IP Library › Granted Patent US 12,551,549
Granted Patent B2
US 12,551,549 · App. 18/402,480 · Granted Feb 17, 2026

Methods of eliciting antibodies that bind to full-length glycosylated HIV-1 ENV using multimerized ENV cores

Inventors: Leonidas Stamatatos (Seattle, WA); Andrew McGuire (Seattle, WA); Katherine Rachael Parks (Seattle, WA); Matthew D. Gray (Seattle, WA)
Assignee: Fred Hutchinson Cancer Center
A61K39/21A61K39/02A61K2039/545C12N2740/16034C12N2740/16134
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Quick Facts
Patent No.
US 12,551,549
App. No.
18/402,480
Granted
Feb 17, 2026
Kind
B2
Abstract

Sequential immunization strategies to guide the maturation of antibodies against the human immunodeficiency virus (HIV) are described. The sequential immunization strategies utilize an HIV envelope protein (Env) that binds germline (gl) B cells as a first (prime) immunization and an Env with a functional glycosylated N276 as a second (boost) immunization. The sequential immunization strategies successfully elicit neutralizing antibodies against HIV.

Claims (20)

1 . A kit comprising (i) a prime immunization comprising a multimerized 426c core HIV-1 Env; and (ii) a boost immunization HIV Env with a glycosylated N276; and instructions that no Env are to be administered to a subject between the (i) prime immunization and the (ii) boost immunization, wherein residue numbering of the HIV-1 Env is according to Hxb2.

2 . A kit of claim 1 , wherein the multimerized 426c core HIV-1 Env has the sequence set forth in SEQ ID NO. 56.

3 . A kit of claim 1 , wherein the multimerized 426c core HIV-1 Env comprises: (i) mutations at one or more of: N460D; N463D; S278R; G471S; V65C; and S115C; (ii) removal of the V1 loop and the V2 loop; (iii) replacement of the V3 loop with a flexible linker; and (iv) an N-terminal truncation; wherein the HIV Env does not have a mutation at position 276, and wherein residue numbering of the HIV-1 Env is according to Hxb2.

4 . A kit of claim 3 , wherein the multimerized 426c core HIV-1 Env comprises mutations at N460D, N463D, S278R, and G471S; or N460D, N463D, S278R, G471S, V65C, and S115C, wherein residue numbering of the HIV-1 Env is according to Hxb2.

5 . A kit of claim 3 , wherein the N-terminal truncation is before residue 49, 48, 47, 46, 45, 44, 43, 42, 41, 40 or 39, wherein residue numbering of the HIV-1 Env is according to Hxb2.

6 . A kit of claim 3 , wherein the N-terminal truncation is before residue 44, wherein residue numbering of the HIV-1 Env is according to Hxb2.

7 . A kit of claim 3 , wherein the multimerized 426c core HIV-1 Env further comprises a C-terminal truncation after residue 499, 498, 497, 496, 495, 494, 493, 492, 491, 490 or 389, wherein residue numbering of the HIV-1 Env is according to Hxb2.

8 . A kit of claim 7 , wherein the C-terminal truncation is after residue 494, wherein residue numbering of the HIV-1 Env is according to Hxb2.

9 . A kit of claim 3 , wherein the flexible linker has a sequence set forth in a sequence selected from SEQ ID NOs. 57-68.

10 . A kit of claim 3 , wherein the V3 loop comprises residues 296-331, wherein residue numbering of the HIV-1 Env is according to Hxb2.

11 . A kit of claim 3 , wherein removal of the V1 loop comprises removal of residues 131-152 and/or removal of the V2 loop comprises removal of residues 161-196, wherein residue numbering of the HIV-1 Env is according to Hxb2.

12 . A kit of claim 3 , wherein removal of the V1 loop and removal of the V2 loop comprises removal of residues 123-196, wherein residue numbering of the HIV-1 Env is according to Hxb2.

13 . A kit of claim 1 , wherein the multimerized 426c core HIV-1 Env retains glycosylation at N463 but lacks glycosylation at N276 and N460, wherein residue numbering of the HIV-1 Env is according to Hxb2.

14 . A kit of claim 1 , wherein the multimerized 426c core HIV-1 Env retains glycosylation at position 463, wherein residue numbering of the HIV-1 Env is according to Hxb2.

15 . A kit of claim 1 , wherein the multimerized 426c core HIV-1 Env has a sequence set forth in a sequence selected from SEQ ID NOs. 69-112.

16 . A kit of claim 1 , wherein the boost immunization HIV Env is selected from the HxB2 core+3 NLGS, the 45_01dH5 core+3 NLGS, or a C4b-multimerized HxB2 wildtype core glycosylated at N276 and having the sequence set forth in SEQ ID NO: 119, wherein residue numbering of the HIV-1 Env is according to Hxb2.

17 . A kit of claim 1 , wherein the boost immunization HIV Env has the sequence set forth in SEQ ID NO. 183.

18 . A kit of claim 1 , wherein the boost immunization HIV Env has a sequence set forth in a sequence selected from SEQ ID NO. 69-SEQ ID NO. 79, SEQ ID NO. 82, SEQ ID NO. 107, SEQ ID NO. 113-118, and SEQ ID NO: 121-SEQ ID NO. 132.

19 . A kit of claim 1 , wherein the boost immunization HIV Env is multimerized.

20 . A kit of claim 1 , wherein the multimerized 426c core HIV-1 Env and the boost immunization HIV Env are multimerized with ferritin.

Assignments (3)
MERGER AND CHANGE OF NAME Recorded Jan 23, 2024
From: SEATTLE CANCER CARE ALLIANCE; FRED HUTCHINSON CANCER RESEARCH CENTER
To: FRED HUTCHINSON CANCER CENTER
Reel/Frame 066219/0421 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 22, 2024
From: STAMATATOS, LEONIDAS; MCGUIRE, ANDREW; PARKS, KATHERINE RACHAEL
To: FRED HUTCHINSON CANCER RESEARCH CENTER
Reel/Frame 066203/0867 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 22, 2024
From: STAMATATOS, LEONIDAS; MCGUIRE, ANDREW; PARKS, KATHERINE RACHAEL
To: FRED HUTCHINSON CANCER RESEARCH CENTER
Reel/Frame 066203/0898 →
Continuity (3)
Continuation 17269199
Provisional Application 62724555 · Aug 29, 2018
Related Publication 20240238405A1 · Jul 18, 2024
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