IP Library › Granted Patent US 12709753

Granted Patent B2

US 12709753 · App. 16/476,529 · Granted Aug 18, 2026

HIV immunotherapy with no pre-immunization step

Inventors: Haishan Li (Rockville, MD); Tyler Lahusen (Rockville, MD); Lingzhi Xiao (Rockville, MD); Charles David Pauza (Rockville, MD)

Assignee: American Gene Technologies International Inc.

C12N15/1138 A61K40/11 A61K40/46 A61P31/18 C12N5/0634 C12N5/0636 C12N5/0637 C12N15/1132 C12N15/86 A61K2239/38 C12N2310/141 C12N2740/15043 C12N2740/16034

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Quick Facts

Patent No.: US 12709753
App. No.: 16/476,529
Granted: Aug 18, 2026
Kind: B2

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Abstract

The present invention relates generally to immunotherapy for the treatment or prevention of HIV. In particular, the disclosure provides lentiviral vectors and associated methods that are optimized to treat HIV without a pre-immunization step.

Claims (46)

1 . A method of treating cells, wherein the cells were isolated from a subject not previously immunized with an HIV-1 vaccine, the method comprising:

(a) contacting peripheral blood mononuclear cells (PBMC) isolated from a subject infected with HIV-1 and not previously immunized with an HIV vaccine, with a therapeutically effective amount of a stimulatory agent, wherein the contacting is carried out ex vivo;

(b) transducing, the PBMC ex vivo with a viral delivery system encoding at least one genetic element, wherein at least one genetic element comprises:

a sequence having at least 95% sequence identity with SEQ ID NO: 31; or

at least two of: (i) a sequence comprising at least 95% sequence identity with SEQ ID NO: 1, (ii) a sequence comprising at least 95% sequence identity with SEQ ID NO: 2, and (iii) a sequence comprising at least 95% sequence identity with SEQ ID NO: 3; or

each of: (iv) a sequence comprising at least 95% sequence identity with SEQ ID NO: 97, (v) a sequence comprising at least 95% sequence identity with SEQ ID NO: 6, and (vi) a sequence comprising at least 95% sequence identity with SEQ ID NO: 7 and

2 . The method of claim 1 , wherein the transduced PBMC are cultured from about 1 to about 35 days.

3 . The method of claim 1 , further comprising infusing, or having infused, the transduced PBMC into a subject.

4 . The method of claim 3 , wherein the subject is a human.

5 . The method of claim 1 , wherein the stimulatory agent comprises a peptide.

6 . The method of claim 5 , wherein the peptide comprises a GAG peptide.

7 . The method of claim 1 , wherein the stimulatory agent comprises a vaccine.

8 . The method of claim 7 , wherein the vaccine comprises an HIV-1 vaccine.

9 . The method of claim 8 , wherein the HIV-1 vaccine comprises a MVA/HIV62B vaccine or a variant thereof.

10 . The method of claim 1 , wherein the viral delivery system comprises a lentiviral particle.

11 . The method of claim 1 , wherein the at least one genetic element, when expressed, is capable of targeting an HIV-1 RNA sequence.

12 . The method of claim 11 , wherein the at least one genetic element comprises a sequence having at least 95% identity with any one of SEQ ID NO: 31, SEQ ID NO: 1, or SEQ ID NO: 97, and wherein the at least one genetic element, when expressed, is capable of inhibiting production of chemokine receptor CCR5.

13 . The method of claim 1 , wherein the at least one genetic element comprises:

SEQ ID NO: 31; or

at least two of: SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3; or

each of: SEQ ID NO: 97, SEQ ID NO: 6, and SEQ ID NO: 7.

14 . A method of treating HIV-1 infection in a subject not previously immunized with an HIV-1 vaccine, the method comprising:

(a) removing leukocytes from the subject, wherein the subject was not previously immunized with an HIV-1 vaccine;

(b) purifying peripheral blood mononuclear cells (PBMC) ex vivo from the leukocytes;

(d) transducing the PBMC ex vivo with a viral delivery system encoding at least one genetic element, wherein the at least one genetic element comprises:

a sequence having at least 95% sequence identity with-SEQ ID NO; or

(e) culturing, or having cultured, the transduced PBMC for at least 1 day.

15 . The method of claim 14 , wherein the transduced PBMC are cultured from about 1 to about 35 days.

16 . The method of claim 14 , further comprising infusing, or having infused, the transduced PBMC into the subject.

17 . The method of any one of claim 14 , wherein the subject is a human.

18 . The method of claim 14 , wherein the stimulatory agent comprises a peptide.

19 . The method of claim 18 , wherein the peptide comprises a GAG peptide.

20 . The method of claim 14 , wherein the stimulatory agent comprises a vaccine.

21 . The method of claim 20 , wherein the vaccine comprises an HIV-1 vaccine.

22 . The method of claim 21 , wherein the HIV-1 vaccine comprises a MVA/HIV62B vaccine or a variant thereof.

23 . The method of claim 1 , wherein the viral delivery system comprises a lentiviral particle.

24 . The method of claim 1 , wherein the at least one genetic element comprises at least one small RNA capable of targeting an HIV-1 RNA sequence.

25 . The method of claim 24 , wherein the at least one genetic element comprises a sequence having at least 95% identity with any one of SEQ ID NO: 31, SEQ ID NO: 1, SEQ ID NO: 97, and wherein the at least one genetic element, when expressed, is capable of inhibiting production of chemokine receptor CCR5.

26 . The method of claim 24 , wherein the at least one genetic element comprises:

SEQ ID NO: 31; or

at least two of: SEQ ID NO: 1, SEQ ID NO: 2, and SEQ ID NO: 3; or

each of: SEQ ID NO: 97, SEQ ID NO: 6, and SEQ ID NO: 7.