IP Library Granted Patent US 8,652,465
Granted Patent B2
US 8,652,465 · App. 11/449,919 · Granted Feb 18, 2014

Methods and compositions for the treatment of persistent infections

Inventors: Gordon Freeman (Brookline, MA); Arlene Sharpe (Brookline, MA); David M. Dorfman (Brookline, MA); Rafi Ahmed (Atlanta, GA); Daniel Barber (Rockville, MD); E. John Wherry (Havertown, PA)
Assignees: Emory University; Dana-Farber Cancer Institute, Inc.; Brigham and Women's Hospital; President and Fellows of Harvard College
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Quick Facts
Patent No.
US 8,652,465
App. No.
11/449,919
Granted
Feb 18, 2014
Kind
B2
Abstract

The present invention provides methods and compositions for the treatment, prevention, or reduction of persistent infections, such as chronic infections, latent infections, and slow infections and cancer. The methods and compositions of the invention are also useful for the alleviation of one or more symptoms associated with such infections and cancer.

Claims (28)

1. A method of reducing a viral titer in a subject having a persistent viral infection, comprising

administering to said subject having an existing persistent viral infection an effective amount of an agent that reduces PD-1 activity, wherein the agent consists of an anti-PD-L1 antibody, wherein said subject is not administered an anti-PD-L2 antibody,

thereby reducing viral titer in the subject with the existing persistent viral infection.

2. The method of claim 1 , wherein said viral infection is an infection with a human immunodeficiency virus (HIV).

3. The method of claim 1 , wherein said anti-PD-L1 antibody reduces the interaction between PD-1 and PD-L1.

4. The method of claim 1 , wherein said anti -PD-L1 antibody increases the cytotoxic T-cell activity in said subject.

5. The method of claim 4 , wherein said cytotoxic T-cell activity is cytokine production or T cell proliferation.

6. The method of claim 5 , wherein said cytokine is IFNγ, TNFα, or IL-2.

7. The method of claim 1 , wherein said antibody is a monoclonal antibody, a humanized antibody, a deimmunized antibody, or an Ig fusion protein.

8. The method of claim 1 , further comprising administering to said subject a second compound, wherein said second compound is a reverse transcriptase inhibitor, a protease inhibitor, an antibacterial compound, an antifungal compound, an anti-parasitic compound, an anti-inflammatory compound, an anti-neoplastic compound or an analgesic.

9. The method of claim 1 , further comprising administering to said subject a second compound, wherein said second compound reduces the expression or activity of cytotoxic T lymphocyte antigen 4 (CTLA-4) or B and T lymphocyte attenuator (BTLA).

10. The method of claim 1 , further comprising administering to said subject a second compound, wherein said second compound is an anti-CTLA-4 antibody, an anti-BTLA antibody, or an anti-B7-H4 antibody.

11. The method of claim 1 , wherein said subject is a human.

12. The method of claim 1 , wherein the reduction of PD-1 activity is assessed by measuring CD8+T cell proliferation, CD8+T cell activity, or both in a sample from said subject.

13. The method of claim 1 , wherein the reduction of PD-1 activity is assessed by measuring the cytotoxic activity of anergic CD8+T cells in a sample from said subject.

14. The method of claim 1 , comprising measuring viral titer in a sample from said subject.

15. The method of claim 1 , further comprising administering to the subject an effective amount of a reverse transcriptase inhibitor.

16. The method of claim 1 , wherein the method consists of administering to the subject an effective amount of an anti-PD-L1 antibody.

17. The method of claim 16 , wherein said viral infection is an infection with a human immunodeficiency virus (HIV).

18. The method of claim 1 , wherein the method consists of administering to the subject an effective amount of an anti-PD-L1 antibody and a second compound, wherein the second compound is selected from the group consisting of a reverse transcriptase inhibitor, a protease inhibitor, an antibacterial compound, an antifungal compound, an anti-parasitic compound, an anti-inflammatory compound, an anti-neoplastic compound and an analgesic.

19. The method of claim 18 , wherein said viral infection is an infection with a human immunodeficiency virus (HIV).

20. The method of claim 1 , wherein the method consists of administering to the subject an effective amount of an anti-PD-L1 antibody and an anti-viral compound, wherein the anti-viral compound is selected from the group consisting of vidarabine, acyclovir, ganciclovir, valganciclovir, a nucleoside-analog reverse transcriptase inhibitor, a non-nucleoside -reverse transcriptase inhibitor, or a protease inhibitor, and wherein said viral infection is an infection with a human immunodeficiency virus (HIV).

21. The method of claim 1 , wherein the reduction of PD-1 activity is assessed by measuring the production of a cytokine by T cells in a sample from said subject.

22. The method of claim 21 , wherein the cytokine is interferon γ, tumor necrosis factor α or interleukin-2.

23. The method of claim 1 , wherein the reduction of PD-1 activity is assessed by measuring induction of the co-stimulation of T cells in a sample from said subject.

24. The method of claim 1 , wherein the reduction of PD-1 activity is assessed by measuring a B cell response in a sample from said subject.

25. The method of claim 1 , wherein PD-1 activity is reduced on CD8 + T cells.

26. The method of claim 25 , wherein the CD8+ cell are memory T cells.

Assignments (5)
CONFIRMATORY LICENSE Recorded Feb 26, 2010
From: BRIGHAM AND WOMEN'S HOSPITAL, INC.
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 023995/0440 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2009
From: SHARPE, ARLENE
To: PRESIDENT AND FELLOWS OF HARVARD COLLEGE
Reel/Frame 022504/0933 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2009
From: DORFMAN, DAVID M.
To: THE BRIGHAM AND WOMEN'S HOSPITAL, INC.
Reel/Frame 022504/0936 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2009
From: FREEMAN, GORDON
To: DANA-FARBER CANCER INSTITUTE
Reel/Frame 022504/0939 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 3, 2009
From: AHMED, RAFI; BARBER, DANIEL; WHERRY, E. JOHN
To: EMORY UNIVERSITY
Reel/Frame 022504/0953 →
Continuity (2)
Provisional Application 60688872 · Jun 8, 2005
Related Publication 20070122378A1 · May 31, 2007