WO2001059078A3 - Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates - Google Patents

Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates Download PDF

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Publication number
WO2001059078A3
WO2001059078A3 PCT/US2001/040069 US0140069W WO0159078A3 WO 2001059078 A3 WO2001059078 A3 WO 2001059078A3 US 0140069 W US0140069 W US 0140069W WO 0159078 A3 WO0159078 A3 WO 0159078A3
Authority
WO
WIPO (PCT)
Prior art keywords
urate oxidase
aggregate
preparation
polymer conjugates
protein
Prior art date
Application number
PCT/US2001/040069
Other languages
French (fr)
Other versions
WO2001059078A2 (en
Inventor
Merry R Sherman
Mark G P Saifer
L David Williams
Original Assignee
Mountain View Pharmaceuticals
Merry R Sherman
Mark G P Saifer
L David Williams
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
Priority to AT01923265T priority Critical patent/ATE463576T1/en
Priority to DE60141742T priority patent/DE60141742D1/en
Application filed by Mountain View Pharmaceuticals, Merry R Sherman, Mark G P Saifer, L David Williams filed Critical Mountain View Pharmaceuticals
Priority to IL15106501A priority patent/IL151065A0/en
Priority to KR1020087024272A priority patent/KR101054247B1/en
Priority to ES01923265T priority patent/ES2343105T3/en
Priority to AU2001249975A priority patent/AU2001249975B2/en
Priority to MXPA02007545A priority patent/MXPA02007545A/en
Priority to AU4997501A priority patent/AU4997501A/en
Priority to EP01923265A priority patent/EP1254237B1/en
Priority to DK01923265.1T priority patent/DK1254237T3/en
Priority to BRPI0108386A priority patent/BRPI0108386B8/en
Priority to JP2001558218A priority patent/JP5165826B2/en
Priority to NZ520434A priority patent/NZ520434A/en
Priority to HU0204544A priority patent/HU227127B1/en
Priority to CA2398679A priority patent/CA2398679C/en
Publication of WO2001059078A2 publication Critical patent/WO2001059078A2/en
Publication of WO2001059078A3 publication Critical patent/WO2001059078A3/en
Priority to IL151065A priority patent/IL151065A/en
Priority to HK03109064.9A priority patent/HK1056742A1/en
Priority to AU2006203252A priority patent/AU2006203252B8/en
Priority to IL193365A priority patent/IL193365A/en
Priority to BE2013C045C priority patent/BE2013C045I2/fr
Priority to CY2013028C priority patent/CY2013028I1/en
Priority to FR13C0036C priority patent/FR13C0036I2/en

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Classifications

    • 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
    • C12N9/0004—Oxidoreductases (1.)
    • C12N9/0012—Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.6, 1.7)
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C12N9/0004—Oxidoreductases (1.)
    • C12N9/0012—Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.6, 1.7)
    • C12N9/0044—Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.6, 1.7) acting on other nitrogen compounds as donors (1.7)
    • C12N9/0046—Oxidoreductases (1.) acting on nitrogen containing compounds as donors (1.4, 1.5, 1.6, 1.7) acting on other nitrogen compounds as donors (1.7) with oxygen as acceptor (1.7.3)
    • 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
    • A61K38/00—Medicinal preparations containing peptides

Abstract

A naturally occurring or recombinant protein, especially a mutein of porcine urate oxidase (uricase), that is essentially free of large aggregates can be rendered substantially non-immunogenic by conjugation with a sufficiently small number of strands of polymer such that the bioactivity of the protein is essentially retained in the conjugate. Such conjugates are unusually well suited for treatment of chronic conditions because they are less likely to induce the formation of antibodies and/or accelerated clearance than are similar conjugates prepared from protein preparations containing traces of large aggregates.
PCT/US2001/040069 2000-02-10 2001-02-07 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates WO2001059078A2 (en)

Priority Applications (22)

Application Number Priority Date Filing Date Title
NZ520434A NZ520434A (en) 2000-02-10 2001-02-07 Urate oxidase free of aggregates larger than octamers, for preparation of non-immunogenic polymer conjugates
JP2001558218A JP5165826B2 (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase for the preparation of non-immunogenic polymer conjugates
IL15106501A IL151065A0 (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
DE60141742T DE60141742D1 (en) 2000-02-10 2001-02-07 AGGREGATE-FREE HARNIC ACID OXIDASE FOR PREPARING NON-IMMUNOGENIC POLYMERIC CONJUGATES
ES01923265T ES2343105T3 (en) 2000-02-10 2001-02-07 URATO OXIDASA WITHOUT AGGREGATES FOR THE PREPARATION OF IMMUNOGENIC POLYMERIC CONJUGATES.
AU2001249975A AU2001249975B2 (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
HU0204544A HU227127B1 (en) 2000-02-10 2001-02-07 Purified urate oxidases, process for preparation thereof and uricase conjugates
AU4997501A AU4997501A (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
EP01923265A EP1254237B1 (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
DK01923265.1T DK1254237T3 (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase to prepare non-immunogenic polymer conjugates
BRPI0108386A BRPI0108386B8 (en) 2000-02-10 2001-02-07 uricase conjugate, pharmaceutical composition and method for the purification of uricase
AT01923265T ATE463576T1 (en) 2000-02-10 2001-02-07 AGGREGATE-FREE URIC ACID OXIDASE FOR THE PRODUCTION OF NON-IMMUNOGENIC POLYMER CONJUGATES
KR1020087024272A KR101054247B1 (en) 2000-02-10 2001-02-07 Purified urate oxidase preparation, composition comprising the same, and purifying method thereof
MXPA02007545A MXPA02007545A (en) 2000-02-10 2001-02-07 Aggregate free urate oxidase for preparation of non immunogenic polymer conjugates.
CA2398679A CA2398679C (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
IL151065A IL151065A (en) 2000-02-10 2002-08-05 Aggregate-free urate oxidases, polymer conjugates thereof and compositions prepared therefrom
HK03109064.9A HK1056742A1 (en) 2000-02-10 2003-12-11 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
AU2006203252A AU2006203252B8 (en) 2000-02-10 2006-07-31 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
IL193365A IL193365A (en) 2000-02-10 2008-08-11 Aggregate-free urate oxidases, polymer conjugates thereof and compositions prepared therefrom
BE2013C045C BE2013C045I2 (en) 2000-02-10 2013-07-03
CY2013028C CY2013028I1 (en) 2000-02-10 2013-07-04 URIC OXIDATION OF FREE AGGREGATES FOR THE PREPARATION OF NON-IMMUNE CONJUGATES WITH POLYMERS
FR13C0036C FR13C0036I2 (en) 2000-02-10 2013-07-04 AGGREGATE-FREE URATE OXIDASE FOR THE PREPARATION OF NON-IMMUNOGENIC CONJUGATED POLYMERS

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/501,730 2000-02-10
US09/501,730 US6783965B1 (en) 2000-02-10 2000-02-10 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates

Publications (2)

Publication Number Publication Date
WO2001059078A2 WO2001059078A2 (en) 2001-08-16
WO2001059078A3 true WO2001059078A3 (en) 2002-03-07

Family

ID=23994789

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/040069 WO2001059078A2 (en) 2000-02-10 2001-02-07 Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates

Country Status (28)

Country Link
US (3) US6783965B1 (en)
EP (3) EP1254237B1 (en)
JP (2) JP5165826B2 (en)
KR (3) KR101054247B1 (en)
CN (2) CN101735991B (en)
AT (1) ATE463576T1 (en)
AU (3) AU2001249975B2 (en)
BE (1) BE2013C045I2 (en)
BR (1) BRPI0108386B8 (en)
CA (1) CA2398679C (en)
CY (3) CY1110142T1 (en)
CZ (1) CZ304864B6 (en)
DE (1) DE60141742D1 (en)
DK (3) DK1254237T3 (en)
ES (2) ES2524153T3 (en)
FR (1) FR13C0036I2 (en)
HK (4) HK1056742A1 (en)
HU (1) HU227127B1 (en)
IL (3) IL151065A0 (en)
LU (1) LU92237I2 (en)
MX (1) MXPA02007545A (en)
NZ (1) NZ520434A (en)
PL (1) PL208064B1 (en)
PT (2) PT2305819E (en)
RU (3) RU2352354C2 (en)
TW (2) TW200914617A (en)
WO (1) WO2001059078A2 (en)
ZA (1) ZA200207206B (en)

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