WO2004078140A3 - SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF - Google Patents

SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF Download PDF

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Publication number
WO2004078140A3
WO2004078140A3 PCT/US2004/006656 US2004006656W WO2004078140A3 WO 2004078140 A3 WO2004078140 A3 WO 2004078140A3 US 2004006656 W US2004006656 W US 2004006656W WO 2004078140 A3 WO2004078140 A3 WO 2004078140A3
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WO
WIPO (PCT)
Prior art keywords
shasegp
neutral active
soluble
preparing
pharmaceutical compositions
Prior art date
Application number
PCT/US2004/006656
Other languages
French (fr)
Other versions
WO2004078140A2 (en
Inventor
Louis H Bookbinder
Anirban Kundu
Gregory I Frost
Original Assignee
Halozyme Inc
Louis H Bookbinder
Anirban Kundu
Gregory I Frost
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32962713&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2004078140(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to CA2517145A priority Critical patent/CA2517145C/en
Priority to JP2006509139A priority patent/JP4464395B2/en
Priority to AU2004218354A priority patent/AU2004218354B2/en
Priority to MXPA05009429A priority patent/MXPA05009429A/en
Priority to BRPI0408116-1A priority patent/BRPI0408116B1/en
Priority to PL04717941T priority patent/PL1603541T5/en
Priority to KR1020137028488A priority patent/KR20130135986A/en
Priority to EP04717941A priority patent/EP1603541B2/en
Priority to SI200431327T priority patent/SI1603541T2/en
Priority to NZ542873A priority patent/NZ542873A/en
Priority to CN2004800114897A priority patent/CN1942588B/en
Priority to DE602004024041T priority patent/DE602004024041D1/en
Priority to EA200501384A priority patent/EA009383B1/en
Priority to KR1020117020286A priority patent/KR101233457B1/en
Priority to KR1020127015300A priority patent/KR101363658B1/en
Priority to AT04717941T priority patent/ATE448323T1/en
Priority to DK04717941.1T priority patent/DK1603541T4/en
Priority to ES04717941T priority patent/ES2335005T5/en
Application filed by Halozyme Inc, Louis H Bookbinder, Anirban Kundu, Gregory I Frost filed Critical Halozyme Inc
Publication of WO2004078140A2 publication Critical patent/WO2004078140A2/en
Priority to IL170300A priority patent/IL170300A/en
Publication of WO2004078140A3 publication Critical patent/WO2004078140A3/en
Priority to HK06106817.2A priority patent/HK1086746A1/en
Priority to IL227867A priority patent/IL227867A/en

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    • 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)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
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    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
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    • A—HUMAN NECESSITIES
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    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P9/00—Drugs for disorders of the cardiovascular system
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    • A61P9/00—Drugs for disorders of the cardiovascular system
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
    • C07H21/00—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
    • C07H21/04—Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with deoxyribosyl as saccharide radical
    • 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)
    • C12N9/24—Hydrolases (3) acting on glycosyl compounds (3.2)
    • C12N9/2402—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1)
    • C12N9/2474—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
    • C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
    • C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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

Abstract

The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGP's), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino­terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated forms of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.
PCT/US2004/006656 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF WO2004078140A2 (en)

Priority Applications (21)

Application Number Priority Date Filing Date Title
CN2004800114897A CN1942588B (en) 2003-03-05 2004-03-05 Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof
DK04717941.1T DK1603541T4 (en) 2003-03-05 2004-03-05 Soluble Hyaluronidase Glycoprotein (sHASEGP), Method for Preparing the Same,
AU2004218354A AU2004218354B2 (en) 2003-03-05 2004-03-05 Soluble hyaluronidase glycoprotein (sHASEGP), process for preparing the same, uses and pharmaceutical compositions comprising thereof
MXPA05009429A MXPA05009429A (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF.
BRPI0408116-1A BRPI0408116B1 (en) 2003-03-05 2004-03-05 POLYMER-CONJUGATED SOLUBLE HYALURONIDASE POLYPEPTIDES, PHARMACEUTICAL COMPOSITIONS COMPRISING SOLUBLE PH20 POLYPEPTIDES, THEIR USES AND PREPARATION PROCESS, AND NUCLEIC ACIDS ENCODING SOLUBLE HYALURONIDASE POLYPEPTIDES
PL04717941T PL1603541T5 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
KR1020137028488A KR20130135986A (en) 2003-03-05 2004-03-05 Soluble hyaluronidase glycoprotein (shasegp), process for preparing the same, uses and pharmaceutical compositions comprising thereof
EP04717941A EP1603541B2 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
SI200431327T SI1603541T2 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
NZ542873A NZ542873A (en) 2003-03-05 2004-03-05 Soluble, neutral-active hyaluronidase activity glycoprotein (sHASEGP) that is produced with high yield in a mammalian expression system by introducing nucleic acids that lack a narrow region encoding amino acids in the carboxy terminus of the human PH20 cDNA
DE602004024041T DE602004024041D1 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (SHASEGP), METHOD OF ITS PREPARATION, USES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEREOF
CA2517145A CA2517145C (en) 2003-03-05 2004-03-05 Soluble hyaluronidase glycoprotein (shasegp), process for preparing the same, uses and pharmaceutical compositions comprising thereof
KR1020127015300A KR101363658B1 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
KR1020117020286A KR101233457B1 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
EA200501384A EA009383B1 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF
AT04717941T ATE448323T1 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (SHASEGP), METHOD FOR PRODUCTION THEREOF, USES AND PHARMACEUTICAL COMPOSITIONS CONTAINING SAME
JP2006509139A JP4464395B2 (en) 2003-03-05 2004-03-05 Soluble hyaluronidase glycoprotein (sHASEGP), process for its preparation, use and pharmaceutical composition comprising it
ES04717941T ES2335005T5 (en) 2003-03-05 2004-03-05 Soluble hyaluronidase glycoprotein (shasegp), process to prepare it, uses and pharmaceutical compositions that comprise it
IL170300A IL170300A (en) 2003-03-05 2005-08-16 Nucleic acid molecules encoding soluble hyaluronidase glycoproteins (shasegps), and methods for preparing the encoded shasegps
HK06106817.2A HK1086746A1 (en) 2003-03-05 2006-06-14 Soluble hyaluronidase glycoprotein (shasegp), process for preparing the same, uses and pharmaceutical compositions comprising thereof
IL227867A IL227867A (en) 2003-03-05 2013-08-08 Soluble hyaluronidase glycoprotein (shasegp), process for preparing the same, uses and pharmaceutical compositions comprising them

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US45236003P 2003-03-05 2003-03-05
US60/452,360 2003-03-05

Publications (2)

Publication Number Publication Date
WO2004078140A2 WO2004078140A2 (en) 2004-09-16
WO2004078140A3 true WO2004078140A3 (en) 2005-11-17

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ID=32962713

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/006656 WO2004078140A2 (en) 2003-03-05 2004-03-05 SOLUBLE HYALURONIDASE GLYCOPROTEIN (sHASEGP), PROCESS FOR PREPARING THE SAME, USES AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEREOF

Country Status (27)

Country Link
US (14) US7767429B2 (en)
EP (7) EP2330213A1 (en)
JP (3) JP4464395B2 (en)
KR (4) KR20130135986A (en)
CN (2) CN102943067B (en)
AT (1) ATE448323T1 (en)
AU (2) AU2004218354B2 (en)
BR (1) BRPI0408116B1 (en)
CA (1) CA2517145C (en)
CY (6) CY1109750T1 (en)
DE (1) DE602004024041D1 (en)
DK (4) DK2163643T3 (en)
EA (1) EA009383B1 (en)
ES (4) ES2532399T3 (en)
FR (1) FR16C0030I1 (en)
HK (4) HK1086746A1 (en)
HU (2) HUE027661T2 (en)
IL (2) IL170300A (en)
LU (2) LU92780I2 (en)
MX (1) MXPA05009429A (en)
NZ (1) NZ542873A (en)
PL (4) PL2177620T3 (en)
PT (3) PT1603541E (en)
SG (2) SG2012041067A (en)
SI (4) SI1603541T2 (en)
WO (1) WO2004078140A2 (en)
ZA (1) ZA200507978B (en)

Cited By (13)

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US7923011B2 (en) 2006-10-12 2011-04-12 Genentech, Inc. Antibodies to lymphotoxin-alpha
US8497072B2 (en) 2005-11-30 2013-07-30 Abbott Laboratories Amyloid-beta globulomer antibodies
US8664367B2 (en) 2010-05-14 2014-03-04 Abbvie, Inc. IL-I binding proteins
US8691224B2 (en) 2005-11-30 2014-04-08 Abbvie Inc. Anti-Aβ globulomer 5F7 antibodies
US8835610B2 (en) 2009-03-05 2014-09-16 Abbvie Inc. IL-17 binding proteins
US8877190B2 (en) 2006-11-30 2014-11-04 Abbvie Inc. Aβ conformer selective anti-Aβ globulomer monoclonal antibodies
US8895004B2 (en) 2007-02-27 2014-11-25 AbbVie Deutschland GmbH & Co. KG Method for the treatment of amyloidoses
US8927249B2 (en) 2008-12-09 2015-01-06 Halozyme, Inc. Extended soluble PH20 polypeptides and uses thereof
US8962803B2 (en) 2008-02-29 2015-02-24 AbbVie Deutschland GmbH & Co. KG Antibodies against the RGM A protein and uses thereof
US8987419B2 (en) 2010-04-15 2015-03-24 AbbVie Deutschland GmbH & Co. KG Amyloid-beta binding proteins
US9034323B2 (en) 2008-04-28 2015-05-19 Halozyme, Inc. Method for control of post-prandial glucose
US9176150B2 (en) 2003-01-31 2015-11-03 AbbVie Deutschland GmbH & Co. KG Amyloid beta(1-42) oligomers, derivatives thereof and antibodies thereto, methods of preparation thereof and use thereof
US9562223B2 (en) 2003-03-05 2017-02-07 Halozyme, Inc. Methods for reducing intraocular pressure by administering a soluble hyaluronidase glycoprotein (sHASEGP)

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