HRP20171194T1 - Trovalentni konstrukti nanotijela protiv ljudskog respiratornog sincicijskog virusa (hrsv) za prevenciju i/ili liječenje infekcija dišnih puteva - Google Patents
Trovalentni konstrukti nanotijela protiv ljudskog respiratornog sincicijskog virusa (hrsv) za prevenciju i/ili liječenje infekcija dišnih puteva Download PDFInfo
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- HRP20171194T1 HRP20171194T1 HRP20171194TT HRP20171194T HRP20171194T1 HR P20171194 T1 HRP20171194 T1 HR P20171194T1 HR P20171194T T HRP20171194T T HR P20171194TT HR P20171194 T HRP20171194 T HR P20171194T HR P20171194 T1 HRP20171194 T1 HR P20171194T1
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- amino acid
- gln108leu
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- arg105gln
- asp85glu
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- 206010057190 Respiratory tract infections Diseases 0.000 title claims 2
- 230000002265 prevention Effects 0.000 title claims 2
- 208000020029 respiratory tract infectious disease Diseases 0.000 title claims 2
- 241000711920 Human orthopneumovirus Species 0.000 title 1
- 150000001413 amino acids Chemical class 0.000 claims 48
- 229920001184 polypeptide Polymers 0.000 claims 34
- 102000004196 processed proteins & peptides Human genes 0.000 claims 34
- 108090000765 processed proteins & peptides Proteins 0.000 claims 34
- 102220597331 Coiled-coil domain-containing protein 144A_Q108L_mutation Human genes 0.000 claims 25
- 102220571078 Growth arrest and DNA damage-inducible protein GADD45 gamma_A83R_mutation Human genes 0.000 claims 22
- 102220138536 rs146905561 Human genes 0.000 claims 22
- 102200007401 rs3755955 Human genes 0.000 claims 22
- 102200133317 rs869025586 Human genes 0.000 claims 22
- 102220612213 Calcyclin-binding protein_E1D_mutation Human genes 0.000 claims 16
- 235000001014 amino acid Nutrition 0.000 claims 16
- 102220463950 rs7782939 Human genes 0.000 claims 16
- 102220578068 ATPase MORC2_G78L_mutation Human genes 0.000 claims 10
- 102200043501 rs1800450 Human genes 0.000 claims 10
- 101710160621 Fusion glycoprotein F0 Proteins 0.000 claims 8
- 238000003556 assay Methods 0.000 claims 8
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 8
- NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 7
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims 7
- ROHFNLRQFUQHCH-UHFFFAOYSA-N Leucine Natural products CC(C)CC(N)C(O)=O ROHFNLRQFUQHCH-UHFFFAOYSA-N 0.000 claims 7
- 102200092858 rs36084266 Human genes 0.000 claims 6
- 238000002360 preparation method Methods 0.000 claims 5
- 102220011971 rs397515737 Human genes 0.000 claims 5
- 239000004475 Arginine Substances 0.000 claims 4
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 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 group 0.000 claims 4
- 239000002773 nucleotide Chemical group 0.000 claims 4
- 125000003729 nucleotide group Chemical group 0.000 claims 4
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims 3
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims 3
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 claims 3
- 125000000539 amino acid group Chemical group 0.000 claims 3
- 235000003704 aspartic acid Nutrition 0.000 claims 3
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims 3
- ZDXPYRJPNDTMRX-UHFFFAOYSA-N glutamine Natural products OC(=O)C(N)CCC(N)=O ZDXPYRJPNDTMRX-UHFFFAOYSA-N 0.000 claims 3
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 2
- 206010013975 Dyspnoeas Diseases 0.000 claims 2
- 102220570985 Uncharacterized protein C7orf57_A74S_mutation Human genes 0.000 claims 2
- 235000013922 glutamic acid Nutrition 0.000 claims 2
- 239000004220 glutamic acid Substances 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 230000002685 pulmonary effect Effects 0.000 claims 2
- 238000000746 purification Methods 0.000 claims 2
- 108010068327 4-hydroxyphenylpyruvate dioxygenase Proteins 0.000 claims 1
- 206010006448 Bronchiolitis Diseases 0.000 claims 1
- 206010011224 Cough Diseases 0.000 claims 1
- 208000000059 Dyspnea Diseases 0.000 claims 1
- 206010024971 Lower respiratory tract infections Diseases 0.000 claims 1
- 206010035664 Pneumonia Diseases 0.000 claims 1
- 206010046306 Upper respiratory tract infection Diseases 0.000 claims 1
- 239000000443 aerosol Substances 0.000 claims 1
- 208000006673 asthma Diseases 0.000 claims 1
- 229940112141 dry powder inhaler Drugs 0.000 claims 1
- 238000002955 isolation Methods 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 208000023504 respiratory system disease Diseases 0.000 claims 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/08—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses
- C07K16/10—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
- C07K16/1027—Paramyxoviridae, e.g. respiratory syncytial virus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0065—Inhalators with dosage or measuring devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- 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
- A61P31/14—Antivirals for RNA viruses
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/22—Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/35—Valency
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C07K2317/00—Immunoglobulins specific features
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- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/567—Framework region [FR]
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- C07K2317/00—Immunoglobulins specific features
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- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
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- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (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)
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Claims (14)
1. Trovalentni polipeptid koji je usmjeren protiv proteina F iz hRSV, koji se bira iz bilo kojeg od (A) do (C):
(A) trovalentnog polipeptida koji se bira između sljedećih polipeptida:
a) SEQ ID Br.: 142-145 i 162-165;
b) polipeptida koji imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 142-145 i 162-165, pod uvjetom da:
i) prva sekvenca aminokiseline koja obuhvaća navedeni polipeptid ima Asparaginsku kiselinu (Asp, D) na položaju 1; i
ii) polipeptid veže protein F iz hRSV s istim ili višim afinitetom, pri se čemu navedeni afinitet mjeri površinskom plazmonskom rezonancijom, i/ili polipeptid ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi s polipeptidom bez 3, 2 ili 1 razlikom u aminokiselini,
c) SEQ ID Br.: 77-79 i 158;
d) polipeptida koji imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 77-79 i 158, pod uvjetom da:
i) sekvence amino kiselina koje obuhvaća navedeni polipeptid imaju Glutamin (Gln, Q) na položaju 105, Leucin (Leu, L) na položaju 78, Arginin (Arg, R) na položaju 83 i/ili Glutaminsku kiselinu (Glu, E) na položaju 85, pri čemu se navedeni položaji određuju prema Kabatovom numeriranju; i
ii) polipeptide veže protein F iz hRSV s istim ili višim afinitetom, pri čemu se navedeni afinitet mjeri površinskom plazmonskom rezonancijom, i/ili polipeptid ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi s polipeptidom bez 3, 2 ili 1 razlikom u aminokiselini,
e) SEQ ID Br.: 159-161;
f) polipeptida koji imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 159-161, pod uvjetom da:
i) sekvenca amino kiseline koja je obuhvaćena u navedenom polipeptidu ima Prolin (Pro, P) na položaju 14, Arginin (Arg, R) na položaju 19, Leucin (Leu, L) na položaju 20 i Leucin (Leu, L) na položaju 108, pri čemu se navedeni položaji određuju prema Kabatovom numeriranju; i
ii) polipeptid veže protein F iz hRSV s istim ili višim afinitetom, pri čemu se navedeni afinitet mjeri površinskom plazmonskom rezonancijom, i/ili polipeptid ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi s polipeptidom bez 3, 2 ili 1 razlikom u aminokiselini;
(B) trovalentnog polipeptida koji sadrži ili se sastoji od tri sekvence aminokiseline koje obuhvaćaju 4 okvirne regije i 3 regije koje određuju komplementarnost (CDR) u kojem:
- CDR1 je SEQ ID NO: 98;
i
- CDR2 je SEQ ID NO: 102;
i
- CDR3 je SEQ ID NO: 121,
(C) trovalentnog polipeptida koji sadrži ili se sastoji od tri sekvence aminokiseline, pri čemu je svaka amino sekvenca aminokiseline odabrana od slijedećeg a) do d):
a) SEQ ID Br.: 60-76;
b) sekvenci amino kiselina koje imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 60-76, pod uvjetom da:
i) sekvenca amino kiseline ima Glutamin (Gln, Q) na položaju 105, pri čemu se navedeni položaj određuje prema Kabatovom numeriranju; i
ii) sekvenca amino kiseline veže protein F iz hRSV s istim ili višim afinitetom, pri čemu se navedeni afinitet mjeri površinskom plazmonskom rezonancijom, i/ili sekvenca amino kiseline ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi sa sekvencom amino kiseline bez 3, 2 ili 1 razlikom u aminokiselini,
c) SEQ ID Br.: 146-153;
d) sekvenci amino kiselina koje imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 146-153, pod uvjetom da:
i) sekvenca amino kiseline ima Prolin (Pro, P) na položaju 14, Arginin (Arg, R) na položaju 19, Leucin (Leu, L) na položaju 20 i Leucin (Leu, L) na položaju 108, pri čemu se navedeni položaji određuju prema Kabatovom numeriranju; i
ii) sekvenca amino kiseline veže protein F iz hRSV s istim ili višim afinitetom, pri čemu se navedeni afinitet mjeri površinskom plazmonskom rezonancijom, i/ili sekvenca amino kiseline ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi sa sekvencom amino kiseline bez 3, 2 ili 1 razlikom u aminokiselini.
2. Trovalentni polipeptid prema zahtjevu 1, naznačen time da sadrži ili se sastoji od SEQ ID NO: 53,
- pri čemu je prva glutaminska kiselina promijenjena je u asparaginsku kiselinu, te u kojoj u barem jednoj VHH sekvenci koja tvori dio od SEQ ID NO: 53, jedan ili više mutiranih aminokiselinskih ostataka su odabrani od sljedećih: Val5Leu, Ala14Pro, Ser19R, Ile20Leu, Glu44Gly, Ala74Ser, Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln, Gln108Leu i Gly54Asp; ili
- u kojoj u barem jednoj VHH sekvenci koja tvori dio od SEQ ID NO: 53, jedan ili više mutiranih aminokiselinskih ostataka su odabrani od sljedećih: Val5Leu, Ala14Pro, Ser19R, Ile20Leu, Glu44Gly, Ala74Ser, Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln, Gln108Leu i Gly54Asp.
3. Trovalentni polipeptid prema bilo kojem od zahtjeva 1 do 2, naznačen time da sadrži ili se sastoji od SEQ ID NO: 53, u kojoj za barem jednu VHH sekvencu koja tvori dio od SEQ ID NO: 53, su mutirani slijedeći ostatci amino kiselina:
- Val5Leu, Ala14Pro, Glu44Gly, Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln i Gln108Leu;
- Ala83Arg, Asp85Glu, Arg105Gln i Gln108Leu;
- Gly78Leu, Ala83Arg, Asp85Glu i Arg105Gln;
- Val5Leu, Ala14Pro, Glu44Gly, Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln, Gln108Leu i Gly54Asp;
- Ala83Arg, Asp85Glu, Arg105Gln, Gln108Leu i Gly54Asp;
- Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln i Gly54Asp;
- Gly54Asp;
- Ala14Pro, Ser19Arg, Ile20Leu i Gln108Leu;
- Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu i Ala83Arg;
- Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu i Asp85Glu;
- Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu i Arg105Gln;
- Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu, Ala83Arg i Asp85Glu;
- Ala14Pro, Ser19Arg, Ile20Leu, Gln108leu, Ala83Arg i Arg105Gln;
- Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu, Asp85Glu i Arg105Gln;
- Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu, Ala83Arg, Asp85Glu i Arg105Gln.
- Glu1Asp;
- Glu1Asp, Va15Leu, Ala14Pro, Glu44Gly, Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln i Gln108Leu;
- Glu1Asp, Ala83Arg, Asp85Glu, Arg105Gln i Gln108Leu;
- Glu1Asp, Gly78Leu, Ala83Arg, Asp85Glu i Arg105Gln;
- Glu1Asp, Val5Leu, Ala14Pro, Glu44Gly, Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln, Gln108Leu i Gly54Asp;
- Glu1Asp, Ala83Arg, Asp85Glu, Arg105Gln, Gln108Leu i Gly54Asp;
- Glu1Asp, Gly78Leu, Ala83Arg, Asp85Glu, Arg105Gln i Gly54Asp;
- Glu1Asp i Gly54Asp;
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu i Gln108Leu;
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu i Ala83Arg;
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu i Asp85Glu;
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu i Arg105Gln;
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu, Ala83Arg i Asp85Glu;
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu, Ala83Arg i Arg105Gln;
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu, Asp85Glu i Arg105Gln; ili
- Glu1Asp, Ala14Pro, Ser19Arg, Ile20Leu, Gln108Leu, Ala83Arg, Asp85Glu i Arg105Gln.
4. Trovalentni polipeptid prema bilo kojem od zahtjeva 1 do 3, naznačen time da sadrži ili se sastoji od jedne od SEQ ID Br.: 77-79, 142-145 i 158-165.
5. Postupak priprave trovalentnog polipeptida prema bilo kojem od zahtjeva 1 do 4, te navedeni postupak sadrži barem korake povezivanja tri jednovalentne aminokiselinske sekvence ili jednovalentnih konstrukata koji su odabrani od:
a) SEQ ID Br.: 60-76;
b) sekvenci amino kiselina koje imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 60-76, pod uvjetom da:
i) sekvenca amino kiseline ima Glutamin (Gln, Q) na položaju 105, pri čemu se navedeni položaj određuje prema Kabatovom numeriranju; i
ii) sekvenca amino kiseline veže protein F iz hRSV s istim ili višim afinitetom, pri čemu se navedeni afinitet mjeri površinskom plazmonskom rezonancijom, i/ili sekvenca amino kiseline ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi sa sekvencom amino kiseline bez 3, 2 ili 1 razlikom u aminokiselini;
c) SEQ ID Br.:146-153;
d) sekvenci amino kiselina koje imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 146-153, pod uvjetom da:
i) sekvenca amino kiseline ima Prolin (Pro, P) na položaju 14, Arginin (Arg, R) na položaju 19, Leucin (Leu, L) na položaju 20 i Leucin (Leu, L) na položaju 108, pri čemu se navedeni položaji određuju prema Kabatovom numeriranju; i
ii) sekvenca amino kiseline veže protein F iz hRSV s istim ili višim afinitetom, pri čemu se navedeni afinitet mjeri površinskom plazmonskom rezonancijom i/ili sekvenca amino kiseline ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi sa sekvencom amino kiseline bez 3, 2 ili 1 razlikom u aminokiselini,
e) SEQ ID Br.: 138-141 i 154-157;
f) sekvenci amino kiselina koje imaju ne više od 3, poželjno ne više od 2, poželjnije ne više od 1 razlike aminokiselina s jednom od SEQ ID Br.: 138-141 i 154-157, pod uvjetom da:
i) sekvenca amino kiseline ima asparaginsku kiselinu (Asp, D) na položaju 1, pri čemu se navedeni položaj određuje prema Kabatovom numeriranju; i
ii) sekvenca amino kiseline veže protein F iz hRSV s istim ili višim afinitetom, pri čemu se navedeni afinitet mjeri površinskom plazmonskom rezonancijom i/ili sekvenca amino kiseline ima istu ili višu potentnost, pri čemu se navedena potentnost određuje pomoću analize mikroneutralizacije, u usporedbi sa sekvencom amino kiseline bez 3, 2 ili 1 razlikom u aminokiselini,
i na primjer jednu ili više poveznica.
6. Nukleinska kiselina ili nukleotidna sekvenca, naznačena time da kodira polipeptid prema bilo kojem od zahtjeva 1 do 4.
7. Domaćin ili stanica domaćin naznačena time da izražava polipeptid prema bilo kojem od zahtjeva 1 do 4, i/ili koja sadrži nukleinsku kiselinu ili nukleotidnu sekvencu prema zahtjevu 6.
8. Pripravak naznačen time da sadrži polipeptid prema bilo kojem od zahtjeva 1 do 4, ili nukleinsku kiselinu ili nukleotidnu sekvencu prema zahtjevu 6.
9. Pripravak prema zahtjevu 8, naznačen time da je farmaceutski pripravak.
10. Farmaceutski pripravak naznačen time da sadrži polipeptid prema bilo kojem od zahtjeva 1 do 4, te nosač prikladan za plućnu isporuku.
11. Postupak za proizvodnju polipeptida prema bilo kojem od zahtjeva 1 do 4, ili pripravka prema bilo kojem od zahtjeva 8 ili 9, te navedeni postupak barem sadrži korake:
a) eksprimiranje, u pogodnoj stanici domaćinu ili organizmu domaćina ili u drugom pogodnom sustavu za eksprimiranje, nukleinske kiseline ili nukleotidne sekvence prema zahtjevu 6,
ili kultiviranje i/ili održavanje domaćina ili stanice domaćina prema zahtjevu 7 pod uvjetima koji su takvi da navedeni domaćin ili stanica domaćin eksprimira i/ili proizvodi polipeptid prema bilo kojem od zahtjeva 1 do 4, ili pripravak prema bilo kojem od zahtjeva 8 ili 9, nakon čega proizvoljno slijedi:
b) izoliranje pročišćavanje i/ili pročišćavanje tako dobivenog polipeptida prema bilo kojem od zahtjeva 1 do 4.
12. Polipeptid prema bilo kojem od zahtjeva 1 do 4 i/ili pripravak prema bilo kojem od zahtjeva 8 ili 9 naznačen time da je za uporabu u prevenciji i/ili liječenju barem jednog od respiratorne bolesti, infekcije gornjih dišnih putova, infekcije donjih dišnih putova, bronhiolitisa, upale pluća, dispneje, kašlja, teškog disanja i astme.
13. Farmaceutski uređaj prikladan za plućnu isporuku naznačen time da sadrži polipeptid prema bilo kojem od zahtjeva 1 do 4.
14. Farmaceutski uređaj prema zahtjevu 13 koji je inhalator za tekućine, aerosol ili inhalator sa suhim prahom, naznačen time da sadrži polipeptid prema bilo kojem od zahtjeva 1 do 4.
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