DK2734545T3 - Neutraliserende anti-influenza a-virusantistoffer og anvendelser deraf - Google Patents

Neutraliserende anti-influenza a-virusantistoffer og anvendelser deraf Download PDF

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DK2734545T3
DK2734545T3 DK11784765.7T DK11784765T DK2734545T3 DK 2734545 T3 DK2734545 T3 DK 2734545T3 DK 11784765 T DK11784765 T DK 11784765T DK 2734545 T3 DK2734545 T3 DK 2734545T3
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amino acid
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Antonio Lanzavecchia
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Inst Res Biomedicine
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    • 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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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
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    • C12N2760/00011—Details
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    • C12N2760/16111—Influenzavirus A, i.e. influenza A virus
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Claims (13)

1. Isoleret antistof, eller et antigenbindende fragment deraf, som neutraliserer infektion med en gruppe 1-undertype og en gruppe 2-undertype af influenza A-virus og omfatter: (i) CDR1-, CDR2- og CDR3-tungkædesekvenserne som gengivet i SEQ ID NO: 1, 41 og 43, henholdsvis, eller som gengivet i SEQ ID NO: 1, 41 og 42, henholdsvis; og (ii) CDR1-, CDR2- og CDR3-letkædesekvenserne som gengivet i SEQ ID NO: 4, 5 og 6, henholdsvis, eller som gengivet i SEQ ID NO: 44, 5 og 6, henholdsvis, hvor antistoffet eller det antigenbindende fragment deraf omfatter en variabel tungkæderegion med mindst 90 % sekvens-similaritet med aminosyresekvensen som gengivet i SEQ ID NO: 59 eller 55; og en variabel letkæderegion med mindst 90 % sekvenssimilaritet med aminosyresekvensen som gengivet i SEQ ID NO: 57 eller 61, og hvor antistoffet eller det antigenbindende fragment deraf dannes i transficerede celler i titere mindst 3 gange højere end titeren, hvori FI6-variant 2 dannes.
2. Isoleret antistof, eller et antigenbindende fragment deraf, ifølge krav 1, som omfatter en variabel tungkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:59 og en variabel letkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:57; eller en variabel tungkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:59 og en variabel letkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:61; eller en variabel tungkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:55 og en variabel letkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:57; eller en variabel tungkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:55 og en variabel letkæderegion omfattende aminosyresekvensen ifølge SEQ ID NO:61, og hvor antistoffet neutraliserer en gruppe 1-undertype og en gruppe 2-undertype af influenza A-virus.
3. Isoleret antistof, eller et antigenbindende fragment deraf, ifølge krav 1, som neutraliserer infektion med en gruppe 1-undertype og en gruppe 2-undertype af influenza A-virus og specifikt binder sig til en epitop i stammeregionen af en influenza A-HA trimer, hvor den tunge og lette kæde af antistoffet, eller det antigenbindende fragment deraf, indgår i kontakt med aminosyrer i en første, proksimal monomer og en anden, distal, højre monomer af HA-trimeren, og hvor antistoffet eller det antigenbindende fragment deraf indgår i kontakt med aminosyrer i en første, proksimal monomer og en anden, distal, højre monomer i HA-trimeren, og hvor antistoffet eller det antigenbindende fragment deraf omfatter: (i) CDR1-, CDR2- og CDR3-tungkædesekvenserne som gengivet i SEQ ID NO: 1, 41 og 43, henholdsvis, eller som gengivet i SEQ ID NO: 1, 41 og 42, henholdsvis; og (ii) CDR1-, CDR2- og CDR3-letkædesekvenserne som gengivet i SEQ ID NO: 4, 5 og 6, henholdsvis, eller som gengivet i SEQ ID NO: 44, 5 og 6, henholdsvis.
4. Isoleret antistof, eller et antigenbindende fragment deraf, som neutraliserer infektion med en gruppe 1-undertype og en gruppe 2-undertype af influenza A-virus og specifikt binder sig til en epitop i stammeregionen af en influenza A-hæmagglutinin(HA)trimer, hvor den tunge og lette kæde i antistoffet, eller det antigenbindende fragment deraf, indgår i kontakt med aminosyrer i en første, proksimal monomer og en anden, distal, højre monomer af HA-trimeren, og hvor antistoffet eller det antigenbindende fragment deraf dannes i transficerede celler i titere mindst 3 gange højere end titeren, hvori FI6-variant 2 dannes, hvor antistoffet eller det antigenbindende fragment deraf omfatter: (i) CDR1-, CDR2- og CDR3-tungkædesekvenserne som gengivet i SEQ ID NO: 1, 41 og 43, henholdsvis, eller som gengivet i SEQ ID NO: 1, 41 og 42, henholdsvis; og (ii) CDR1-, CDR2- og CDR3-letkædesekvenserne som gengivet i SEQ ID NO: 4, 5 og 6, henholdsvis, eller som gengivet i SEQ ID NO: 44, 5 og 6, henholdsvis.
5. Antistof eller antigenbindende fragment deraf ifølge krav 3 eller 4, udvalgt fra gruppen bestående af: a. et antistof eller antigenbindende fragment deraf, hvori den tunge kæde i antistoffet eller det antigenbindende fragment deraf indgår i kontakt med aminosyrerester i den proksimale monomer, og hvor den lette kæde i antistoffet eller det antigenbindende fragment deraf indgår i kontakt med aminosyrerester i den proksimale monomer og i den distale højre monomer af HA-trimeren; og b. et antistof eller antigenbindende fragment deraf, som specifikt binder sig til en epitop i stammeregionen af en influenza A-HA-trimer, og hvor den første eller anden monomer i HA-trimeren er uspaltet eller spaltet.
6. Antistof eller antigenbindende fragment deraf ifølge krav 3 eller 4, udvalgt fra gruppen bestående af: a. et antistof eller antigenbindende fragment deraf, hvor den tunge kæde af antistoffet eller det antigenbindende fragment deraf indgår i kontakt med aminosyren i position 318 i HA1 og aminosyreresterne i positionerne 18, 19, 20, 21, 38, 41, 42, 45, 49, 53 og 57 i HA2 i den første eller anden monomer, og hvor monomeren er uspaltet eller spaltet; b. et antistof eller antigenbindende fragment deraf, hvori den lette kæde i antistoffet eller det antigenbindende fragment deraf indgår i kontakt med aminosyrerester i positionerne 38, 39 og 43 i HA2 i den proksimale monomer og aminosyreresterne i positionerne 327, 328 og 329 i HA 1 og 1, 2, 3 og 4 i HA2 i den distale højre monomer, og hvor den proksimale og den distale højre monomer er uspaltede; c. et antistof eller antigenbindende fragment deraf, hvori den lette kæde af antistoffet eller det antigenbindende fragment deraf indgår i kontakt med aminosyrerester i positionerne 38, 39, 42 og 46 i HA2 i den proksimale monomer og aminosyrerester i positionerne 321 og 323 i HA1 og 7 og 11 i HA2 i den distale højre monomer, og hvor den proksimale og den distale højre monomer er spaltede; d. et antistof eller antigenbindende fragment deraf, som specifikt binder sig til en epitop, som omfatter aminosyren i position 318 i HA1 og aminosyrerester i positionerne 18, 19, 20, 21, 38, 39, 41, 42, 43, 45, 48, 49, 53, 56 og 57 i HA2 i den proksimale monomer og aminosyrerester i positionerne 327, 328, 329 i HA1 og aminosyrerester i positionerne 1, 2, 3 og 4 i HA2-polypeptidet i den distale højre monomer, hvor den proksimale og den distale højre monomer er uspaltede; e. et antistof eller antigenbindende fragment deraf, som specifikt binder sig til en epitop, som omfatter aminosyren i position 318 i HA1 og aminosyrerester i positionerne 18, 19, 20, 21, 38, 39, 41, 42, 45, 46, 49, 52, 53 og 57 i HA2 i den proksimale monomer og aminosyreresterne i positionerne 321 og 323 i HA1 og aminosyrerester i positionerne 7 og 11 i HA2 i den distale højre monomer, hvor den proksimale og den distale højre monomer er spaltede; og f. et antistof, eller antigenbindende fragment deraf, som specifikt binder sig til en epitop, som omfatter aminosyren i position 329 i HA1 og aminosyreresterne i positionerne 1, 2, 3 og 4 i HA2, hvor nævnte HA1 og HA2 er til stede i en uspaltet monomer af HA-trimeren.
7. Antistof ifølge et hvilket som helst af de foregående krav, eller et antigenbindende fragment deraf, hvor antistoffet er et humant antistof, et monoklonalt antistof, et oprenset antistof, et enkeltkædet antistof, Fab, Fab', F(ab')2, Fv eller scFv.
8. Nukleinsyremolekyle omfattende et polynukleotid kodende for antistoffet, eller et antigenbindende fragment deraf, ifølge et hvilket som helst af de foregående krav.
9. Nukleinsyremolekyle ifølge krav 8, hvor polynukleotidet omfatter en sekvens, som har mindst 75 % similaritet med nukleinsyresekvensen som gengivet i en hvilken som helst af SEQ ID NO: 45-54, 56, 68, 60 eller 62, eller hvor polynukleotidet omfatter en sekvens som gengivet i SEQ ID NO: 60 og 58; eller SEQ ID NO:60 og 62; eller SEQ ID NO:56 og 58, eller SEQ ID NO: 56 og 62.
10. Vektor omfattende nukleinsyremolekylet ifølge krav 8 eller 9.
11. Celle, der udtrykker antistoffet ifølge et hvilket som helst af kravene 1-7 eller et antigenbindende fragment deraf; eller omfattende vektoren ifølge krav 8 eller 9.
12. Farmaceutisk sammensætning omfattende antistoffet ifølge et hvilket som helst af kravene 1-7 eller et antigenbindende fragment deraf, nukleinsyren ifølge krav 8 eller 9, vektoren ifølge krav 10 eller cellen ifølge krav 11, og et farmaceutisk acceptabelt fortyndingsmiddel eller bærestof.
13. Antistof ifølge et hvilket som helst af kravene 1-7 eller et antigenbindende fragment deraf, nukleinsyre ifølge krav 8 eller 9, vektor ifølge krav 10, celle ifølge krav 11 eller farmaceutisk sammensætning ifølge krav 12 til anvendelse (i) i behandling af influenza A-virusinfektion, (ii) i en vaccine eller (iii) i diagnose af influenza A-virusinfektion.
DK11784765.7T 2011-07-18 2011-07-18 Neutraliserende anti-influenza a-virusantistoffer og anvendelser deraf DK2734545T3 (da)

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