# US 11,110,157 B2 · Combination of vaccination and OX40 agonists

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- Number: US 11,110,157 B2
- Document ID: US11110157B2
- Status: Granted
- Kind: B2
- Application number: 16/384,904
- Filed: 2019-04-15
- Published: 2020-01-30
- Granted: 2021-09-07
- Earliest claimed: 2019-04-15
- Assignees: CureVac AG
- Applicants: CureVac AG
- Inventors: Mariola Fotin-Mleczek; Karl-Josef Kallen; Jan C. Schmollinger
- Web page: https://patentgrep.com/patent/US11110157B2

## CPC

- A61K 39/0011: {Cancer antigens}
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61P 35/00: Antineoplastic agents
- C07K 16/2878: {against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95}
- C07K 16/30: from tumour cells
- A61K 2039/505: {comprising antibodies}
- A61K 2039/53: {DNA (RNA) vaccination}
- A61K 2039/55516: {Proteins; Peptides}
- C07K 2319/00: Fusion polypeptide
- C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to a vaccine/agonist combination comprising an RNA vaccine comprising at least one RNA comprising at least one open reading frame (ORF) coding for at least one antigen and a composition comprising at least one OX40 agonist. The present invention furthermore relates to a pharmaceutical composition and a kit of parts comprising the components of such a vaccine/agonist combination. Additionally the present invention relates to medical use of such a vaccine/agonist combination, the pharmaceutical composition and the kit of parts comprising such a vaccine/agonist combination, particularly for the prevention or treatment of tumor or cancer diseases or infectious diseases. Furthermore, the present invention relates to the use of an RNA vaccine in therapy in combination with an OX40 agonist.

## Claims

### Claim 1

A combination kit comprising:
(i) a composition comprising at least one RNA comprising at least one open reading frame (ORF) coding for at least one antigen and
(ii) a composition comprising an OX40 agonist, wherein the OX40 agonist comprises an OX40-binding antibody, or an antigen-binding fragment thereof, or a nucleic-acid encoded an OX40-binding antibody or an antigen-binding fragment thereof.

### Claim 2 (depends on 1)

The combination kit of claim 1, wherein the OX40 agonist comprises an OX40-binding antibody.

### Claim 3 (depends on 2)

The combination kit of claim 2, wherein the OX40 agonist comprises a nucleic-acid encoded an OX40-binding antibody or an antigen-binding fragment thereof.

### Claim 4 (depends on 3)

The combination kit of claim 3, wherein the nucleic-acid encoded an OX40-binding antibody or an antigen-binding fragment thereof is a mRNA.

### Claim 5 (depends on 1)

The combination kit of claim 1, wherein the OX40-binding antibody is monoclonal antibody 9B12.

### Claim 6 (depends on 1)

The combination kit of claim 1, wherein the at least one RNA is an isolated RNA.

### Claim 7 (depends on 1)

The combination kit of claim 1, wherein the at least one RNA is a stabilized RNA.

### Claim 8 (depends on 1)

The combination kit of claim 1, wherein the at least one RNA is at least partially G/C modified, wherein the G/C content of the at least one open reading frame of the at least one RNA of the composition is increased compared to the wild type open reading frame.

### Claim 9 (depends on 1)

The combination kit of claim 1, wherein the at least one RNA comprises a codon-optimized region, wherein the at least one open reading frame of the at least one RNA is codon-optimized.

### Claim 10 (depends on 1)

The combination kit of claim 1, wherein the at least one RNA of the composition is an mRNA.

### Claim 11 (depends on 1)

The combination kit of claim 1, wherein the at least one RNA is complexed with a carrier.

### Claim 12 (depends on 11)

The combination kit of claim 11, wherein the at least one RNA is complexed with a cationic carrier.

### Claim 13 (depends on 12)

The combination kit of claim 12, wherein the cationic carrier is a lipid.