US2019015509A1PendingUtilityA1

Method of treating influenza a

Assignee: MEDIMMUNE LLCPriority: Jan 13, 2016Filed: Jan 12, 2017Published: Jan 17, 2019
Est. expiryJan 13, 2036(~9.5 yrs left)· nominal 20-yr term from priority
C07K 16/108A61K 39/42C07K 2317/21A61K 31/215A61P 31/16C12N 2760/16111C07K 2317/76A61K 31/7012C07K 2317/94C07K 2317/33A61K 2039/505A61K 31/13A61K 2039/545C07K 16/1018C07K 2317/92A61K 45/06A61K 31/351A61K 2300/00A61K 2039/54
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Claims

Abstract

Provided herein are methods for treating, reducing or preventing influenza A virus infection in a patient, as well as compositions and articles of manufacture for treating, reducing or preventing influenza A virus infection in a patient.

Claims

exact text as granted — not AI-modified
1 . A method of treating influenza A virus infection in a patient, the method comprising administering to the patient at least about 200 mg and up to about 3500 mg anti-influenza A antibody or fragment thereof that is capable of binding to influenza A virus hemagglutinin of at least one group 1 subtype and at least one group 2 subtype of influenza A virus. 
     
     
         2 . A method of reducing influenza A virus infection in a patient, the method comprising administering to the patient at least about 200 mg and up to about 3500 mg anti-influenza A antibody or fragment thereof that is capable of binding to influenza A virus hemagglutinin of at least one group 1 subtype and at least one group 2 subtype of influenza A virus. 
     
     
         3 . A method of preventing influenza A virus infection in a patient, the method comprising administering to the patient at least about 200 mg and up to about 3500 mg anti-influenza A antibody or fragment thereof that is capable of binding to influenza A virus hemagglutinin of at least one group 1 subtype and at least one group 2 subtype of influenza A virus. 
     
     
         4 . The method according to any of the preceding claims, wherein the anti-influenza A antibody or fragment thereof is administered at a dose of at least about 250 mg and up to about 3000 mg. 
     
     
         5 . The method according to any of the preceding claims, wherein the anti-influenza A antibody or fragment thereof is capable of neutralizing at least one group 1 subtype and at least one group 2 subtype of influenza A virus. 
     
     
         6 . The method according to any of the preceding claims, wherein administering includes parenteral administration. 
     
     
         7 . The method according to any of the preceding claims, wherein administering includes intravenous administration. 
     
     
         8 . The method according to  claim 7 , wherein anti-influenza A antibody or fragment thereof is administered as a single dose. 
     
     
         9 . The method according to any of the preceding claims, wherein anti-influenza A antibody or fragment thereof is administered after the patient is exposed to influenza A virus, infected with influenza A virus, exhibits symptoms of influenza A virus infection, or a combination thereof. 
     
     
         10 . The method according to any of  claims 1 - 8 , wherein anti-influenza A antibody or fragment thereof is administered before the patient is exposed to influenza A virus, infected with influenza A virus, exhibits symptoms of influenza A virus infection, or a combination thereof. 
     
     
         11 . The method according to any of  claims 1 - 8 , wherein anti-influenza A antibody or fragment thereof is administered to a subject within 30 days of exposure, infection, symptom onset, or a combination thereof. 
     
     
         12 . The method according to any of the preceding claims, wherein anti-influenza A antibody or fragment thereof is capable of neutralizing one or more influenza A virus group 1 subtype selected from: H1, H2, H5, H6, H8, H9, H11, H12, H13, H16, H17, H18, and variants thereof; and one or more influenza A virus group 2 subtypes selected from: H3, H4, H7, H10, H14 and H15 and variants thereof. 
     
     
         12 . The method according to any one of the preceding claims, wherein anti-influenza A antibody or fragment thereof includes one or more heavy chain CDRs having an amino acid sequence at least 75% identical to an amino acid sequence selected from SEQ ID NO:3, SEQ ID NO:4, and SEQ ID NO:5 and one or more light chain CDRs having amino acid sequence at least 75% identical to an amino acid sequence selected from an amino acid sequence shown in SEQ ID NO:8, SEQ ID NO:9 and SEQ ID NO:10. 
     
     
         13 . The method according to any one of the preceding claims, wherein anti-influenza A antibody or fragment thereof includes one or more heavy chain CDRs with an amino acid sequence selected from SEQ ID NO:3, SEQ ID NO:4, and SEQ ID NO:5 and one or more light chain CDRs with an amino acid sequence selected from SEQ ID NO:8, SEQ ID NO:9 and SEQ ID NO:10. 
     
     
         14 . The method according any one of the preceding claims, wherein anti-influenza A antibody or fragment thereof comprises a VH having an amino acid sequence with at least 75% identity to the amino acid sequence of SEQ ID NO: 2 and a VL having an amino acid sequence with at least 75% identity to the amino acid sequence of SEQ ID NO: 7. 
     
     
         15 . The method according any one of the preceding claims, wherein anti-influenza A antibody or fragment thereof comprises a VH having an amino acid sequence shown in SEQ ID NO: 2 and a VL having an amino acid sequence shown in SEQ ID NO: 7. 
     
     
         16 . The method according to any of the preceding claims, wherein anti-influenza A antibody comprises MEDI8852. 
     
     
         17 . The method according to any of the preceding claims, wherein the antibody or fragment thereof is administered in combination with one or more small molecule antiviral medications. 
     
     
         18 . The method according to  claim 17 , wherein the small molecule antiviral medication is selected from oseltamivir (TAMIFLU®), zanamivir (RELENZA®), amantadine and rimantadine. 
     
     
         19 . A composition for treating influenza A virus infection in a patient, the composition comprising anti-influenza A antibody or fragment thereof that is capable of binding to influenza A virus hemagglutinin at least one group 1 subtype and at least one group 2 subtype of influenza A virus formulated for administering at least about 200 mg and up to about 3500 mg anti-influenza A antibody or fragment thereof to a patient. 
     
     
         20 . A composition for reducing influenza A virus infection in a patient, the composition comprising anti-influenza A antibody or fragment thereof that is capable of binding to influenza A virus hemagglutinin at least one group 1 subtype and at least one group 2 subtype of influenza A virus formulated for administering at least about 200 mg and up to about 3500 mg anti-influenza A antibody or fragment thereof to a patient. 
     
     
         21 . A composition for preventing influenza A virus infection in a patient, the composition comprising anti-influenza A antibody or fragment thereof that is capable of binding to influenza A virus hemagglutinin of at least one group 1 subtype and at least one group 2 subtype of influenza A virus formulated for administering at least about 200 mg and up to about 3500 mg anti-influenza A antibody or fragment thereof to a patient. 
     
     
         22 . The composition according to any of  claims 19 - 21 , wherein anti-influenza A antibody or fragment thereof is capable of neutralizing one or more influenza A virus group 1 subtype selected from: H1, H2, H5, H6, H8, H9, H11, H12, H13, H16, H17, H18, and variants thereof; and one or more influenza A virus group 2 subtypes selected from: H3, H4, H7, H10, H14 and H15 and variants thereof. 
     
     
         23 . The composition according to any of  claims 19 - 22 , wherein anti-influenza A antibody or fragment thereof includes one or more heavy chain CDRs having an amino acid sequence at least 75% identical to an amino acid sequence selected from SEQ ID NO:3, SEQ ID NO:4, and SEQ ID NO:5 and one or more light chain CDRs having amino acid sequence at least 75% identical to an amino acid sequence selected from an amino acid sequence shown in SEQ ID NO:8, SEQ ID NO:9 and SEQ ID NO:10. 
     
     
         24 . The composition according to any of  claims 19 - 23 , wherein anti-influenza A antibody or fragment thereof includes one or more heavy chain CDRs with an amino acid sequence selected from SEQ ID NO:3, SEQ ID NO:4, and SEQ ID NO:5 and one or more light chain CDRs with an amino acid sequence selected from SEQ ID NO:8, SEQ ID NO:9 and SEQ ID NO:10. 
     
     
         25 . The composition according to any of  claims 19 - 24 , wherein anti-influenza A antibody or fragment thereof comprises a VH having an amino acid sequence with at least 75% identity to the amino acid sequence of SEQ ID NO: 2 and a VL having an amino acid sequence with at least 75% identity to the amino acid sequence of SEQ ID NO: 7. 
     
     
         26 . The composition according to any of  claims 19 - 25 , wherein anti-influenza A antibody or fragment thereof comprises a VH having an amino acid sequence shown in SEQ ID NO: 2 and a VL having an amino acid sequence shown in SEQ ID NO: 7. 
     
     
         27 . The composition according to any of  claims 19 - 26 , wherein anti-influenza A anti-influenza A antibody comprises MEDI8852. 
     
     
         28 . The composition according to any of  claims 19 - 27 , wherein the composition further comprises a pharmaceutically acceptable carrier. 
     
     
         29 . The composition according to any of  claims 19 - 28 , wherein the composition further comprises one or more small molecule antiviral medications. 
     
     
         30 . The composition according to  claim 29 , wherein the small molecule antiviral medications is selected from oseltamivir (TAMIFLU®), zanamivir (RELENZA®), amantadine and rimantadine. 
     
     
         31 . An article of manufacture comprising a container and a composition within the container, wherein the composition comprises anti-influenza A antibody or fragment thereof that is capable of binding to influenza A virus hemagglutinin of at least one group 1 subtype and at least one group 2 subtype of influenza A virus and instructions to administer of at least about 200 mg and up to about 3500 mg anti-influenza A antibody or fragment thereof to a patient. 
     
     
         32 . The article of manufacture according to  claim 31 , wherein the label or package insert includes instructions to administer anti-influenza A antibody or fragment thereof at a dose of at least about 200 mg and up to about 3500 mg. 
     
     
         33 . The article of manufacture according to  claim 31  or  32 , wherein anti-influenza A antibody or fragment thereof is capable of neutralizing one or more influenza A virus group 1 subtype selected from: H1, H2, H5, H6, H8, H9, H11, H12, H13, H16, H17, H18, and variants thereof; and one or more influenza A virus group 2 subtypes selected from: H3, H4, H7, H10, H14 and H15 and variants thereof. 
     
     
         34 . The article of manufacture according to any of  claims 31 - 33 , wherein anti-influenza A antibody or fragment thereof includes one or more heavy chain CDRs having an amino acid sequence at least 75% identical to an amino acid sequence selected from SEQ ID NO:3, SEQ ID NO:4, and SEQ ID NO:5 and one or more light chain CDRs having amino acid sequence at least 75% identical to an amino acid sequence selected from an amino acid sequence shown in SEQ ID NO:8, SEQ ID NO:9 and SEQ ID NO:10. 
     
     
         35 . The article of manufacture according to any of  claims 31 - 34 , wherein anti-influenza A antibody or fragment thereof includes one or more heavy chain CDRs with an amino acid sequence selected from SEQ ID NO:3, SEQ ID NO:4, and SEQ ID NO:5 and one or more light chain CDRs with an amino acid sequence selected from SEQ ID NO:8, SEQ ID NO:9 and SEQ ID NO:10. 
     
     
         36 . The article of manufacture according to any of  claims 31 - 35 , wherein anti-influenza A antibody or fragment thereof comprises a VH having an amino acid sequence with at least 75% identity to the amino acid sequence of SEQ ID NO: 2 and a VL having an amino acid sequence with at least 75% identity to the amino acid sequence of SEQ ID NO: 7. 
     
     
         37 . The article of manufacture according to any of  claims 31 - 36 , wherein anti-influenza A antibody or fragment thereof comprises a VH having an amino acid sequence shown in SEQ ID NO: 2 and a VL having an amino acid sequence shown in SEQ ID NO: 7. 
     
     
         38 . The article of manufacture according to any of  claims 31 - 37 , wherein anti-influenza A antibody comprises MEDI8852. 
     
     
         39 . The article of manufacture according to any of  claims 31 - 38 , further comprising one or more small molecule antiviral medications. 
     
     
         40 . The article of manufacture according to  claim 39 , wherein the small molecule antiviral medications is selected from oseltamivir (TAMIFLU®), zanamivir (RELENZA®), amantadine and rimantadine. 
     
     
         41 . The article of manufacture according to any of  claims 31 - 40 , wherein the composition further comprises a pharmaceutically acceptable carrier.

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