IP Library Granted Patent US 10,428,350
Granted Patent B2
US 10,428,350 · App. 16/182,443 · Granted Oct 1, 2019

Methods and compositions for the activation of gamma-delta T-cells

Inventors: Charles David Pauza (Baltimore, MD); Haishan Li (North Potomac, MD); Tyler Lahusen (Frederick, MD); Mei-Ling Liou (Germantown, MD)
Assignee: American Gene Technologies International Inc.
C12N15/86A61K31/675A61K31/7105A61K38/16C12N5/0636C12N15/113A61K48/00A61K2039/5158C12N5/00C12N2310/14C12N2310/141C12N2310/531
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Quick Facts
Patent No.
US 10,428,350
App. No.
16/182,443
Granted
Oct 1, 2019
Kind
B2
Abstract

The present invention relates generally to methods and compositions for gene therapy and immunotherapy that activate gamma delta T-cells, and in particular, can be used in the treatment of various cancers and infectious diseases.

Claims (29)

1. A method of treating a cancer in a subject in need thereof, the method comprising administering or having administered a therapeutically-effective amount of an immunotherapy-based composition to the subject, wherein the immunotherapy-based composition is obtained from an immunotherapy-based viral delivery system comprising:

(i) at least one helper plasmid comprising DNA sequences for expressing a functional protein derived from each of a gag, pol, and rev gene;

(ii) an envelope plasmid comprising a DNA sequence for expressing an envelope protein capable of infecting a target cell; and

(iii) a therapeutic vector comprising:

at least one encoded shRNA that, when expressed, inhibits production of farnesyl diphosphate synthase (FDPS) or,

at least one encoded microRNA that, when expressed, inhibits production of farnesyl diphosphate synthase (FDPS).

2. The method of claim 1 , wherein the at least one helper plasmid comprises first and second helper plasmids, wherein the first help helper plasmid comprises DNA sequences for expressing such proteins derived from the gag and pol genes, and the second helper plasmid comprises a DNA sequence for expressing such protein derived from the rev gene.

3. The method of claim 1 , wherein the immunotherapy-based viral delivery system is transfected into a packaging cell prior to administering the immunotherapy-based composition to the subject.

4. The method of claim 3 , wherein the packaging cell produces the immunotherapy-based composition following transfection with the immunotherapy-based viral delivery system.

5. The method of claim 1 , wherein the shRNA comprises a sequence having at least 80 percent identity with SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, or SEQ ID NO: 4; or wherein the microRNA comprises a sequence having at least 80 percent identity with SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, or SEQ ID NO: 10.

6. The method of claim 1 , wherein the target cell comprises a cancer cell.

7. The method of claim 6 , wherein the cancer cell is capable of activating a gamma delta T cell resident in the subject following infection of the cancer cell with the immunotherapy-based composition.

8. The method of claim 1 , further comprising administering or having administered an effective amount of an aminobisphosphonate drug to the subject.

9. The method of claim 8 , wherein the aminobisphosphonate drug is administered to the subject separately from the immunotherapy-based composition.

10. The method of claim 8 , wherein the aminobisphosphonate drug is administered to the subject together with the immunotherapy-based composition.

11. A method of treating a cancer in a subject in need thereof, the method comprising:

(a) obtaining or having obtained an immunotherapy-based viral delivery system comprising:

(i) at least one helper plasmid comprising DNA sequences for expressing a functional protein derived from each of a gag, pol, and rev gene;

(ii) an envelope plasmid comprising a DNA sequence for expressing an envelope protein capable of infecting a target cell; and

(iii) a therapeutic vector comprising:

at least one encoded shRNA that, when expressed, inhibits production of farnesyl diphosphate synthase (FDPS); or,

at least one encoded microRNA that, when expressed, inhibits production of farnesyl diphosphate synthase (FDPS);

(b) transfecting or having transfected the immunotherapy-based viral delivery system into a packaging cell to produce an immunotherapy-based composition; and

(c) administering or having administered a therapeutically-effective amount of the immunotherapy-based composition to the subject.

12. The method of claim 11 , wherein the at least one helper plasmid comprises first and second helper plasmids, wherein the first help helper plasmid comprises DNA sequences for expressing such proteins derived from the gag and pol genes, and the second helper plasmid comprises a DNA sequence for expressing such protein derived from the rev gene.

13. The method of claim 11 , wherein the shRNA comprises a sequence having at least 80 percent identity with SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, or SEQ ID NO: 4; or wherein the microRNA comprises a sequence having at least 80 percent identity with SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, or SEQ ID NO: 10.

14. The method of claim 11 , further comprising administering an effective amount of an aminobisphosphonate drug to the subject.

15. The method of claim 14 , wherein the aminobisphosphonate drug is administered to the subject separately from the immunotherapy-based composition.

16. The method of claim 14 , wherein the aminobisphosphonate drug is administered to the subject together with the immunotherapy-based composition.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 15, 2018
From: PAUZA, CHARLES DAVID; LI, HAISHAN; LAHUSEN, TYLER; LIOU, MEI-LING
To: AMERICAN GENE TECHNOLOGIES INTERNATIONAL INC.
Reel/Frame 047519/0445 →
Continuity (6)
Continuation 16008991 · Jun 14, 2018
Continuation 15850937 · Dec 21, 2017
Continuation 15652080 · Jul 17, 2017
Continuation PCTUS2017013399 · Jan 13, 2017
Provisional Application 62279474 · Jan 15, 2016
Related Publication 20190062786A1 · Feb 28, 2019
Cited By (6)
US 12,359,203 US 12,403,155 US 12,410,445 US 12,410,446 US 12,559,769 US 12,709,753