WO2005055950A3 - Glycopegylated factor ix - Google Patents

Glycopegylated factor ix Download PDF

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Publication number
WO2005055950A3
WO2005055950A3 PCT/US2004/041070 US2004041070W WO2005055950A3 WO 2005055950 A3 WO2005055950 A3 WO 2005055950A3 US 2004041070 W US2004041070 W US 2004041070W WO 2005055950 A3 WO2005055950 A3 WO 2005055950A3
Authority
WO
WIPO (PCT)
Prior art keywords
conjugates
peptide
methods
glycosyltransferase
factor
Prior art date
Application number
PCT/US2004/041070
Other languages
French (fr)
Other versions
WO2005055950A2 (en
Inventor
Shawn Defrees
Robert J Bayer
Caryn Bowe
Krishnasamy Panneerselvam
Original Assignee
Neose Technologies Inc
Shawn Defrees
Robert J Bayer
Caryn Bowe
Krishnasamy Panneerselvam
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 JP2006542888A priority Critical patent/JP4738346B2/en
Priority to CA002549413A priority patent/CA2549413A1/en
Priority to CN2004800359517A priority patent/CN1889937B/en
Priority to AU2004296860A priority patent/AU2004296860B2/en
Application filed by Neose Technologies Inc, Shawn Defrees, Robert J Bayer, Caryn Bowe, Krishnasamy Panneerselvam filed Critical Neose Technologies Inc
Priority to NZ546733A priority patent/NZ546733A/en
Priority to EP04813394A priority patent/EP1694315A4/en
Priority to BRPI0417341-4A priority patent/BRPI0417341A/en
Priority to MXPA06006023A priority patent/MXPA06006023A/en
Priority to US11/166,028 priority patent/US20060040856A1/en
Publication of WO2005055950A2 publication Critical patent/WO2005055950A2/en
Publication of WO2005055950A3 publication Critical patent/WO2005055950A3/en
Priority to IL175661A priority patent/IL175661A0/en
Priority to KR1020067010603A priority patent/KR101209111B1/en
Priority to US12/184,956 priority patent/US20090081188A1/en
Priority to US12/851,651 priority patent/US8632770B2/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • 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)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/644—Coagulation factor IXa (3.4.21.22)
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Microbiology (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention provides conjugates between Factor IX 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/US2004/041070 2003-12-03 2004-12-03 Glycopegylated factor ix WO2005055950A2 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
EP04813394A EP1694315A4 (en) 2003-12-03 2004-12-03 Glycopegylated factor ix
CN2004800359517A CN1889937B (en) 2003-12-03 2004-12-03 Glycopegylated factor IX
AU2004296860A AU2004296860B2 (en) 2003-12-03 2004-12-03 Glycopegylated factor IX
MXPA06006023A MXPA06006023A (en) 2003-12-03 2004-12-03 Glycopegylated factor ix.
NZ546733A NZ546733A (en) 2003-12-03 2004-12-03 Glycopegylated factor IX
CA002549413A CA2549413A1 (en) 2003-12-03 2004-12-03 Glycopegylated factor ix
BRPI0417341-4A BRPI0417341A (en) 2003-12-03 2004-12-03 glyceguiled factor ix
JP2006542888A JP4738346B2 (en) 2003-12-03 2004-12-03 GlycoPEGylated factor IX
US11/166,028 US20060040856A1 (en) 2003-12-03 2005-06-23 Glycopegylated factor IX
IL175661A IL175661A0 (en) 2003-12-03 2006-05-16 Glycopegylated factor ix
KR1020067010603A KR101209111B1 (en) 2003-12-03 2006-05-30 Glycopegylated factor ix
US12/184,956 US20090081188A1 (en) 2003-12-03 2008-08-01 Glycopegylated factor ix
US12/851,651 US8632770B2 (en) 2003-12-03 2010-08-06 Glycopegylated factor IX

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US52708903P 2003-12-03 2003-12-03
US60/527,089 2003-12-03
US53938704P 2004-01-26 2004-01-26
US60/539,387 2004-01-26
US59274404P 2004-07-29 2004-07-29
US60/592,744 2004-07-29
US61451804P 2004-09-29 2004-09-29
US60/614,518 2004-09-29
US62338704P 2004-10-29 2004-10-29
US60/623,387 2004-10-29

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/166,028 Continuation-In-Part US20060040856A1 (en) 2003-12-03 2005-06-23 Glycopegylated factor IX

Publications (2)

Publication Number Publication Date
WO2005055950A2 WO2005055950A2 (en) 2005-06-23
WO2005055950A3 true WO2005055950A3 (en) 2005-10-20

Family

ID=34682416

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/041070 WO2005055950A2 (en) 2003-12-03 2004-12-03 Glycopegylated factor ix

Country Status (10)

Country Link
EP (1) EP1694315A4 (en)
JP (1) JP4738346B2 (en)
KR (1) KR101209111B1 (en)
AU (1) AU2004296860B2 (en)
BR (1) BRPI0417341A (en)
CA (1) CA2549413A1 (en)
IL (1) IL175661A0 (en)
MX (1) MXPA06006023A (en)
NZ (1) NZ546733A (en)
WO (1) WO2005055950A2 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Families Citing this family (43)

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US7763769B2 (en) 2001-02-16 2010-07-27 Kci Licensing, Inc. Biocompatible wound dressing
US7700819B2 (en) 2001-02-16 2010-04-20 Kci Licensing, Inc. Biocompatible wound dressing
US7214660B2 (en) 2001-10-10 2007-05-08 Neose Technologies, Inc. Erythropoietin: remodeling and glycoconjugation of erythropoietin
US7173003B2 (en) 2001-10-10 2007-02-06 Neose Technologies, Inc. Granulocyte colony stimulating factor: remodeling and glycoconjugation of G-CSF
BRPI0408358A (en) 2003-03-14 2006-03-21 Neose Technologies Inc branched water-soluble polymers and their conjugates
MXPA05010773A (en) 2003-04-09 2005-12-12 Neose Technologies Inc Glycopegylation methods and proteins/peptides produced by the methods.
WO2005012484A2 (en) 2003-07-25 2005-02-10 Neose Technologies, Inc. Antibody-toxin conjugates
US8633157B2 (en) 2003-11-24 2014-01-21 Novo Nordisk A/S Glycopegylated erythropoietin
US20080305992A1 (en) 2003-11-24 2008-12-11 Neose Technologies, Inc. Glycopegylated erythropoietin
CN101072789B (en) 2004-01-08 2013-05-15 生物种属学股份公司 O-linked glycosylation of peptides
EP1765411B2 (en) 2004-06-30 2017-10-11 Nektar Therapeutics Polymer-factor ix moiety conjugates
AU2014280936B2 (en) * 2004-06-30 2016-12-15 Nektar Therapeutics Polymer-factor ix moiety conjugates
US20080300173A1 (en) 2004-07-13 2008-12-04 Defrees Shawn Branched Peg Remodeling and Glycosylation of Glucagon-Like Peptides-1 [Glp-1]
WO2006031811A2 (en) 2004-09-10 2006-03-23 Neose Technologies, Inc. Glycopegylated interferon alpha
JP5948627B2 (en) 2004-10-29 2016-07-20 レイショファーム ゲーエムベーハー Fibroblast growth factor (FGF) remodeling and carbohydrate pegylation
EP1858543B1 (en) 2005-01-10 2013-11-27 BioGeneriX AG Glycopegylated granulocyte colony stimulating factor
EP2386571B1 (en) 2005-04-08 2016-06-01 ratiopharm GmbH Compositions and methods for the preparation of protease resistant human growth hormone glycosylation mutants
US20070105755A1 (en) 2005-10-26 2007-05-10 Neose Technologies, Inc. One pot desialylation and glycopegylation of therapeutic peptides
JP2009515508A (en) * 2005-08-19 2009-04-16 ネオス テクノロジーズ インコーポレイテッド GlycoPEGylated Factor VII and Factor VIIA
WO2007056191A2 (en) 2005-11-03 2007-05-18 Neose Technologies, Inc. Nucleotide sugar purification using membranes
US9187532B2 (en) 2006-07-21 2015-11-17 Novo Nordisk A/S Glycosylation of peptides via O-linked glycosylation sequences
JP2010505874A (en) 2006-10-03 2010-02-25 ノヴォ ノルディスク アー／エス Purification method for polypeptide conjugates
CN101600448B (en) * 2006-10-04 2015-11-25 诺和诺德公司 The sugar of the PEGization that glycerol connects and glycopeptide
US8637007B2 (en) 2006-12-15 2014-01-28 Baxter International Inc. Factor VIIa-polysialic acid conjugate having prolonged in vivo half-life
KR20150064246A (en) 2007-04-03 2015-06-10 바이오제너릭스 게엠베하 Methods of treatment using glycopegylated g―csf
EP2517714A1 (en) * 2007-04-26 2012-10-31 Inspiration Biopharmaceuticals, Inc. Recombinant vitamin K dependent proteins with high sialic acid content and methods of preparing same
CA2690611C (en) 2007-06-12 2015-12-08 Novo Nordisk A/S Improved process for the production of nucleotide sugars
US8207112B2 (en) 2007-08-29 2012-06-26 Biogenerix Ag Liquid formulation of G-CSF conjugate
JP5613876B2 (en) * 2007-10-15 2014-10-29 ザ・ユニヴァーシティ・オヴ・ノース・キャロライナ・アト・チャペル・ヒル Human factor IX variants with extended half-life
US20090176708A1 (en) * 2007-12-27 2009-07-09 Peter Turecek Chemically modified factor ix
WO2009108806A1 (en) 2008-02-27 2009-09-03 Novo Nordisk A/S Conjugated factor viii molecules
KR20110005862A (en) * 2008-04-16 2011-01-19 바이엘 헬스케어 엘엘씨 Modified factor ix polypeptides and uses thereof
US8642737B2 (en) 2010-07-26 2014-02-04 Baxter International Inc. Nucleophilic catalysts for oxime linkage
ES2856055T3 (en) 2009-07-27 2021-09-27 Baxalta GmbH Glycopolysialylation of proteins other than blood clotting proteins
US8809501B2 (en) 2009-07-27 2014-08-19 Baxter International Inc. Nucleophilic catalysts for oxime linkage
CA2769326A1 (en) 2009-07-27 2011-02-10 Baxter International Inc. Blood coagulation protein conjugates
ES2590679T3 (en) 2009-07-27 2016-11-23 Lipoxen Technologies Limited Glycopolyallylation of proteins other than blood coagulation proteins
EA201290069A1 (en) * 2009-07-31 2012-07-30 Байер Хелскер Ллс MODIFIED POLYPEPTIDES OF FACTOR IX AND THEIR APPLICATION
US8697844B2 (en) 2009-11-24 2014-04-15 Novo Nordisk A/S Method of purifying pegylated proteins
NZ605348A (en) 2010-07-09 2015-01-30 Biogen Idec Hemophilia Inc Factor ix polypeptides and methods of use thereof
KR102025442B1 (en) 2010-12-22 2019-09-25 박스알타 인코퍼레이티드 Materials and methods for conjugating a water soluble fatty acid derivative to a protein
TW201519900A (en) * 2013-04-28 2015-06-01 Bayer Healthcare Llc Compositions and methods for inducing immune tolerance to coagulation factor proteins
CN113573726A (en) 2019-03-19 2021-10-29 康诺贝林伦瑙有限公司 Factor IX variants and their use in therapy

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8076292B2 (en) 2001-10-10 2011-12-13 Novo Nordisk A/S Factor VIII: remodeling and glycoconjugation of factor VIII
US8791070B2 (en) 2003-04-09 2014-07-29 Novo Nordisk A/S Glycopegylated factor IX
US8632770B2 (en) 2003-12-03 2014-01-21 Novo Nordisk A/S Glycopegylated factor IX
US8404809B2 (en) 2005-05-25 2013-03-26 Novo Nordisk A/S Glycopegylated factor IX

Also Published As

Publication number Publication date
KR20060123224A (en) 2006-12-01
EP1694315A2 (en) 2006-08-30
CA2549413A1 (en) 2005-06-23
NZ546733A (en) 2009-07-31
IL175661A0 (en) 2006-09-05
JP2007513190A (en) 2007-05-24
MXPA06006023A (en) 2006-08-23
JP4738346B2 (en) 2011-08-03
AU2004296860A1 (en) 2005-06-23
WO2005055950A2 (en) 2005-06-23
AU2004296860B2 (en) 2010-04-22
BRPI0417341A (en) 2007-04-17
KR101209111B1 (en) 2012-12-06
EP1694315A4 (en) 2009-10-28

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