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1. WO2011003886 - PEGYLATED L-ASPARAGINASE

Publication Number WO/2011/003886
Publication Date 13.01.2011
International Application No. PCT/EP2010/059599
International Filing Date 06.07.2010
IPC
A61K 47/48 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
48the non-active ingredient being chemically bound to the active ingredient, e.g. polymer drug conjugates
C12N 9/82 2006.01
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes, e.g. ligases (6.); Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating, or purifying enzymes
14Hydrolases (3.)
78acting on carbon to nitrogen bonds other than peptide bonds (3.5)
80acting on amide bonds in linear amides
82Asparaginase
A61P 35/02 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
02specific for leukemia
CPC
A61K 38/50
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43Enzymes; Proenzymes; Derivatives thereof
46Hydrolases (3)
50acting on carbon-nitrogen bonds, other than peptide bonds (3.5), e.g. asparaginase
A61K 47/60
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
51the non-active ingredient being a modifying agent
56the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
59obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
60the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
A61P 35/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
A61P 35/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
35Antineoplastic agents
02specific for leukemia
C12N 9/82
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes; Proenzymes; Compositions thereof
14Hydrolases (3)
78acting on carbon to nitrogen bonds other than peptide bonds (3.5)
80acting on amide bonds in linear amides ; (3.5.1)
82Asparaginase ; (3.5.1.1)
C12N 9/96
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9Enzymes; Proenzymes; Compositions thereof
96Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
Applicants
  • ALIZE PHARMA II [FR]/[FR] (AllExceptUS)
  • ABRIBAT, Thierry [FR]/[FR] (UsOnly)
Inventors
  • ABRIBAT, Thierry
Agents
  • TETAZ, Franck
Priority Data
61/223,32006.07.2009US
PCT/EP2010/05415630.03.2010EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) PEGYLATED L-ASPARAGINASE
(FR) L-ASPARAGINASE PEGYLÉE
Abstract
(EN)
Disclosed is a conjugate of a protein having substantial L-asparagine aminohydrolase activity and polyethylene glycol. In particular, the polyethylene glycol has a molecular weight less than or equal to about 5000 Da and the protein is an L-asparaginase from Erwinia. The conjugate of the invention has shown superior properties such as maintenance of a high level of in vitro activity and an unexpected increase in half-life in vivo. Also disclosed are methods of producing the conjugate and use of the conjugate in therapy. In particular, a method is disclosed for use of the conjugate in the treatment of cancer, particularly Acute Lymphoblastic Leukemia (ALL). More specifically, a method is disclosed for use of the conjugate as a second line therapy for patients who have developed hypersensitivity or have had a disease relapse after treatment with other L-asparaginase preparations.
(FR)
L'invention porte sur un conjugué d'une protéine ayant une activité L-asparagine aminohydrolase substantielle et du polyéthylène glycol. En particulier, le polyéthylène glycol a une masse moléculaire inférieure ou égale à environ 5 000 Da, et la protéine est une L-asparaginase d'Erwinia. Le conjugué de l'invention a présenté des propriétés supérieures telles que l'entretien d'un taux élevé d'activité in vitro et une augmentation inattendue de demi-vie in vivo. L'invention porte également sur des procédés de fabrication du conjugué et sur l'utilisation du conjugué en thérapie. En particulier, l'invention porte sur un procédé d'utilisation du conjugué dans le traitement du cancer, en particulier d'une leucémie lymphoblastique aigüe (ALL). Plus spécifiquement, l'invention porte sur un procédé pour l'utilisation du conjugué en tant que thérapie de seconde ligne pour des patients qui ont développé une hypersensibilité ou ont eu une rechute de maladie après traitement par d'autres préparations de L-asparaginase.
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