DK2854841T3 - Kallikrein-1-glycosyleringsisoformer af humant væv - Google Patents

Kallikrein-1-glycosyleringsisoformer af humant væv Download PDF

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Publication number
DK2854841T3
DK2854841T3 DK13801165.5T DK13801165T DK2854841T3 DK 2854841 T3 DK2854841 T3 DK 2854841T3 DK 13801165 T DK13801165 T DK 13801165T DK 2854841 T3 DK2854841 T3 DK 2854841T3
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Denmark
Prior art keywords
klk1
polypeptide
amino acid
seq
composition
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DK13801165.5T
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English (en)
Inventor
Matthew Charles
Tadeusz Kolodka
Mark Williams
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Diamedica Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4853—Kallikrein (3.4.21.34 or 3.4.21.35)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6445—Kallikreins (3.4.21.34; 3.4.21.35)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21035—Tissue kallikrein (3.4.21.35)

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)

Claims (15)

1. Sammensætning, omfattende en første moden og aktiv form af et kallikrein-1 (KLKI)-polypeptid af humant væv og en anden moden og aktiv form af et kallikrein-1 (KLKI)-polypeptid af humant væv, hvor det første KLK1-polypeptid omfatter tre N-forbundne glycaner, som er forbundet ved resterne 78, 84 og 141 som defineret ved SEQ ID NO:1, og det andet KLK1-polypeptid omfatter to N-forbundne glycaner, som er forbundet ved resterne 78 og 84, men ikke 141, som defineret ved SEQ ID NO:2; og hvor det første KLK1-polypeptid og det andet KLK1-polypeptid foreligger i sammensætningen i et forhold liggende fra 45:55 til 55:45.
2. Sammensætning ifølge krav 1, hvor forholdet imellem det første KLK1-polypeptid og det andet KLK1-polypeptid i sammensætningen er 50:50.
3. Sammensætning ifølge krav 1 eller 2, hvor det eller de nævnte KLKI-polypeptid(er) omfatter aminosyrerester 78-141 ifølge SEQ ID NO:1 eller aminosyrerester 78-141 ifølge SEQ ID NO:2.
4. Sammensætning ifølge ethvert af kravene 1-3, hvor det eller de nævnte KLK1-polypeptid(er) omfatter aminosyresrester 25-262 ifølge SEQ ID NO:1 eller aminosyrerester 25-262 ifølge SEQ ID NO:2.
5. Sammensætning ifølge krav 1 eller 2, hvor det eller de nævnte KLKI-polypeptid(er) omfatter en aminosyresekvens med i det mindste 95% sekvensidentitet med amino-syresterne 25-262 ifølge SEQ ID NO:1 eller SEQ ID NO:2.
6. Sammensætning ifølge krav 5, hvor det eller de nævnte KLKI-polypeptid(er) omfatter en aminosyresekvens med i det mindste 95% sekvensidentitet med aminosyreresterne 25-262 ifølge SEQ ID NO:2, og hvor det eller de nævnte KLK1-polypeptid(er) omfatter E145 og/eller A188.
7. Sammensætning ifølge ethvert af kravene 1-3, hvor det eller de nævnte KLK1-polypeptid(er) omfatter en aminosyresekvens med i det mindste 95% sekvensidentitet med aminosyreresterne 25-262 ifølge SEQ ID NO:2, og hvor det eller de nævnte KLKI-polypeptid(er) omfatter Q145 og/eller V188.
8. Sammensætning ifølge ethvert af kravene 1-7, hvor det eller de nævnte KLK1-polypeptid(er) består af aminosyreresterne 25-262 ifølge SEQ ID NO:1 eller amino-syreresterne 25-262 ifølge SEQ ID NO:2.
9. Sammensætning ifølge ethvert af kravene 1-8, som yderligere omfatter en farmaceutisk acceptabel diluent, adjuvans eller bærestof.
10. Sammensætning ifølge ethvert af kravene 1-9, hvor sammensætningen er i det væsentlige fri for andre glycosylerede isoformer (glycoformer) af KLK1.
11. Sammensætning ifølge ethvert af kravene 1-10, hvor sammensætningen harendo-toxinniveauer på mindre end 1 EU/mg protein, værtscelleproteiner på mindre end 100 ng/mg totalt protein, værtscelle DNA på mindre end 10 pg/mg totalt protein og/eller er i det væsentlige fri for aggregater (mere end 95%, som foreligger som en enkelt spids ved SEC HPLC).
12. Indretning omfattende en sammensætning ifølge ethvert af kravene 1-11, hvor indretningen er egnet til at afgive sammensætningen subkutant.
13. Indretning ifølge krav 12, hvor indretningen er en sprøjte.
14. Sprøjte ifølge krav 13, som yderligere omfatter et kanylearrangement forbundet med sprøjten.
15. Sprøjte ifølge krav 14, hvor nålen har en længde på 1/4 tomme til 5/8 tomme, og en kanylekaliber på omkring 25 til omkring 31.
DK13801165.5T 2012-06-04 2013-06-04 Kallikrein-1-glycosyleringsisoformer af humant væv DK2854841T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261655388P 2012-06-04 2012-06-04
US201361789978P 2013-03-15 2013-03-15
PCT/CA2013/050425 WO2013181755A1 (en) 2012-06-04 2013-06-04 Human tissue kallikrein 1 glycosylation isoforms

Publications (1)

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DK2854841T3 true DK2854841T3 (da) 2017-05-22

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US (3) US20130323222A1 (da)
EP (1) EP2854841B1 (da)
CA (1) CA2880085C (da)
CY (1) CY1119073T1 (da)
DK (1) DK2854841T3 (da)
ES (1) ES2625548T3 (da)
HR (1) HRP20170673T1 (da)
HU (1) HUE032613T2 (da)
LT (1) LT2854841T (da)
PL (1) PL2854841T3 (da)
PT (1) PT2854841T (da)
SI (1) SI2854841T1 (da)
WO (1) WO2013181755A1 (da)

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Publication number Priority date Publication date Assignee Title
WO2013173923A1 (en) 2012-05-25 2013-11-28 Diamedica, Inc. Formulations of human tissue kallikrein-1 for parenteral delivery and related methods
PT2854841T (pt) 2012-06-04 2017-05-15 Diamedica Inc Isoformas de glicosilação da calicreína 1 em tecido humano
AU2018230478B2 (en) 2017-03-09 2025-01-23 Diamedica Inc. Dosage forms of tissue kallikrein 1
CN116135973A (zh) * 2021-11-16 2023-05-19 江苏众红生物工程创药研究院有限公司 低糖基化修饰的激肽原酶及其聚乙二醇修饰物和应用
US20250242001A1 (en) * 2024-01-30 2025-07-31 DiaMedica Therapeutics, Inc. Tissue kallikrein-1 for treating pregnancy disorders

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EP2854841A4 (en) 2016-03-09
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US20150196624A1 (en) 2015-07-16
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US9839678B2 (en) 2017-12-12
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