# US 11,464,848 B2 · Respiratory syncytial virus vaccine

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- Number: US 11,464,848 B2
- Document ID: US11464848B2
- Status: Granted
- Kind: B2
- Application number: 16/494,103
- Filed: 2018-03-15
- Published: 2020-04-30
- Granted: 2022-10-11
- Earliest claimed: 2017-03-15
- Assignees: ModernaTX, Inc.
- Applicants: ModernaTX, Inc.
- Inventors: Giuseppe Ciaramella; Kapil Bahl; Amy Espeseth; Dai Wang; Andrew J. Bett
- Web page: https://patentgrep.com/patent/US11464848B2

## CPC

- A61K 39/12: Viral antigens
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/1272: comprising non-phosphatidyl surfactants as bilayer-forming substances, e.g. cationic lipids or non-phosphatidyl liposomes coated or grafted with polymers (lipids as modifying agents {A61K47/543})
- A61K 9/5123: {Organic compounds, e.g. fats, sugars}
- A61K 9/5146: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyamines, polyanhydrides}
- A61K 31/7105: Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
- A61K 31/7115: Nucleic acids or oligonucleotides having modified bases, i.e. other than adenine, guanine, cytosine, uracil or thymine
- A61P 31/14: for RNA viruses
- C07K 16/11: Paramyxoviridae (F); Pneumoviridae (F), e.g. respiratory syncytial virus [RSV]
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/572: {cytotoxic response}
- A61K 2039/70: {Multivalent vaccine}
- C07K 2317/10: characterized by their source of isolation or production
- C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding
- C12N 2760/18533: Use of viral protein as therapeutic agent other than vaccine, e.g. apoptosis inducing or anti-inflammatory
- C12N 2760/18534: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The disclosure describes respiratory syncytial virus (RSV) ribonucleic acid (RNA) vaccines, as well as methods of using the vaccines and compositions comprising the vaccines.

## Claims

### Claim 1

A composition comprising a ribonucleic acid (RNA) polynucleotide having an open reading frame encoding a respiratory syncytial virus (RSV) antigenic polypeptide and a lipid nanoparticle comprising 10-20 mol % neutral lipid, 35-45 mol % cholesterol, 1-5% PEG-modified lipid, and 40-50 mol % ionizable cationic lipid, wherein the ionizable cationic lipid comprises Compound 25:

### Claim 2 (depends on 1)

The composition of claim 1, wherein the antigenic polypeptide is glycoprotein G.

### Claim 3 (depends on 1)

The composition of claim 1, wherein the antigenic polypeptide is glycoprotein F.

### Claim 4 (depends on 1)

The composition of claim 1, further comprising an adjuvant.

### Claim 5 (depends on 1)

The composition of claim 1, further comprising a pharmaceutically acceptable carrier.

### Claim 6 (depends on 1)

The composition of claim 1, wherein the open reading frame is codon-optimized.

### Claim 7 (depends on 1)

The composition of claim 1, wherein the vaccine is multivalent.

### Claim 8 (depends on 1)

The composition of claim 1, wherein the RNA polynucleotide encodes at least 2 antigenic polypeptides.

### Claim 9 (depends on 1)

The composition of claim 1, wherein the RNA polynucleotide comprises a chemical modification.

### Claim 10 (depends on 9)

The composition of claim 9, wherein the chemical modification is selected from the group consisting of pseudouridine, 1-methylpseudouridine, 1-ethylpseudouridine, 2-thiouridine, 4′-thiouridine, 5-methylcytosine, 2-thio-1-methyl-1-deaza-pseudouridine, 2-thio-1-methyl-pseudouridine, 2-thio-5-aza-uridine, 2-thio-dihydropseudouridine, 2-thio-dihydrouridine, 2-thio-pseudouridine, 4-methoxy-2-thio-pseudouridine, 4-methoxy-pseudouridine, 4-thio-1-methyl-pseudouridine, 4-thio-pseudouridine, 5-aza-uridine, dihydropseudouridine, 5-methoxyuridine and 2′-O-methyl uridine.

### Claim 11 (depends on 1)

The composition of claim 1, wherein the nanoparticle has a mean diameter of 50-200 nm.

### Claim 12 (depends on 1)

The composition of claim 1, wherein the sterol is a cholesterol.

### Claim 13 (depends on 1)

The composition of claim 1, wherein the nanoparticle has a polydispersity value of less than 0.4.

### Claim 14 (depends on 1)

The composition of claim 1, wherein the nanoparticle has a net neutral charge at a neutral pH value.

### Claim 15 (depends on 1)

A method of administering to a subject the RSV composition of claim 1.

### Claim 16 (depends on 3)

The composition of claim 3, wherein the glycoprotein F is a stabilized prefusion form of glycoprotein F.

### Claim 17 (depends on 10)

The composition of claim 10, wherein the chemical modification is 1-methylpseudouridine.