14, til anvendelse i forebyggelsen og/eller behandlingen af virale gastrointestinale infektioner grundet humane norovirusser.
16. Konjugationsfremgangsmåde til fremstilling af det antigene multivalente molekylekonstrukt ifølge et hvilket som helst af kravene 1-6, hvilken omfatter de følgende trin: a) kemisk aktivering af de mindst tre antigenisk forskellige kulhydratstrukturer valgt mellem : - kapsulære polysaccharider af Salmonella typhi, Vibrio cholerae, Escherichia coli og Clostridium difficile eller - lipopolysaccharider fra Salmonella typhi, Escherichia coli, Vibrio cholerae, Salmonella enteritidis, Shigella flexneri, Shigella sonnei, Salmonella paratyphi A, Salmonella dysenteriae og Salmonella cholerasuis; til polyfunktionalitet af O-de-hydrogen-afkobling via oxidation og reducerende aminering, som danner imin-reducerede bindinger med en alkyldiamin-spacer, derefter derivatiseret til aktive estere; b) simultan kobling af de mindst tre ester-afledte kulhydratstrukturer til aminogrupperne af det polyfunktionelle bærerprotein Enterotoxoid A eller Cytotoxoid B fra Clostridium difficile, igennem dannelsen af amidbindinger; hvor mindst et mol af bærerprotein reageres med mindst et mol af hver, eller deres molære sum, af nævnte antigenisk forskellige kulhydratstrukturer.
17. Konjugationsfremgangsmåde ifølge krav 16, hvor kulhydratstrukturerne er kemisk aktiveret i deres tilsvarende diaminsmørsyrederivater og de aktive estere er succinimidylestere.
18. Konjugationsfremgangsmåde til fremstilling af det antigene multivalente molekylekonstrukt ifølge et hvilket som helst af kravene 1-6, hvilken omfatter den simultane kobling af aminogrupperne af det polyfunktionelle bærerprotein Enterotoxoid A eller Cytotoxoid B fra Clostridium difficile med mindst tre antigenisk forskellige kulhydratstrukturer valgt mellem: - kapsulære polysaccharider af Salmonella typhi, Vibrio cholera, Escherichia coli og Clostridium difficile eller - lipopolysaccharider fra Salmonella typhi, Escherichia coli, Vibrio cholerae, Salmonella enteritidis, Shigella flexneri, Shigella sonnei, Salmonella paratyphi A, Salmonella dysenteriae og Salmonella cholerasuis-, via reducerende aminering, som danner imin-reducerede bindinger, hvor sådanne kulhydratstrukturer tidligere er aktiveret til polyfunktionalitet, med eller uden molekylespacere, igennem O-de-hydrogen-afkobling i vicinale hydroxylgrupper, via oxidation.
19. Konjugationsfremgangsmåde ifølge et hvilket som helst af kravene 16-18, yderligere omfattende et videre trin til afgiftning af nævnte lipopolysaccharider alternativt ved a) udspaltning af Lipid A-delen før eller efter koblingsreaktionen udføres, eller b) mætning af Lipid A-bindingsstedet igennem en specifik strategi, der bruger syntetiske anti-endotoxin-peptider (SAEP), før eller efter koblingsreaktionen udføres; hvor mindst et mol af bærerprotein reageres med mindst et mol af hver, eller deres molære sum, af nævnte antigenisk forskellige kulhydratstrukturer.
20. Konjugationsfremgangsmåde ifølge et hvilket som helst af kravene 16-19, hvor kulhydratstrukturerne af trin a) omfatter mindst en af de gentagende basisepitoper bestående af et minimum af fem til tolv monosaccharidrester som vurderet ved molekylemassebestemmelse og NMR-spektroskopi, hvor nævnte gentagende basisepitoper antigent bedømmes ved reaktivitet med type-specifikke eller gruppe-specifikke polyklonale eller monoklonale antistoffer igennem bestemmelsen af deres respektive MIC50-værdier i inhibitionen af deres homologe polysaccharid-antistof-referencesystem.
21. Antigent multivalent molekylekonstrukt opnåelig igennem konjugationsfremgangsmåden ifølge et hvilket som helst af kravene 16-20.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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ITMI20141361 | 2014-07-25 | ||
PCT/EP2015/066988 WO2016012587A1 (en) | 2014-07-25 | 2015-07-24 | Glycoconjugate vaccines comprising basic units of a molecular construct expressing built-in multiple epitopes for the formulation of a broad-spectrum vaccine against infections due to enteropathogenic bacteria |
Publications (1)
Publication Number | Publication Date |
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DK3174553T3 true DK3174553T3 (da) | 2018-07-23 |
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DK15742232.0T DK3174553T3 (da) | 2014-07-25 | 2015-07-24 | Glycokonjugat-vacciner omfattende basisenheder af et molekylekonstrukt, som udtrykker flere integrerede epitoper til formuleringen af en bredspektret vaccine mod infektioner grundet enteropatogene bakterier |
Country Status (10)
Country | Link |
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US (3) | US10500263B2 (da) |
EP (1) | EP3174553B1 (da) |
CN (1) | CN106659799B (da) |
CA (1) | CA2954087C (da) |
DK (1) | DK3174553T3 (da) |
EA (1) | EA035556B1 (da) |
ES (1) | ES2672045T3 (da) |
HU (1) | HUE038212T2 (da) |
SG (1) | SG11201700089QA (da) |
WO (1) | WO2016012587A1 (da) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
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ES2672045T3 (es) * | 2014-07-25 | 2018-06-12 | Biosynth S.R.L. | Vacunas de productos glicoconjugados que comprenden unidades básicas de una construcción molecular que expresa múltiples epítopos incorporados para la formulación de una vacuna de amplio espectro contra infecciones debidas a bacterias enteropatógenas |
JP6992057B2 (ja) | 2016-06-10 | 2022-01-13 | クラリティ コスメティックス インコーポレイテッド | 非面皰形成性の毛髪および頭皮ケア製剤ならびにその使用方法 |
US11260119B2 (en) | 2018-08-24 | 2022-03-01 | Pfizer Inc. | Escherichia coli compositions and methods thereof |
MX2022016587A (es) * | 2020-06-18 | 2023-02-01 | Glaxosmithkline Biologicals Sa | Bioconjugado tetravalente de shigella (shigella4v). |
WO2022216734A1 (en) * | 2021-04-06 | 2022-10-13 | The Board Of Trustees Of The University Of Illinois | Multivalent cholera multiepitope fusion antigen (mefa) and methods of use |
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ITMI20130142A1 (it) | 2013-01-31 | 2014-08-01 | Biosynth Srl | Vaccini glicoconiugati comprendenti unita' di base di un costrutto molecolare esprimente epitopi multipli incorporati |
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ES2672045T3 (es) * | 2014-07-25 | 2018-06-12 | Biosynth S.R.L. | Vacunas de productos glicoconjugados que comprenden unidades básicas de una construcción molecular que expresa múltiples epítopos incorporados para la formulación de una vacuna de amplio espectro contra infecciones debidas a bacterias enteropatógenas |
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2015
- 2015-07-24 ES ES15742232.0T patent/ES2672045T3/es active Active
- 2015-07-24 EA EA201692546A patent/EA035556B1/ru not_active IP Right Cessation
- 2015-07-24 DK DK15742232.0T patent/DK3174553T3/da active
- 2015-07-24 HU HUE15742232A patent/HUE038212T2/hu unknown
- 2015-07-24 US US15/329,205 patent/US10500263B2/en active Active
- 2015-07-24 CN CN201580039496.6A patent/CN106659799B/zh active Active
- 2015-07-24 EP EP15742232.0A patent/EP3174553B1/en active Active
- 2015-07-24 WO PCT/EP2015/066988 patent/WO2016012587A1/en active Application Filing
- 2015-07-24 CA CA2954087A patent/CA2954087C/en active Active
- 2015-07-24 SG SG11201700089QA patent/SG11201700089QA/en unknown
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2019
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2021
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US11246919B2 (en) | 2022-02-15 |
EA201692546A1 (ru) | 2017-08-31 |
CN106659799A (zh) | 2017-05-10 |
US20170209563A1 (en) | 2017-07-27 |
SG11201700089QA (en) | 2017-02-27 |
CA2954087C (en) | 2023-09-19 |
HUE038212T2 (hu) | 2018-10-29 |
US11576959B2 (en) | 2023-02-14 |
EP3174553A1 (en) | 2017-06-07 |
ES2672045T3 (es) | 2018-06-12 |
US20200129606A1 (en) | 2020-04-30 |
US10500263B2 (en) | 2019-12-10 |
CN106659799B (zh) | 2020-07-17 |
EP3174553B1 (en) | 2018-04-18 |
EA035556B1 (ru) | 2020-07-07 |
CA2954087A1 (en) | 2016-01-28 |
WO2016012587A1 (en) | 2016-01-28 |
US20210138059A1 (en) | 2021-05-13 |
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