HRP20171120T1 - Uvjetno replicirajući citomegalovirus kao cjepivo za cmv - Google Patents
Uvjetno replicirajući citomegalovirus kao cjepivo za cmv Download PDFInfo
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- HRP20171120T1 HRP20171120T1 HRP20171120TT HRP20171120T HRP20171120T1 HR P20171120 T1 HRP20171120 T1 HR P20171120T1 HR P20171120T T HRP20171120T T HR P20171120TT HR P20171120 T HRP20171120 T HR P20171120T HR P20171120 T1 HRP20171120 T1 HR P20171120T1
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- Prior art keywords
- cmv
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- conditionally
- replication
- fusion protein
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- 241000701022 Cytomegalovirus Species 0.000 title claims 20
- 230000003362 replicative effect Effects 0.000 title 1
- 229960005486 vaccine Drugs 0.000 title 1
- 102000037865 fusion proteins Human genes 0.000 claims 12
- 108020001507 fusion proteins Proteins 0.000 claims 12
- 230000002950 deficient Effects 0.000 claims 10
- 230000010076 replication Effects 0.000 claims 10
- 102000018679 Tacrolimus Binding Proteins Human genes 0.000 claims 7
- 108010027179 Tacrolimus Binding Proteins Proteins 0.000 claims 7
- 108090000623 proteins and genes Proteins 0.000 claims 6
- 102000004169 proteins and genes Human genes 0.000 claims 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 238000000034 method Methods 0.000 claims 4
- 102000039446 nucleic acids Human genes 0.000 claims 4
- 108020004707 nucleic acids Proteins 0.000 claims 4
- 150000007523 nucleic acids Chemical class 0.000 claims 4
- 101150110861 TRM2 gene Proteins 0.000 claims 3
- 101150063032 UL51 gene Proteins 0.000 claims 3
- 210000002919 epithelial cell Anatomy 0.000 claims 3
- NMFHJNAPXOMSRX-PUPDPRJKSA-N [(1r)-3-(3,4-dimethoxyphenyl)-1-[3-(2-morpholin-4-ylethoxy)phenyl]propyl] (2s)-1-[(2s)-2-(3,4,5-trimethoxyphenyl)butanoyl]piperidine-2-carboxylate Chemical compound C([C@@H](OC(=O)[C@@H]1CCCCN1C(=O)[C@@H](CC)C=1C=C(OC)C(OC)=C(OC)C=1)C=1C=C(OCCN2CCOCC2)C=CC=1)CC1=CC=C(OC)C(OC)=C1 NMFHJNAPXOMSRX-PUPDPRJKSA-N 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 2
- 230000000368 destabilizing effect Effects 0.000 claims 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 2
- 230000035772 mutation Effects 0.000 claims 2
- 230000002207 retinal effect Effects 0.000 claims 2
- 102200001904 rs104894321 Human genes 0.000 claims 2
- 102200015453 rs121912293 Human genes 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 238000006467 substitution reaction Methods 0.000 claims 2
- 101150093131 131 gene Proteins 0.000 claims 1
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- 102220470089 60S ribosomal protein L21_F15S_mutation Human genes 0.000 claims 1
- 206010011831 Cytomegalovirus infection Diseases 0.000 claims 1
- 102220534940 Integrator complex subunit 13_M66T_mutation Human genes 0.000 claims 1
- 102220476922 Interleukin-1 receptor-associated kinase 3_K105I_mutation Human genes 0.000 claims 1
- 102220486989 Olfactory receptor 2T1_H25R_mutation Human genes 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 101150032047 UL131 gene Proteins 0.000 claims 1
- 101150011902 UL52 gene Proteins 0.000 claims 1
- 101150016730 UL79 gene Proteins 0.000 claims 1
- 101150094182 UL84 gene Proteins 0.000 claims 1
- 239000002671 adjuvant Substances 0.000 claims 1
- 230000002238 attenuated effect Effects 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000028993 immune response Effects 0.000 claims 1
- 230000036039 immunity Effects 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 210000001127 pigmented epithelial cell Anatomy 0.000 claims 1
- 230000001681 protective effect Effects 0.000 claims 1
- 230000001850 reproductive effect Effects 0.000 claims 1
- 102200000381 rs121917855 Human genes 0.000 claims 1
- 102200118243 rs33937393 Human genes 0.000 claims 1
- 102220005320 rs33945546 Human genes 0.000 claims 1
- 102220005150 rs33971048 Human genes 0.000 claims 1
- 102220049017 rs587784387 Human genes 0.000 claims 1
- 102200067619 rs80357382 Human genes 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
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- C12N7/00—Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
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- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
- C07K14/01—DNA viruses
- C07K14/03—Herpetoviridae, e.g. pseudorabies virus
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- A—HUMAN NECESSITIES
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- A61P31/20—Antivirals for DNA viruses
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- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
- C07K14/01—DNA viruses
- C07K14/03—Herpetoviridae, e.g. pseudorabies virus
- C07K14/04—Varicella-zoster virus
- C07K14/045—Cytomegalovirus
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- C12N15/09—Recombinant DNA-technology
- C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
- C12N15/62—DNA sequences coding for fusion proteins
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- A61K39/00—Medicinal preparations containing antigens or antibodies
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- A61K2039/5252—Virus inactivated (killed)
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- C12N2710/00011—Details
- C12N2710/16011—Herpesviridae
- C12N2710/16111—Cytomegalovirus, e.g. human herpesvirus 5
- C12N2710/16134—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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Claims (22)
1. Citomegalovirus (CMV) s uvjetno defektnom replikacijom koji sadrži:
(a) pentamjerni gH kompleks koji sadrži UL128, UL130, UL131, gH i gL; i
(b) nukleinsku kiselinu koja kodira fuzijski protein između esencijalnog proteina i destabilizirajućeg proteina, pri čemu je esencijalni protein izabran iz grupe koja se sastoji od IE1/2, UL51, UL52, UL79 i UL84, pri čemu, destabilizirajući protein je FK506-vezujući protein (FKBP) ili FKBP derivat, pri čemu, FKBP derivat je FKBP koji sadrži jednu ili više aminokiselinskih supstitucija izabranih iz grupe koja se sastoji od: F15S, V24A, H25R, F36V, E60G, M66T, R71G, D100G, D100N, E102G, K105I i L106P, i pri čemu divlji tip esencijalnog proteina nije više prisutan.
2. CMV sa uvjetno defektnom replikacijom prema patentnom zahtjevu 1, naznačen time što FKBP derivat je FKBP koji sadrži aminokiselinske supstitucije F36V i L106P.
3. CMV sa uvjetno defektnom replikacijom prema bilo kojem od patentnih zahtjeva 1-2, naznačen time što esencijalni protein je IE1/2 ili UL51.
4. CMV sa uvjetno defektnom replikacijom prema bilo kojem od patentnih zahtjeva 1-2, naznačen time što CMV sadrži nukleinsku kiselinu koja kodira najmanje dva fuzijska proteina, pri čemu prvi fuzijski protein sadrži IE 1/2 i drugi fuzijski protein sadrži UL51.
5. CMV sa uvjetno defektnom replikacijom prema patentnom zahtjevu 4, naznačen time što
(a) prvi fuzijski protein je SEQ ID NO: 1 ili aminokiselina koja je najmanje 95% identična sa SEQ ID NO:1; i
(b) drugi fuzijski protein je SEQ ID NO:3 ili aminokiselina koja je najmanje 95% identična sa SEQ ID NO:3.
6. CMV sa uvjetno defektnom replikacijom prema patentnom zahtjevu 5, naznačen time što prvi fuzijski protein je SEQ ID NO: 1 i drugi fuzijski protein je SEQ ID NO: 3.
7. CMV sa uvjetno defektnom replikacijom prema patentnom zahtjevu 5, naznačen time što
(a) prvi fuzijski protein je kodiran sa SEQ ID NO:2 ili nukleinskom kiselinom koja je najmanje 95% identična sa SEQ ID NO:2; i
(b) drugi fuzijski protein je kodiran sa SEQ ID NO:4 ili nukleinskom kiselinom koja je najmanje 95% identična sa SEQ ID NO:4.
8. CMV sa uvjetno defektnom replikacijom prema patentnom zahtjevu 7 naznačen time što prvi fuzijski protein je kodiran sa SEQ ID NO: 2 i drugi fuzijski protein je kodiran sa SEQ ID NO: 4.
9. CMV sa uvjetno defektnom replikacijom prema bilo kojem od patentnih zahtjeva 1-8, naznačen time što CMV je atenuirani soj koji je obnovio ekspresiju gH kompleksa zahvaljujući popravku mutacije u UL 131 genu.
10. CMV sa uvjetno defektnom replikacijom prema patentnom zahtjevu 9, naznačen time što CMV je AD169 koji je obnovio ekspresiju gH kompleksa zahvaljujući popravku mutacije u UL131 genu.
11. Kompozicija koja sadrži CMV sa uvjetno defektnom replikacijom prema bilo kojem od patentnih zahtjeva 1-10 i farmaceutski prihvatljiv nosač.
12. Kompozicija prema patentnom zahtjevu 11 koja dalje sadrži adjuvans.
13. Upotreba CMV sa uvjetno defektnom replikacijom prema bilo kojem od patentnih zahtjeva 1-10 u proizvodnji lijeka za induciranje zaštitnog imunog odgovora kod pacijenta protiv CMV infekcije.
14. Upotreba prema patentnom zahtjevu 13, naznačena time što pacijent je čovjek sa oslabljenim imunitetom.
15. Upotreba prema patentnom zahtjevu 14, naznačena time što pacijent je žena u reproduktivnoj dobi.
16. Postupak za pripremu CMV sa uvjetno defektnom replikacijom prema bilo kojem od patentnih zahtjeva 1-10 koji sadrži umnožavanje rekombinantnog CMV u epitelnim stanicama u prisustvu Shield-1.
17. Postupak prema patentnom zahtjevu 16, naznačen time što su epitelne stanice humane pigmentirane retinalne epitelne stanice.
18. Postupak prema patentnom zahtjevu 17, naznačen time što humane retinalne pigmentisane epitelne stanice su ARPE-19 ćelije deponovane u American Type Culture Collection (ATCC) kao pristupni br. CRL-2302.
19. Postupak prema patentnom zahtjevu 16, naznačen time što Shield-1 je prisutan u koncentraciji od najmanje 0.5 µM.
20. Kompozicija koja sadrži CMV sa UVJETNO defektnom replikacijom prema bilo kojem od patentnih zahtjeva 1-10 u puferu na pH između 5-7 pri čemu pufer sadrži:
(a) između 15-35 mM Histidina; i
(b) između 100-200 mM NaCl.
21. Kompozicija prema patentnom zahtjevu 20, naznačena time što pufer sadrži 25 mM Histidina sa 150mM NaCl na pH od 6.
22. Kompozicija prema patentnom zahtjevu 21 koja dalje sadrži 9% tež./zapr. saharoze.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161532667P | 2011-09-09 | 2011-09-09 | |
| PCT/US2012/053599 WO2013036465A2 (en) | 2011-09-09 | 2012-09-04 | A conditional replicating cytomegalovirus as a vaccine for cmv |
| EP12830346.8A EP2753364B1 (en) | 2011-09-09 | 2012-09-04 | A conditional replicating cytomegalovirus as a vaccine for cmv |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20171120T1 true HRP20171120T1 (hr) | 2017-10-06 |
Family
ID=47832753
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20171120TT HRP20171120T1 (hr) | 2011-09-09 | 2017-07-20 | Uvjetno replicirajući citomegalovirus kao cjepivo za cmv |
| HRP20191111TT HRP20191111T1 (hr) | 2011-09-09 | 2019-06-18 | Uvjetno replicirajući citomegalovirusi kao cjepivo za cmv |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191111TT HRP20191111T1 (hr) | 2011-09-09 | 2019-06-18 | Uvjetno replicirajući citomegalovirusi kao cjepivo za cmv |
Country Status (33)
| Country | Link |
|---|---|
| US (1) | US9546355B2 (hr) |
| EP (3) | EP3251700B1 (hr) |
| JP (1) | JP5926804B2 (hr) |
| KR (1) | KR101668163B1 (hr) |
| CN (1) | CN103889462B (hr) |
| AR (1) | AR087772A1 (hr) |
| AU (1) | AU2012304783B2 (hr) |
| BR (1) | BR112014005404A8 (hr) |
| CA (1) | CA2846870C (hr) |
| CL (1) | CL2014000541A1 (hr) |
| CY (2) | CY1119107T1 (hr) |
| DK (2) | DK2753364T3 (hr) |
| ES (2) | ES2633190T3 (hr) |
| HR (2) | HRP20171120T1 (hr) |
| HU (2) | HUE035322T2 (hr) |
| IL (1) | IL231272B (hr) |
| IN (1) | IN2014CN01809A (hr) |
| LT (2) | LT3251700T (hr) |
| ME (2) | ME03488B (hr) |
| MX (1) | MX353037B (hr) |
| NZ (1) | NZ622156A (hr) |
| PE (1) | PE20141525A1 (hr) |
| PL (2) | PL3251700T3 (hr) |
| PT (2) | PT3251700T (hr) |
| RS (2) | RS58891B1 (hr) |
| RU (2) | RU2670012C1 (hr) |
| SG (1) | SG11201400419YA (hr) |
| SI (2) | SI2753364T1 (hr) |
| TR (1) | TR201910644T4 (hr) |
| TW (1) | TWI570240B (hr) |
| UA (1) | UA114896C2 (hr) |
| WO (1) | WO2013036465A2 (hr) |
| ZA (1) | ZA201401708B (hr) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2016501023A (ja) * | 2012-12-04 | 2016-01-18 | メルク・シャープ・アンド・ドーム・コーポレーションＭ | 条件付き複製ウイルスベクター |
| MX2015016978A (es) * | 2013-06-10 | 2016-04-25 | Merck Sharp & Dohme | Proteinas de union a antigeno neutralizantes de citomegalovirus. |
| WO2016011293A1 (en) | 2014-07-16 | 2016-01-21 | Oregon Health & Science University | Human cytomegalovirus comprising exogenous antigens |
| EP3048114A1 (en) * | 2015-01-22 | 2016-07-27 | Novartis AG | Cytomegalovirus antigens and uses thereof |
| WO2017070613A1 (en) | 2015-10-22 | 2017-04-27 | Modernatx, Inc. | Human cytomegalovirus vaccine |
| US10611800B2 (en) | 2016-03-11 | 2020-04-07 | Pfizer Inc. | Human cytomegalovirus gB polypeptide |
| US11446398B2 (en) | 2016-04-11 | 2022-09-20 | Obsidian Therapeutics, Inc. | Regulated biocircuit systems |
| WO2018075980A1 (en) | 2016-10-21 | 2018-04-26 | Modernatx, Inc. | Human cytomegalovirus vaccine |
| BR112020008482A8 (pt) * | 2017-11-01 | 2023-01-31 | Merck Sharp & Dohme | Composto leuco |
| US20210047626A1 (en) * | 2018-04-24 | 2021-02-18 | Merck Sharp & Dohme Corp. | Scalable chromatography process for purification of human cytomegalovirus |
| US11629172B2 (en) | 2018-12-21 | 2023-04-18 | Pfizer Inc. | Human cytomegalovirus gB polypeptide |
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| CA3146798A1 (en) * | 2019-07-12 | 2021-01-21 | Kobenhavns Universitet | Fusion toxin proteins for treatment of diseases related to cmv infections |
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| US20060110406A1 (en) * | 2003-02-25 | 2006-05-25 | Medimmune Vaccines, Inc. | Refrigerator-temperature stable influenza vaccine compositions |
| WO2004076645A2 (en) * | 2003-02-27 | 2004-09-10 | University Of Massachusetts | Compositions and methods for cytomegalovirus treatment |
| NZ560929A (en) * | 2005-02-18 | 2009-12-24 | Novartis Vaccines & Diagnostic | Immunogens from uropathogenic escherichia coli |
| EP2037959B1 (en) * | 2006-06-07 | 2016-01-27 | The Trustees Of Princeton University | Cytomegalovirus surface protein complex for use in vaccines and as a drug target |
| US8173792B2 (en) * | 2007-02-09 | 2012-05-08 | The Board Of Trustees Of The Leland Stanford Junior University | Method for regulating protein function in cells using synthetic small molecules |
| US9439960B2 (en) * | 2007-10-10 | 2016-09-13 | The Trustees Of Princeton University | Cytomegalovirus vaccines and methods of production |
| US8530636B2 (en) * | 2008-05-07 | 2013-09-10 | The Board Of Trustees Of The Leland Stanford Junior University | Method for regulating protein function in cells in vivo using synthetic small molecules |
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