IP Library › Granted Patent US 12,611,453
Granted Patent B2
US 12,611,453 · App. 17/610,040 · Granted Apr 28, 2026

Method of inducing an HIV-1-specific immune response using a chimpanzee adenovirus vector encoding an hivacat t-cell immunogen and TLR7 agonist

Inventors: Romas Geleziunas (Belmont, CA); Devi Sengupta (San Francisco, CA); Christian Brander (Tiana, ES); Beatriz Mothe Pujadas (Tiana, ES); Ian McGowan (Barcelona, ES)
Assignee: Gilead Sciences, Inc.
A61K39/21A61K31/519C12N7/00C12N15/86A61K2039/5256A61K2039/54A61K2039/545C12N2710/10332C12N2710/10341C12N2710/10362
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Quick Facts
Patent No.
US 12,611,453
App. No.
17/610,040
Granted
Apr 28, 2026
Kind
B2
Abstract

The present disclosure describes methods, compositions, and kits related to the combination of a TLR7 modulating compound and an HIV vaccine. The combination can be used in a method of treating or preventing an HIV infection in a human.

Claims (67)

1 . A method of treating an HIV-1 infection in a human in need thereof suffering from HIV-1 infection, the method comprising administering to the human 6 mg of a compound of Formula (I):

and a first virus that is a replication-defective chimpanzee adenovirus comprising a nucleic acid encoding an immunogenic polypeptide comprising:

(i) a sequence having at least 90% sequence identity to SEQ ID NO: 1;

(ii) a sequence having at least 90% sequence identity to SEQ ID NO: 2;

(iii) a sequence having at least 90% sequence identity to SEQ ID NO: 3;

(iv) a sequence having at least 90% sequence identity to SEQ ID NO: 4;

(v) a sequence having at least 90% sequence identity to SEQ ID NO: 5;

(vi) a sequence having at least 90% sequence identity to SEQ ID NO: 6;

(vii) a sequence having at least 90% sequence identity to SEQ ID NO: 7;

(viii) a sequence having at least 90% sequence identity to SEQ ID NO: 8;

(ix) a sequence having at least 90% sequence identity to SEQ ID NO: 9;

(x) a sequence having at least 90% sequence identity to SEQ ID NO: 10;

a sequence having at least 90% sequence identity to SEQ ID NO: 11;

(xii) a sequence having at least 90% sequence identity to SEQ ID NO: 12;

(xiii) a sequence having at least 90% sequence identity to SEQ ID NO: 13;

(xiv) a sequence having at least 90% sequence identity to SEQ ID NO: 14;

(xv) a sequence having at least 90% sequence identity to SEQ ID NO: 15; and

(xvi) a sequence having at least 90% sequence identity to SEQ ID NO: 16;

wherein at least two of (i) to (xvi) are joined by a single, dual, or triple alanine amino acid linker, wherein the linker results in the formation of an AAA sequence in the junction region between adjoining sequences, and

wherein the sequence of each of (i) to (xvi) is 11-85 amino acids in length.

2 . The method of claim 1 , wherein the immunogenic polypeptide comprises:

(i) a sequence having at least 95% sequence identity to SEQ ID NO: 1;

(ii) a sequence having at least 95% sequence identity to SEQ ID NO: 2;

(iii) a sequence having at least 95% sequence identity to SEQ ID NO: 3;

(iv) a sequence having at least 95% sequence identity to SEQ ID NO: 4;

(v) a sequence having at least 95% sequence identity to SEQ ID NO: 5;

(vi) a sequence having at least 95% sequence identity to SEQ ID NO: 6;

(vii) a sequence having at least 95% sequence identity to SEQ ID NO: 7;

(viii) a sequence having at least 95% sequence identity to SEQ ID NO: 8;

(ix) a sequence having at least 95% sequence identity to SEQ ID NO: 9;

(x) a sequence having at least 95% sequence identity to SEQ ID NO: 10;

(xi) a sequence having at least 95% sequence identity to SEQ ID NO: 11;

(xii) a sequence having at least 95% sequence identity to SEQ ID NO: 12;

(xiii) a sequence having at least 95% sequence identity to SEQ ID NO: 13;

(xiv) a sequence having at least 95% sequence identity to SEQ ID NO: 14;

(XV) a sequence having at least 95% sequence identity to SEQ ID NO: 15; and

(xvi) a sequence having at least 95% sequence identity to SEQ ID NO: 16.

3 . The method of claim 1 , wherein the immunogenic polypeptide comprises the sequences of SEQ ID NOS: 1-16, wherein at least two of SEQ ID NOS: 1-16 are joined by the single, dual, or triple alanine amino acid linker, and wherein the linker results in the formation of an AAA sequence in the junction region between adjoining sequences.

4 . The method of claim 1 , wherein the immunogenic polypeptide has an amino acid sequence according to SEQ ID NO: 17.

5 . The method of claim 1 , wherein the nucleic acid has a nucleic acid sequence according to SEQ ID NO: 18.

6 . The method of claim 1 , wherein the first virus comprises an Adenoviridae or a Poxviridae viral vector.

7 . The method of claim 1 , wherein the first virus comprises an adenovirus viral vector.

8 . The method of claim 7 , wherein the first virus is a chimpanzee adenovirus.

9 . The method of claim 7 , wherein 5×10 10 viral particles of the first virus is administered.

10 . The method of claim 1 , wherein the first virus is administered once every 12 weeks.

11 . The method of claim 10 , wherein the first virus is administered twice.

12 . The method of claim 1 , wherein the method further comprises administering a second virus comprising the nucleic acid encoding the immunogenic polypeptide.

13 . The method of claim 12 , wherein the second virus comprises a modified vaccinia virus Ankara (MVA) vector.

14 . The method of claim 13 , wherein 2×10 8 plaque-forming units of the second virus is administered.

15 . The method of claim 12 , wherein the second virus is administered once every 12 weeks.

16 . The method of claim 15 , wherein the second virus is administered twice.

17 . The method of claim 12 , wherein the first virus and the second virus are administered intramuscularly.

18 . The method of claim 12 , wherein the first virus is administered at Week 0 and Week 12, and the second virus is administered at Week 24 and Week 36.

19 . The method of claim 1 , wherein the compound of Formula (I) is administered every two weeks after the third administration of virus.

20 . The method of claim 18 , wherein the compound of Formula (I) is administered at Weeks 26, 28, 30, 32, 34, 38, 40, 42, 44, and 46.

21 . The method of claim 1 , wherein the human is virologically suppressed.

22 . The method of claim 21 , wherein the virologically suppressed human has a viral load of less than 200, 100, 50, or 20 copies of HIV-1 RNA per mL of plasma or blood.

23 . The method of claim 21 , wherein the virological suppression results from administration of anti-retroviral therapy.

24 . The method of claim 23 , wherein the anti-retroviral therapy comprises one or more agents selected from the group consisting of raltegravir, elvitegravir, soltegravir, cabotegravir, dolutegravir, abacavir, didanosine, tenofovir disoproxil fumarate, tenofovir alafenamide, emtricitabine, lamivudine, stavudine, zidovudine, abacavir, elvucitabine, tenofovir exalidex, festinavir, nevirapine, efavirenz, etravirine, rilpivirine, fosdevirine, doravirine, lersivirine, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, saquinavir, tipranavir, ritonavir, fosamprenavir, maraviroc, enfuvirtide, fostemsavir, bevirimat, cobicistat, and bictegravir; or a pharmaceutically acceptable salt thereof.

25 . A method of treating an HIV-1 infection in a virologically suppressed human in need thereof suffering from HIV-1 infection, the method comprising administering to the human a compound of Formula (I):

a first virus comprising 5×10 10 viral particles of a replication-defective chimpanzee adenovirus comprising a nucleic acid encoding an immunogenic polypeptide having an amino acid sequence of SEQ ID NO: 17, and

a second virus comprising 2×10 8 plaque-forming units of a modified vaccinia virus Ankara (MVA) comprising a nucleic acid encoding an immunogenic polypeptide having an amino acid sequence of SEQ ID NO: 17;

wherein

the first virus is administered at Week 0 and Week 12,

the second virus is administered at Week 24 and Week 36,

6 mg of the compound of Formula (I) is administered at Week 26 and Week 28, and

6 mg of the compound of Formula (I) is administered at Weeks 30, 32, 34, 38, 40, 42, 44, and 46.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 26, 2026
From: AELIX THERAPEUTICS, S.L.
To: GILEAD SCIENCES, INC.
Reel/Frame 074762/0969 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 28, 2022
From: BRANDER, CHRISTIAN; MOTHE PUJADAS, BEATRIZ; MCGOWAN, IAN
To: AELIX THERAPEUTICS S.L.
Reel/Frame 060336/0289 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 5, 2022
From: GELEZIUNAS, ROMAS; SENGUPTA, DEVI
To: GILEAD SCIENCES, INC.
Reel/Frame 059505/0784 →
Continuity (2)
Provisional Application 62851363 · May 22, 2019
Related Publication 20220218711A1 · Jul 14, 2022
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