# US 11,298,426 B2 · Recombinant vaccines and use thereof

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- Number: US 11,298,426 B2
- Document ID: US11298426B2
- Status: Granted
- Kind: B2
- Application number: 15/895,402
- Filed: 2018-02-13
- Published: 2018-06-28
- Granted: 2022-04-12
- Earliest claimed: 2003-10-14
- Assignees: BioNTech SE
- Applicants: BioNTech SE
- Inventors: Ozlem Tureci; Ugur Sahin; Sebastian Kreiter
- Web page: https://patentgrep.com/patent/US11298426B2

## CPC

- A61K 47/64: Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent (peptidic linkers A61K47/65)
- A61P 31/12: Antivirals
- A61K 48/00: Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61P 31/14: for RNA viruses
- A61P 31/20: for DNA viruses
- A61P 31/22: for herpes viruses
- A61P 35/00: Antineoplastic agents
- A61P 37/04: Immunostimulants
- C07K 14/4748: {Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE}
- C07K 14/70539: {MHC-molecules, e.g. HLA-molecules}
- C07K 2319/02: containing a signal sequence
- C07K 2319/03: containing a transmembrane segment
- 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)

## Abstract

The present invention relates to fusion molecules of antigens, the nucleic acids coding therefor and the use of such fusion molecules and nucleic acids. In particular, said invention relates to fusion molecules, comprising an antigen and the trans-membrane region and cytoplasmic region of a MHC molecule and/or the cytoplasmic region of a MHC or a SNARE molecule.

## Claims

### Claim 1

A nucleic acid molecule which codes for a fusion protein comprising an antigen, and a transmembrane region and a cytoplasmic region of a chain of an human leukocyte antigen (HLA) molecule but is free from (i) α1, α2 and α3 domains of the α chain of an HLA Class I molecule, (ii) β2-microglobulin of an HLA Class I molecule, (iii) α1, α2 domains of the α chain of an HLA Class II molecule, and (iv) β1 and β2 domains of the β chain of an HLA Class II molecule.

### Claim 2 (depends on 1)

The nucleic acid molecule of claim 1, wherein the nucleic acid molecule is RNA.

### Claim 3 (depends on 1)

The nucleic acid molecule of claim 1, wherein the nucleic acid molecule is mRNA.

### Claim 4 (depends on 1)

The nucleic acid molecule of claim 1, wherein the HLA molecule is an HLA class I molecule.

### Claim 5 (depends on 1)

The nucleic acid molecule of claim 1, wherein the HLA molecule is an HLA class I molecule selected from the group consisting of: HLA-A, HLA-B, HLA-C, HLA-E, and HLA-F.

### Claim 6 (depends on 1)

The nucleic acid molecule of claim 1, wherein the HLA molecule is an HLA class II molecule.

### Claim 7 (depends on 1)

The nucleic acid molecule of claim 1, wherein the HLA molecule is an HLA class II molecule selected from the group consisting of: HLA-DQα, HLA-DQβ, HLA-DPα, HLA-DPβ, HLA-DRα, and HLA-DRβ.

### Claim 8 (depends on 1)

The nucleic acid molecule of claim 1, further comprising a leader sequence.

### Claim 9 (depends on 8)

The nucleic acid molecule of claim 8, wherein the leader sequence is a secretion signal.

### Claim 10 (depends on 8)

The nucleic acid molecule of claim 8, wherein the leader sequence is derived from an HLA molecule.

### Claim 11 (depends on 1)

The nucleic acid molecule of claim 1, wherein the nucleic acid molecule has the followng arrangment of segments: N-terminus-leader sequence/antigen/transmembrane region/cytoplasmic region-C-terminus and the individual segments are separated from one another by linker sequences.

### Claim 12 (depends on 1)

The nucleic acid molecule of claim 1, where the fusion protein comprises the amino acid residue sequence of SEQ ID NO: 6.

### Claim 13 (depends on 1)

The nucleic acid molecule of claim 1, wherein the antigen is a tumor antigen.

### Claim 14 (depends on 1)

An isolated host cell which comprises the nucleic acid molecule of claim 1.

### Claim 15 (depends on 14)

A composition which comprises the isolated host cell of claim 14.

### Claim 16 (depends on 1)

A composition which comprises the nucleic acid molecule of claim 1 in a pharmaceutically acceptable carrier.

### Claim 17 (depends on 1)

A method for inducing the formation of MHC/peptide complexes in a cell, the method comprising contacting the cell with at least one nucleic acid molecule of claim 1.

### Claim 18 (depends on 1)

A method for increasing the number of MCH/peptide complexes in a cell, wherein the method comprises providing to the cell one or more nucleic acid molecules of claim 1.

### Claim 19 (depends on 1)

A method for increasing the presentation of cell surface molecules on antigen-presenting cells (APCs), wherein the method comprises providing to the APCs one or more nucleic acid molecules of claim 1.

### Claim 20 (depends on 1)

A method for inducing an immune response in a living creature, wherein the method comprises administering to the living creature one or more nucleic acid molecule of claim 1 or host cells comprising the nucleic acid molecule of claim 1.

### Claim 21 (depends on 1)

A method for stimulating or activating T cells, wherein the method comprises contacting the T cell or administering to a living creature one or more nucleic acid molecule of claim 1 or host cells comprising the nucleic acid molecule of claim 1.
