HRP20230468T1 - Varijante ljudske alfa galaktozidaze - Google Patents
Varijante ljudske alfa galaktozidaze Download PDFInfo
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- HRP20230468T1 HRP20230468T1 HRP20230468TT HRP20230468T HRP20230468T1 HR P20230468 T1 HRP20230468 T1 HR P20230468T1 HR P20230468T T HRP20230468T T HR P20230468TT HR P20230468 T HRP20230468 T HR P20230468T HR P20230468 T1 HRP20230468 T1 HR P20230468T1
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- Prior art keywords
- alpha galactosidase
- seq
- recombinant
- optionally
- galactosidase
- Prior art date
Links
- 108010030291 alpha-Galactosidase Proteins 0.000 title claims 14
- 102000005840 alpha-Galactosidase Human genes 0.000 title claims 14
- 108010049936 agalsidase alfa Proteins 0.000 claims 9
- 230000035772 mutation Effects 0.000 claims 6
- 108091033319 polynucleotide Proteins 0.000 claims 5
- 102000040430 polynucleotide Human genes 0.000 claims 5
- 239000002157 polynucleotide Substances 0.000 claims 5
- 238000002360 preparation method Methods 0.000 claims 5
- 208000024720 Fabry Disease Diseases 0.000 claims 4
- 239000000825 pharmaceutical preparation Substances 0.000 claims 4
- 210000004027 cell Anatomy 0.000 claims 3
- 238000000034 method Methods 0.000 claims 3
- 208000024891 symptom Diseases 0.000 claims 3
- 230000037213 diet Effects 0.000 claims 2
- 235000005911 diet Nutrition 0.000 claims 2
- 239000013604 expression vector Substances 0.000 claims 2
- 210000002966 serum Anatomy 0.000 claims 2
- 108020004705 Codon Proteins 0.000 claims 1
- 102000004190 Enzymes Human genes 0.000 claims 1
- 108090000790 Enzymes Proteins 0.000 claims 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 230000003197 catalytic effect Effects 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 235000015872 dietary supplement Nutrition 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 210000003527 eukaryotic cell Anatomy 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 230000005847 immunogenicity Effects 0.000 claims 1
- 238000001802 infusion Methods 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920001184 polypeptide Polymers 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 102000004196 processed proteins & peptides Human genes 0.000 claims 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 1
- 238000000746 purification 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)
- C12N9/2465—Hydrolases (3) acting on glycosyl compounds (3.2) hydrolysing O- and S- glycosyl compounds (3.2.1) acting on alpha-galactose-glycoside bonds, e.g. alpha-galactosidase (3.2.1.22)
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- 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
- A61P3/00—Drugs for disorders of the metabolism
-
- 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
- A61P3/06—Antihyperlipidemics
-
- 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
- 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
- C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
- C12N15/09—Recombinant DNA-technology
- C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- C12N15/79—Vectors or expression systems specially adapted for eukaryotic hosts
-
- 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)
- C12Y302/01022—Alpha-galactosidase (3.2.1.22)
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Epidemiology (AREA)
- Biotechnology (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Microbiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Plant Pathology (AREA)
- Physics & Mathematics (AREA)
- Enzymes And Modification Thereof (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (16)
1. Rekombinantna alfa galaktozidaza A i/ili biološki aktivan fragment rekombinantne alfa galaktozidaze A, naznačena time, da sadrži aminokiselinski slijed koji je najmanje oko 90%, najmanje oko 91%, najmanje oko 92%, najmanje oko 93%, najmanje oko 94%, najmanje oko 95%, najmanje oko 96%, najmanje oko 97%, najmanje oko 98%, ili najmanje oko 99% istovjetan slijedu SEQ ID NO: 5, pri čemu navedena alfa galaktozidaza A sadrži mutaciju na poziciji 206, gdje se pozicija numerira pozivanjem na SEQ ID NO: 5.
2. Rekombinantna alfa galaktozidaza A prema patentnom zahtjevu 1, naznačena time, da:
a) navedena mutacija na poziciji 206 je mutacija 206A, 206M, 206Q, 206R, 206T, 206E, 206G ili 206S;
b) navedena mutacija na poziciji 206 je mutacija 206A;
c) navedena alfa galaktozidaza A sadrži mutacije 206T/359S; i/ili
d) alfa galaktozidaza A se bira od bilo kojeg od sljedova SEQ ID NO: 10, 13, 18, 21, 24, 40, 42, 44, 46, 119-121, 236-435, 437-442, 444-687 i 689-733.
3. Rekombinantna alfa galaktozidaza A, naznačena time, da sadrži polipeptidni slijed SEQ ID NO: 15, 13, 10, 18, 40, 42, 44 ili 46.
4. Rekombinantna alfa galaktozidaza A prema bilo kojem od patentnih zahtjeva 1-3, naznačena time, da je navedena rekombinantna alfa galaktozidaza A:
a) temperaturno stabilnija nego alfa galaktozidaza A sa SEQ ID NO: 5;
b) stabilnija na pH 7,4 nego alfa galaktozidaza A sa SEQ ID NO: 5; opcionalno gdje je navedena rekombinantna alfa galaktozidaza A:
(i) stabilnija na pH 4,3 nego alfa galaktozidaza A sa SEQ ID NO: 5; ili
(ii) stabilnija kod izloženosti serumu nego alfa galaktozidaza A sa SEQ ID NO: 5;
c) deimunizirana alfa galaktozidaza A;
d) deimunizirana alfa galaktozidaza A odabrana od sljedova SEQ ID NO: 10, 13, 18, 21, 40, 42, 44, 46, 121, 236, 237, 239-337, 339-368, 370-373, 375, 376, 378-431, 433-435, 437-442, 444-453, 455-478, 480-498, 500-510, 512-550, 552-649, 651-687 i 689-733.
e) pročišćena; i/ili
f) izražava najmanje jedno poboljšano svojstvo odabrano od sljedećih: i) unaprijeđeno katalitičko djelovanje; ii) povećana tolerancija na pH 7,4; iii) povećana tolerancija na pH 4,3; iv) povećana tolerancija na serum; ili v) smanjeni imunogenicitet; ili kombinacija od bilo kojega od i), ii), iii), iv) ili v), u usporedbi s referentnim slijedom, opcionalno gdje navedeni referentni slijed je SEQ ID NO: 5 ili SEQ ID NO: 10.
5. Pripravak, naznačen time, da sadrži najmanje jednu rekombinantnu alfa galaktozidazu A prema bilo kojem od patentnih zahtjeva 1-4.
6. Rekombinantni polinukleotidni slijed, naznačen time, da kodira najmanje jednu rekombinantnu alfa galaktozidazu A koja je predstavljena u bilo kojem od patentnih zahtjeva 1-5, opcionalno gdje je navedeni polinukleotidni slijed kodonski optimiran.
7. Vektor ekspresije, naznačen time, da sadrži rekombinantni polinukleotidni slijed prema patentnom zahtjevu 6, opcionalno pritom je navedeni rekombinantni polinukleotidni slijed operabilno povezan s kontrolnim slijedom, primjerice gdje navedeni kontrolni slijed je promotor, opcionalno gdje navedeni promotor je heterologni promotor.
8. Stanica domaćina, naznačena time, da sadrži vektor ekspresije prema patentnom zahtjevu 7, opcionalno gdje je navedena stanica domaćina eukariotska stanica.
9. Postupak za proizvodnju varijante alfa galaktozidaze A, naznačen time, da obuhvaća kultiviranje navedene stanice domaćina prema patentnom zahtjevu 8, pod takvim uvjetima u kojima će navedena alfa galaktozidaza A kodirana putem navedenog rekombinantnog polinukleotidnog slijeda, biti proizvedena.
10. Postupak prema patentnom zahtjevu 9, naznačen time, da nadalje obuhvaća dobivanje navedene alfa galaktozidaze A, dok opcionalno postupak nadalje obuhvaća fazu pročišćavanja navedene alfa galaktozidaze A.
11. Farmaceutski pripravak, naznačen time, da sadrži enzimski pripravak prema patentnom zahtjevu 5.
12. Farmaceutski pripravak prema patentnom zahtjevu 11, naznačen time, da navedeni pripravak:
a) nadalje sadrži farmaceutski prihvatljiv nosač i/ili pomoćno sredstvo;
b) prikladan je za parenteralnu injekciju ili infuziju kod čovjeka; i/ili
c) služi za liječenje Fabryjeve bolesti.
13. Farmaceutski pripravak prema patentnom zahtjevu 11 ili 12, naznačen time, da je za uporabu u liječenju i/ili prevenciji simptoma Fabryjeve bolesti kod pojedinca.
14. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 13, naznačen time, da:
a) navedeni simptomi Fabryjeve bolesti se popravljaju;
b) navedeni pojedinac može jesti prema režimu prehrane koji manje ograničava sadržaj masti nego što je to slučaj kod režima prehrane potrebnih za pojedince kod kojih su izraženi simptomi Fabryjeve bolesti;
c) navedeni pojedinac je (i) malo dijete ili dijete, ili (ii) odrasla osoba ili mlada odrasla osoba.
15. Pripravak prema bilo kojem od patentnih zahtjeva 5, 11 i 12, naznačen time, da je za uporabu kao lijek.
16. Neterapijska uporaba pripravka prema patentnom zahtjevu 5, naznačena time, da je kao dodatak prehrani.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462095313P | 2014-12-22 | 2014-12-22 | |
US201562216452P | 2015-09-10 | 2015-09-10 | |
EP15874075.3A EP3237621B1 (en) | 2014-12-22 | 2015-12-02 | Human alpha-galactosidase variants |
PCT/US2015/063329 WO2016105889A1 (en) | 2014-12-22 | 2015-12-02 | Human alpha-galactosidase variants |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20230468T1 true HRP20230468T1 (hr) | 2023-11-10 |
Family
ID=56151383
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230468TT HRP20230468T1 (hr) | 2014-12-22 | 2015-12-02 | Varijante ljudske alfa galaktozidaze |
Country Status (19)
Country | Link |
---|---|
US (5) | US20170360900A1 (hr) |
EP (2) | EP4234699A1 (hr) |
JP (4) | JP6650943B2 (hr) |
KR (2) | KR102438885B1 (hr) |
AU (2) | AU2015370125B2 (hr) |
BR (1) | BR112017013300A2 (hr) |
CA (1) | CA2970638A1 (hr) |
DK (1) | DK3237621T3 (hr) |
ES (1) | ES2944889T3 (hr) |
FI (1) | FI3237621T3 (hr) |
HR (1) | HRP20230468T1 (hr) |
HU (1) | HUE062016T2 (hr) |
IL (1) | IL252479B (hr) |
LT (1) | LT3237621T (hr) |
PL (1) | PL3237621T3 (hr) |
PT (1) | PT3237621T (hr) |
RS (1) | RS64574B1 (hr) |
SI (1) | SI3237621T1 (hr) |
WO (1) | WO2016105889A1 (hr) |
Families Citing this family (9)
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LT3237621T (lt) | 2014-12-22 | 2023-09-25 | Codexis, Inc. | Žmogaus alfa-galaktozidazės variantai |
GB201508025D0 (en) | 2015-05-11 | 2015-06-24 | Ucl Business Plc | Fabry disease gene therapy |
EP3393501B1 (en) * | 2015-12-24 | 2023-06-07 | Oxyrane UK Limited | Human alpha-n-acetylgalactosaminidase polypeptide |
US11708569B2 (en) | 2018-08-29 | 2023-07-25 | University Of Copenhagen | Modified recombinant lysosomal alpha-galactosidase A and aspartylglucoaminidase having low mannose-6-phosphate and high sialic acid |
CA3123598A1 (en) * | 2018-12-20 | 2020-06-25 | Codexis, Inc. | Human alpha-galactosidase variants |
JP2022545718A (ja) | 2019-08-30 | 2022-10-28 | コデクシス, インコーポレイテッド | 操作されたリパーゼ改変体 |
US20220348896A1 (en) * | 2019-09-18 | 2022-11-03 | The Medical College Of Wisconsin, Inc. | Improved Alpha-Galactosidase Protein for Enzyme Replacement Therapy (ERT) and Methods of Use |
EP4077679A4 (en) | 2019-12-20 | 2024-04-24 | Codexis Inc | MODIFIED ACID ALPHA-GLUCOSIDASE VARIANTS |
WO2021173928A2 (en) * | 2020-02-28 | 2021-09-02 | Codexis, Inc. | Human alpha-galactosidase variants |
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