# US 2025/0082702 A1 · Anticancer composition comprising recombinant adenovirus expressing degradation factor for extracellular matrix

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- Number: US 2025/0082702 A1
- Document ID: US20250082702A1
- Status: Published application
- Kind: A1
- Application number: 18/955,792
- Filed: 2024-11-21
- Published: 2025-03-13
- Earliest claimed: 2016-12-09
- Assignees: Genemedicine Co., Ltd.
- Applicants: Genemedicine Co., Ltd.
- Inventors: Chae Ok YUN; Hyo Min Ahn
- Web page: https://patentgrep.com/patent/US20250082702A1

## CPC

- A61K 35/761: Adenovirus
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 31/7068: having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K 38/177: {Receptors; Cell surface antigens; Cell surface determinants}
- A61K 38/208: {IL-12}
- A61K 38/28: Insulins
- A61K 39/395: Antibodies (agglutinins A61K38/36 {; as drug carriers A61K47/50}); Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K 39/39558: {against tumor tissues, cells, antigens}
- A61P 35/00: Antineoplastic agents
- C07K 16/2818: {against CD28 or CD152}
- C07K 16/2827: {against B7 molecules, e.g. CD80, CD86}
- C07K 16/32: against translation products of oncogenes
- A61K 2039/505: {comprising antibodies}
- 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 2710/10032: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2710/10043: viral genome or elements thereof as genetic vector
- C12N 2710/10071: Demonstrated in vivo effect
- C12N 2710/10332: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent
- C12N 2710/10343: viral genome or elements thereof as genetic vector
- C12N 2830/50: regulating RNA stability, not being an intron, e.g. poly A signal
- C12N 2840/203: having an IRES
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention relates to an anticancer composition comprising a recombinant adenovirus which expresses degradation factors for the extracellular matrix. The recombinant adenovirus according to the present invention exhibits an excellent anti-tumor effect by remarkably reducing the main structural components of the extracellular matrix in a tumor tissue, including collagen I, collagen III, fibronectin, elastin, and the like and highly expressing a therapeutic gene selectively only in tumor cells through viral proliferation. Particularly, when administered in combination with therapeutic materials, such as anticancer agents or immune checkpoint inhibitors, the recombinant adenovirus significantly increases the diffusion and distribution of the co-administered therapeutic materials in tumor tissues while allowing the exertion of the preexisting anticancer effects, thereby further improving an anti-cancer effect. Accordingly, the present invention may be available as a core technique in the cancer treatment field.

## Claims

### Claim 1

A method for treating cancer, comprising:
administering to an individual a recombinant oncolytic adenovirus that expresses a gene encoding Interleukin 12 (IL-12) and a gene encoding decorin, or a gene encoding Interleukin 12 (IL-12) and a gene encoding relaxin, and
administering to an individual an immune checkpoint inhibitor, wherein the immune checkpoint inhibitor is programmed cell death-1 (PD-1) immune checkpoint inhibitors, programmed cell death-ligand 1 (PD-L1) immune checkpoint inhibitors, or cytolytic T lymphocyte associated antigen-4 (CTLA-4) antagonists.

### Claim 2 (depends on 1)

The method of claim 1, wherein the recombinant oncolytic adenovirus has one or more deletion regions selected from the group consisting of an E1 region and an E3 region.

### Claim 3 (depends on 2)

The method of claim 2, wherein the gene encoding IL-12 is inserted into the E1 region of the recombinant adenovirus.

### Claim 4 (depends on 2)

The method of claim 2, wherein the gene encoding decorin or relaxin is inserted into the E1 or E3 region of the recombinant oncolytic adenovirus.

### Claim 5 (depends on 1)

The method of claim 1, wherein the recombinant adenovirus is administered simultaneously, separately, or sequentially in combination with immune checkpoint inhibitors.

### Claim 6 (depends on 1)

The method of claim 1, wherein administration of the recombinant oncolytic adenovirus and the immune checkpoint inhibitors enhances anti-tumor immunity.

### Claim 7 (depends on 1)

The method of claim 1, wherein the cancer is any one selected from the group consisting of gastric cancer, lung cancer, non-small cell lung cancer, breast cancer, ovarian cancer, liver cancer, bronchial cancer, nasopharyngeal cancer, laryngeal cancer, pancreatic cancer, bladder cancer, colon cancer, cervical cancer, bone cancer, non-small cell bone cancer, hematologic malignancy, skin cancer, head or neck cancer, uterine cancer, colorectal cancer, anal near cancer, colon cancer, fallopian tube cancer, endometrial cancer, vaginal cancer, vulva cancer, Hodgkin's disease, esophageal cancer, small intestine cancer, endocrine cancer, thyroid cancer, parathyroid cancer, adrenal cancer, soft tissue sarcoma, urethral cancer, penile cancer, prostate cancer, chronic or acute leukemia, lymphocytic lymphoma, kidney or hydroureter cancer, renal cell carcinoma, renal pelvic carcinoma, salivary gland cancer, sarcoma cancer, pseudomyxoma peritonei, hepatoblastoma, testicular cancer, glioblastoma, cheilocarcinoma, ovarian germ cell tumors, basal cell carcinoma, multiple myeloma, gallbladder cancer, choroidal melanoma, cancer of the ampulla of Vater, peritoneal cancer, tongue cancer, small cell cancer, pediatric lymphoma, neuroblastoma, duodenal cancer, ureteral cancer, astrocytoma, meningioma, renal pelvis cancer, pudendum cancer, thymus cancer, central nervous system (CNS) tumors, primary central nervous system lymphoma, spinal cord tumors, brain stem neuroglioma, and pituitary adenoma.

### Claim 8 (depends on 1)

The method of claim 1, wherein the cancer is a recurrent cancer or an anticancer agent-resistant cancer.