IP Library Granted Patent US 9,738,703
Granted Patent B2
US 9,738,703 · App. 14/864,705 · Granted Aug 22, 2017

Neutralizing antibodies to HIV-1 and their use

Inventors: John Mascola (Rockville, MD); Richard Wyatt (San Diego, CA); Xueling Wu (Potomac, MD); Yuxing Li (Boyds, MD); Carl-Magnus Hogerkorp (Vellinge, SE); Mario Roederer (Washington, DC); Zhi-yong Yang (Potomac, MD); Gary Nabel (Cambridge, MA); Peter Kwong (Washington, DC); Tongqing Zhou (Boyds, MD); Mark Connors (Bethesda, MD); William Schief (Encinitas, CA)
Assignees: The United States of America, as represented by the Secretary, Department of Health and Human Services; University of Washington
C07K16/1063A61K39/42A61K45/06C07K2317/565C07K2317/76C07K2317/92C12N2740/10011C12N2740/16011C12N2740/16111
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Quick Facts
Patent No.
US 9,738,703
App. No.
14/864,705
Granted
Aug 22, 2017
Kind
B2
Abstract

Monoclonal neutralizing antibodies are disclosed that specifically bind to the CD4 binding site of HIV-1 gp120. Monoclonal neutralizing antibodies also are disclosed that specifically bind to HIV-1 gp41. The identification of these antibodies, and the use of these antibodies are also disclosed. Methods are also provided for enhancing the binding and neutralizing activity of any antibody using epitope scaffold probes.

Claims (31)

1. A method of treating a human immunodeficiency virus (HIV)-1 infection in a subject or inhibiting infection of a subject with HIV-1, comprising:

administering to the subject a therapeutically effective amount of an antibody or a functional fragment thereof comprising:

a heavy chain variable region comprising a heavy chain complementarity determining region (HCDR) 1, a HCDR2, and a HCDR3, comprising amino acids 26-33, 51-58, and 97-110, of SEQ ID NO: 1, respectively; and

a light chain variable region comprising a light chain complementarity determining region (LCDR) 1, a LCDR2, and a LCDR3, comprising amino acids 27-30, 48-50, and 87-91, of SEQ ID NO: 2, respectively; and

wherein the antibody or the functional fragment specifically binds to gp120, thereby treating the HIV-1 infection in the subject or inhibiting infection of the subject with HIV-1.

2. The method of claim 1 , wherein the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1.

3. The method of claim 1 , wherein the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2.

4. The method of claim 1 , wherein:

the heavy chain variable region comprises the HCDR1, the HCDR2, and the HCDR3, and an amino acid sequence at least 90% identical to the amino acid sequence set forth as SEQ ID NO: 1; and

the light chain variable region comprises the LCDR1, the LCDR2, and the LCDR3, and an amino acid sequence at least 90% identical to the amino acid sequence set forth as SEQ ID NO: 2.

5. The method of claim 1 , wherein the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1, and the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2.

6. The method of claim 1 , wherein the antibody is an IgG, an IgM, or an IgA.

7. The method of claim 1 , wherein the antibody is an IgG1.

8. The method of claim 1 , wherein the fragment is a Fab fragment, a Fab′ fragment, a F(ab)′ 2 fragment, a single chain Fv protein (scFv), or a disulfide stabilized Fv protein (dsFv).

9. The method of claim 8 , wherein the fragment is a Fab fragment.

10. The method of claim 1 , wherein the method comprises treating the HIV-1 infection and the subject is infected with HIV-1.

11. The method of claim 1 , wherein the method comprises treating the HIV-1 infection and the subject has acquired immune deficiency syndrome (AIDS).

12. The method of claim 1 , wherein the method comprises inhibiting infection of the subject with HIV-1 and the subject is at risk of infection with HIV-1.

13. The method of claim 1 , wherein the subject is pregnant.

14. The method of claim 1 , wherein the subject is a breastfeeding mother.

15. The method of claim 1 , wherein the subject is an infant.

16. The method of claim 1 , wherein the administration is an intravenous administration or a subcutaneous administration.

17. The method of claim 1 , further comprising administering to the subject an anti-viral agent.

18. A method for treating a human immunodeficiency virus (HIV)-1 infection in a subject or inhibiting infection of a subject with HIV-1, comprising:

administering to the subject a therapeutically effective amount of an expression vector comprising a nucleic acid molecule encoding an antibody or a functional fragment thereof comprising:

a heavy chain variable region comprising a heavy chain complementarity determining region (HCDR) 1, a HCDR2, and a HCDR3, comprising amino acids 26-33, 51-58, and 97-110, of SEQ ID NO: 1, respectively; and

a light chain variable region comprising a light chain complementarity determining region (LCDR) 1, a LCDR2, and a LCDR3, comprising amino acids 27-30, 48-50, and 87-91, of SEQ ID NO: 2, respectively; and

wherein the antibody or the functional fragment specifically binds to gp120, and wherein expression of the antibody or antigen binding fragment in the subject treats the HIV-1 infection in the subject or inhibiting infection of the subject with HIV-1.

19. The method of claim 18 , wherein the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1, and the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2.

20. The method of claim 1 , wherein the heavy chain variable region comprises the HCDR1, the HCDR2, and the HCDR3, and an amino acid sequence at least 90% identical to SEQ ID NO: 1.

21. The method of claim 1 , wherein the light chain variable region comprises an amino acid sequence at least 90% identical to SEQ ID NO: 2.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2015
From: SCHIEF, WILLIAM
To: UNIVERSITY OF WASHINGTON
Reel/Frame 036662/0061 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2015
From: MASCOLA, JOHN R.; WU, XUELING; LI, YUXING; HOGERKORP, CARL-MAGNUS; WYATT, RICHARD; ROEDERER, MARIO; YANG, ZHI-YONG; NABEL, GARY; KWONG, PETER; ZHOU, TONGQING; CONNORS, MARK; OFEK, GILAD; SHAPIRO, LAWRENCE; ZHU, JIANG
To: THE UNITED STATES OF AMERICA, AS REPRESENTED BY THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Reel/Frame 036662/0120 →
Continuity (8)
Division 13498125
Provisional Application 61385531 · Sep 22, 2010
Provisional Application 61402314 · Aug 27, 2010
Provisional Application 61346808 · May 20, 2010
Provisional Application 61290135 · Dec 24, 2009
Provisional Application 61252613 · Oct 16, 2009
Provisional Application 61246039 · Sep 25, 2009
Related Publication 20160009789A1 · Jan 14, 2016