# US 10,117,920 B2 · Combination of vaccination and inhibition of the PD-1 pathway > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,117,920 B2 - Document ID: US10117920B2 - Status: Granted - Kind: B2 - Application number: 15/890,413 - Filed: 2018-02-07 - Published: 2018-06-21 - Granted: 2018-11-06 - Earliest claimed: 2013-02-22 - Assignees: CureVac AG - Applicants: CureVac AG - Inventors: Mariola Fotin-Mleczek; Karl-Josef Kallen; Jochen Probst - Web page: https://patentgrep.com/patent/US10117920B2 ## CPC - A61K 39/39558: {against tumor tissues, cells, antigens} - A61K 39/0005: {Vertebrate antigens (from snakes A61K39/38)} - A61K 39/0011: {Cancer antigens} - A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61P 31/04: Antibacterial agents - A61P 31/10: Antimycotics - A61P 31/12: Antivirals - A61P 33/00: Antiparasitic agents - A61P 35/00: Antineoplastic agents - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C07K 16/2803: {against the immunoglobulin superfamily} - C07K 16/2818: {against CD28 or CD152} - A61K 2039/505: {comprising antibodies} - A61K 2039/53: {DNA (RNA) vaccination} - A61K 2039/55516: {Proteins; Peptides} - C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding - 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/inhibitor 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 PD-1 pathway inhibitor, preferably directed against PD-1 receptor or its ligands PD-L1 and PD-L2. The present invention furthermore relates to a pharmaceutical composition and a kit of parts comprising the components of such a vaccine/inhibitor combination. Additionally the present invention relates to medical use of such a vaccine/inhibitor combination, the pharmaceutical composition and the kit of parts comprising such a vaccine/inhibitor 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 a PD-1 pathway inhibitor and to the use of a PD-1 pathway inhibitor in therapy in combination with an RNA vaccine. ## Claims ### Claim 1 A method of treating a subject having a cancer or a tumor disease, the method comprising administering to the subject an effective amount of: (i) an immunogenic composition comprising at least one mRNA comprising at least one open reading frame (ORF) encoding at least one tumor antigen, wherein the RNA is codon optimized for human codon usage, wherein the at least one mRNA comprises an increased G/C content relative to a wild-type RNA encoding the antigen; and (ii) a PD-1 pathway inhibitor, wherein the PD-1 pathway inhibitor is an antagonistic antibody directed against PD-L1. ### Claim 2 (depends on 1) The method of claim 1, wherein the at least one mRNA is complexed with a carrier. ### Claim 3 (depends on 2) The method of claim 2, wherein the carrier is a cationic, polycationic or polymeric carrier. ### Claim 4 (depends on 3) The method of claim 3, wherein the carrier comprises protamine. ### Claim 5 (depends on 3) The method of claim 3, wherein the carrier comprises a cationic or polycationic lipid. ### Claim 6 (depends on 1) The method of claim 1, wherein the PD-1 pathway inhibitor is administered after said immunogenic composition. ### Claim 7 (depends on 1) The method of claim 1, wherein the immunogenic composition and the PD-1 pathway inhibitor are administered sequentially. ### Claim 8 (depends on 1) The method of claim 1, wherein the immunogenic composition and the PD-1 pathway inhibitor are administered concurrently. ### Claim 9 (depends on 7) The method of claim 7, wherein the immunogenic composition and the PD-1 pathway inhibitor are administered in the same composition. ### Claim 10 (depends on 1) The method of claim 1, wherein the immunogenic composition and the PD-1 pathway inhibitor are administered via different administration routes. ### Claim 11 A kit of parts comprising: (i) an immunogenic composition comprising at least one mRNA comprising at least one open reading frame (ORF) encoding at least one tumor antigen, wherein the RNA is codon optimized for human codon usage, wherein the at least one mRNA comprises an increased G/C content relative to a wild-type RNA encoding the antigen; and (ii) a composition comprising a PD-1 pathway inhibitor, wherein the PD-1 pathway inhibitor is an antagonistic antibody directed against PD-L1. ### Claim 12 A pharmaceutical composition comprising an effective amount of: (i) at least one mRNA comprising at least one open reading frame (ORF) encoding at least one tumor antigen, wherein the RNA is codon optimized for human codon usage and comprises an increased G/C content relative to a wild-type RNA encoding the antigen, and (ii) a PD-1 pathway inhibitor, wherein the PD-1 pathway inhibitor is an antagonistic antibody directed against PD-L1.