IP Library › Granted Patent US 12,521,577
Granted Patent B2
US 12,521,577 · App. 18/762,384 · Granted Jan 13, 2026

Betacoronavirus RNA vaccines

Inventors: Giuseppe Ciaramella (Sudbury, MA); Sunny Himansu (Winchester, MA)
Assignee: ModernaTX, Inc.
A61K39/12A61K39/155A61K39/215A61P11/00A61P31/14C07K16/10C07K16/1002C07K16/1027A61K2039/53A61K2039/55511A61K2039/55555A61K2039/6018A61K2039/70C07K2317/76C12N2760/18034C12N2760/18334C12N2760/18434C12N2760/18534C12N2760/18634C12N2770/20034Y02A50/30
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Quick Facts
Patent No.
US 12,521,577
App. No.
18/762,384
Granted
Jan 13, 2026
Kind
B2
Abstract

The disclosure relates to ribonucleic acid (RNA) vaccines and combination vaccines, as well as methods of using the vaccines and compositions comprising the vaccines. Specific embodiments relate to non-self-replicating RNA betacoronavirus vaccines formulated in a lipid nanoparticle.

Claims (20)

1 . A betacoronavirus vaccine for human subjects comprising a messenger ribonucleic acid (mRNA) formulated in a lipid nanoparticle, wherein the mRNA comprises an open reading frame encoding a full-length betacoronavirus (BetaCoV) S protein, wherein the open reading frame comprises nucleosides consisting of N1-methylpseudouridine, adenosine, guanosine, and cytidine, wherein the lipid nanoparticle comprises 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % cholesterol, and 0.5-15 mol % PEG-modified lipid, and wherein the vaccine is formulated for intramuscular injection at a dose that comprises 20-50 μg of the mRNA and a ratio of lipid to mRNA of from 5:1 to 30:1, and has an efficacy against betacoronavirus infection in human subjects of at least 90%.

2 . The vaccine of claim 1 , wherein the mRNA comprises a 5′ untranslated region (UTR) and a 3′ UTR, a poly (A) tail, and a 5′ cap analog.

3 . The vaccine of claim 2 , wherein the 5′ cap analog is 7mG(5′)ppp(5′)NlmpNp.

4 . The vaccine of claim 1 , wherein the ionizable cationic lipid is Compound 25:

5 . The vaccine of claim 1 , wherein the neutral lipid is 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and the PEG-modified lipid is 1,2-dimyristoyl-racalycero-3-methoxypolyethylene glycol-2000 (PEG-DMG) or PEG-CDMA.

6 . The vaccine of claim 4 , wherein the lipid nanoparticle comprises 50% ionizable cationic lipid, 10% neutral lipid, 38.5% cholesterol, and 1.5% PEG-modified lipid, wherein the neutral lipid is 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and the PEG-modified lipid is PEG-DMG.

7 . The vaccine of claim 1 , wherein the vaccine comprises 20 μg of the mRNA.

8 . The vaccine of claim 1 , wherein the vaccine comprises 25 μg of the mRNA.

9 . The vaccine of claim 1 , wherein the vaccine comprises 30 μg of the mRNA.

10 . The vaccine of claim 1 , wherein the vaccine comprises 50 μg of the mRNA.

11 . A betacoronavirus vaccine for human subjects comprising a messenger ribonucleic acid (mRNA) formulated in a lipid nanoparticle, wherein the mRNA comprises an open reading frame encoding a full-length betacoronavirus (BetaCoV) S protein, wherein the open reading frame comprises nucleosides consisting of N1-methylpseudouridine, adenosine, guanosine, and cytidine, wherein the lipid nanoparticle comprises 20-60 mol % ionizable cationic lipid, 5-25 mol % neutral lipid, 25-55 mol % cholesterol, and 0.5-15 mol % PEG-modified lipid, and wherein the vaccine is formulated for intramuscular injection at a dose that comprises 20-50 μg of the mRNA, and has an efficacy against betacoronavirus infection in human subjects of at least 90%.

12 . The vaccine of claim 11 , wherein the mRNA comprises a 5′ untranslated region (UTR) and a 3′ UTR, a poly (A) tail, and a 5′ cap analog.

13 . The vaccine of claim 12 , wherein the 5′ cap analog is 7mG(5′)ppp(5′)NlmpNp.

14 . The vaccine of claim 11 , wherein the neutral lipid is 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and the PEG-modified lipid is 1,2-dimyristoyl-racalycero-3-methoxypolyethylene glycol-2000 (PEG-DMG) or PEG-CDMA.

15 . The vaccine of claim 11 , wherein the ionizable cationic lipid is Compound 25:

16 . The vaccine of claim 15 , wherein the lipid nanoparticle comprises 50% ionizable cationic lipid, 10% neutral lipid, 38.5% cholesterol, and 1.5% PEG-modified lipid, wherein the neutral lipid is 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and the PEG-modified lipid is PEG-DMG.

17 . The vaccine of claim 11 , wherein the vaccine comprises 20 μg of the mRNA.

18 . The vaccine of claim 11 , wherein the vaccine comprises 25 μg of the mRNA.

19 . The vaccine of claim 11 , wherein the vaccine comprises 30 μg of the mRNA.

20 . The vaccine of claim 11 , wherein the vaccine comprises 50 μg of the mRNA.

Assignments (2)
SECURITY INTEREST Recorded Nov 19, 2025
From: MODERNATX, INC.
To: ARES CAPITAL CORPORATION, AS AGENT
Reel/Frame 073634/0354 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 9, 2024
From: CIARAMELLA, GIUSEPPE; HIMANSU, SUNNY
To: MODERNATX, INC.
Reel/Frame 069530/0106 →
Continuity (16)
Continuation 18528323 · Dec 4, 2023
Continuation 16897734 · Jun 10, 2020
Continuation 16368270 · Mar 28, 2019
Continuation 16040981 · Jul 20, 2018
Continuation 15674599 · Aug 11, 2017
Continuation PCTUS2016058327 · Oct 21, 2016
Provisional Application 62247362 · Oct 28, 2015
Provisional Application 62247394 · Oct 28, 2015
Provisional Application 62247297 · Oct 28, 2015
Provisional Application 62247483 · Oct 28, 2015
Provisional Application 62244837 · Oct 22, 2015
Provisional Application 62244946 · Oct 22, 2015
Provisional Application 62245031 · Oct 22, 2015
Provisional Application 62244813 · Oct 22, 2015
Provisional Application 62244802 · Oct 22, 2015
Related Publication 20240366749A1 · Nov 7, 2024
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