HRP20192249T1 - Varijante ph20 polipeptida, njihove formulacije i uporabe - Google Patents
Varijante ph20 polipeptida, njihove formulacije i uporabe Download PDFInfo
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- HRP20192249T1 HRP20192249T1 HRP20192249TT HRP20192249T HRP20192249T1 HR P20192249 T1 HRP20192249 T1 HR P20192249T1 HR P20192249T T HRP20192249T T HR P20192249TT HR P20192249 T HRP20192249 T HR P20192249T HR P20192249 T1 HRP20192249 T1 HR P20192249T1
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- position corresponding
- amino acid
- polypeptide
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- 229920001184 polypeptide Polymers 0.000 title claims 32
- 102000004196 processed proteins & peptides Human genes 0.000 title claims 32
- 108090000765 processed proteins & peptides Proteins 0.000 title claims 32
- 101150055528 SPAM1 gene Proteins 0.000 title claims 26
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 102100021102 Hyaluronidase PH-20 Human genes 0.000 claims 25
- 125000003275 alpha amino acid group Chemical group 0.000 claims 21
- 238000006467 substitution reaction Methods 0.000 claims 13
- 206010028980 Neoplasm Diseases 0.000 claims 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
- 239000008194 pharmaceutical composition Substances 0.000 claims 5
- 208000024172 Cardiovascular disease Diseases 0.000 claims 3
- 229920002683 Glycosaminoglycan Polymers 0.000 claims 3
- 108010003272 Hyaluronate lyase Proteins 0.000 claims 3
- 102000001974 Hyaluronidases Human genes 0.000 claims 3
- 208000019693 Lung disease Diseases 0.000 claims 3
- 238000009825 accumulation Methods 0.000 claims 3
- 210000004556 brain Anatomy 0.000 claims 3
- 239000003814 drug Substances 0.000 claims 3
- 230000000694 effects Effects 0.000 claims 3
- 229960002773 hyaluronidase Drugs 0.000 claims 3
- 102000039446 nucleic acids Human genes 0.000 claims 3
- 108020004707 nucleic acids Proteins 0.000 claims 3
- 150000007523 nucleic acids Chemical class 0.000 claims 3
- 229940124597 therapeutic agent Drugs 0.000 claims 3
- 150000001413 amino acids Chemical group 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 229920002307 Dextran Polymers 0.000 claims 1
- OVRNDRQMDRJTHS-FMDGEEDCSA-N N-acetyl-beta-D-glucosamine Chemical group CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O OVRNDRQMDRJTHS-FMDGEEDCSA-N 0.000 claims 1
- 125000000539 amino acid group Chemical group 0.000 claims 1
- CKLJMWTZIZZHCS-REOHCLBHSA-N aspartic acid group Chemical group N[C@@H](CC(=O)O)C(=O)O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims 1
- 230000021523 carboxylation Effects 0.000 claims 1
- 238000006473 carboxylation reaction Methods 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 201000010099 disease Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 230000006126 farnesylation Effects 0.000 claims 1
- 230000013595 glycosylation Effects 0.000 claims 1
- 238000006206 glycosylation reaction Methods 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 230000033444 hydroxylation Effects 0.000 claims 1
- 238000005805 hydroxylation reaction Methods 0.000 claims 1
- 238000002955 isolation Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 230000004048 modification Effects 0.000 claims 1
- 238000012986 modification Methods 0.000 claims 1
- 230000035515 penetration Effects 0.000 claims 1
- 230000026731 phosphorylation Effects 0.000 claims 1
- 238000006366 phosphorylation reaction Methods 0.000 claims 1
Classifications
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- 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
-
- 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
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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
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- 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
- 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
- A61K47/06—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
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- 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
-
- C—CHEMISTRY; METALLURGY
- 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
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- 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
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- 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
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- 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
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- 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
Claims (21)
1. Modificirani PH20 polipeptid, koji sadrži jednu ili više aminokiselinskih zamjena u nemodificiranom PH20 polipeptidu, naznačen time što:
nemodificirani PH20 polipeptid se sastoji od sekvence aminokiselina navedene u SEQ ID NO: 3, 7 ili 32-66; modificirani PH20 polipeptid ispoljava aktivnost hijaluronidaze koja je najmanje 120% od aktivnosti hijaluronidaze u poređenju sa nemodificiranim PH20 polipeptidom koji ne sadrži aminokiselinsku zamjenu (zamjene); aminokiselinska zamjena je na položaju koji odgovara položaju izabranom od 1, 12, 15, 24, 26, 27, 29, 30, 31, 32, 33, 37, 39, 46, 48, 52, 58, 63, 67, 68, 69, 70, 71, 72, 73, 74, 75, 84, 86, 87, 92, 93, 94, 97, 118, 120, 127, 131, 135, 141, 142, 147, 148, 150, 151, 152, 155, 156, 163, 164, 165, 166, 169, 170, 174, 198, 206, 209, 212, 213, 215, 219, 233, 234, 236, 238, 247, 257, 259, 260, 261, 263, 269, 271, 272, 276, 277, 278, 282, 291, 293, 305, 308, 309, 310, 313, 315, 317, 318, 320, 324, 325, 326, 328, 347, 353, 359, 371, 377, 380, 389, 392, 395, 399, 405, 407, 409, 410, 418, 419, 421, 425, 431, 433, 436, 437, 438, 439, 440, 441, 442, 443, 445, 446 i 447 u vezi sa aminokiselinskim položajima navedenim u SEQ ID NO:3, pri čemu odgovarajući aminokiselinski položaji su identificirani poravnanjem PH20 polipeptida sa polipeptidom koji ima sekvencu aminokiselina navedenu u SEQ ID NO:3, uz uvjet da ako modificirani PH20 polipeptid obuhvaća samo jednu aminokiselinsku zamjenu, zamjena ne odgovara aminokiselinskoj zamjeni N219A u vezi sa aminokiselinskim položajima navedenim u SEQ ID NO:3; i modificirani PH20 polipeptid sadrži do 10 aminokiselinskih zamjena u usporedbi sa nemodificiranim PH20 polipeptidom koji ne sadrži zamjenu (zamjene).
2. Modificirani PH20 polipeptid prema patentnom zahtjevu 1, naznačen time što aminokiselinska zamjena je izabrana od: histidina (H) na položaju koji odgovara položaju 1; Q na položaju koji odgovara položaju 1; V na položaju koji odgovara položaju 15; E na položaju koji odgovara položaju 24; H na položaju koji odgovara položaju 24; K na položaju koji odgovara položaju 27; R na položaju koji odgovara položaju 27; E na položaju koji odgovara položaju 29; I na položaju koji odgovara položaju 29; L na položaju koji odgovara položaju 29; M na položaju koji odgovara položaju 29; P na položaju koji odgovara položaju 29; S na položaju koji odgovara položaju 29; V na položaju koji odgovara položaju 29; G na položaju koji odgovara položaju 30; H na položaju koji odgovara položaju 30; K na položaju koji odgovara položaju 30; M na položaju koji odgovara položaju 30; R na položaju koji odgovara položaju 30; S na položaju koji odgovara položaju 30; A na položaju koji odgovara položaju 31; C na položaju koji odgovara položaju 31; H na položaju koji odgovara položaju 31; I na položaju koji odgovara položaju 31; K na položaju koji odgovara položaju 31; L na položaju koji odgovara položaju 31; P na položaju koji odgovara položaju 31; R na položaju koji odgovara položaju 31; S na položaju koji odgovara položaju 31; T na položaju koji odgovara položaju 31; V na položaju koji odgovara položaju 31; F na položaju koji odgovara položaju 32; G na položaju koji odgovara položaju 32; H na položaju koji odgovara položaju 32; W na položaju koji odgovara položaju 33; F na položaju koji odgovara položaju 37; N na položaju koji odgovara položaju 39; T na položaju koji odgovara položaju 39; F na položaju koji odgovara položaju 48; H na položaju koji odgovara položaju 48; N na položaju koji odgovara položaju 48; W na položaju koji odgovara položaju 63; V na položaju koji odgovara položaju 67; A na položaju koji odgovara položaju 69; C na položaju koji odgovara položaju 69; F na položaju koji odgovara položaju 69; G na položaju koji odgovara položaju 69; I na položaju koji odgovara položaju 69; L na položaju koji odgovara položaju 69; M na položaju koji odgovara položaju 69; P na položaju koji odgovara položaju 69; R na položaju koji odgovara položaju 69; W na položaju koji odgovara položaju 69; Y na položaju koji odgovara položaju 69; R na položaju koji odgovara položaju 71; S na položaju koji odgovara položaju 71; M na položaju koji odgovara položaju 72; Q na položaju koji odgovara položaju 72; H na položaju koji odgovara položaju 73; L na položaju koji odgovara položaju 73; W na položaju koji odgovara položaju 73; F na položaju koji odgovara položaju 75; L na položaju koji odgovara položaju 75; R na položaju koji odgovara položaju 75; T na položaju koji odgovara položaju 75; C na položaju koji odgovara položaju 87; T na položaju koji odgovara položaju 87; Y na položaju koji odgovara položaju 87; C na položaju koji odgovara položaju 92; I na položaju koji odgovara položaju 93; L na položaju koji odgovara položaju 93; R na položaju koji odgovara položaju 93; T na položaju koji odgovara položaju 93; R na položaju koji odgovara položaju 94; Q na položaju koji odgovara položaju 118; F na položaju koji odgovara položaju 120; V na položaju koji odgovara položaju 120; Y na položaju koji odgovara položaju 120; D na položaju koji odgovara položaju 135; G na položaju koji odgovara položaju 135; R na položaju koji odgovara položaju 135; H na položaju koji odgovara položaju 141; Y na položaju koji odgovara položaju 141; R na položaju koji odgovara položaju 147; V na položaju koji odgovara položaju 147; K na položaju koji odgovara položaju 148; G na položaju koji odgovara položaju 150; K na položaju koji odgovara položaju 151; L na položaju koji odgovara položaju 151; M na položaju koji odgovara položaju 151; Q na položaju koji odgovara položaju 151; R na položaju koji odgovara položaju 151; R na položaju koji odgovara položaju 152; G na položaju koji odgovara položaju 155; K na položaju koji odgovara položaju 155; D na položaju koji odgovara položaju 156; A na položaju koji odgovara položaju 163; E na položaju koji odgovara položaju 163; K na položaju koji odgovara položaju 163; R na položaju koji odgovara položaju 163; M na položaju koji odgovara položaju 164; D na položaju koji odgovara položaju 165; N na položaju koji odgovara položaju 165; R na položaju koji odgovara položaju 170; D na položaju koji odgovara položaju 198; N na položaju koji odgovara položaju 212; M na položaju koji odgovara položaju 215; S na položaju koji odgovara položaju 219; K na položaju koji odgovara položaju 233; R na položaju koji odgovara položaju 233; R na položaju koji odgovara položaju 236; I na položaju koji odgovara položaju 247; T na položaju koji odgovara položaju 257; P na položaju koji odgovara položaju 259; Y na položaju koji odgovara položaju 260; K na položaju koji odgovara položaju 263; R na položaju koji odgovara položaju 263; A na položaju koji odgovara položaju 269; L na položaju koji odgovara položaju 271; M na položaju koji odgovara položaju 271; T na položaju koji odgovara položaju 272; D na položaju koji odgovara položaju 276; S na položaju koji odgovara položaju 276; Y na položaju koji odgovara položaju 276; H na položaju koji odgovara položaju 278; K na položaju koji odgovara položaju 278; N na položaju koji odgovara položaju 278; R na položaju koji odgovara položaju 278; S na položaju koji odgovara položaju 278; T na položaju koji odgovara položaju 278; Y na položaju koji odgovara položaju 278; M na položaju koji odgovara položaju 282; A na položaju koji odgovara položaju 293; C na položaju koji odgovara položaju 293; F na položaju koji odgovara položaju 293; M na položaju koji odgovara položaju 293; P na položaju koji odgovara položaju 293; Q na položaju koji odgovara položaju 293; V na položaju koji odgovara položaju 293; E na položaju koji odgovara položaju 305; G na položaju koji odgovara položaju 308; N na položaju koji odgovara položaju 308; K na položaju koji odgovara položaju 313; R na položaju koji odgovara položaju 313; H na položaju koji odgovara položaju 320; K na položaju koji odgovara položaju 320; R na položaju koji odgovara položaju 320; R na položaju koji odgovara položaju 324; A na položaju koji odgovara položaju 325; D na položaju koji odgovara položaju 325; E na položaju koji odgovara položaju 325; G na položaju koji odgovara položaju 325; H na položaju koji odgovara položaju 325; K na položaju koji odgovara položaju 325; M na položaju koji odgovara položaju 325; N na položaju koji odgovara položaju 325; Q na položaju koji odgovara položaju 325; S na položaju koji odgovara položaju 325; V na položaju koji odgovara položaju 326; I na položaju koji odgovara položaju 328; K na položaju koji odgovara položaju 328; L na položaju koji odgovara položaju 328; S na položaju koji odgovara položaju 328; Y na položaju koji odgovara položaju 328; V na položaju koji odgovara položaju 353; T na položaju koji odgovara položaju 359; R na položaju koji odgovara položaju 371; P na položaju koji odgovara položaju 377; T na položaju koji odgovara položaju 377; W na položaju koji odgovara položaju 380; Y na položaju koji odgovara položaju 380; K na položaju koji odgovara položaju 389; M na položaju koji odgovara položaju 392; R na položaju koji odgovara položaju 395; G na položaju koji odgovara položaju 405; A na položaju koji odgovara položaju 409; Q na položaju koji odgovara položaju 409; T na položaju koji odgovara položaju 410; P na položaju koji odgovara položaju 418; K na položaju koji odgovara položaju 425; K na položaju koji odgovara položaju 436; I na položaju koji odgovara položaju 437; M na položaju koji odgovara položaju 437; T na položaju koji odgovara položaju 438; F na položaju koji odgovara položaju 441; R na položaju koji odgovara položaju 442; A na položaju koji odgovara položaju 446; D na položaju koji odgovara položaju 447; N na položaju koji odgovara položaju 447; i/ili sa Q na položaju koji odgovara položaju 447, u vezi sa aminokiselinskim položajima navedenim u SEQ ID NO:3.
3. Modificirani PH20 polipeptid prema patentnom zahtjevu 1, naznačen time što je zamjena aminokiseline odabrana između E na položaju koji odgovara položaju 12; E na položaju koji odgovara položaju 26; K na položaju koji odgovara položaju 26; R na položaju koji odgovara položaju 46; Q na položaju koji odgovara položaju 52; Q na položaju koji odgovara položaju 58; H na položaju koji odgovara položaju 68; Q na položaju koji odgovara položaju 68; A na položaju koji odgovara položaju 70; C na položaju koji odgovara položaju 70; F na položaju koji odgovara položaju 70; G na položaju koji odgovara položaju 70; H na položaju koji odgovara položaju 70; K na položaju koji odgovara položaju 70; L na položaju koji odgovara položaju 70; N na položaju koji odgovara položaju 70; P na položaju koji odgovara položaju 70; R na položaju koji odgovara položaju 70; S na položaju koji odgovara položaju 70; T na položaju koji odgovara položaju 70; A na položaju koji odgovara položaju 74; C na položaju koji odgovara položaju 74; G na položaju koji odgovara položaju 74; N na položaju koji odgovara položaju 74; P na položaju koji odgovara položaju 74; R na položaju koji odgovara položaju 74; S na položaju koji odgovara položaju 74; V na položaju koji odgovara položaju 74; W na položaju koji odgovara položaju 74; G na položaju koji odgovara položaju 84; R na položaju koji odgovara položaju 84; G na položaju koji odgovara položaju 97; H na položaju koji odgovara položaju 127; N na položaju koji odgovara položaju 127; G na položaju koji odgovara položaju 131; V na položaju koji odgovara položaju 131; R na položaju koji odgovara položaju 142; A na položaju koji odgovara položaju 166; F na položaju koji odgovara položaju 166; H na položaju koji odgovara položaju 166; L na položaju koji odgovara položaju 166; R na položaju koji odgovara položaju 166; Y na položaju koji odgovara položaju 166; K na položaju koji odgovara položaju 174; K na položaju koji odgovara položaju 206; M na položaju koji odgovara položaju 213; N na položaju koji odgovara položaju 213; S na položaju koji odgovara položaju 238; N na položaju koji odgovara položaju 261; R na položaju koji odgovara položaju 277; T na položaju koji odgovara položaju 277; L na položaju koji odgovara položaju 309; N na položaju koji odgovara položaju 309; Q na položaju koji odgovara položaju 309; R na položaju koji odgovara položaju 309; T na položaju koji odgovara položaju 309; A na položaju koji odgovara položaju 310; G na položaju koji odgovara položaju 310; H na položaju koji odgovara položaju 315; I na položaju koji odgovara položaju 317; K na položaju koji odgovara položaju 317; R na položaju koji odgovara položaju 317; M na položaju koji odgovara položaju 318; G na položaju koji odgovara položaju 347; S na položaju koji odgovara položaju 347; M na položaju koji odgovara položaju 399; T na položaju koji odgovara položaju 399; W na položaju koji odgovara položaju 399; D na položaju koji odgovara položaju 407; Q na položaju koji odgovara položaju 407; F na položaju koji odgovara položaju 419; I na položaju koji odgovara položaju 419; R na položaju koji odgovara položaju 419; S na položaju koji odgovara položaju 419; K na položaju koji odgovara položaju 421; N na položaju koji odgovara položaju 421; Q na položaju koji odgovara položaju 421; R na položaju koji odgovara položaju 421; S na položaju koji odgovara položaju 421; A na položaju koji odgovara položaju 431; H na položaju koji odgovara položaju 431; K na položaju koji odgovara položaju 431; Q na položaju koji odgovara položaju 431; R na položaju koji odgovara položaju 431; S na položaju koji odgovara položaju 431; V na položaju koji odgovara položaju 431; L na položaju koji odgovara položaju 433; R na položaju koji odgovara položaju 433; V na položaju koji odgovara položaju 439; H na položaju koji odgovara položaju 440; R na položaju koji odgovara položaju 440; A na položaju koji odgovara položaju 443; M na položaju koji odgovara položaju 443; M na položaju koji odgovara položaju 445; i/ili sa P na položaju koji odgovara položaju 445, u vezi sa aminokiselinskim položajima navedenim u SEQ ID NO:3.
4. Modificirani PH20 polipeptid prema patentnom zahtjevu 1, koji sadrži sekvencu aminokiselina navedenu u bilo kojoj od SEQ ID NOS: 73, 78, 91, 95, 96, 105, 106, 108, 109, 111, 112, 113, 115, 117, 118, 119, 120, 123-126, 128-136, 139-141, 149, 154, 155, 164, 165, 167, 191, 192, 196, 197, 199-205, 207, 208, 225, 226, 228, 229, 231, 233, 237, 253, 254, 256, 257, 277, 283, 293, 295, 296, 298, 300, 303, 316, 318, 321, 322, 338-340, 344, 348, 367, 369, 371, 377, 384-388, 394, 398, 399, 401, 406-408, 410, 412, 414, 416, 431, 448, 459, 465, 469, 478, 479, 482, 493, 497, 501, 503, 507, 508, 510-512, 514, 518, 522, 523, 537-543, 545, 558, 559, 561, 563-566, 569, 572, 574, 594, 596, 618-620, 624-634, 637, 640-644, 652, 657, 675, 695, 698, 699, 700, 712, 717, 725, 738, 748-750, 757, 775, 799-801, 807, 822, 825, 844, 847, 851 i 853, ili sekvencu aminokiselina koja ispoljava najmanje 96% identičnosti sevence sa sekvencom aminokiselina navedenom u bilo kojoj od SEQ ID NOS: 73, 78, 91, 95, 96, 105, 106, 108, 109, 111, 112, 113, 115, 117, 118, 119, 120, 123-126, 128-136, 139-141, 149, 154, 155, 164, 165, 167, 191, 192, 196, 197, 199-205, 207, 208, 225, 226, 228, 229, 231, 233, 237, 253, 254, 256, 257, 277, 283, 293, 295, 296, 298, 300, 303, 316, 318, 321, 322, 338-340, 344, 348, 367, 369, 371, 377, 384-388, 394, 398, 399, 401, 406-408, 410, 412, 414, 416, 431, 448, 459, 465, 469, 478, 479, 482, 493, 497, 501, 503, 507, 508, 510-512, 514, 518, 522, 523, 537-543, 545, 558, 559, 561, 563-566, 569, 572, 574, 594, 596, 618-620, 624-634, 637, 640-644, 652, 657, 675, 695, 698, 699, 700, 712, 717, 725, 738, 748-750, 757, 775, 799-801, 807, 822, 825, 844, 847, 851 i 853 i koja sadrži aminokiselinsku zamjenu u poređenju sa odgovarajućim položajima u polipeptidu prema bilo kom od SEQ ID NOS:3, 7 i 32-66.
5. Modificirani PH20 polipeptid prema patentnom zahtjevu 3, koji sadrži sekvencu aminokiselina navedenu u bilo kojoj od SEQ ID NOS: 86, 89, 99, 100, 159, 173, 181, 193, 195, 209-220, 238, 239, 242, 247-252, 267, 269, 277, 308, 324, 325, 330, 335, 355, 419, 421-423, 425, 428, 435, 455, 456, 462, 463, 484, 490, 506, 531, 533, 579, 581-583, 585, 587, 588, 602, 605, 606, 609, 613, 648, 731, 732, 734, 742, 746, 760, 762, 764, 765, 769-773, 779, 782, 783, 786-789, 794, 795, 814, 816, 819, 826, 830, 836 i 838, ili sekvencu aminokiselina koja ispoljava najmanje 96% identičnosti sekvence sa sekvencom aminokiselina navedenom u bilo kojoj od 86, 89, 99, 100, 159, 173, 181, 193, 195, 209-220, 238, 239, 242, 247-252, 267, 269, 277, 308, 324, 325, 330, 335, 355, 419, 421-423, 425, 428, 435, 455, 456, 462, 463, 484, 490, 506, 531, 533, 579, 581-583, 585, 587, 588, 602, 605, 606, 609, 613, 648, 731, 732, 734, 742, 746, 760, 762, 764, 765, 769-773, 779, 782, 783, 786-789, 794, 795, 814, 816, 819, 826, 830, 836 i 838 i koji sadrži aminokiselinsku zamjenu u poređenju sa odgovarajućim položajima u polipeptidu prema bilo kojoj od SEQ ID NOS:3, 7 i 32-66.
6. Modificirani PH20 polipeptid prema bilo kojem od patentnih zahtjeva 1-5 koji ispoljava najmanje 2.0-puta veću aktivnost hijaluronidaze u poređenju sa PH20 polipeptidom koji ne sadrži aminokiselinsku zamjenu (zamjene).
7. Modificirani PH20 polipeptid prema bilo kojem od patentnih zahtjeva 1-6 koji sadrži jednu ili više modifikacija izabranih od glikozilacije, sialacije, albuminacije, farnezilacije, karboksilacije, hidroksilacije i fosforilacije.
8. Modificirani PH20 polipeptid prema bilo kojem od patentnih zahtjeva 1-7 koji sadrži najmanje N-acetilglukozamin grupu vezanu za svaki od najmanje tri asparaginska (N) ostatka.
9. Modificirani PH20 polipeptid prema patentnom zahtjevu 8, naznačen time što tri asparaginska ostatka odgovaraju aminokiselinskim ostacima 200, 333 i 358 od SEQ ID NO:3.
10. Modificirani PH20 polipeptid prema bilo kojem od patentnih zahtjeva 1-9 koji je konjugiran za polimer.
11. Modificirani PH20 polipeptid prema patentnom zahtjevu 10, naznačen time što je polimer dekstran ili PEG.
12. Molekula nukleinske kiseline, koja kodira modificirani PH20 polipeptid prema bilo kojem od patentnih zahtjeva 1-11.
13. Vektor, koji sadrži molekulu nukleinske kiseline prema patentnom zahtjevu 12.
14. Izolirana stanica, koja sadrži vektor prema patentnom zahtjevu 13.
15. Postupak za proizvodnju modificiranog PH20 polipeptida, koji sadrži:
uvođenje molekula nukleinske kiseline prema patentnom zahtjevu 12 u stanicu sposobnu za ugrađivanje N-vezanih šećernih grupa u polipeptid;
kultiviranje stanice pod uvjetima čime se kodirani modificirani PH20 polipeptid proizvodi i izlučuje od strane stanice; i
izoliranje eksprimiranog polipeptida.
16. Farmaceutska kompozicija, koja sadrži modificirani PH20 polipeptid prema bilo kojem od patentnih zahtjeva 1-11.
17. Farmaceutska kompozicija prema patentnom zahtjevu 16 za uporabu za liječenje bolesti ili poremećaja izabranog od onog koji obuhvaća akumulaciju glikozaminoglikana u mozgu; kardiovaskularnog poremećaja; oftalmičkog poremećaja; i plućne bolesti.
18. Farmaceutska kompozicija prema patentnom zahtjevu 16 za uporabu za liječenje tumora.
19. Farmaceutska kompozicija prema patentnom zahtjevu 16 za isporuku terapeutskog sredstva za uporabu u liječenju tumora; za uporabu u liječenju akumulacije glikozaminoglikana u mozgu; za uporabu u liječenju kardiovaskularnog poremećaja; za uporabu u liječenju oftalmičkog poremećaja; ili za uporabu u liječenju plućne bolesti.
20. Farmaceutska kompozicija prema patentnom zahtjevu 16 za povećanje prodiranja terapeutskih sredstava u solidne tumore ili za povećanje biodostupnosti terapeutskih sredstava za uporabu u liječenju tumora; za uporabu u liječenju akumulacije glikozaminoglikana u mozgu; za uporabu u liječenju kardiovaskularnog poremećaja; za uporabu u liječenju oftalmičkog poremećaja; ili za uporabu u liječenju plućne bolesti.
21. Modificirani polipeptid prema patentnom zahtjevu 11 za uporabu za liječenje tumora, naznačen time što je modificirani PH20 polipeptid konjugiran za PEG.
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| US201161631313P | 2011-12-30 | 2011-12-30 | |
| US201261796208P | 2012-11-01 | 2012-11-01 | |
| EP16189970.3A EP3130347B1 (en) | 2011-12-30 | 2012-12-28 | Ph20 polypeptide variants, formulations and uses thereof |
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| HRP20192249T1 true HRP20192249T1 (hr) | 2020-03-06 |
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| HRP20192249TT HRP20192249T1 (hr) | 2011-12-30 | 2019-12-13 | Varijante ph20 polipeptida, njihove formulacije i uporabe |
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| EP (2) | EP2797622B1 (hr) |
| JP (2) | JP6067746B2 (hr) |
| CN (1) | CN104244968B (hr) |
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| HK (1) | HK1202814A1 (hr) |
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