# US 11,305,008 B2 · Nucleic acid based vaccine against middle east respiratory syndrome-coronavirus

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- Number: US 11,305,008 B2
- Document ID: US11305008B2
- Status: Granted
- Kind: B2
- Application number: 17/230,383
- Filed: 2021-04-14
- Published: 2022-02-24
- Granted: 2022-04-19
- Earliest claimed: 2018-11-27
- Assignees: King Abdulaziz University
- Applicants: King Abdulaziz University
- Inventors: Anwar M. Hashem
- Web page: https://patentgrep.com/patent/US11305008B2

## CPC

- A61K 39/215: Coronaviridae, e.g. avian infectious bronchitis virus
- A61K 39/12: Viral antigens
- A61P 31/14: for RNA viruses
- C07K 14/005: from viruses
- C07K 14/165: Coronaviridae, e.g. avian infectious bronchitis virus
- C07K 14/70575: {NGF/TNF-superfamily, e.g. CD70, CD95L, CD153, CD154 (NGF C07K14/48, TNF C07K14/525)}
- C12N 15/62: DNA sequences coding for fusion proteins
- A61K 2039/6031: {Proteins}
- C07K 2319/03: containing a transmembrane segment
- C12N 2770/20022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes
- C12N 2770/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2770/20071: Demonstrated in vivo effect
- 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

An immunogenic CD40-targeted trimeric MERS-CoV S1 fusion polypeptide as well as a corresponding polynucleotide encoding it and its use for safely inducing immune responses directed against MERS-CoV without inducing vaccine associated respiratory pathologies associated with non-targeted vaccines.

## Claims

### Claim 1

A nucleic acid based vaccine, comprising:
a polynucleotide encoding a fusion protein comprising:
at least one immunogenic fragment, receptor-binding domain, or epitope of S1 polypeptide of Middle East respiratory syndrome coronavirus (MERS-CoV),
a trimerization motif, and
a ligand that binds to CD40; and
one or more linkers between the at least one immunogenic fragment, receptor-binding domain, or epitope of S1 polypeptide, the trimerization motif, and the ligand that binds to CD40,
a carrier; and
a buffer.

### Claim 2 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the fusion protein comprises an S1 polypeptide that has an amino acid sequence that is at least 70% identical to SEQ ID NO: 2; the trimerization motif comprises SEQ ID NO: 6 and the ligand that binds to CD40 is at least 70% identical to the amino acid sequence of SEQ ID NO: 23 or SEQ ID NO: 25 or 27 or to a CD40-binding fragment thereof; and the peptide linker, when present, comprises SEQ ID NO: 8.

### Claim 3 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the polynucleotide comprises RNA.

### Claim 4 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the polynucleotide comprises DNA.

### Claim 5 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the fusion protein comprises at least one receptor-binding domain, immunogenic fragment, or epitope of S1 polypeptide of Middle East respiratory syndrome coronavirus (MERS-CoV) comprising an amino acid sequence that is at least 70% identical to the amino acid sequence of SEQ ID NO: 2.

### Claim 6 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the fusion protein comprises at least one trimerization motif comprising the amino acid sequence of SEQ ID NO: 6.

### Claim 7 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the fusion protein comprises human CD40L comprising the sequence of SEQ ID NO: 23 or a sequence that is at least 70% identical thereto, or a CD40-binding fragment thereof.

### Claim 8 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the fusion protein comprises CD40 ligand is camelid CD40L comprising the sequence of SEQ ID NO: 25 or 27 or a sequence that is at least 70% identical thereto, or a CD40-binding fragment thereof.

### Claim 9 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the encoded fusion protein comprises a peptide linker comprising SEQ ID NO: 8.

### Claim 10 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the ligand that binds to CD40 is at least 95% identical to the amino acid sequence of SEQ ID NO: 23.

### Claim 11 (depends on 1)

The nucleic acid based vaccine of claim 1, wherein the ligand that binds to CD40 is at least 95% identical to the amino acid sequence of SEQ ID NO: 25 or SEQ ID NO: 27.