# US 10,370,670 B2 · Double-stranded ribonucleic acid for adjuvants

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- Number: US 10,370,670 B2
- Document ID: US10370670B2
- Status: Granted
- Kind: B2
- Application number: 15/791,742
- Filed: 2017-10-24
- Published: 2018-02-15
- Granted: 2019-08-06
- Earliest claimed: 2012-12-06
- Assignees: Kyowa Hakko Bio Co., Ltd.
- Applicants: Kyowa Hakko Bio Co., Ltd.
- Inventors: Tetsuo Nakano; Eitora Yamamura
- Web page: https://patentgrep.com/patent/US10370670B2

## CPC

- C12N 15/117: Nucleic acids having immunomodulatory properties, e.g. containing CpG-motifs
- A61K 31/713: Double-stranded nucleic acids or oligonucleotides
- A61K 39/39: characterised by the immunostimulating additives, e.g. chemical adjuvants
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- C12N 15/111: {General methods applicable to biologically active non-coding nucleic acids}
- C12N 2310/17: Immunomodulatory nucleic acids
- C12N 2310/53: partially self-complementary or closed
- C12N 2310/533: having a mismatch or nick in at least one of the strands
- C12N 2320/31: Combination therapy
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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

## Abstract

The invention provides a double-stranded ribonucleic acid (dsRNA) having a chain length suitable for simultaneously showing low toxicity and high function in the use of an adjuvant and the like, and resisting variation of chain length even when subjected to a heating and cooling treatment, or a salt thereof; an immune potentiator, adjuvant, pharmaceutical product and the like containing the dsRNA and the like; and a production method of such dsRNA and the like. The invention is characterized in that the weight average chain length of two or more single-stranded ribonucleic acids (ssRNAs) constituting the first chain constituting dsRNA is not more than ½ of the weight average chain length of one ssRNA constituting the second chain.

## Claims

### Claim 1

A double-stranded ribonucleic acid (dsRNA) having a weight average chain length within the range of 0.2 kilobase pairs (kbp) to 0.6 kbp, or a salt thereof, wherein
the first chain of the dsRNA consists of two or more polyinosinic acids having a weight average chain length of 0.1-0.2 kilobase (kb),
the second chain of the dsRNA consists of one single-stranded ribonucleic acid (ssRNA) having a weight average chain length of 0.3-0.4 kb, which contains cytidylic acid at a rate of not less than 80%,
the dsRNA has a median value of 0.1-0.35 kbp, and
the weight average chain length of the two or more polyinosinic acids constituting the first chain is not more than ½ of the weight average chain length of one ssRNA which contains cytidylic acid at a ratio of not less than 80% constituting the second chain.