# US 11,306,129 B2 · Modified interleukin 12 and use thereof in preparing drugs for treating tumours

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- Number: US 11,306,129 B2
- Document ID: US11306129B2
- Status: Granted
- Kind: B2
- Application number: 15/758,853
- Filed: 2016-09-09
- Published: 2019-01-10
- Granted: 2022-04-19
- Earliest claimed: 2015-09-09
- Assignees: Beijing Bio-Targeting Therapeutics Technology Inc.; Zhengzhou University
- Applicants: Beijing Bio-Targeting Therapeutics Technology Inc.; Zhengzhou University
- Inventors: Yaohe Wang; Pengju Wang; Lemoine Nick; Dongling Gao
- Web page: https://patentgrep.com/patent/US11306129B2

## CPC

- C07K 14/5434: {IL-12}
- A61K 35/761: Adenovirus
- A61K 38/20: Interleukins [IL]
- A61K 48/00: Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61P 35/00: Antineoplastic agents
- C07K 14/54: Interleukins [IL]
- C12N 15/86: Viral vectors
- C12N 15/861: Adenoviral vectors
- C12N 15/863: Poxviral vectors, {e.g. entomopoxvirus}
- C12N 15/869: Herpesviral vectors
- C12N 2710/10043: viral genome or elements thereof as genetic vector
- C12N 2710/10071: Demonstrated in vivo effect
- C12N 2710/24143: viral genome or elements thereof as genetic vector
- C12N 2710/24171: Demonstrated in vivo effect
- 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)
- 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
- 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 discloses a modified interleukin 12 (nsIL-12) and its gene, recombinant vector and use in manufacture of a medicament for treatment of tumors. When the oncolytic adenovirus vector carrying the modified interleukin 12 gene targets tumor tissue, the modified interleukin 12 is continuously expressed at a low level and mainly distributed in the local tumor tissue, which improves the specificity to tumor cells and reduces the systemic toxicity of interleukin 12; the modified interleukin 12 shows stronger inhibitory effect on tumor growth in intraperitoneally disseminated tumors and orthotopic tumors, and has low toxicity. The modified interleukin 12 armed oncolytic viruses show excellent anti-tumor effects, with a significant regression of tumors and lower toxicity compared with the existing IL-12 armed virus.

## Claims

### Claim 1

A recombinant vector, which is an oncolytic virus and comprises a nucleotide sequence encoding a modified IL-12, which is non-secretory, wherein the non-secretory IL-12 has the following structure: p40-linker-p35 or p35-linker-p40; and wherein the non-secretory IL-12 does not contain a secretory signal peptide, and wherein the recombinant vector is the viral vector with the CCTCC Accession NO: V201520.

### Claim 2 (depends on 1)

A method for treatment of a disease associated with IL-12, which comprises administering to a subject the recombinant vector according to claim 1.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the disease is a cancer.

### Claim 4 (depends on 2)

The method according to claim 2, wherein the disease is pancreatic cancer, head and neck cancer, lung cancer, esophageal cancer, ovarian cancer, colorectal cancer, colon cancer or gastric cancer.

### Claim 5 (depends on 2)

The method according to claim 2, wherein the disease is an intraperitoneally disseminated tumor.