COMPOSITIONS AND METHODS FOR THE THERAPY AND DIAGNOSIS OF INFLUENZA

• US 20140363441A1
• Filed: 04/18/2014
• Published: 12/11/2014
• Est. Priority Date: 04/22/2013
• Status: Abandoned Application

• Current Assignee: Theraclone Sciences, Inc.
• Original Assignee: Theraclone Sciences, Inc.
• Inventors: Grandea, Andres G. III, King, Gordon, Cox, Thomas C., Olsen, Ole, Mitcham, Jennifer, Moyle, Matthew, Hammond, Phil
• Application Number:
  US14/256,345
• Publication Number:
  US 20140363441A1
• Time in Patent Office: Days
• US Class Current: 424/142.1
• CPC Class Codes: A61K 2039/505 comprising antibodies
• CPC Class Codes: A61K 2039/507 Comprising a combination of two or more separate antibodies
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/215 of carboxylic acids
• CPC Class Codes: A61K 39/42 viral
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: C07K 16/1018 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: C07K 2317/21 from primates, e.g. man
• CPC Class Codes: C07K 2317/33 Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
• CPC Class Codes: C07K 2317/34 Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
• CPC Class Codes: C07K 2317/732 Antibody-dependent cellular cytotoxicity [ADCC]
• CPC Class Codes: C07K 2317/734 Complement-dependent cytotoxicity [CDC]
• CPC Class Codes: C07K 2317/92 Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
• CPC Class Codes: C07K 2317/94 Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

The present invention provides novel human anti-influenza antibodies and related compositions and methods. These antibodies are used in the diagnosis and treatment of influenza infection.

Claims

1. A composition comprising:

(a) an isolated fully human monoclonal anti-M2e antibody composition, wherein the antibody comprises a V_H CDR1 region comprising the amino acid sequence of NYYWS (SEQ ID NO;

     72);

a V_H CDR2 region comprising the amino acid sequence of FIYYGGNTKYNPSLKS (SEQ ID NO;

     74);

a V_H CDR3 region comprising the amino acid sequence of ASCSGGYCILD (SEQ ID NO;

     76);

a V_L CDR1 region comprising the amino acid sequence of RASQNIYKYLN (SEQ ID NO;

     59);

a V_L CDR2 region comprising the amino acid sequence of AASGLQS (SEQ ID NO;

     61); and

a V_L CDR3 region comprising the amino acid sequence of QQSYSPPLT (SEQ ID NO;

     63); and

(b) an oseltamivir composition.

3. A pharmaceutical composition comprising the composition of claim 1 or 2 and a pharmaceutical carrier.

4. The composition of any one of claims 1-3, wherein said oseltamivir is oseltamivir phosphate.

5. The composition of any one of claims 1-3, further comprising a second anti-influenza A antibody.

6. The composition of claim 5, wherein said second anti-influenza A antibody is an anti-M2e antibody or an anti-HA antibody.

7. A method for the treatment or prevention of an influenza virus infection in a subject, comprising administering to the subject the composition of any one of claims 1-3.

8. The method of claim 7, wherein said anti-M2e antibody is administered at a dosage of between 10 and 40 mg/kg/day.

9. The method of claim 8, wherein said anti-M2e antibody is administered once or twice per day.

10. The method of claim 7, wherein said oseltamivir composition is administered at a dosage of 10 mg/kg.

11. The method of claim 10, wherein said oseltamivir composition is administered once or twice per day.

12. The method of claim 7, wherein said anti-M2e antibody or said oseltamivir composition is administered prior to influenza infection.

13. The method of claim 7, wherein said anti-M2e antibody or said oseltamivir composition is administered after influenza infection.

14. The method of claim 13, wherein said anti-M2e antibody is administered within 4 days or 48 hours after influenza infection.

15. The method of claim 7, wherein said anti-M2e antibody and said oseltamivir composition are administered simultaneously or sequentially.

16. The method of claim 15, wherein said anti-M2e antibody and said oseltamivir composition are administered sequentially, and wherein said anti-M2e antibody is administered before said oseltamivir composition.

17. The method of claim 15, wherein said anti-M2e antibody and said oseltamivir composition are administered sequentially, and wherein said anti-M2e antibody is administered after said oseltamivir composition.

18. A kit comprising the composition of claim 3.

2. A composition comprising:

(a) an isolated fully human monoclonal anti-M2e antibody composition, wherein the antibody comprises a V_H CDR1 region comprising the amino acid sequence of SNYMS (SEQ ID NO;

     103);

a V_H CDR2 region comprising the amino acid sequence of VIYSGGSTYYADSVK (SEQ ID NO;

     105);

a V_H CDR3 region comprising the amino acid sequence of CLSRMRGYGLDV (SEQ ID NO;

     107);

a V_L CDR1 region comprising the amino acid sequence of RTSQSISSYLN (SEQ ID NO;

     92);

a V_L CDR2 region comprising the amino acid sequence of AASSLQSGVPSRF (SEQ ID NO;

     94); and

a V_L CDR3 region comprising the amino acid sequence of QQSYSMPA (SEQ ID NO;

     96); and

(b) an oseltamivir composition.