Granted Patent
B2
US 12,558,407 · App. 17/607,495 · Granted Feb 24, 2026
Compositions for treatment of diffuse intrinsic pontine glioma
Inventors:
Elias Sayour (Newberry, FL); James Andrew McGuiness (Gainesville, FL); Hector Ruben Mendez-Gomez (Gainesville, FL); Duane A. Mitchell (Gainesville, FL)
A61K39/001114A61K39/0011A61P35/00C07K14/70539C07K14/70596A61K2039/53A61K2039/55555A61K2039/80C07K2319/00
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Abstract
Provided herein are compositions comprising a liposome comprising RNA molecules and a cationic lipid, wherein the RNA molecules encode at least one MHC Class II epitope of a mutant Histone 3 (H3) protein comprising a K27M mutation and optionally at least one MHC Class I epitope of the mutant H3 protein. In exemplary embodiments, the RNA molecules comprise a sequence of SEQ ID NO: 12 or 14. Methods of increasing central memory T cells, increasing an immune response, or treating a diffuse midline glioma (DMG), in a subject are provided herein. In exemplary embodiments, the methods comprise administering to the subject the compositions provided herein.
Claims (18)
1 . A composition comprising a liposome comprising ribonucleic acid (RNA) molecules and a cationic lipid, wherein the RNA molecules encode at least one MHC Class II epitope (i) comprising at least 30 amino acids of a mutant Histone 3 (H3) protein comprising a K27M mutation and (ii) comprising the amino acid sequence of MAPRKQLATKAARMSAPSTGGVKKPH (SEQ ID NO: 13) or RKQLATKAARMSAPSTGGVKK (SEQ ID NO: 15), wherein the liposome has a zeta potential of about 30 mV to about 60 mV.
2 . The composition of claim 1 , wherein at least a portion of the RNA molecules comprise the nucleotide sequence of SEQ ID NO: 12.
3 . The composition of claim 1 , wherein the RNA molecules encode at least 2 MHC Class II epitope of the mutant H3 protein.
4 . The composition of claim 1 , wherein the RNA molecules encode a peptide that binds to at least one or more human MHC Class II molecules.
5 . The composition of claim 1 , wherein the liposome comprises RNA molecules that encode at least one MHC Class I epitope of the mutant H3 protein.
6 . The composition of claim 1 , wherein the RNA molecules encode a peptide that binds to at least one or more human MHC Class I molecules.
7 . The composition of claim 1 , wherein the cationic liposome is 1,2-dioleoyl-3-trimethylammonium-propane (DOTAP).
8 . The composition of claim 1 , wherein the composition comprises a plurality of liposomes, each liposome of which is about 50 nm to about 250 nm in diameter.
9 . The composition of claim 1 , wherein the RNA molecules are complexed with the cationic lipid via electrostatic interactions.
10 . The composition of claim 1 , wherein the RNA molecules comprise a 5′-cap.
11 . The composition of claim 1 , wherein the RNA molecules further encode a lysosome-associated membrane protein (LAMP).
12 . A method of generating a liposome comprising ribonucleic acid (RNA) molecules and a cationic lipid, wherein the RNA molecules encode at least one MHC Class II epitope of a mutant Histone 3 (H3) protein comprising a K27M mutation, said method comprising (i) in vitro transcribing a nucleic acid comprising a nucleotide sequence encoding the RNA molecules, (ii) chemically adding a 5′-cap to the in vitro transcribed RNA molecules, and (iii) mixing the RNA molecules comprising the 5′-cap with a cationic lipid, wherein the liposome has a zeta potential of about 30 mV to about 60 mV.
13 . A liposome generated by the method of claim 12 .
14 . A composition comprising the liposome of claim 13 .
15 . A method of increasing in a subject the number of central memory T cells having antigen specificity for an epitope of a mutant Histone 3 (H3) protein comprising a K27M mutation, said method comprising administering to the subject a composition of claim 1 in an amount effective to increase the central memory T cells in the subject.
16 . A method of enhancing in a subject an immune response against a diffuse midline glioma (DMG) expressing a mutant Histone 3 (H3) protein comprising a K27M mutation, said method comprising administering to the subject a composition of claim 1 in an amount effective to increase an immune response against the DMG in the subject.
17 . A method of treating a subject with a diffuse midline glioma (DMG) expressing a mutant Histone 3 (H3) protein comprising a K27M mutation, said method comprising administering to the subject a composition of claim 1 , in an amount effective to treat the DMG in the subject.
18 . The composition of claim 1 , wherein the RNA molecules encode SEQ ID NO: 1.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 18, 2022
From: SAYOUR, ELIAS; MCGUINESS, JAMES ANDREW; MENDEZ-GOMEZ, HECTOR RUBEN; MITCHELL, DUANE A.
To: UNIVERSITY OF FLORIDA RESEARCH FOUNDATION, INC.
Reel/Frame 059940/0311 →
CONFIRMATORY LICENSE
Recorded Jan 26, 2022
From: UNIVERSITY OF FLORIDA
To: THE GOVERNMENT OF THE UNITED STATES AS REPRESENTED BY THE SECRETARY OF THE ARMY
Reel/Frame 058860/0490 →
Continuity (2)
Provisional Application
62842525
· May 2, 2019
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