# US 2021/0330779 A1 · Method for treating cervical cancer > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330779 A1 - Document ID: US20210330779A1 - Status: Published application - Kind: A1 - Application number: 17/240,224 - Filed: 2021-04-26 - Published: 2021-10-28 - Earliest claimed: 2020-04-24 - Assignees: Genexine, Inc. - Applicants: Genexine, Inc. - Inventors: Young Chul SUNG - Web page: https://patentgrep.com/patent/US20210330779A1 ## CPC - A61K 39/12: Viral antigens - C07K 16/2818: {against CD28 or CD152} - C07K 16/2827: {against B7 molecules, e.g. CD80, CD86} - C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) - A01K 2207/12: Animals modified by administration of exogenous cells - A01K 2227/105: Murine - A01K 2267/0331: Animal model for proliferative diseases - A61K 2039/505: {comprising antibodies} - A61K 2039/507: {Comprising a combination of two or more separate antibodies} - A61K 2039/53: {DNA (RNA) vaccination} - A61K 2039/545: {characterised by the dose, timing or administration schedule} - A61K 2039/6031: {Proteins} - A61K 2039/70: {Multivalent vaccine} - A61K 2039/892: {Reproductive system [uterus, ovaries, cervix, testes]} - A61P 35/00: Antineoplastic agents - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/76: Antagonist effect on antigen, e.g. neutralization or inhibition of binding - C12N 2710/20022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes - C12N 2710/20034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein - 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) - 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) - A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract A treatment of cervical tumor caused by human papillomavirus (HPV) infection is disclosed. Methods for improving cervical tumor treatment and methods for treating cervical tumor caused by HPV infection include administering a combination of a HPV-specific fusion protein and an immunomodulatory agent. ## Claims ### Claim 1 A method for treating human papillomavirus (HPV)-induced cancer in a subject in need thereof, comprising administering an HPV vaccine and a checkpoint inhibitor agent to the subject, over a common period of time, for generating a therapeutic effect greater than either the HPV vaccine or checkpoint inhibitor alone when used as monotherapy. ### Claim 2 (depends on 1) The method of claim 1, wherein the HPV vaccine comprises a nucleic acid construct of SEQ ID NO: 15 or a functional variant with sequence identity of 85% or more to SEQ ID NO: 15. ### Claim 3 (depends on 1) The method of claim 1, wherein the checkpoint inhibitor agent is a programmed cell death protein (PD)-1/PD-L1 inhibitor. ### Claim 4 (depends on 1) The method of claim 1, wherein a dose of the HPV vaccine is 0.5-5 mg and the HPV vaccine is administered multiple times. ### Claim 5 (depends on 1) The method of claim 1, wherein the HPV vaccine is administered intramuscularly and the checkpoint inhibitor is administered intravenously. ### Claim 6 (depends on 1) The method of claim 1, wherein the checkpoint inhibitor is an anti-PD-1 antibody or anti-PD-L1 antibody. ### Claim 7 (depends on 6) The method of claim 6, wherein the checkpoint inhibitor is selected from the group consisting of pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab, cemiplimab, and a combination thereof. ### Claim 8 (depends on 1) The method of claim 1, wherein a dose of the checkpoint inhibitor is in a range from about 50 mg to 500 mg and the checkpoint inhibitor is administered before, at the same time, of after the first administration of the HPV vaccine. ### Claim 9 (depends on 1) The method of claim 1, wherein the dose of the HPV vaccine is a 2 mg and the HPV vaccine is administered at week 1, 2, 4, 7, 13, and 19, and further optionally at week 46; and wherein the dose of the checkpoint inhibitor is a 200 mg and the checkpoint inhibitor is administered at an interval of 3 weeks. ### Claim 10 (depends on 1) The method of claim 1, wherein the HPV-induced cancer is cervical cancer. ### Claim 11 (depends on 1) The method of claim 1, wherein the cervical cancer is squamous cell carcinoma or adenocarcinoma. ### Claim 12 (depends on 1) The method of claim 1, wherein the HPV-induced caner is metastatic, recurrent, or advanced cancer and the subject has been or is subject to an anti-cancer treatment. ### Claim 13 (depends on 1) The method of claim 1, wherein the HPV is HPV 16, HPV 18, or a combination thereof. ### Claim 14 (depends on 1) The method of claim 1, wherein the subject is PD-L1 positive or PD-L1 negative. ### Claim 15 (depends on 1) The method of claim 1, wherein the subject is PD-L1 positive and HPV is HPV 16. ### Claim 16 A method for treating a human papillomavirus (HPV)-induced cancer patient by combining two distinct treatments for administration to the subject within a common time period of at least 13 weeks, said method comprising a HPV vaccine therapy and an immune checkpoint inhibitor therapy, wherein an immune checkpoint inhibitor is administered multiple times at a first fixed dose and a vaccine is administered multiple times at a second fixed dose; and wherein a first administration of the HPV vaccine and a first administration of the immune checkpoint inhibitor are occurred on day of the at least 13 weeks period, and subsequent administrations of the HPV vaccine and subsequent administration of the immune checkpoint inhibitor are occurred within the common time period, wherein the HPV-induced cancer is metastatic, recurrent or advanced cervical cancer and the subject has been or is subject to an anti-cancer treatment, said cervical cancer being squamous cell carcinoma or adenocarcinoma; wherein the HPV is HPV 16, HPV 18, or a combination thereof; and/or wherein the subject is PD-L1 positive or PD-L1 negative. ### Claim 17 (depends on 16) The method of claim 16, wherein the first fixed dose of the immune checkpoint inhibitor is 50 mg to 500 mg and the second fixed dose of the HPV vaccine is 0.5-5 mg. ### Claim 18 (depends on 16) The method of claim 16, wherein the HPV vaccine is administered intramuscularly and the immune checkpoint inhibitor is administered intravenously. ### Claim 19 (depends on 16) The method of claim 16, wherein the immune checkpoint inhibitor is an anti-PD1 antibody or anti-PDL1 antibody, and wherein the HPV vaccine comprises a nucleic acid construct of SEQ ID NO: 15 or a functional variant with sequence identity of 85% or more to SEQ ID NO: 15. ### Claim 20 (depends on 16) The method of claim 16, wherein the cervical cancer is squamous cell carcinoma; wherein the HPV is HPV 16; and/or wherein the subject is PD-L1 positive.