HRP20231440T1 - Protutijela koja neutraliziraju virus hepatitisa b i njihova upotreba - Google Patents

Protutijela koja neutraliziraju virus hepatitisa b i njihova upotreba Download PDF

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HRP20231440T1
HRP20231440T1 HRP20231440TT HRP20231440T HRP20231440T1 HR P20231440 T1 HRP20231440 T1 HR P20231440T1 HR P20231440T T HRP20231440T T HR P20231440TT HR P20231440 T HRP20231440 T HR P20231440T HR P20231440 T1 HRP20231440 T1 HR P20231440T1
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antibody
vector
polynucleotide
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hepatitis
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HRP20231440TT
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Davide Corti
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Humabs Biomed Sa
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    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/08Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
    • C07K16/081Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from DNA viruses
    • C07K16/082Hepadnaviridae, e.g. hepatitis B virus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39541Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
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    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P31/12Antivirals
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    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705Receptors; Cell surface antigens; Cell surface determinants
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    • 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
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/79Vectors or expression systems specially adapted for eukaryotic hosts
    • C12N15/85Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86Viral vectors
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983Viruses
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    • A61K39/00Medicinal preparations containing antigens or antibodies
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/00Immunoglobulins specific features
    • C07K2317/60Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622Single chain antibody (scFv)
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/72Increased effector function due to an Fc-modification
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/00Immunoglobulins specific features
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    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • C07K2317/732Antibody-dependent cellular cytotoxicity [ADCC]
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    • C07ORGANIC CHEMISTRY
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    • C07K2317/734Complement-dependent cytotoxicity [CDC]
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    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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    • C07K2319/00Fusion polypeptide
    • C07K2319/01Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02Fusion polypeptide containing a localisation/targetting motif containing a signal sequence
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    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/33Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
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    • 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
    • G01N2333/005Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/01DNA viruses
    • G01N2333/02Hepadnaviridae, e.g. hepatitis B virus
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/26Infectious diseases, e.g. generalised sepsis

Claims (15)

1. Izolirano protutijelo koje veže HBsAg koje sadrži: (i) teški lanac (HC) koji sadrži aminokiselinsku sekvencu prema SEQ ID NO:91; i (ii) laki lanac (LC) koji sadrži aminokiselinsku sekvencu prema SEQ ID NO:93.
2. Protutijelo prema zahtjevu 1, naznačeno time što je protutijelo sposobno vezati HBsAg genotipa odabranog između HBsAg genotipova A, B, C, D, E, F, G, H, I, i J, ili bilo koju njihovu kombinaciju.
3. Protutijelo prema zahtjevu 1 ili zahtjevu 2, naznačeno time što je protutijelo sposobno smanjiti koncentraciju DNA virusa hepatitisa B u serumu (HBV) kod sisavca koji ima HBV infekciju.
4. Protutijelo prema bilo kojem od zahtjeva 1-3, naznačeno time što je protutijelo sposobno smanjiti koncentraciju HBsAg u serumu kod sisavca koji ima HBV infekciju.
5. Protutijelo prema bilo kojem od zahtjeva 1-4, naznačeno time što je protutijelo sposobno smanjiti koncentraciju HBeAg u serumu kod sisavca koji ima HBV infekciju.
6. Protutijelo prema bilo kojem od zahtjeva 1-5, naznačeno time što je protutijelo sposobno smanjiti koncentraciju HBcrAg u serumu kod sisavca koji ima HBV infekciju.
7. Izolirani polinukleotid koji sadrži nukleotidnu sekvencu koja kodira protutijelo prema bilo kojem od zahtjeva 1-6, po izboru, naznačen time što je nukleotidna sekvenca kodon optimiziran za ekspresiju u stanici domaćinu.
8. Polinukleotid prema zahtjevu 7, naznačen time što sadrži (i) nukleotidnu sekvencu koja ima najmanje 80% identičnosti s nukleotidnom sekvencom prema bilo kojoj od SEQ ID NO:103 i SEQ ID NO:105, ili (ii) VH-kodirajuću nukleotidnu sekvencu prema SEQ ID NO:103, i VL- kodirajuću nukleotidnu sekvencu prema SEQ ID NO:105.
9. Vektor naznačen time što sadrži polinukleotid prema zahtjevu 7 ili 8, naznačen time što, po izboru, vektor sadrži lentivirusni vektor ili retrovirusni vektor.
10. Stanica domaćina naznačena time što sadrži heterologni polinukleotid prema zahtjevu 7 ili 8.
11. Farmaceutski pripravak naznačen time što sadrži: (i) protutijelo prema bilo kojem od zahtjeva 1-6; (ii) polinukleotid prema zahtjevu 7 ili 8; (iii) vektor prema zahtjevu 9; (iv) stanicu domaćina prema zahtjevu 10; ili (v) bilo koju kombinaciju (i)-(iv); i farmaceutski prihvatljivu pomoćnu tvar, razrjeđivač ili nosač.
12. Postupak proizvodnje protutijela prema bilo kojem od zahtjeva 1-6, naznačen time što obuhvaća uzgoj stanice domaćina prema zahtjevu 10 pod uvjetima i tijekom vremena dovoljnog za proizvodnju protutijela.
13. (i) Protutijelo prema bilo kojem od zahtjeva 1-6; (ii) polinukleotid prema zahtjevu 7 ili 8; (iii) vektor prema zahtjevu 9; (iv) stanica domaćina prema zahtjevu 10; i/ili (v) farmaceutski pripravak prema zahtjevu 11, za upotrebu u postupku liječenja, prevencije i/ili ublažavanja infekcije hepatitisom B i/ili hepatitisom D kod subjekta, koji se sastoji od davanja subjektu učinkovite količine: (i), (ii), (iii), (iv), ili (v).
14. (i) Protutijelo; (ii) polinukleotid; (iii) vektor; (iv) stanica domaćin; i/ili (v) farmaceutski pripravak, za upotrebu prema zahtjevu 13, koji dalje uključuje davanje subjektu jednog ili više od: (vi) inhibitora polimeraze, pri čemu inhibitor polimeraze izborno sadrži lamivudin, adefovir, entekavir, telbivudin, tenofovir, ili bilo koju njihovu kombinaciju; (vii) interferon, pri čemu interferon izborno sadrži IFNbeta i/ili IFNalfa; (viii) inhibitor kontrolne točke, pri čemu inhibitor kontrolne točke po izboru sadrži anti-PD-1 protutijelo ili njegov fragment koji veže antigen, anti-PD-L1 protutijelo ili njegov fragment koji veže antigen, i/ili anti-CTLA4 protutijelo ili njegov fragment koji veže antigen; (ix) agonist molekule stimulativne imunološke kontrolne točke; ili (x) bilo koju kombinaciju (vi)-(ix).
15. (i) Protutijelo; (ii) polinukleotid; (iii) vektor; (iv) stanica domaćin; i/ili (v) farmaceutski pripravak za upotrebu prema zahtjevu 13 ili 14, naznačeni time što je infekcija hepatitisom B kronična infekcija hepatitisom B; i/ili subjekt je primio transplantaciju jetre, subjekt nije imuniziran protiv hepatitisa B, subjekt je novorođenče, i/ili subjekt je podvrgnut ili je bio podvrgnut hemodijalizi.
HRP20231440TT 2018-12-19 2019-12-18 Protutijela koja neutraliziraju virus hepatitisa b i njihova upotreba HRP20231440T1 (hr)

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US201862782274P 2018-12-19 2018-12-19
US201962860085P 2019-06-11 2019-06-11
EP19839558.4A EP3898668B1 (en) 2018-12-19 2019-12-18 Antibodies that neutralize hepatitis b virus and uses thereof
PCT/US2019/067216 WO2020132091A2 (en) 2018-12-19 2019-12-18 Antibodies that neutralize hepatitis b virus and uses thereof

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US (1) US20220127336A1 (hr)
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AU (1) AU2019403245A1 (hr)
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