Granted Patent B2

US 12,622,960 · App. 18/416,835 · Granted May 12, 2026

Inventor: Giuseppe Ciaramella (Sudbury, MA)

Assignee: ModernaTX, Inc.

A61K39/25A61K9/127A61K9/51A61K31/7105A61K39/0012A61K49/0091B82Y5/00C12N15/86A61K9/1271A61K9/1272A61K47/28A61K47/543A61K47/544C12N2710/16722C12N2710/16734

Abstract

Claims (30)

1 . A messenger ribonucleic acid (mRNA) vaccine comprising;

(a) an mRNA polynucleotide comprising from 5′ to 3′ a 5′untranslated region UTR, an open reading frame (ORF) encoding a varicella zoster virus (VZV) glycoprotein E(gE) protein, the protein comprising an amino acid sequence of SEQ ID NO: 38, a protein comprising a Y569A or a Y582G mutation, relative to the amino acid sequence of SEQ ID NO: 10, a protein comprising a truncated polypeptide lacking the cytoplasmic tail domain shown in amino acids 574-623 of SEQ ID NO: 10, or a truncated polypeptide lacking the transmembrane anchor domain shown in amino acids 562-573 of SEQ ID NO: 10 and a 3′ UTR, wherein 100% of uracil nucleosides in the ORF of the mRNA polynucleotide are N1-methylpseudouridine; and

(b) a lipid nanoparticle comprising 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), PEG-distearoyl glycerol (PEG DMG) and a compound of Formula (I):

or a salt thereof, wherein:

R 1 is selected from the group consisting of C 5-30 alkyl, C 5-20 alkenyl, and —R″M′R′;

R 2 and R 3 are independently selected from the group consisting of C 1-14 alkyl and C 2-14 alkenyl;

R 4 is —(CH 2 ) n Q, wherein Q is-OR, and n is selected from 1, 2, 3, 4, and 5;

each R 5 is H;

each R 6 is H;

M and M′ are independently selected from —C(O)O— and —OC(O)—;

R 7 is H;

R is H;

R′ is selected from the group consisting of C 1-18 alkyl and C 2-18 alkenyl;

R″ is selected from the group consisting of C 3-14 alkyl and C 3-14 alkenyl; and

m is selected from 5, 6, 7, 8, 9, 10, 11, 12, and 13.

2 . The mRNA vaccine of claim 1 , wherein the VZV gE protein comprises the amino acid sequence of SEQ ID NO: 38.

3 . The mRNA vaccine of claim 1 , wherein the ORF comprises a nucleotide sequence comprising at least 90% sequence identity to the mRNA sequence corresponding to SEQ ID NO: 62.

4 . The mRNA vaccine of claim 1 , wherein the ORF comprises the nucleotide sequence of SEQ ID NO: 62.

5 . The mRNA vaccine of claim 2 , wherein the ORF comprises a nucleotide sequence comprising at least 90% sequence identity to a mRNA sequence corresponding to SEQ ID NO: 62.

6 . The mRNA vaccine of claim 1 , wherein the ORF comprises a nucleotide sequence comprising at least 90% sequence identity to nucleotides 49-1767 of SEQ ID NO: 101.

7 . The mRNA vaccine of claim 1 , wherein the ORF comprises a nucleotide sequence comprising nucleotides 49-1767 of SEQ ID NO: 101.

8 . The mRNA vaccine of claim 2 , wherein the ORF comprises a nucleotide sequence comprising at least 90% sequence identity to nucleotides 49-1767 of SEQ ID NO: 101.

9 . The mRNA vaccine of claim 1 , wherein the VZV gE protein comprises a Y569A mutation, relative to the amino acid sequence of SEQ ID NO: 10.

10 . The mRNA vaccine of claim 1 , wherein the VZV gE protein comprises a Y582G mutation, relative to the amino acid sequence of SEQ ID NO: 10.

11 . The mRNA vaccine of claim 1 , wherein the VZV gE protein is a truncated polypeptide lacking the cytoplasmic tail domain shown in amino acids 574-623 of SEQ ID NO: 10.

12 . The mRNA vaccine of claim 1 , wherein the VZV gE protein is a truncated polypeptide lacking the transmembrane anchor domain shown in amino acids 562-573 of SEQ ID NO: 10.

13 . The mRNA vaccine of claim 1 , wherein the mRNA vaccine comprises a second mRNA polynucleotide comprising a second ORF encoding a VZV antigen selected from the group consisting of gB, gI, gM, and gH.

14 . A method of inducing an antigen specific immune response in a subject, comprising:

administering to the subject the mRNA vaccine of claim 1 .

15 . The method of claim 14 , wherein the mRNA vaccine is administered in a total dose of 25 μg-100 μg of the mRNA polynucleotide.

Assignments (2)

Continuity (5)

References Cited (400)