Compositions and methods for treating and preventing influenza

Abstract

This disclosure relates to peptide agents, e.g., antibodies and antigen-binding fragments thereof, that bind hemagglutinin protein of influenza viruses, and methods of their use.

1 .- 22 . (canceled) 
     
     
         23 . A method of treating a human subject, the method comprising administering to the subject an amount of an anti-HA antibody molecule of between 11 and 16 mg/kg,
 wherein the anti-HA antibody molecule comprises: (a) a heavy chain immunoglobulin variable region segment comprising: a CDR1 comprising the sequence of SEQ ID NO:68; a CDR2 comprising the sequence of SEQ ID NO:69; and a CDR3 comprising the sequence of SEQ ID NO:70; and (b) a light chain immunoglobulin variable region segment comprising: a CDR1 comprising the sequence of SEQ ID NO: 145; a CDR2 comprising the sequence of SEQ ID NO:72; and a CDR3 comprising the sequence of SEQ ID NO:73,   thereby treating the subject.   
     
     
         24 . The method of  claim 23 , wherein the subject is infected, or is at risk of being infected, with an influenza virus. 
     
     
         25 . The method of  claim 23 , wherein the antibody molecule is administered to prevent the subject from influenza, or a disorder associated with influenza. 
     
     
         26 . The method of  claim 23 , wherein the influenza virus is an H1N1 virus, an H3N2 virus, an H7N9 virus, or a combination thereof. 
     
     
         27 . The method of  claim 23 , wherein the antibody molecule is administered at a dose of between 12 and 14 mg/kg. 
     
     
         28 . The method of  claim 23 , wherein the antibody molecule is administered at a dose of between 11 and 14 mg/kg. 
     
     
         29 . The method of  claim 23 , wherein the antibody molecule is administered at a dose of between 11 and 12 mg/kg. 
     
     
         30 . The method of  claim 23 , wherein the subject is 65 years of age or above. 
     
     
         31 . The method of  claim 23 , wherein the antibody molecule is administered 1 to 15 weeks prior to the date of an epidemic peak of influenza in a region where the subject resides. 
     
     
         32 . The method of  claim 23 , wherein the antibody molecule is administered 2 to 10 weeks prior to the date of an epidemic peak of influenza in a region where the subject resides. 
     
     
         33 . The method of  claim 23 , wherein the antibody molecule is administered 4 to 8 weeks prior to the date of an epidemic peak of influenza in a region where the subject resides. 
     
     
         34 . The method of  claim 23 , wherein the subject resides in a single-family residence, an assisted living facility, a hospital, nursing home, or an institution in which more than 2 unrelated people reside. 
     
     
         35 . The method of  claim 23 , wherein administering comprises a single intravenous infusion. 
     
     
         36 . The method of  claim 23 , further comprising administering to the subject a second therapeutic agent for influenza, or a disorder or symptom associated with influenza. 
     
     
         37 . The method of  claim 23 , wherein said antibody molecule comprises a heavy chain immunoglobulin variable region segment that comprises SEQ ID NO: 25. 
     
     
         38 . The method of  claim 23 , wherein said antibody molecule comprises a light chain immunoglobulin variable region segment that comprises SEQ ID NO: 52. 
     
     
         39 . The method of  claim 23 , wherein said antibody molecule comprises a heavy chain immunoglobulin variable region segment that comprises SEQ ID NO: 25 and a light chain immunoglobulin variable region segment that comprises SEQ ID NO: 52. 
     
     
         40 . The method of  claim 23 , wherein said antibody molecule is an IgG antibody. 
     
     
         41 . A method of treating a human subject, the method comprising administering to the subject an amount of an anti-HA antibody molecule of between 11 and 16 mg/kg,
 wherein the subject is infected, or is at risk of being infected, with an influenza virus, and is 65 years of age or above; and   wherein the anti-HA antibody molecule comprises: (a) a heavy chain immunoglobulin variable region segment comprising: a CDR1 comprising the sequence of SEQ ID NO:68; a CDR2 comprising the sequence of SEQ ID NO:69; and a CDR3 comprising the sequence of SEQ ID NO:70; and (b) a light chain immunoglobulin variable region segment comprising: a CDR1 comprising the sequence of SEQ ID NO: 145; a CDR2 comprising the sequence of SEQ ID NO:72; and a CDR3 comprising the sequence of SEQ ID NO:73,   thereby treating the subject.   
     
     
         42 . A method of preventing a human subject from becoming infected with influenza virus, the method comprising administering to the subject an amount of an anti-HA antibody molecule of between 11 and 16 mg/kg,
 wherein the anti-HA antibody molecule is administered 1 to 15 weeks prior to the date of an epidemic peak of influenza in a region that includes the city, province or state, in which the subject lives; and   wherein the anti-HA antibody molecule comprises: (a) a heavy chain immunoglobulin variable region segment comprising: a CDR1 comprising the sequence of SEQ ID NO:68; a CDR2 comprising the sequence of SEQ ID NO:69; and a CDR3 comprising the sequence of SEQ ID NO:70; and (b) a light chain immunoglobulin variable region segment comprising: a CDR1 comprising the sequence of SEQ ID NO: 145; a CDR2 comprising the sequence of SEQ ID NO:72; and a CDR3 comprising the sequence of SEQ ID NO:73,   thereby preventing the subject from becoming infected with influenza virus.