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NZ741060B2 - Novel insulin analogs and use thereof - Google Patents

Novel insulin analogs and use thereof Download PDF

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Publication number
NZ741060B2
NZ741060B2 NZ741060A NZ74106016A NZ741060B2 NZ 741060 B2 NZ741060 B2 NZ 741060B2 NZ 741060 A NZ741060 A NZ 741060A NZ 74106016 A NZ74106016 A NZ 74106016A NZ 741060 B2 NZ741060 B2 NZ 741060B2
Authority
NZ
New Zealand
Prior art keywords
seq
insulin analog
chain
tyrosine
analog peptide
Prior art date
Application number
NZ741060A
Other versions
NZ741060A (en
Inventor
In Young Choi
Jin Young Kim
Se Chang Kwon
Jong Soo Lee
Hyung Kyu Lim
Euh Lim Oh
Original Assignee
Hanmi Pharm Co Ltd
Filing date
Publication date
Application filed by Hanmi Pharm Co Ltd filed Critical Hanmi Pharm Co Ltd
Priority claimed from PCT/KR2016/009606 external-priority patent/WO2017039267A1/en
Publication of NZ741060A publication Critical patent/NZ741060A/en
Publication of NZ741060B2 publication Critical patent/NZ741060B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/12General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by hydrolysis, i.e. solvolysis in general
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/36Extraction; Separation; Purification by a combination of two or more processes of different types
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575Hormones
    • C07K14/62Insulins
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09Recombinant DNA-technology
    • C12N15/63Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/70Vectors or expression systems specially adapted for E. coli

Abstract

The present invention relates to a novel insulin analog, and more specifically, to an insulin analog with an improved in vitro effect compared with native insulin, a nucleic acid encoding the same, an expression vector including the nucleic acid, a transformant introduced with the expression vector, a method of producing the insulin analog from the transformant, a pharmaceutical composition for treating diabetes containing the insulin analog as an active ingredient, and a method for treating diabetes using the insulin analog or the pharmaceutical composition.

Claims (16)

Claims
1. An insulin analog peptide comprising an A-chain of SEQ ID NO: 3 indicated in the following General Formula 1 and a B-chain of SEQ ID NO: 4 indicated in the following General Formula 2: (General Formula 1) Xaa1-Ile-Val-Glu-Xaa2-Cys-Cys-Thr-Ser-Ile-Cys-Xaa3-Leu-Xaa4-Gln-Xaa5-Glu- Asn-Xaa6-Cys-Xaa7(SEQ ID NO: 3), (General Formula 2) Phe-Val-Asn-Gln-His-Leu-Cys-Gly-Ser-His-Leu-Val-Glu-Ala-Leu-Xaa8-Leu-Val- y-Glu-Arg-Gly-Phe-Xaa9-Tyr-Xaa10-Xaa11-Lys-Thr (SEQ ID NO: 4) (i) wherein, in the n of SEQ ID NO: 3, Xaa1 is glycine; Xaa2 is glutamine; Xaa3 is serine; Xaa4 is aspartic acid; Xaa5 is leucine; Xaa6 is tyrosine; and Xaa7 is asparagine; and in the B-chain of SEQ ID NO: 4, Xaa8 is tyrosine; Xaa9 is phenylalanine; Xaa10 is threonine; and Xaa11 is proline; (ii) n, in the A-chain of SEQ ID NO: 3, Xaa1 is e, Xaa2 is glutamine, Xaa3 is serine, Xaa4 is ic acid, Xaa5 is leucine, Xaa6 is tyrosine, and Xaa7 is asparagine, and in the B-chain of SEQ ID NO: 4, Xaa8 is tyrosine, Xaa9 is absent, Xaa10 is threonine, and Xaa11 is proline; or (iii) wherein, in the A-chain of SEQ ID NO: 3, Xaa1 is glycine, Xaa2 is glutamine, Xaa3 is serine, Xaa4 is alanine, Xaa5 is e, Xaa6 is tyrosine, and Xaa7 is asparagine, in the B-chain of SEQ ID NO: 4, Xaa8 is glutamic acid, Xaa9 is absent, Xaa10 is threonine, and Xaa11 is proline.
2. The insulin analog peptide of claim 1, n, in the A-chain of SEQ ID NO: 3, Xaa1 is glycine; Xaa2 is glutamine; Xaa3 is serine; Xaa4 is aspartic acid; Xaa5 is leucine; Xaa6 is ne; and Xaa7 is asparagine; and in the B-chain of SEQ ID NO: 4, Xaa8 is tyrosine; Xaa9 is phenylalanine; Xaa10 is ine; and Xaa11 is proline.
3. The insulin analog peptide of claim 1, wherein, in the A-chain of SEQ ID NO: 3, Xaa1 is glycine, Xaa2 is glutamine, Xaa3 is serine, Xaa4 is glutamic acid, Xaa5 is leucine, Xaa6 is tyrosine, and Xaa7 is asparagine, in the B-chain of SEQ ID NO: 4, Xaa8 is tyrosine, Xaa9 is absent, Xaa10 is threonine, and Xaa11 is proline.
4. The insulin analog e of claim 3, wherein the peptide comprises an amino acid sequence represented by SEQ ID NO: 20.
5.The insulin analog peptide of claim 1, wherein, in the A-chain of SEQ ID NO: 3, Xaa1 is glycine, Xaa2 is ine, Xaa3 is serine, Xaa4 is e, Xaa5 is leucine, Xaa6 is tyrosine, and Xaa7 is asparagine, and in the B-chain of SEQ ID NO: 4, Xaa8 is glutamic acid, Xaa9 is absent, Xaa10 is threonine, and Xaa11 is proline.
6. The insulin analog peptide of claim 5, wherein the peptide comprises an amino acid sequence represented by SEQ ID NO: 22.
7. A nucleic acid encoding the n analog peptide according to any one of claims 1 to 6.
8. The nucleic acid of claim 7, wherein the nucleic acid comprises a nucleotide sequence selected from the group consisting of SEQ ID NOS: 19, and 21.
9. A recombinant expression vector comprising the nucleic acid according to claim 7.
10. An isolated transformant which is transformed with the recombinant expression vector according to claim 9.
11. The transformant of claim 10, wherein the transformant is E. coli.
12. A method of preparing the insulin analog peptide ing to claim 1, comprising: a) preparing a recombinant expression vector comprising a nucleic acid encoding the insulin analog peptide according to claim 1; b) transforming the recombinant expression vector into a host cell and obtaining an isolated transformant rom; c) culturing the transformant and expressing the insulin analog peptide; and d) isolating and purifying the expressed insulin analog e.
13. The method of claim 12, n the nucleic acid comprises a nucleotide sequence selected from the group consisting of SEQ ID NOS: 19, and 21.
14. The method of claim 12, wherein the transformant is E. coli.
15. The method of claim 12, wherein the isolating and purifying comprise: d-1) obtaining the ormant cells from the culture and pulverizing the same; d-2) recovering the expressed insulin analog e from the pulverized cell lysate followed by refolding the same; d-3) purifying the refolded insulin analog peptide by cation exchange chromatography; d-4) ng the purified insulin analog peptide with trypsin and carboxypeptidase B; d-5) sequentially ing the treated insulin analog e by cation exchange chromatography and anion exchange chromatography.
16. A pharmaceutical composition for treating diabetes comprising the insulin analog peptide according to any one of claims 1 to 6 and a pharmaceutically able carrier. None set by CAR MigrationNone set by CAR Unmarked set by CAR None set by CAR MigrationNone set by CAR Unmarked set by CAR [
NZ741060A 2016-08-29 Novel insulin analogs and use thereof NZ741060B2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20150121819 2015-08-28
PCT/KR2016/009606 WO2017039267A1 (en) 2015-08-28 2016-08-29 Novel insulin analogs and use thereof

Publications (2)

Publication Number Publication Date
NZ741060A NZ741060A (en) 2024-05-31
NZ741060B2 true NZ741060B2 (en) 2024-09-03

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