WO2006127910A3 - Glycopegylated erythropoietin formulations - Google Patents

Glycopegylated erythropoietin formulations Download PDF

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Publication number
WO2006127910A3
WO2006127910A3 PCT/US2006/020257 US2006020257W WO2006127910A3 WO 2006127910 A3 WO2006127910 A3 WO 2006127910A3 US 2006020257 W US2006020257 W US 2006020257W WO 2006127910 A3 WO2006127910 A3 WO 2006127910A3
Authority
WO
WIPO (PCT)
Prior art keywords
conjugates
peptide
methods
glycosyltransferase
glycopegylated erythropoietin
Prior art date
Application number
PCT/US2006/020257
Other languages
French (fr)
Other versions
WO2006127910A2 (en
Inventor
Shawn Defrees
Robert J Bayer
David A Zope
Jichao Kang
Walter Scott Willett Jr
Original Assignee
Neose Technologies Inc
Shawn Defrees
Robert J Bayer
David A Zope
Jichao Kang
Walter Scott Willett Jr
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 claimed from US11/144,223 external-priority patent/US8633157B2/en
Application filed by Neose Technologies Inc, Shawn Defrees, Robert J Bayer, David A Zope, Jichao Kang, Walter Scott Willett Jr filed Critical Neose Technologies Inc
Priority to JP2008513711A priority Critical patent/JP2008542288A/en
Priority to EP06771180A priority patent/EP1888098A2/en
Priority to US11/914,104 priority patent/US20110003744A1/en
Publication of WO2006127910A2 publication Critical patent/WO2006127910A2/en
Publication of WO2006127910A3 publication Critical patent/WO2006127910A3/en

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/475Growth factors; Growth regulators
    • C07K14/505Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • 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
    • A61K47/54Medicinal 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 compound
    • A61K47/549Sugars, nucleosides, nucleotides or nucleic acids
    • 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

Abstract

The present invention provides conjugates between erythropoietin and PEG moieties. The conjugates are linked via an intact glycosyl linking group interposed between and covalently attached to the peptide and the modifying group. The conjugates are formed from glycosylated peptides by the action of a glycosyltransferase. The glycosyltransferase ligates a modified sugar moiety onto a glycosyl residue on the peptide. Also provided are methods for preparing the conjugates, methods for treating various disease conditions with the conjugates, and pharmaceutical formulations including the conjugates.
PCT/US2006/020257 2005-05-25 2006-05-25 Glycopegylated erythropoietin formulations WO2006127910A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2008513711A JP2008542288A (en) 2005-05-25 2006-05-25 GlycoPEGylated erythropoietin formulation
EP06771180A EP1888098A2 (en) 2005-05-25 2006-05-25 Glycopegylated erythropoietin formulations
US11/914,104 US20110003744A1 (en) 2005-05-25 2006-05-25 Glycopegylated Erythropoietin Formulations

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
US68500705P 2005-05-25 2005-05-25
US68463705P 2005-05-25 2005-05-25
US60/685,007 2005-05-25
US60/684,637 2005-05-25
US68754805P 2005-06-02 2005-06-02
US11/144,223 2005-06-02
US60/687,548 2005-06-02
US11/144,223 US8633157B2 (en) 2003-11-24 2005-06-02 Glycopegylated erythropoietin
US76462506P 2006-02-01 2006-02-01
US60/764,625 2006-02-01
US77408806P 2006-02-15 2006-02-15
US77394106P 2006-02-15 2006-02-15
US60/773,941 2006-02-15
US60/774,088 2006-02-15

Publications (2)

Publication Number Publication Date
WO2006127910A2 WO2006127910A2 (en) 2006-11-30
WO2006127910A3 true WO2006127910A3 (en) 2007-07-26

Family

ID=37452843

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/020257 WO2006127910A2 (en) 2005-05-25 2006-05-25 Glycopegylated erythropoietin formulations

Country Status (3)

Country Link
US (1) US7842661B2 (en)
EP (1) EP1888098A2 (en)
WO (1) WO2006127910A2 (en)

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US8076292B2 (en) 2001-10-10 2011-12-13 Novo Nordisk A/S Factor VIII: remodeling and glycoconjugation of factor VIII
US8404809B2 (en) 2005-05-25 2013-03-26 Novo Nordisk A/S Glycopegylated factor IX
US8632770B2 (en) 2003-12-03 2014-01-21 Novo Nordisk A/S Glycopegylated factor IX
US8791070B2 (en) 2003-04-09 2014-07-29 Novo Nordisk A/S Glycopegylated factor IX
US9150848B2 (en) 2008-02-27 2015-10-06 Novo Nordisk A/S Conjugated factor VIII molecules
KR101572286B1 (en) 2008-01-22 2015-11-27 아라임 파마슈티칼즈, 인크. Tissue protective peptides and peptide analogs for preventing and treating diseases and disorders associated with tissue damage

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