HRP20202080T1 - Modificirani meningokokni fhbp polipeptidi - Google Patents
Modificirani meningokokni fhbp polipeptidi Download PDFInfo
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- HRP20202080T1 HRP20202080T1 HRP20202080TT HRP20202080T HRP20202080T1 HR P20202080 T1 HRP20202080 T1 HR P20202080T1 HR P20202080T T HRP20202080T T HR P20202080TT HR P20202080 T HRP20202080 T HR P20202080T HR P20202080 T1 HRP20202080 T1 HR P20202080T1
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- Prior art keywords
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- amino acid
- polypeptide
- acid sequence
- residue
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- 229920001184 polypeptide Polymers 0.000 title claims 21
- 102000004196 processed proteins & peptides Human genes 0.000 title claims 21
- 108090000765 processed proteins & peptides Proteins 0.000 title claims 21
- 125000003275 alpha amino acid group Chemical group 0.000 claims 16
- 238000006467 substitution reaction Methods 0.000 claims 12
- 150000001413 amino acids Chemical class 0.000 claims 6
- 101710186862 Factor H binding protein Proteins 0.000 claims 5
- 238000002360 preparation method Methods 0.000 claims 4
- 241000894006 Bacteria Species 0.000 claims 3
- 241000124008 Mammalia Species 0.000 claims 2
- 230000005875 antibody response Effects 0.000 claims 2
- 150000001720 carbohydrates Chemical class 0.000 claims 2
- 230000037430 deletion Effects 0.000 claims 2
- 238000012217 deletion Methods 0.000 claims 2
- 239000012634 fragment Substances 0.000 claims 2
- 230000002163 immunogen Effects 0.000 claims 2
- 238000003780 insertion Methods 0.000 claims 2
- 230000037431 insertion Effects 0.000 claims 2
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 150000007523 nucleic acids Chemical class 0.000 claims 2
- 239000013612 plasmid Substances 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 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
- 239000005711 Benzoic acid Substances 0.000 claims 1
- 239000004398 Ethyl lauroyl arginate Substances 0.000 claims 1
- 101000737574 Homo sapiens Complement factor H Proteins 0.000 claims 1
- 241000588650 Neisseria meningitidis Species 0.000 claims 1
- 101100203230 Neisseria meningitidis serogroup B (strain MC58) siaA gene Proteins 0.000 claims 1
- 230000000844 anti-bacterial effect Effects 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 239000004301 calcium benzoate Substances 0.000 claims 1
- 101150059761 ctrA gene Proteins 0.000 claims 1
- WSFSSNUMVMOOMR-UHFFFAOYSA-N formaldehyde Substances O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 102000045512 human CFH Human genes 0.000 claims 1
- 230000001939 inductive effect Effects 0.000 claims 1
- GZQKNULLWNGMCW-PWQABINMSA-N lipid A (E. coli) Chemical compound O1[C@H](CO)[C@@H](OP(O)(O)=O)[C@H](OC(=O)C[C@@H](CCCCCCCCCCC)OC(=O)CCCCCCCCCCCCC)[C@@H](NC(=O)C[C@@H](CCCCCCCCCCC)OC(=O)CCCCCCCCCCC)[C@@H]1OC[C@@H]1[C@@H](O)[C@H](OC(=O)C[C@H](O)CCCCCCCCCCC)[C@@H](NC(=O)C[C@H](O)CCCCCCCCCCC)[C@@H](OP(O)(O)=O)O1 GZQKNULLWNGMCW-PWQABINMSA-N 0.000 claims 1
- 239000012528 membrane Substances 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 101150084069 mltA gene Proteins 0.000 claims 1
- 230000035772 mutation Effects 0.000 claims 1
- 239000002773 nucleotide Substances 0.000 claims 1
- 125000003729 nucleotide group Chemical group 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
- 101150054232 pyrG gene Proteins 0.000 claims 1
- 238000003786 synthesis reaction Methods 0.000 claims 1
- 231100000331 toxic Toxicity 0.000 claims 1
- 230000002588 toxic effect Effects 0.000 claims 1
Classifications
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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
- A61K39/095—Neisseria
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
- C07K14/22—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Neisseriaceae (F)
-
- 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
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N15/74—Vectors or expression systems specially adapted for prokaryotic hosts other than E. coli, e.g. Lactobacillus, Micromonospora
-
- 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
- A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
- A61K2039/52—Bacterial cells; Fungal cells; Protozoal cells
- A61K2039/523—Bacterial cells; Fungal cells; Protozoal cells expressing foreign proteins
-
- 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
- A61K2039/55511—Organic adjuvants
-
- 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
-
- 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
- C12N2800/00—Nucleic acids vectors
- C12N2800/10—Plasmid DNA
- C12N2800/101—Plasmid DNA for bacteria
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Plant Pathology (AREA)
- Physics & Mathematics (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
Claims (13)
1. Mutantni v3 ili v2 fHbp, naznačen time što je:
(A) polipeptid koji sadrži v2 aminokiselinski slijed mutantnog fHbp, gdje:
(i) aminokiselinski slijed je najmanje 80% istovjetan slijedom u odnosu na SEQ ID NO: 5 i/ili sadrži fragment SEQ ID NO: 5 koji je dug najmanje 7 aminokiselina i sadrži ostatak koji odgovara ostatku 32 iz SEQ ID NO: 5; no
(ii) aminokiselinski slijed se razlikuje od SEQ ID NO: 5 na ostatku 32 zamjenom S32V,
gdje polipeptid može izazvati protutijela koja mogu prepoznati divlji tip meningokoknog polipeptida koji se sastoji od SEQ ID NO. 4, ili
(B) polipeptid koji sadrži v3 aminokiselinski slijed mutantnog fHbp, gdje:
(i) aminokiselinski slijed je najmanje 80% istovjetan slijedom u odnosu na SEQ ID NO: 17 i/ili sadrži fragment SEQ ID NO: 17 koji je dug najmanje 7 aminokiselina i sadrži ostatak koji odgovara ostatku 32 iz SEQ ID NO: 17; no
(ii) aminokiselinski slijed se razlikuje od SEQ ID NO: 17 na ostatku 32 zamjenom S32V, gdje polipeptid može izazvati protutijela koja mogu prepoznati divlji tip meningokoknog polipeptida koji se sastoji od SEQ ID NO. 40.
2. Polipeptid u skladu s patentnim zahtjevom 1, naznačen time što:
(A) aminokiselinski slijed dodatno se razlikuje od SEQ ID NO: 5 zamjenom na jednom ili više od L123, V124, S125, G126, L127 i/ili G128; gdje se jednu ili više zamjena bira iz skupine koju čine: L123R; V124I; S125G ili S125T; G126D; L127I; G128A; ili
(B) aminokiselinski slijed dodatno se razlikuje od SEQ ID NO: 17 zamjenom na L126, gdje je zamjena L126R.
3. Polipeptid u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što također sadrži jednu ili više dodatnih mutacija koje ometaju sposobnost vezanja polipeptida na ljudski čimbenik H; primjerice, u v2 koji sadrži zamjenu na jednom ili više ostataka R73, D203, E210, G228, S121, F122, A192, E194, V199, I200, L201, T213, H215, F219, T231, te E240, ili u v3 koji sadrži zamjenu na jednom ili više ostataka Q35, 178, L87, A88, V127, V202, E213, T216, H218, T234, V241, E243, te G248.
4. Polipeptid, naznačen time što sadrži:
i. aminokiselinski slijed SEQ ID NO: 45, koji može imati 1, 2, 3, 4 ili 5 zamjena, delecija i/ili insercija jedne aminokiseline, gdje polipeptid može izazvati protutijela koja se vežu na meningokokni fHbp polipeptid koji se sastoji od aminokiselinskog slijeda u SEQ ID NO: 2 (primjerice, koji sadrži aminokiselinski slijed SEQ ID NO: 45 s 1, 2, ili 3 zamjene jedne aminokiseline), no nije mutiran na ostatku V32 ili R123; i/ili
ii. aminokiselinski slijed SEQ ID NO: 44, koji može imati 1, 2, 3, 4 ili 5 zamjena, delecija i/ili insercija jedne aminokiseline, gdje polipeptid može izazvati protutijela koja se vežu na meningokokni fHbp polipeptid koji se sastoji od aminokiselinskog slijeda u SEQ ID NO: 40 (primjerice, koji sadrži aminokiselinski slijed SEQ ID NO: 44 s 1, 2, ili 3 zamjene jedne aminokiseline), no nije mutiran na ostatku V32 ili R126.
5. Polipeptid u skladu s patentnim zahtjevom 4, naznačen time što sadrži ili se sastoji od aminokiselinskog slijeda u SEQ ID NO: 45.
6. Polipeptid u skladu s patentnim zahtjevom 4, naznačen time što sadrži ili se sastoji od aminokiselinskog slijeda u SEQ ID NO: 44.
7. Plazmidna ili druga nukleinska kiselina, naznačena time što je nukleinska kiselina koja sadrži nukleotidni slijed koji kodira polipeptid u skladu s bilo kojim od patentnih zahtjeva 1 do 6.
8. Stanica domaćin, naznačena time što je se transformira plazmidom u skladu s patentnim zahtjevom 7; primjerice, kada je stanica meningokokna bakterija, poput meningokokne bakterije kod koje je negativno reguliran ili izbačen mltA i također može imati negativno reguliran ili izbačen: (i) najmanje jedan gen koji sudjeluje u činjenju lipidnog A dijela u LPS toksičnim, osobito IpxI1; i/ili (ii) najmanje jedan gen koji sudjeluje u sintezi ili eksportiranju kapsularnih polisaharida, osobito synX i/ili ctrA.
9. Membranske vezikule koje se pripravlja iz stanice domaćina u skladu s patentnim zahtjevom 8, naznačene time što vezikule sadrže polipeptid u skladu s bilo kojim od patentnih zahtjeva 1 do 6.
10. Imunogeni pripravak, naznačen time što sadrži polipeptid u skladu s bilo kojim od patentnih zahtjeva 1 do 6, ili vezikulu u skladu s patentnim zahtjevom 9.
11. Pripravak u skladu s patentnim zahtjevom 10, naznačen time što dodatno sadrži drugi polipeptid koji, prilikom primjene na sisavcu, izaziva protutijelo kao odgovor koji je baktericidan za meningokoke.
12. Pripravak u skladu s patentnim zahtjevom 10 ili patentnim zahtjevom 11, naznačen time što dodatno sadrži (i) konjugirani kapsularni saharid iz seroskupine A, C, W135 bakterije N. meningitidis i/ili Y i/ili (ii) konjugirani kapsularni saharid iz bakterije S. pneumoniae.
13. Imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 10 do 12, naznačen time što je namijenjen upotrebi u postupku izazivanja protutijela kao odgovora kod sisavca.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14157399 | 2014-02-28 | ||
| EP14177566 | 2014-07-17 | ||
| EP15707351.1A EP3110442B1 (en) | 2014-02-28 | 2015-02-27 | Modified meningococcal fhbp polypeptides |
| PCT/EP2015/054174 WO2015128480A1 (en) | 2014-02-28 | 2015-02-27 | Modified meningococcal fhbp polypeptides |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20202080T1 true HRP20202080T1 (hr) | 2021-02-19 |
Family
ID=52596977
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20202080TT HRP20202080T1 (hr) | 2014-02-28 | 2020-12-31 | Modificirani meningokokni fhbp polipeptidi |
Country Status (23)
| Country | Link |
|---|---|
| US (3) | US10392424B2 (hr) |
| EP (2) | EP3110442B1 (hr) |
| JP (3) | JP6786394B2 (hr) |
| KR (2) | KR20160127104A (hr) |
| CN (1) | CN106661092B (hr) |
| AU (2) | AU2015222121B2 (hr) |
| BR (1) | BR112016019735A2 (hr) |
| CA (1) | CA2940447C (hr) |
| CY (1) | CY1123622T1 (hr) |
| DK (1) | DK3110442T3 (hr) |
| EA (1) | EA034954B1 (hr) |
| ES (1) | ES2841378T3 (hr) |
| HR (1) | HRP20202080T1 (hr) |
| HU (1) | HUE052293T2 (hr) |
| IL (1) | IL247125B (hr) |
| LT (1) | LT3110442T (hr) |
| MX (2) | MX2016011176A (hr) |
| PL (1) | PL3110442T3 (hr) |
| RS (1) | RS61246B1 (hr) |
| SG (2) | SG10201907875TA (hr) |
| SI (1) | SI3110442T1 (hr) |
| WO (1) | WO2015128480A1 (hr) |
| ZA (1) | ZA201605534B (hr) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2940447C (en) | 2014-02-28 | 2023-07-11 | Glaxosmithkline Biologicals Sa | Modified meningococcal fhbp polypeptides |
| SG11201610945PA (en) * | 2014-07-17 | 2017-01-27 | Glaxosmithkline Biolog Sa | Modified meningococcal fhbp polypeptides |
| SG10201900041VA (en) * | 2014-07-17 | 2019-02-27 | Glaxosmithkline Biologicals Sa | Meningococcus vaccines |
| EP4074726A3 (en) | 2014-07-23 | 2022-11-23 | Children's Hospital & Research Center at Oakland | Factor h binding protein variants and methods of use thereof |
| KR20220011796A (ko) * | 2017-01-31 | 2022-01-28 | 화이자 인코포레이티드 | 네이세리아 메닌기티디스 조성물 및 그의 방법 |
| EP3607967A1 (en) | 2018-08-09 | 2020-02-12 | GlaxoSmithKline Biologicals S.A. | Modified meningococcal fhbp polypeptides |
| EP3934696A1 (en) | 2019-03-08 | 2022-01-12 | GlaxoSmithKline Biologicals S.A. | Carbocyclic derivatives and conjugated derivatives thereof, and their use in vaccines |
| GB202013262D0 (en) | 2020-08-25 | 2020-10-07 | Glaxosmithkline Biologicals Sa | Vaccine Composition |
| MX2023009728A (es) | 2021-02-19 | 2023-08-30 | Sanofi Pasteur Inc | Vacuna recombinante meningococica b. |
| GB202115151D0 (en) | 2021-10-21 | 2021-12-08 | Glaxosmithkline Biologicals Sa | Methods |
| GB202208093D0 (en) | 2022-06-01 | 2022-07-13 | Glaxosmithkline Biologicals Sa | Immunogenic composition |
| GB202208089D0 (en) | 2022-06-01 | 2022-07-13 | Glaxosmithkline Biologicals Sa | Immunogenic composition |
| WO2024030931A1 (en) | 2022-08-03 | 2024-02-08 | Sanofi Pasteur Inc. | Adjuvanted immunogenic composition against neisseria meningitidis b |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4057685A (en) | 1972-02-02 | 1977-11-08 | Abbott Laboratories | Chemically modified endotoxin immunizing agent |
| DE2848965A1 (de) | 1978-11-11 | 1980-05-22 | Behringwerke Ag | Verfahren zur herstellung von membranproteinen aus neisseria meningitidis und diese enthaltende vaccine |
| US4356170A (en) | 1981-05-27 | 1982-10-26 | Canadian Patents & Development Ltd. | Immunogenic polysaccharide-protein conjugates |
| US4673574A (en) | 1981-08-31 | 1987-06-16 | Anderson Porter W | Immunogenic conjugates |
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| US4663160A (en) | 1983-03-14 | 1987-05-05 | Miles Laboratories, Inc. | Vaccines for gram-negative bacteria |
| US4761283A (en) | 1983-07-05 | 1988-08-02 | The University Of Rochester | Immunogenic conjugates |
| US4882317A (en) | 1984-05-10 | 1989-11-21 | Merck & Co., Inc. | Covalently-modified bacterial polysaccharides, stable covalent conjugates of such polysaccharides and immunogenic proteins with bigeneric spacers and methods of preparing such polysaccharides and conjugataes and of confirming covalency |
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| IT1187753B (it) | 1985-07-05 | 1987-12-23 | Sclavo Spa | Coniugati glicoproteici ad attivita' immunogenica trivalente |
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