CA3083499C - METHODS OF TREATMENT WITH ASPARAGINASE - Google Patents

METHODS OF TREATMENT WITH ASPARAGINASE

Info

Publication number
CA3083499C
CA3083499C CA3083499A CA3083499A CA3083499C CA 3083499 C CA3083499 C CA 3083499C CA 3083499 A CA3083499 A CA 3083499A CA 3083499 A CA3083499 A CA 3083499A CA 3083499 C CA3083499 C CA 3083499C
Authority
CA
Canada
Prior art keywords
conjugate
asparaginase
peg
breast
adenocarcinoma
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
CA3083499A
Other languages
English (en)
French (fr)
Other versions
CA3083499A1 (en
Inventor
Polly Pine
Hemamalini Gursahani
Original Assignee
Jazz Pharmaceuticals Ireland Ltd
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
Application filed by Jazz Pharmaceuticals Ireland Ltd filed Critical Jazz Pharmaceuticals Ireland Ltd
Priority to CA3240356A priority Critical patent/CA3240356A1/en
Publication of CA3083499A1 publication Critical patent/CA3083499A1/en
Application granted granted Critical
Publication of CA3083499C publication Critical patent/CA3083499C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/05—Dipeptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/07—Tetrapeptides
    • 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)
    • A61K38/50—Hydrolases (3) acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/56—Medicinal 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
    • A61K47/59—Medicinal 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
    • A61K47/60—Medicinal 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal 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
    • A61K47/51—Medicinal 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
    • A61K47/68—Medicinal 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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6815—Enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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)
    • C12N9/78—Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5)
    • C12N9/80—Hydrolases (3) acting on carbon to nitrogen bonds other than peptide bonds (3.5) acting on amide bonds in linear amides (3.5.1)
    • C12N9/82—Asparaginase (3.5.1.1)
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y305/00—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5)
    • C12Y305/01—Hydrolases acting on carbon-nitrogen bonds, other than peptide bonds (3.5) in linear amides (3.5.1)
    • C12Y305/01001—Asparaginase (3.5.1.1)
    • Y—GENERAL 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
CA3083499A 2017-11-30 2018-11-30 METHODS OF TREATMENT WITH ASPARAGINASE Active CA3083499C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3240356A CA3240356A1 (en) 2017-11-30 2018-11-30 Methods of treatment with asparaginase

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201762592982P 2017-11-30 2017-11-30
US62/592,982 2017-11-30
US201862625078P 2018-02-01 2018-02-01
US62/625,078 2018-02-01
US201862631142P 2018-02-15 2018-02-15
US62/631,142 2018-02-15
US201862673075P 2018-05-17 2018-05-17
US62/673,075 2018-05-17
PCT/US2018/063448 WO2019109018A1 (en) 2017-11-30 2018-11-30 Methods of treatment with asparaginase

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3240356A Division CA3240356A1 (en) 2017-11-30 2018-11-30 Methods of treatment with asparaginase

Publications (2)

Publication Number Publication Date
CA3083499A1 CA3083499A1 (en) 2019-06-06
CA3083499C true CA3083499C (en) 2024-10-01

Family

ID=66664263

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3083499A Active CA3083499C (en) 2017-11-30 2018-11-30 METHODS OF TREATMENT WITH ASPARAGINASE
CA3240356A Pending CA3240356A1 (en) 2017-11-30 2018-11-30 Methods of treatment with asparaginase

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3240356A Pending CA3240356A1 (en) 2017-11-30 2018-11-30 Methods of treatment with asparaginase

Country Status (12)

Country Link
US (1) US20230173042A1 (https=)
EP (1) EP3716997A4 (https=)
JP (2) JP2021505661A (https=)
KR (2) KR20200119234A (https=)
CN (1) CN111818937A (https=)
AU (2) AU2018375183B2 (https=)
BR (1) BR112020010976A2 (https=)
CA (2) CA3083499C (https=)
IL (1) IL274865B2 (https=)
MX (1) MX2020005567A (https=)
SG (1) SG11202004965RA (https=)
WO (1) WO2019109018A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US12478604B1 (en) 2016-07-22 2025-11-25 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
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
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
JP2022553399A (ja) * 2019-10-25 2022-12-22 ジャズ ファーマシューティカルズ アイルランド リミテッド 組換えｌ－アスパラギナーゼ
WO2022211829A1 (en) 2021-03-30 2022-10-06 Jazz Pharmaceuticals Ireland Ltd. Dosing of recombinant l-asparaginase
CN117377494A (zh) * 2021-04-06 2024-01-09 爵士制药爱尔兰有限公司 L-天冬酰胺酶的调配物
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
WO2024015529A2 (en) 2022-07-14 2024-01-18 Jazz Pharmaceuticals Ireland Ltd. Combination therapies involving l-asparaginase

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002044360A2 (en) * 2000-11-28 2002-06-06 Phoenix Pharmacologics, Inc. Modified arginine deiminase
CN1360049A (zh) * 2000-12-20 2002-07-24 上海博德基因开发有限公司 一种新的多肽——人l－天冬酰胺酶24.53和编码这种多肽的多核苷酸
US7985548B2 (en) * 2006-03-03 2011-07-26 The United States Of America As Represented By The Department Of Health And Human Services Materials and methods directed to asparagine synthetase and asparaginase therapies
ITMI20060612A1 (it) * 2006-03-30 2007-09-30 Keryos Spa New activaded poly-ethylene glycols-and related polymers and their applications
WO2011003633A1 (en) * 2009-07-06 2011-01-13 Alize Pharma Ii Pegylated l-asparaginase
HK1204578A1 (en) * 2012-03-21 2015-11-27 Erytech Pharma Medicament for the treatment of acute myeloid leukemia (aml)
CN105802948B (zh) * 2014-12-29 2020-06-09 江苏众红生物工程创药研究院有限公司 聚乙二醇定点修饰的门冬酰胺酶及其制备方法与应用
CN105802946B (zh) * 2014-12-29 2025-08-22 江苏众红生物工程创药研究院有限公司 聚乙二醇化的门冬酰胺酶及其应用
EP3535386A4 (en) * 2016-11-04 2020-04-15 Georgia State University Research Foundation, Inc. ENDOTOXIN-FREE ASPARAGINASE
GB201919219D0 (en) * 2019-12-23 2020-02-05 Otsuka Pharma Co Ltd Cancer biomarkers

Also Published As

Publication number Publication date
IL274865B1 (en) 2025-04-01
KR20250086810A (ko) 2025-06-13
IL274865B2 (en) 2025-08-01
CA3240356A1 (en) 2019-06-06
US20230173042A1 (en) 2023-06-08
MX2020005567A (es) 2020-08-20
IL274865A (en) 2020-07-30
AU2018375183A1 (en) 2020-06-25
CN111818937A (zh) 2020-10-23
SG11202004965RA (en) 2020-06-29
AU2018375183B2 (en) 2024-09-26
WO2019109018A1 (en) 2019-06-06
BR112020010976A2 (pt) 2020-11-17
CA3083499A1 (en) 2019-06-06
EP3716997A1 (en) 2020-10-07
EP3716997A4 (en) 2022-02-23
JP2024069234A (ja) 2024-05-21
KR20200119234A (ko) 2020-10-19
AU2024278286A1 (en) 2025-02-13
JP2021505661A (ja) 2021-02-18

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