HRP20171180T4 - Pegilirana l-asparaginaza - Google Patents

Pegilirana l-asparaginaza Download PDF

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Publication number
HRP20171180T4
HRP20171180T4 HRP20171180TT HRP20171180T HRP20171180T4 HR P20171180 T4 HRP20171180 T4 HR P20171180T4 HR P20171180T T HRP20171180T T HR P20171180TT HR P20171180 T HRP20171180 T HR P20171180T HR P20171180 T4 HRP20171180 T4 HR P20171180T4
Authority
HR
Croatia
Prior art keywords
conjugate
use according
peg
asparaginase
seq
Prior art date
Application number
HRP20171180TT
Other languages
English (en)
Inventor
Thierry Abribat
Original Assignee
Jazz Pharmaceuticals Ii Sas
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42670528&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20171180(T4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from PCT/EP2010/054156 external-priority patent/WO2011003633A1/en
Application filed by Jazz Pharmaceuticals Ii Sas filed Critical Jazz Pharmaceuticals Ii Sas
Publication of HRP20171180T1 publication Critical patent/HRP20171180T1/hr
Publication of HRP20171180T4 publication Critical patent/HRP20171180T4/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/78Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5)
    • C12N9/80Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5) acting on amide bonds in linear amides (3.5.1)
    • C12N9/82Asparaginase (3.5.1.1)
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • General Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Veterinary Medicine (AREA)
  • Microbiology (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Claims (15)

1. Konjugat za upotrebu u terapiji, pri čemu konjugat sadrži L-asparaginazu iz Erwinia chrysanthemi koja je bar 90% identična aminokiselinskoj sekvenci SEQ ID NO: 1 i polietilen glikol (PEG), gdje PEG ima molekulsku masu manju ili jednaku oko 5000 Da.
2. Konjugat za upotrebu prema zahtjevu 1, gdje spomenuta L-asparaginaza je bar 95% identična aminokiselinskoj sekvenci SEQ ID NO:1, ili je bar 99% identična aminokiselinskoj sekvenci SEQ ID NO:1
3. Konjugat za upotrebu prema zahtjevu 1, gdje je spomenuta L-asparaginaza identična SEQ ID NO:1.
4. Konjugat za upotrebu prema bilo kojem od zahtjeva 1 do 3, gdje spomenuti PEG ima molekulsku masu u okviru opsega od bar 500 Da.
5. Konjugat za upotrebu prema zahtjevu 3, gdje spomenuti PEG ima molekulsku masu od oko 5000 Da, manju od oko 5000 Da, manju od oko 4000 Da, manju od oko 3000 Da, ili manju od oko 2500 Da.
6. Konjugat za upotrebu prema zahtjevu 1, gdje je spomenuta L-asparaginaza identična sa SEQ ID NO:1 i spomenuti PEG ima molekulsku masu od oko 5000 Da.
7. Konjugat za upotrebu prema bilo kojem od zahtjeva 1 do 6 gdje je PEG kovalentno vezan za jednu ili više amino grupa spomenute L-asparaginaze.
8. Konjugat za upotrebu prema zahtjevu 7, gdje je PEG kovalentno vezan za jednu ili više amino grupa amidnom vezom.
9. Konjugat za upotrebu prema zahtjevu 7 ili 8, gdje je PEG kovalentno vezan sa od 40% do 100% dostupnih amino grupa, naročito između 40% do oko 90% ukupnih amino grupa.
10. Konjugat za upotrebu prema bilo kojem od zahtjeva 1 do 9 koji ima formulu: Asp-[NH-CO(CH2)x-CO-NH-PEG]n gdje Asp je L-asparaginaza, NH je jedna ili više NH grupa lizinskih ostataka i/ili N-kraj u Asp, PEG je polietilen glikolni dio, n je broj koji predstavlja bar 40% do oko 100% dostupnih amino grupa (npr. ostataka lizina i/ili N-kraja) u Asp, i x je cijeli broj od oko 1 do 8, posebno X je cijeli broj u opsegu od oko 2 do 5.
11. Konjugat za upotrebu prema bilo kojem od zahtjeva 1 do 10, gdje je spomenuti PEG monometoksi-polietilen glikol.
12. Konjugat za upotrebu prema bilo kojem od zahtjeva 1 do 10 za liječenje pacijenta od bolesti koji se liječe trošenjem L-asparaginaze, opcionalno gdje je spomenuta bolest hematološki malignitet i pacijentu se daje doza od 10 000 internecionalnih jedinica po kvadratnom metru površine tijela pacijenta (IU/m2) do 15 000 IU/m2.
13. Konjugat za upotrebu prema bilo kojem od zahtjeva 1 do 10 za liječenje pacijenta od bolesti koje se liječe trošenjem L-asparaginaze, opcionalno gdje je spomenuta bolest koja se liječi trošenjem asparaginaze tumor, opcionalno gdje je spomenuti tumor izabran iz grupe koju čine akutna limfoblastna leukemija (ALL), nekotchkinov limfom, NK limfom i tumor gušterače.
14. Konjugat za upotrebu prema zahtjevu 13, gdje je spomenuti tumor NK limfom.
15. Konjugat za upotrebu prema zahtjevu 13, gdje je spomenuti pacijent imao recidiv bolesti, opcionalno gdje se spomenuti recidiv bolesti javlja poslije liječenja sa L-asparaginazom E.coli ili njenim PEG-ilovanim oblikom.
HRP20171180TT 2009-07-06 2010-07-06 Pegilirana l-asparaginaza HRP20171180T4 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US22332009P 2009-07-06 2009-07-06
PCT/EP2010/054156 WO2011003633A1 (en) 2009-07-06 2010-03-30 Pegylated l-asparaginase
PCT/EP2010/059599 WO2011003886A1 (en) 2009-07-06 2010-07-06 Pegylated l-asparaginase
EP10730170.7A EP2451486B2 (en) 2009-07-06 2010-07-06 Pegylated l-asparaginase

Publications (2)

Publication Number Publication Date
HRP20171180T1 HRP20171180T1 (hr) 2018-01-26
HRP20171180T4 true HRP20171180T4 (hr) 2023-06-09

Family

ID=42670528

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20171180TT HRP20171180T4 (hr) 2009-07-06 2010-07-06 Pegilirana l-asparaginaza

Country Status (7)

Country Link
EP (1) EP2451486B2 (hr)
CY (1) CY1119779T1 (hr)
HR (1) HRP20171180T4 (hr)
ME (1) ME02945B (hr)
PL (1) PL2451486T5 (hr)
RS (1) RS57077B2 (hr)
SI (1) SI2451486T2 (hr)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
UY37341A (es) 2016-07-22 2017-11-30 Flamel Ireland Ltd Formulaciones de gamma-hidroxibutirato de liberación modificada con farmacocinética mejorada
EP3700921A4 (en) * 2017-10-27 2021-12-15 Pfenex Inc. PROCESS FOR THE PRODUCTION OF RECOMBINANT ERWINIA ASPARAGINASE
CN110684759B (zh) * 2018-07-06 2023-10-17 南京吉芮康生物科技研究院有限公司 重组l-门冬酰胺酶及其制备方法和用途
CN113473980A (zh) 2019-03-01 2021-10-01 弗拉梅尔爱尔兰有限公司 在进食状态下具有改善的药代动力学的γ-羟基丁酸酯组合物
GB201912020D0 (en) * 2019-08-21 2019-10-02 Porton Biopharma Ltd Therapeutic Conjugate
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5672662A (en) * 1995-07-07 1997-09-30 Shearwater Polymers, Inc. Poly(ethylene glycol) and related polymers monosubstituted with propionic or butanoic acids and functional derivatives thereof for biotechnical applications

Also Published As

Publication number Publication date
SI2451486T2 (sl) 2023-05-31
ME02945B (me) 2018-04-20
CY1119779T1 (el) 2018-06-27
RS57077B1 (sr) 2018-06-29
RS57077B2 (sr) 2023-06-30
SI2451486T1 (en) 2018-01-31
HRP20171180T1 (hr) 2018-01-26
EP2451486B2 (en) 2023-01-18
PL2451486T3 (pl) 2018-02-28
PL2451486T5 (pl) 2023-05-15
EP2451486B1 (en) 2017-05-03
EP2451486A1 (en) 2012-05-16

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