Claims for Patent: 9,988,437

Summary for Patent: 9,988,437

Title:	Anti-human Respiratory Syncytial Virus (RSV) antibodies and methods of use
Abstract:	Provided herein are antibodies or antigen-binding fragments thereof that immunospecifically bind to the fusion (F) protein of Respiratory Syncytial Virus (RSV). Also provided are methods for of prevention, treatment and diagnosis of viral infection and/or the treatment of one more symptoms of RSV-mediated disease. Methods of generating antibodies that immunospecifically bind RSV F protein also are provided.
Inventor(s):	Williamson; Robert Anthony (London, GB), Wadia; Jehangir (San Diego, CA), Pascual; Gabriel (San Diego, CA), Keogh; Elissa (San Diego, CA)
Assignee:	Janssen Vaccines & Prevention B.V. (Leiden, NL)
Application Number:	15/077,558
Patent Claims:	1. A chimeric anti-respiratory syncytial virus (RSV) antibody or antigen-binding fragment thereof, comprising: a heavy chain CDR1 of SEQ ID NO: 458, a heavy chain CDR2 of SEQ ID NO: 459, a heavy chain CDR3 of SEQ ID NO: 460; a light chain CDR1 of SEQ ID NO: 461, a light chain CDR2 of SEQ ID NO: 462, and a light chain CDR3 of SEQ ID NO: 463. 2. The chimeric anti-RSV antibody of claim 1, wherein the chimeric anti-RSV antibody is a full-length antibody. 3. The chimeric anti-RSV antibody of claim 1, wherein the chimeric anti-RSV antibody is a full-length IgG antibody. 4. The chimeric anti-RSV antibody or antigen-binding fragment of claim 1, wherein the chimeric anti-RSV antibody or antigen-binding fragment is an antigen-binding fragment selected from the group consisting of a Fab, Fab', F(ab').sub.2, single-chain Fv (scFv), Fv, dsFv, diabody, Fd and Fd' fragments. 5. The chimeric anti-RSV antibody or antigen-binding fragment of claim 1, wherein the chimeric anti-RSV antibody or antigen-binding fragment is a Fab or scFv. 6. The chimeric antibody or antigen-binding fragment of claim 1, wherein the chimeric anti-RSV antibody or antigen-binding fragment neutralizes RSV. 7. The chimeric antibody or antigen-binding fragment of claim 1, wherein the chimeric anti-RSV antibody or antigen-binding fragment neutralizes RSV subtypes A and B. 8. A multivalent antibody comprising: a first antigen-binding portion comprising the chimeric antibody or antigen-binding fragment of claim 1 or such an antigen-binding fragment thereof conjugated to a multimerization domain; and a second antigen-binding portion comprising an antigen-binding fragment of an antiviral antibody conjugated to a second multimerization domain, wherein: the first multimerization domain and the second multimerization domain are complementary or the same, whereby the first antigen-binding portion and second antigen-binding portion form a multivalent antibody. 9. The multivalent antibody of claim 8, wherein the second antigen-binding portion comprises an anti-RSV antibody or antigen-binding fragment thereof. 10. The multivalent antibody of claim 8, wherein the anti-RSV antibody or antigen-binding fragment is an antibody or antigen-binding fragment, wherein RSV does not produce a virus that escapes neutralization by the antibody or antigen-binding fragment thereof after more than 10 or more rounds of viral replication in the presence of the antibody or antigen-binding fragment thereof. 11. A pharmaceutical composition comprising: the antibody or antigen-binding fragment of claim 1; and a pharmaceutically acceptable carrier or excipient. 12. The pharmaceutical composition of claim 11 formulated as a gel, ointment, liquid, suspension, aerosol, tablet, pill or powder. 13. The pharmaceutical composition of claim 11 formulated as a nasal spray. 14. The pharmaceutical composition of claim 11 formulated for pulmonary, intranasal, or parenteral administration. 15. The pharmaceutical composition of claim 11 formulated for single dosage administration. 16. The pharmaceutical composition of claim 11 that is a sustained release formulation. 17. A method of treating a viral infection in a subject, the method comprising: administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 11. 18. A method of treating or inhibiting one or more symptoms of a viral infection in a subject, the method comprising: administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 11. 19. A method of inhibiting a viral infection in a subject, the method comprising: administering to the subject a prophylactically effective amount of the pharmaceutical composition of claim 11. 20. The method of claim 17, wherein the viral infection is an RSV infection. 21. The method of claim 20, wherein the infection is an upper respiratory tract infection. 22. The method of claim 17, wherein the subject is a mammal. 23. The method of claim 22, wherein the subject is a human. 24. The method of claim 23, wherein the human subject is a human infant, a human infant born prematurely or at risk of hospitalization for a RSV infection, an elderly human, a human subject who has cystic fibrosis, bronchopulmonary dysplasia, congenital heart disease, congenital immunodeficiency, acquired immunodeficiency, leukemia, or non-Hodgkin lymphoma or a human subject having an organ or tissue transplant or a blood transfusion. 25. The method of claim 24, wherein the transplant is a bone marrow transplant or a liver transplant. 26. The method of claim 17, wherein the pharmaceutical composition is administered topically, parenterally, locally, or systemically. 27. The method of claim 17, wherein the pharmaceutical composition is administered intranasally, intramuscularly, intradermally, intraperitoneally, intravenously, subcutaneously, orally, or by pulmonary administration. 28. The method of claim 17, wherein the composition is administered by a nebulizer or an inhaler. 29. The method of claim 17, wherein the composition is administered one time, two times, three times, four times or five times during RSV season. 30. The method of claim 17, wherein the composition is administered one time, two times, three times, four times or five times within one month, two months or three months, prior to a RSV season. 31. The method of claim 17, further comprising administration of one or more antiviral agents. 32. The method of claim 31, wherein the antiviral agent is ribavirin. 33. The method of claim 17, further comprising administration of one or more additional antiviral antibodies or antigen-binding fragments thereof. 34. The method of claim 33, wherein the one or more additional antiviral antibodies are anti-RSV antibodies or antigen-binding fragments thereof. 35. The method of claim 34, wherein the one or more additional anti-RSV antibodies are selected from the group consisting of palivizumab, motavizumab, AFFF, P12f2, P12f4, P11d4, Ale9, A12a6, A13c4, A17d4, A4B4, A8c7, 1X-493L1, FR H3-3F4, M3H9, Y10H6, DG, AFFF(1), 6H8, L1-7E5, L2-15B10, A13a11, A1h5, A4B4(1), A4B4LIFR-S28R, A4B4-F52S, rsv6, rsvl 1, rsvl 3, rsvl 9, rsv21, rsv22, rsv23, RF-1, RF-2, and antigen-binding fragments thereof. 36. The method of claim 33, wherein the one or more additional antiviral antibodies is selected from the group consisting of an antibody or antigen-binding fragment that immunospecifically binds an antigen of parainfluenza virus (PIV) or human metapneumovirus (hMPV). 37. The method of claim 31, wherein the pharmaceutical composition and the antiviral agent are formulated as separate compositions. 38. The method of claim 31, wherein the pharmaceutical composition and the antiviral agent are administered sequentially, simultaneously, or intermittently. 39. The method of claim 17, further comprising administration of hormonal therapy, immunotherapy or an anti-inflammatory agent. 40. A method of detecting respiratory syncytial virus (RSV) infection in a subject, the method comprising: (a) assaying the level of RSV antigen in a fluid, cell, or tissue sample from the subject utilizing the antibody or antigen-binding fragment of claim 1; and (b) comparing the assayed level of RSV antigen with a control level wherein an increase in the assayed level of RSV antigen compared to the control level of the RSV antigen is indicative of a RSV infection. 41. A polynucleotide encoding the chimeric antibody or antigen-binding fragment of claim 1. 42. A polynucleotide encoding the heavy chain of the chimeric antibody of claim 1. 43. A polynucleotide encoding the light chain of the chimeric antibody of claim 1. 44. A kit comprising the chimeric antibody or antigen-binding fragment of claim 1, in one or more containers, and instructions for use.

Details for Patent 9,988,437

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	For Injection	103770	06/19/1998		2029-08-13
Swedish Orphan Biovitrum Ab (publ)	SYNAGIS	palivizumab	Injection	103770	07/23/2004		2029-08-13