# US 12,178,863 B2 · Combination of vaccination and OX40 agonists

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- Number: US 12,178,863 B2
- Document ID: US12178863B2
- Status: Granted
- Kind: B2
- Application number: 17/396,760
- Filed: 2021-08-08
- Published: 2021-12-02
- Granted: 2024-12-31
- 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/US12178863B2

## 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 method of treatment or prophylaxis of cancer comprising administering to a subject in need thereof a therapeutically effective amount of:
(i) at least one RNA molecule comprising from 5′ to 3′:
(a) a 5′ cap;
(b) at least one open reading frame (ORF) coding for at least one antigen that is expressed in a cancer cell;
(c) a 3′ untranslated region (UTR) comprising a poly (A) sequence; and
(ii) a composition comprising a polypeptide comprising an extracellular domain of human OX40 ligand, wherein the polypeptide lacks a transmembrane domain.

### Claim 2 (depends on 1)

The method of claim 1, wherein the at least one RNA is a mRNA.

### Claim 3 (depends on 1)

The method of claim 1, wherein the at least one RNA is at least partially G/C modified.

### Claim 4 (depends on 1)

The method of claim 1, wherein the at least one RNA is complexed with a cationic or polycationic compound.

### Claim 5 (depends on 4)

The method of claim 4, wherein the cationic compound is a cationic lipid.

### Claim 6 (depends on 1)

The method of claim 1, wherein the at least one antigen is a tumor surface antigen.

### Claim 7 (depends on 1)

The method of claim 1, wherein the at least one RNA encodes multiple T-cell epitopes of one or more tumor antigens.

### Claim 8 (depends on 1)

The method of claim 1, wherein the polypeptide comprising the extracellular domain of OX40 ligand further comprises a FC portion of an immunoglobulin.

### Claim 9 (depends on 1)

The method of claim 1, wherein the polypeptide comprising the extracellular domain of OX40 ligand further comprises a TRAF2 trimerization domain, a Matrilin-4 trimerization domain, or a combination thereof.

### Claim 10 (depends on 1)

The method of claim 1, wherein the composition comprising the polypeptide comprising the extracellular domain of OX40 ligand is administered essentially simultaneously with the at least one RNA.

### Claim 11 (depends on 1)

The method of claim 1, wherein the composition comprising the polypeptide comprising the extracellular domain of OX40 ligand is administered before the at least one RNA.

### Claim 12 (depends on 1)

The method of claim 1, wherein the composition comprising the polypeptide comprising the extracellular domain OX40 ligand is administered after the at least one RNA.

### Claim 13

A method of treatment comprising administering to a subject having a cancer a therapeutically effective amount of:
(i) at least one mRNA encoding a T-cell epitope of a tumor antigen that is expressed in a cancer cell of the subject; and
(ii) a composition comprising a polypeptide comprising the extracellular domain of OX40 ligand, wherein the polypeptide lacks a transmembrane domain.

### Claim 14 (depends on 13)

The method of claim 13, wherein the at least one mRNA encodes multiple T-cell epitopes of one or more tumor antigens.