IP Library Granted Patent US 11,980,663
Granted Patent B2
US 11,980,663 · App. 15/736,284 · Granted May 14, 2024

HIV pre-immunization and immunotherapy

Inventor: Charles David Pauza (Rockville, MD)
Assignee: American Gene Technologies International Inc.
A61K39/21A61K35/17A61K39/12A61P31/18C12N15/1138C12N15/86C12Q1/06A61K2039/5156A61K2039/5158A61K2039/57A61K48/00C12N2310/14C12N2740/15041C12N2740/15043C12N2740/16034C12N2740/16041
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Quick Facts
Patent No.
US 11,980,663
App. No.
15/736,284
Granted
May 14, 2024
Kind
B2
Abstract

The present invention relates generally to immunization and immunotherapy for the treatment or prevention of HIV. In particular, the methods relate to in vivo and ex vivo enrichment of HIV-specific CD4 T cells. In certain embodiments, the disclosed compositions and methods can incorporate therapy in order to further enhance the HIV-specific CD4 T cells.

Claims (38)

1. A method of treating HIV infection, comprising:

(a) immunizing a subject with a therapeutically effective amount of an HIV vaccine;

(b) purifying peripheral blood mononuclear cells (PBMC) obtained from the subject;

(c) contacting the PBMC ex vivo with a therapeutically effective amount of an HIV vaccine;

(d) transducing the PBMC ex vivo with a viral delivery system that comprises a microRNA cluster encoding:

(i) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5 and at least one microRNA capable of inhibiting the production of HIV tat gene,

(ii) at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene or

(iii) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5, at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene;

(e) culturing the transduced PBMC for about 1 to about 35 days; and

(f) infusing the transduced PBMC into the subject,

wherein the subject receives a cyclophosphamide pre-treatment prior to infusing the transduced PBMC.

2. The method of claim 1 , wherein step (a) and step (b) comprise the same HIV vaccine.

3. The method of claim 1 , wherein step (a) and step (c) comprise different HIV vaccines.

4. The method of claim 1 , wherein the subject was receiving cART or HAART prior to infusing the transduced PBMC into the subject.

5. The method of claim 1 , wherein the viral delivery system further comprises at least one microRNA capable of inhibiting the production of chemokine receptor CXCR4.

6. The method of claim 1 , wherein the microRNA cluster further encodes a microRNA capable of inhibiting an HIV gene selected from the group consisting of gag, pol, env, rev, nef, vpr, and vpu.

7. The method of claim 1 , wherein the transduced PBMC are cultured for about 1 to about 10 days prior to infusing the transduced PBMC into the subject.

8. A method of treating HIV in a HIV+subject, comprising:

(a) immunizing a subject with a therapeutically effective amount of an HIV vaccine;

(b) purifying peripheral blood mononuclear cells (PBMC) obtained from the subject;

(c) contacting the PBMC ex vivo with a therapeutically effective amount of an HIV vaccine;

(d)transducing the PBMC ex vivo with a viral delivery system that comprises a microRNA cluster encoding:

(i) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5 and at least one microRNA capable of inhibiting the production of HIV tat gene,

(ii) at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene or

(iii) at least one microRNA capable of inhibiting the production of chemokine receptor CCR5, at least one microRNA capable of inhibiting the production of HIV tat gene and at least one microRNA capable of inhibiting the production of HIV vif gene;

(e) culturing the transduced PBMC for about 1 to about 35 days; and

(f) infusing the transduced PBMC into the subject,

wherein the subject receives a cyclophosphamide pre-treatment prior to infusing the transduced PBMC.

9. The method of claim 8 , wherein step (a) and step (12) comprise the same HIV vaccine.

10. The method of claim 8 , wherein step (a) and step (c) comprise different HIV vaccines.

11. The method of claim 8 , wherein the viral delivery system further comprises at least one microRNA capable of inhibiting the production of chemokine receptor CXCR4.

12. The method of claim 8 , wherein the microRNA cluster further encodes a microRNA capable of inhibiting an HIV gene selected from the group consisting of gag, pol, env, rev, nef, vpr, and vpu.

13. The method of claim 1 , wherein the microRNA comprises miR30 CCR5 encoded by the sequence comprising SEQ ID NO. 10.

14. The method of claim 8 , wherein the microRNA comprises miR30 CCR5 encoded by the sequence comprising SEQ ID NO. 10.

15. The method of claim 13 , wherein the microRNA comprises miR21 vif encoded by the sequence comprising SEQ ID NO. 11.

16. The method of claim 14 , wherein the microRNA comprises miR21 vif encoded by the sequence comprising SEQ ID NO. 11.

17. The method of claim 15 , wherein the microRNA comprises miR185 tat encoded by the sequence comprising SEQ ID NO. 12.

18. The method of claim 16 , wherein the microRNA comprises miR185 tat encoded by the sequence comprising SEQ ID NO. 12.

Assignments (2)
SECURITY INTEREST Recorded Nov 8, 2023
From: AMERICAN GENE TECHNOLOGIES INTERNATIONAL INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS COLLATERAL AGENT
Reel/Frame 065521/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 19, 2019
From: PAUZA, CHARLES DAVID
To: AMERICAN GENE TECHNOLOGIES INTERNATIONAL INC.
Reel/Frame 048641/0288 →
Continuity (2)
Provisional Application 62190139 · Jul 8, 2015
Related Publication 20180177866A1 · Jun 28, 2018
Cited By (1)
US 12,709,753