DK2797622T3 - PH20-polypeptidvarianter, formuleringer og anvendelser deraf - Google Patents

PH20-polypeptidvarianter, formuleringer og anvendelser deraf Download PDF

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DK2797622T3
DK2797622T3 DK12816624.6T DK12816624T DK2797622T3 DK 2797622 T3 DK2797622 T3 DK 2797622T3 DK 12816624 T DK12816624 T DK 12816624T DK 2797622 T3 DK2797622 T3 DK 2797622T3
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position corresponding
polypeptide
amino acid
modified
seq
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DK12816624.6T
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Ge Wei
Qiping Zhao
Robert James Connor
H Michael Shepard
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Halozyme Inc
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    • 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
    • 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
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
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    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/34—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
    • 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
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/914—Hydrolases (3)
    • G01N2333/924—Hydrolases (3) acting on glycosyl compounds (3.2)
    • G01N2333/926—Hydrolases (3) acting on glycosyl compounds (3.2) acting on alpha -1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90—Enzymes; Proenzymes
    • G01N2333/914—Hydrolases (3)
    • G01N2333/924—Hydrolases (3) acting on glycosyl compounds (3.2)
    • G01N2333/926—Hydrolases (3) acting on glycosyl compounds (3.2) acting on alpha -1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
    • G01N2333/928—Hydrolases (3) acting on glycosyl compounds (3.2) acting on alpha -1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase acting on alpha -1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
    • 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

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  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Diabetes (AREA)
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Claims (19)

1. Modificeret PH20-polypeptid, omfattende en aminosyreerstatning i et umodificeret PH20-polypeptid, hvori: det umodificerede PH20-polypeptid består af sekvensen af aminosyrer anført i enhver af SEQ ID NOS: 3, 7 eller 32 - 66; aminosyreerstatningen er i en aminosyreposition svarende til en position 10, 12, 20, 22, 26, 34, 36, 46, 50, 52, 58, 68, 70, 74, 82, 83, 84, 86, 97, 127, 138, 142, 143, 144, 166, 169, 174, 193, 195, 196, 204, 205, 206, 213, 234, 237, 238, 240, 249, 261, 267, 277, 279, 291, 309, 310, 314, 315, 317, 318, 347, 367, 375, 376, 399, 401, 407, 416, 419, 421, 431, 433, 439, 440, 443 eller 445 med henvisning til aminosyrepositioner anført i SEQ ID NO: 3, med det forbehold, at hvis det modificerede PH20-polypeptid indbefatter kun én enkelt aminosyreerstatning, så svarer erstatningen ikke til aminosyreerstatninger V12A eller E249Q med henvisning til aminosyrepositioner anført i SEQ ID NO: 3; tilsvarende aminosyrepositioner er identificeret ved at indrette PH20-polypeptidet på linie langs med polypeptidet anført i SEQ ID NO: 3; det modificerede PH20-polypeptid udviser øget stabilitet i nærværet af et phenolkonserveringsmiddel/-midler sammenlignet med det umodificerede PH20-polypeptid, som ikke indeholder aminosyreerstatningen; øget stabilitet viser sig som øget hyaluronidaseaktivitet, i nærværet af phenolkonserveringsmidlet/-midlerne, sammenlignet med hyaluronidaseaktivitet af det umodificerede PH20-polypeptid, som ikke indeholder aminosyreerstatningen, i nærværet af de(t)samme phenolkonserveringsmiddel/-midler, og aktiviteten sammenlignes under de samme betingelser.
2. Modificeret PH20-polypeptid ifølge krav 1, hvori konserveringsmidlet er et phenolkonserveringsmiddel, der er m-cresol, phenol, eller m-cresol og phenol.
3. Modificeret PH20-polypeptid ifølge krav 1 eller krav 2, omfattende mindst en aminosyreerstatning valgt blandt erstatning med: T i en position svarende til position 52, K i en position svarende til position 58, R i en position svarende til position 58, V i en position svarende til position 83, P i en position svarende til position 204, M i en position svarende til position 234, A i en position svarende til position 261, Q i en position svarende til position 310; og H i en position svarende til position 421, med henvisning til aminosyrerestpositioner anført i SEQ ID NO: 3.
4. Modificeret PH20-polypeptid ifølge ethvert af kravene 1-3, omfattende erstatning med P i en position svarende til position 204 i et PH20-polypeptid med henvisning til aminosyrerestpositioner anført i SEQ ID NO: 3.
5. Modificeret PH20-polypeptid ifølge ethvert af kravene 1-4, omfattende op til 5 aminosyreerstatninger.
6. Modificeret polypeptid ifølge ethvert af kravene 2-4, omfattende erstatning med P i en position svarende til position 204 i et PH20-polypeptid og op til 5 yderligere aminosyreerstatninger, hvori aminosyreerstatningen/-erstatningerne er i et umodificeret PH20-polypeptid, som består af sekvensen af aminosyrer anført i SEQ ID NO: 3.
7. Modificeret PH20-polypeptid ifølge ethvert af kravene 1 -6, der er glycosyleret.
8. Modificeret PH20-polypeptid ifølge ethvert af kravene 1-7, der er modificeret ved konjugering til en polymer, for eksempel dextran eller PEG, og/eller er konjugeret til en enhed valgt blandt et multimeriseringsdomæne, toksin, påviselig mærke eller lægemiddel.
9. Nukleinsyremolekyle, der koder for et modificeret PH20-polypeptid ifølge ethvert af kravene 1 -8.
10. Vektor omfattende nukleinsyremolekylet ifølge krav 9.
11. Celle omfattende vektoren ifølge krav 10.
12. Fremgangsmåde til at fremstille et modificeret PH20-polypeptid omfattende, at: indføre nukleinsyren ifølge krav 9 eller vektoren ifølge krav 10 i en celle, der er i stand til at inkorporere N-koblede sukkerenheder ind i polypeptidet; og dyrke cellen under betingelser, hvorved et kodet modificeret PH20-polypeptid produceres, og udskilles af cellen.
13. Fremgangsmåde ifølge krav 12 yderligere omfattende at genvinde det udtrykte polypeptid.
14. Farmaceutisk sammensætning omfattende et modificeret PH20-polypeptid ifølge ethvert af kravene 1 -8 i en farmaceutisk acceptabel excipiens.
15. Farmaceutisk sammensætning ifølge krav 14 omfattende et terapeutisk aktivt middel.
16. Farmaceutisk sammensætning ifølge krav 15, hvori det terapeutiske middel er et insulin.
17. Farmaceutisk sammensætning ifølge krav 15, hvori det terapeutiske middel er et insulin, der er et hurtigtvirkende insulin.
18. Farmaceutisk sammensætning ifølge krav 15, hvori det terapeutiske middel er et hurtigtvirkende insulin, som er et almindeligt insulin eller er et insulin-analog.
19. Farmaceutisk sammensætning ifølge ethvert af kravene 14-18 til anvendelse ved behandling af en hyaluronan-associeret sygdom eller lidelse, eller til anvendelse ved behandling af diabetes, eller til anvendelse i afgivelse af et terapeutisk middel til et individ.
DK12816624.6T 2011-12-30 2012-12-28 PH20-polypeptidvarianter, formuleringer og anvendelser deraf DK2797622T3 (da)

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US201161631313P 2011-12-30 2011-12-30
US201261796208P 2012-11-01 2012-11-01
PCT/US2012/072182 WO2013102144A2 (en) 2011-12-30 2012-12-28 Ph20 polypeptede variants, formulations and uses thereof

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MX361727B (es) 2018-12-14
ES2609582T3 (es) 2017-04-21
US20140178330A9 (en) 2014-06-26
LT3130347T (lt) 2019-10-25
CN104244968B (zh) 2017-07-25
US20240011008A1 (en) 2024-01-11
CA2861919A1 (en) 2013-07-04
US20240002825A1 (en) 2024-01-04
US11066656B2 (en) 2021-07-20
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US11041149B2 (en) 2021-06-22
US20230295593A1 (en) 2023-09-21

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