DK2689016T3 - Immunogene sammensætninger i partikelform og fremgangmsåder til produktion heraf - Google Patents
Immunogene sammensætninger i partikelform og fremgangmsåder til produktion heraf Download PDFInfo
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- DK2689016T3 DK2689016T3 DK12712389.1T DK12712389T DK2689016T3 DK 2689016 T3 DK2689016 T3 DK 2689016T3 DK 12712389 T DK12712389 T DK 12712389T DK 2689016 T3 DK2689016 T3 DK 2689016T3
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- A—HUMAN NECESSITIES
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- A61K39/385—Haptens or antigens, bound to carriers
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/12—Viral antigens
- A61K39/155—Paramyxoviridae, e.g. parainfluenza virus
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- 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
- A61P31/12—Antivirals
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/16—Antivirals for RNA viruses for influenza or rhinoviruses
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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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
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- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
- C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
- C12N9/2462—Lysozyme (3.2.1.17)
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- C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
- C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
- C12Y302/01017—Lysozyme (3.2.1.17)
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- A—HUMAN NECESSITIES
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- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
- A61K2039/541—Mucosal route
- A61K2039/543—Mucosal route intranasal
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6068—Other bacterial proteins, e.g. OMP
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- C07—ORGANIC CHEMISTRY
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- C07K2319/00—Fusion polypeptide
- C07K2319/40—Fusion polypeptide containing a tag for immunodetection, or an epitope for immunisation
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- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16111—Influenzavirus A, i.e. influenza A virus
- C12N2760/16122—New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
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- C12N2760/00011—Details
- C12N2760/16011—Orthomyxoviridae
- C12N2760/16111—Influenzavirus A, i.e. influenza A virus
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- C12N2760/18511—Pneumovirus, e.g. human respiratory syncytial virus
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- C12N2760/00011—Details
- C12N2760/18011—Paramyxoviridae
- C12N2760/18511—Pneumovirus, e.g. human respiratory syncytial virus
- C12N2760/18534—Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
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Claims (16)
1. Immunogen sammensætning i partikelform, hvilken sammensætning omfatter: i. en ikke-levedygtig bakterielignende partikel (BLP) opnået fra en Gram-positiv bakterie som partikelbærer; ii. oligomerer af et rekombinant produceret polypeptid, der ikke-kovalent er bundet til BLP’en, hvor det rekombinante polypeptid omfatter: A) et N- eller C-terminalt antigent domæne, der mindst omfatter et overfladeeksponeret polypeptid af patogen eller tumoroprindelse, eller en antigen del deraf, hvilket antigent domæne er kondenseret til B) et oligomeriseringsdomæne (OMD), hvilket oligomeriseringsdomæne er kondenseret via C) et linker-domæne til D) et peptidoglycan-bindende domæne (PBD) bestående af en enkelt kopi af et LysM-domæne, der medierer den ikke-kovalente binding af polypeptidet til BLP’en, og hvor polypeptidet som en helhed kun indeholder en enkelt kopi af et LysM-domæne; og iii. et farmaceutisk acceptabelt fortyndingsmiddel eller excipiens.
2. Immunogen sammensætning ifølge krav 1, hvor det overfladeeksponerede polypeptid i det antigene domæne af det rekombinante polypeptid omfatter et ektodomæne af et kappeklædt virusprotein, fortrinsvis hvor virusset er influenzavirus, animalsk coronavirus, humane respiratoriske coronavira, humant immundefekt virus (HIV) eller paramyxovirus, navnlig respiratorisk syncytialvirus (RSV) eller metapneumovirus.
3. Immunogen sammensætning ifølge krav 2, hvor det overfladeeksponerede polypeptid eller den antigene del deraf er udvalgt lfa gruppen bestående af influenzahæmagglutinin (HA) ektodomæne eller en del deraf, influenzaneuraminidase (NA) ektodomæne eller en del deraf, coronavirus spike- (S) protein ektodomæne eller en del deraf, RSV-glycoprotein F- eller G-ektodomæner eller dele deraf og HIV gpl40 ektodomæne eller en del deraf.
4. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor linker-domænet af det rekombinante polypeptid består af mellem 10 og 60, fortrinsvis 20-50, mere fortrinsvis 25-40 aminosyrer, for eksempel ca. 30 aminosyrer.
5. Immunogen sammensætning ifølge krav 4, hvor linker-domænet omfatter en aminosyresekvens udvalgt fra gruppen bestående af: GASSAGNTNSGGSTTTITNNNSGTNSSST, GSASSTNSGGSNNSASTTPTTSVTPAKPTSQ og QSAAASNPSTGSGSTATNNSNSTSSNSNAS.
6. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor oligomeriseringsdomænet (OMD) af det rekombinante polypeptid er et dimeriserings-, trimeriserings- eller tetrameriseringsdomæne, fortrinsvis hvor oligomeriseringsdomænet er udvalgt fra et GCN4-baseret di-, tri- eller tetrameriseringsdomæne, den C-terminale domænesekvens af T4 fibritin (foldon) eller en funktionel del eller analog deraf (C-terminale 27 til 30 rester) og det opløselige trimeriseringsdomæne af kyllingebruskmatrix- (CART) protein.
7. Immunogen sammensætning ifølge et hvilket som helst af kravene 1 -6, hvor det rekombinante polypeptid endvidere omfatter, i tilfælde af et N-terminalt antigent domæne, en C-terminal capping-sekvens, eller i tilfælde af et C-terminalt antigent domæne, en N-terminal capping-sekvens.
8. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor bakterien er en ikke-patogen bakterie, fortrinsvis en bakterie af fødevarekvalitet, mere fortrinsvis hvor bakterien er udvalgt fra gruppen bestående af en Lactococcus, en Lactobacillus, en Bacillus og en Mycobacterium ssp.
9. Immunogen sammensætning ifølge et hvilket som helst af de foregående krav, hvor partikelbæreren ikke-kovalent er forsynet med mindst en første oligomer af polypeptider omfattende overfladeeksponerede polypeptider eller antigene dele deraf afledt af et første patogen og en anden oligomer af polypeptider omfattende overfladeeksponerede polypeptider eller antigene dele deraf afledt af et andet patogen.
10. Fremgangsmåde til tilvejebringelse af en immunogen sammensætning ifølge et hvilket som helst af kravene 1 til 9, hvilken fremgangsmåde omfatter følgende trin: a) tilvejebringelse af et rekombinant polypeptid som anført i et hvilket som helst af kravene 1-7, omfattende dyrkning af en værtscelle omfattende en ekspressionsvektor, der koder for polypeptidet i et egnet medium, der muliggør ekspression af polypeptidet, og isolering af polypeptidet; b) tilvejebringelse af en ikke-levedygtig bakterielignende partikel (BLP) opnået fra en Gram-positiv bakterie, c) tilladelse til ikke-kovalent binding af polypeptidet/-peptideme til BLP’en for at danne et immunogent kompleks omfattende oligomerer af et overfladeeksponeret polypeptid af patogen oprindelse eller en antigen del deraf, der er ikke-kovalent bundet til en partikelbærer, og d) formulering af det immunogene kompleks til en immunogen sammensætning.
11. Immunogen sammensætning ifølge et hvilket som helst af kravene 1 til 9 til anvendelse i en fremgangsmåde til fremkaldelse af et immunrespons mod et patogen hos et individ, hvilken fremgangsmåde omfatter administration af sammensætningen til individet.
12. Immunogen sammensætning til anvendelse ifølge krav 11 til fremkaldelse af et immunrespons mod en virussygdom hos et individ, fortrinsvis hvor virussygdommen er forårsaget af influenzavirus, animalsk coronavirus, humane respiratoriske coronavira, humant immundefekt virus (HIV) eller paramyxovirus, navnlig respiratorisk syncytialvirus (RSV) eller metapneumo virus.
13. Rekombinant polypeptid omfattende: A) et N- eller C-terminalt antigent domæne, der mindst omfatter et overfladeeksponeret polypeptid (f.eks. af patogen eller tumorcelleoprindelse) eller en antigen del deraf, hvilket antigent domæne er kondenseret til B) et oligomeriseringsdomæne (OMD), hvilket oligomeriseringsdomæne er kondenseret via C) et linker-domæne til D) et peptidoglycan-bindende domæne (PBD) bestående af en enkelt kopi af et LysM-domæne, der er i stand til at mediere den ikke-kovalente binding af polypeptidet til en peptidoglycanbærerpartikel, der er en ikke-levedygtig bakterielignende partikel (BLP), der er opnået fra en Gram-positiv bakterie, og hvor polypeptidet som en helhed kun indeholder en enkelt kopi af et LysM-domæne.
14. Nukleinsyresekvens, der koder for et polypeptid ifølge krav 13.
15. Vektor omfattende en nukleinsyresekvens ifølge krav 14.
16. Værtscelle, der omfatter en nukleinsyresekvens ifølge krav 14 eller en vektor ifølge krav 15, fortrinsvis hvor værtscellen er en eukaryot værtscelle, mere fortrinsvis en pattedyreværtscelle.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11159233 | 2011-03-22 | ||
PCT/NL2012/050177 WO2012128628A1 (en) | 2011-03-22 | 2012-03-22 | Immunogenic compositions in particulate form and methods for producing the same |
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DK2689016T3 true DK2689016T3 (da) | 2015-04-27 |
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DK12712389.1T DK2689016T3 (da) | 2011-03-22 | 2012-03-22 | Immunogene sammensætninger i partikelform og fremgangmsåder til produktion heraf |
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Country | Link |
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US (1) | US9585953B2 (da) |
EP (1) | EP2689016B1 (da) |
JP (1) | JP6069295B2 (da) |
CN (1) | CN103547676B (da) |
AU (1) | AU2012231896B2 (da) |
BR (1) | BR112013024157A2 (da) |
CA (1) | CA2830901A1 (da) |
DK (1) | DK2689016T3 (da) |
ES (1) | ES2535421T3 (da) |
WO (1) | WO2012128628A1 (da) |
ZA (1) | ZA201307124B (da) |
Families Citing this family (19)
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EP1746103A1 (en) * | 2005-07-20 | 2007-01-24 | Applied NanoSystems B.V. | Bifunctional protein anchors |
HRP20220756T1 (hr) | 2009-07-15 | 2022-09-02 | Glaxosmithkline Biologicals S.A. | Proteinski pripravci rsv f i postupci za izradu istih |
US9060975B2 (en) * | 2013-03-14 | 2015-06-23 | Mucosis Bv | Heat-stable respiratory syncytial virus F protein oligomers and their use in immunological compositions |
KR20170068598A (ko) * | 2014-10-20 | 2017-06-19 | 주노 쎄러퓨티크스 인코퍼레이티드 | 입양 세포 치료에서 복용을 위한 방법 및 조성물 |
US11413310B2 (en) | 2017-06-02 | 2022-08-16 | Juno Therapeutics, Inc. | Articles of manufacture and methods for treatment using adoptive cell therapy |
CN107899017B (zh) * | 2017-08-16 | 2021-06-08 | 祝康生物科技有限公司 | 一种天然生物纳米靶向药物复合体材料及其制备方法和应用 |
JP7376208B2 (ja) | 2017-10-25 | 2023-11-08 | アレーロ セラピューティクス ビーヴイ | 抗原特異的製剤の投与による免疫疾患の治療 |
EP3741856A4 (en) * | 2018-01-16 | 2021-10-27 | Kao Corporation | MANUFACTURING METHOD FOR PROTEASE OF THE M23A FAMILY |
US10822591B2 (en) | 2018-06-12 | 2020-11-03 | Kentucky Bioprocessing, Inc. | Virus purification |
US11529413B2 (en) | 2018-06-12 | 2022-12-20 | Kbio Holdings Limited | Virus and antigen purification and conjugation |
US11696948B2 (en) | 2018-06-12 | 2023-07-11 | Kbio Holdings Limited | Vaccines formed by virus and antigen conjugation |
US11690907B2 (en) | 2018-06-12 | 2023-07-04 | Kbio Holdings Limited | Vaccines formed by virus and antigen conjugation |
US20220267478A1 (en) * | 2019-07-30 | 2022-08-25 | Academia Sinica | Peptide-loaded carrier systems and uses thereof |
CN110627911B (zh) * | 2019-10-14 | 2022-11-22 | 吉林大学 | 一种可诱导hiv-1广谱中和抗体的包膜蛋白三聚体免疫原及用途 |
KR102571164B1 (ko) * | 2020-04-22 | 2023-08-25 | 포항공과대학교 산학협력단 | 삼량체를 형성하는 인플루엔자 바이러스 표면 단백질 유래 재조합 혈구응집소 (ha)의 단백질 유전자 디자인, 식물에서의 상기 ha 재조합 단백질을 대량 생산하는 방법 및 이를 포함하는 인플루엔자 바이러스 감염 질환의 예방 및 치료용 약학적 조성물 |
WO2021215855A1 (ko) * | 2020-04-22 | 2021-10-28 | 포항공과대학교 산학협력단 | 삼량체를 형성하는 인플루엔자 바이러스 표면 단백질 유래 재조합 혈구응집소 단백질 및 이의 용도 |
JP2024520730A (ja) * | 2021-06-07 | 2024-05-24 | アイコサバックス, インコーポレイテッド | コロナウイルスに対するウイルス様粒子ワクチン |
EP4140475A1 (en) * | 2021-08-30 | 2023-03-01 | Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. | Synthetic virus-like lipoparticles |
CN116027033B (zh) * | 2022-12-02 | 2024-05-24 | 吉林大学 | 一种基于细菌样颗粒检测细菌和病毒抗原、抗体的方法 |
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EP0916726A1 (en) | 1997-11-13 | 1999-05-19 | Rijksuniversiteit te Groningen | Attaching substances to micro-organisms |
ATE433491T1 (de) * | 2001-01-18 | 2009-06-15 | Vlaams Interuniv Inst Biotech | Oligomerische komplexe von chimären proteinen mit verbessertem immunogenen potential |
AU2002314626B2 (en) | 2001-06-11 | 2008-01-03 | Applied Nanosystems B.V. | Methods for binding AcmA-type protein anchor fusions to cell-wall material of micro-organisms |
JP4817625B2 (ja) * | 2003-08-11 | 2011-11-16 | 一般財団法人阪大微生物病研究会 | 粘膜免疫誘導アジュバントを含む新規ワクチン |
CN1921884B (zh) * | 2003-12-24 | 2012-02-08 | 塞鲁斯公司 | 重组核酸分子,表达盒和细菌,及其使用方法 |
WO2009052571A1 (en) | 2007-10-23 | 2009-04-30 | Clinical Genomics Pty. Ltd. | A method of diagnosing neoplasms |
SG188813A1 (en) * | 2007-12-24 | 2013-04-30 | Id Biomedical Corp Quebec | Recombinant rsv antigens |
HRP20220756T1 (hr) * | 2009-07-15 | 2022-09-02 | Glaxosmithkline Biologicals S.A. | Proteinski pripravci rsv f i postupci za izradu istih |
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2012
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- 2012-03-22 JP JP2014501027A patent/JP6069295B2/ja not_active Expired - Fee Related
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- 2012-03-22 BR BR112013024157A patent/BR112013024157A2/pt not_active Application Discontinuation
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ZA201307124B (en) | 2014-05-28 |
EP2689016B1 (en) | 2015-03-11 |
WO2012128628A9 (en) | 2013-05-10 |
BR112013024157A2 (pt) | 2016-12-06 |
CN103547676A (zh) | 2014-01-29 |
AU2012231896A1 (en) | 2013-10-17 |
JP6069295B2 (ja) | 2017-02-01 |
ES2535421T3 (es) | 2015-05-11 |
JP2014513934A (ja) | 2014-06-19 |
AU2012231896B2 (en) | 2015-04-09 |
US9585953B2 (en) | 2017-03-07 |
EP2689016A1 (en) | 2014-01-29 |
CN103547676B (zh) | 2016-11-16 |
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