HRP20151268T1 - Pripravci prokariotske fenilalanin amonijak liaze i postupci upotrebe navedenog pripravka - Google Patents
Pripravci prokariotske fenilalanin amonijak liaze i postupci upotrebe navedenog pripravka Download PDFInfo
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- HRP20151268T1 HRP20151268T1 HRP20151268TT HRP20151268T HRP20151268T1 HR P20151268 T1 HRP20151268 T1 HR P20151268T1 HR P20151268T T HRP20151268T T HR P20151268TT HR P20151268 T HRP20151268 T HR P20151268T HR P20151268 T1 HRP20151268 T1 HR P20151268T1
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- Prior art keywords
- avpal
- avpal variant
- variant
- preparation
- phenylalanine
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- 239000000203 mixture Substances 0.000 title claims 5
- 108700023158 Phenylalanine ammonia-lyases Proteins 0.000 title claims 2
- 229920001223 polyethylene glycol Polymers 0.000 claims 9
- 239000002202 Polyethylene glycol Substances 0.000 claims 8
- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 claims 7
- COLNVLDHVKWLRT-QMMMGPOBSA-N L-phenylalanine Chemical compound OC(=O)[C@@H](N)CC1=CC=CC=C1 COLNVLDHVKWLRT-QMMMGPOBSA-N 0.000 claims 6
- 108010069013 Phenylalanine Hydroxylase Proteins 0.000 claims 6
- 102100038223 Phenylalanine-4-hydroxylase Human genes 0.000 claims 6
- COLNVLDHVKWLRT-UHFFFAOYSA-N phenylalanine Natural products OC(=O)C(N)CC1=CC=CC=C1 COLNVLDHVKWLRT-UHFFFAOYSA-N 0.000 claims 6
- 125000000151 cysteine group Chemical group N[C@@H](CS)C(=O)* 0.000 claims 5
- 125000003607 serino group Chemical group [H]N([H])[C@]([H])(C(=O)[*])C(O[H])([H])[H] 0.000 claims 4
- 201000010099 disease Diseases 0.000 claims 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 3
- 230000000694 effects Effects 0.000 claims 3
- 201000011252 Phenylketonuria Diseases 0.000 claims 2
- 230000037213 diet Effects 0.000 claims 2
- 235000005911 diet Nutrition 0.000 claims 2
- 230000035772 mutation Effects 0.000 claims 2
- 229920003169 water-soluble polymer Polymers 0.000 claims 2
- 208000014249 Classic phenylketonuria Diseases 0.000 claims 1
- 102220537984 Clavesin-1_S110C_mutation Human genes 0.000 claims 1
- 241000078013 Trichormus variabilis Species 0.000 claims 1
- 230000037354 amino acid metabolism Effects 0.000 claims 1
- 102200021562 c.1117G>A Human genes 0.000 claims 1
- 230000003197 catalytic effect Effects 0.000 claims 1
- 230000007812 deficiency Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000005847 immunogenicity Effects 0.000 claims 1
- 230000006320 pegylation Effects 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 235000021075 protein intake Nutrition 0.000 claims 1
- 102200000387 rs121917857 Human genes 0.000 claims 1
- 102200057376 rs1553135971 Human genes 0.000 claims 1
- 102220034979 rs199475615 Human genes 0.000 claims 1
- 102200027736 rs5030841 Human genes 0.000 claims 1
- 102200031316 rs5030849 Human genes 0.000 claims 1
- 102200031487 rs5030853 Human genes 0.000 claims 1
- 102200031113 rs5030856 Human genes 0.000 claims 1
- 102200031139 rs5030860 Human genes 0.000 claims 1
- 102200031429 rs62514931 Human genes 0.000 claims 1
- 102200031124 rs62516101 Human genes 0.000 claims 1
- 102200031116 rs62516103 Human genes 0.000 claims 1
- 102220034971 rs62642095 Human genes 0.000 claims 1
- 102200027738 rs62642926 Human genes 0.000 claims 1
- 102200027873 rs62642929 Human genes 0.000 claims 1
- 102200031143 rs62644465 Human genes 0.000 claims 1
- 102200027763 rs75193786 Human genes 0.000 claims 1
- 102200027764 rs76394784 Human genes 0.000 claims 1
- 102200031444 rs76687508 Human genes 0.000 claims 1
- 102200031393 rs77958223 Human genes 0.000 claims 1
- 102200094634 rs80356692 Human genes 0.000 claims 1
Classifications
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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
- A61K38/51—Lyases (4)
-
- 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
- C12N9/88—Lyases (4.)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Microbiology (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Biotechnology (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Epidemiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Oncology (AREA)
- Obesity (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Enzymes And Modification Thereof (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Claims (19)
1. Varijanta fenilalanin amonijak liaze iz Anabaena variabilis (AvPAL), naznačena time, da navedena AvPAL varijanta ima snažniju aktivnost pretvaranja fenilalanina i/ili smanjenu imunogenost u odnosu na divlji tip AvPAL (SEQ ID NO:4), pri čemu su jedan ili više cisteinskih ostataka odabranih iz skupine koju čine cisteinski ostaci na položajima 503 i 565 bili supstituirani serinskim ostatkom.
2. AvPAL varijanta u skladu s patentnim zahtjevom 1, naznačena time, da je cisteinski ostatak na poziciji 565 AvPAL-a supstituiran serinskim ostatkom (SEQ ID NO:10).
3. AvPAL varijanta u skladu s patentnim zahtjevom 1, naznačena time, da su cisteinski ostaci na položajima 503 i 565 AvPAL-a supstituirani serinskim ostatkom (SEQ ID NO:11).
4. AvPAL varijanta u skladu s bilo kojim patentnim zahtjevom od 1 do 3, naznačena time, da sadržava polimer topljiv u vodi.
5. AvPAL varijanta u skladu s patentnim zahtjevom 4, naznačena time, da je polimer topljiv u vodi polietilen glikol.
6. AvPAL varijanta u skladu s patentnim zahtjevom 5, naznačena time, da se može dobiti reakcijom AvPAL varijante s polietilen glikolom aktiviranim NHS-om u omjeru 3 polietilenglikola po ostatku lizina AvPAL varijante.
7. Farmaceutski pripravak, naznačen time, da je namijenjen za uporabu u liječenju bolesti metabolizma aminokiselina koje sadržavaju AvPAL varijantu u skladu s bilo kojim od patentnih zahtjeva 1 do 6 i farmaceutski prihvatljiv nosač.
8. Pripravak koji sadržava AvPAL varijantu u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time, da je namijenjen za uporabu u liječenju bolesti uzrokovanih u cijelosti ili djelomično nedostatkom fenilalanin hidroksilaze (PAH).
9. Pripravak za primjenu u skladu s patentnim zahtjevom 8, naznačen time, da je bolest karakterizirana povišenom razinom fenilalanina ili je pripravak pripremljen za liječenje subjekta kojem aktivnost PAH iznosi 10 % ili manje od 10 % normalne aktivnosti PAH.
10. AvPAL varijanta u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time, da je namijenjena liječenju ljudi koji pate od fenilketonurije (PKU).
11. Pripravak koji sadrži varijantu AvPAL u skladu s bilo kojim od zahtjeva 1 do 6, za uporabu u liječenju teškog klasičnog PKU-a, naznačen time, da je pripravak učinkovit za snižavanje koncentracije fenilalanina u plazmi subjekta u usporedbi s navedenom koncentracijom kada se navedeni pripravak ne primjenjuje.
12. Pripravak za primjenu u skladu s patentnim zahtjevom 11, naznačen time, da je kod subjekta dijagnosticiran mutantni PAH.
13. Pripravak za primjenu u skladu s patentnim zahtjevom 12, naznačen time, da sadržava mutaciju u katalitičkoj domeni PAH ili jednu ili više mutacija odabranih iz skupine koju čine F39L, L48S, I65T, R68S, A104D, S110C, D129G, E178G, V190A, P211T, R241C, R261Q, A300S, L308F, A313T, K320N, A373T, V388M E390G, A395P, P407S i Y414C.
14. Pripravak, naznačen time, da sadržava varijantu AvPAL u skladu s bilo kojim od zahtjeva 1 do 6, za uporabu u liječenju trudnica s hiperfenilalaninemijom (HPA), koji se pripravlja za primjenu u kombinaciji s prehranom s ograničenim unosom proteina, pri čemu pripravak i dijeta s ograničenim unosom proteina učinkovito smanjuju koncentraciju fenilalanina u plazmi navedene ženske osobe u usporedbi s navedenom koncentracijom kada se navedeni pripravak ne primjenjuje
15. Pripravak koji sadrži AvPAL varijantu u skladu s bilo kojim od patentnih zahtjeva 1 do 6 za uporabu u liječenju dojenčadi koje boluje od PKU-a, naznačen time, da je pripravljen za primjenu kod dojenčeta u dobi između 0 i 3 godine starosti i kojem je koncentracija fenilalanina u plazmi između 360 μΜ do 4800 μΜ, pri čemu se pripravak pripravlja za primjenu u količini koja učinkovito smanjuje koncentraciju fenilalanina u plazmi kod navedenog dojenčeta.
16. AvPAL varijanta, naznačena time, da su cisteinski ostaci na položajima 503 i 565 AvPAL- a supstituirani serinskim ostacima (SEQ ID. NO. 11).
17. AvPAL varijanta u skladu s patentnim zahtjevom 16, naznačena time, da je varijanta pegilirana.
18. AvPAL varijanta u skladu s patentnim zahtjevom 17, naznačena time, da se pegilacija može postići reakcijom AvPAL varijante s polietilen glikolom aktiviranim s NHS-om u omjeru od najmanje 1,6 polietilenglikola po lizinskom ostatku AvPAL varijante; AvPAL varijante s polietilen glikolom aktiviranim s NHS-om u omjeru od najmanje 2.4 polietilenglikola po lizinskom ostatku AvPAL varijante ili reakcijom AvPAL varijante s polietilen glikolom aktiviranim s NHS-om u omjeru 3 polietilenglikola po lizinskom ostatku AvPAL varijante
19. AvPAL varijanta u skladu s patentnim zahtjevom 17, naznačena time, da je barem 28 & lizinskih ostataka na položajima 2, 10, 32, 145, 195, 301, 413, 493 te 522 AvPAL varijante pegilirano, pri čemu je barem 51 % lizinskih ostataka pegilirano na položajima 2, 10, 195, 413, 493 te 522 AvPAL varijante ili pri čemu je najmanje 75 % lizinskih ostataka pegilirano na položajima 2, 10, 195, 493 i 522 AvPAL varijante.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/807,227 US7534595B2 (en) | 2006-06-12 | 2007-05-25 | Compositions of prokaryotic phenylalanine ammonia-lyase and methods of using compositions thereof |
| PCT/US2008/006661 WO2008153776A1 (en) | 2007-05-25 | 2008-05-23 | Compositions of prokaryotic phenylalanine ammonia-lyase and methods of using said compositions |
| EP08754717.0A EP2152868B1 (en) | 2007-05-25 | 2008-05-23 | Compositions of prokaryotic phenylalanine ammonia-lyase and methods of using said compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20151268T1 true HRP20151268T1 (hr) | 2015-12-18 |
Family
ID=39868905
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20151268TT HRP20151268T1 (hr) | 2007-05-25 | 2015-11-24 | Pripravci prokariotske fenilalanin amonijak liaze i postupci upotrebe navedenog pripravka |
Country Status (30)
| Country | Link |
|---|---|
| US (1) | US7534595B2 (hr) |
| EP (2) | EP2152868B1 (hr) |
| JP (1) | JP5670183B2 (hr) |
| KR (2) | KR20150038753A (hr) |
| CN (1) | CN101842482B (hr) |
| AR (2) | AR066716A1 (hr) |
| AU (1) | AU2008263190B2 (hr) |
| BR (1) | BRPI0811267B8 (hr) |
| CA (1) | CA2687450C (hr) |
| CL (1) | CL2008001497A1 (hr) |
| CY (2) | CY1116894T1 (hr) |
| DK (1) | DK2152868T3 (hr) |
| EA (1) | EA018443B1 (hr) |
| ES (1) | ES2551315T3 (hr) |
| HK (1) | HK1135141A1 (hr) |
| HR (1) | HRP20151268T1 (hr) |
| HU (2) | HUE025784T2 (hr) |
| IL (1) | IL202132A (hr) |
| LT (1) | LTC2152868I2 (hr) |
| LU (1) | LUC00133I2 (hr) |
| MX (1) | MX2009012453A (hr) |
| MY (1) | MY151413A (hr) |
| NL (1) | NL301011I2 (hr) |
| NO (1) | NO2019037I1 (hr) |
| PE (1) | PE20090315A1 (hr) |
| PL (1) | PL2152868T3 (hr) |
| PT (1) | PT2152868E (hr) |
| SI (1) | SI2152868T1 (hr) |
| TW (1) | TWI418633B (hr) |
| WO (1) | WO2008153776A1 (hr) |
Families Citing this family (34)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7534595B2 (en) | 2006-06-12 | 2009-05-19 | Biomarin Pharmaceutical Inc. | Compositions of prokaryotic phenylalanine ammonia-lyase and methods of using compositions thereof |
| US7531341B1 (en) | 2006-06-12 | 2009-05-12 | Biomarin Pharmaceutical Inc. | Compositions of prokaryotic phenylalanine ammonia-lyase and methods of using compositions thereof |
| US7537923B2 (en) | 2007-08-17 | 2009-05-26 | Biomarin Pharmaceutical Inc. | Compositions of prokaryotic phenylalanine ammonia-lyase and methods of treating cancer using compositions thereof |
| US20110201022A1 (en) | 2008-07-30 | 2011-08-18 | Biomarin Pharmaceutical Inc. | Assays for detection of phenylalanine ammonia-lyase and antibodies to phenylalanine ammonia-lyase |
| SI3025728T1 (sl) * | 2010-02-04 | 2018-11-30 | Biomarin Pharmaceutical Inc. | Metoda za čiščenje prokariontskih fenilalanin amonij-liaznih variant |
| US20150246083A1 (en) * | 2012-07-27 | 2015-09-03 | University Of North Texas | Genetically modified probiotic for the treatment of phenylketonuria (pku) disease |
| ES2729048T3 (es) * | 2013-04-18 | 2019-10-30 | Codexis Inc | Polipéptidos de fenilalanina amoníaco-liasa modificados |
| EP3071515A2 (en) | 2013-11-18 | 2016-09-28 | Rubius Therapeutics, Inc. | Synthetic membrane-receiver complexes |
| AU2015241422B2 (en) | 2014-04-01 | 2020-12-03 | Rubius Therapeutics, Inc. | Methods and compositions for immunomodulation |
| HUE056444T2 (hu) | 2014-04-16 | 2022-02-28 | Codexis Inc | Génmódosított tirozin-ammónia-liáz |
| HUE062016T2 (hu) | 2014-12-22 | 2023-09-28 | Codexis Inc | Humán alfa-galaktozidáz variánsok |
| TW202330904A (zh) * | 2015-08-04 | 2023-08-01 | 美商再生元醫藥公司 | 補充牛磺酸之細胞培養基及用法 |
| IL305149A (en) | 2016-07-26 | 2023-10-01 | Biomarin Pharm Inc | Novel adeno-associated virus capsid proteins |
| JP7024951B2 (ja) * | 2016-08-30 | 2022-02-24 | 三菱ケミカル株式会社 | 変異型酵素の製造方法及び変異型アルコールアシルトランスフェラーゼ |
| CN106497905A (zh) * | 2016-12-14 | 2017-03-15 | 江南大学 | 一株鱼腥藻来源的苯丙氨酸脱氨酶的突变体 |
| EP3579867A4 (en) * | 2017-02-13 | 2021-03-10 | Codexis, Inc. | MANIPULATED PHENYLALANINE AMMONIA LYASE POLYPEPTIDES |
| CN107653275A (zh) * | 2017-10-30 | 2018-02-02 | 安徽工程大学 | D‑苯丙氨酸的制备方法 |
| CN108004225B (zh) * | 2017-12-19 | 2020-05-08 | 江南大学 | 一种成团泛菌来源的苯丙氨酸氨基变位酶的突变体 |
| CN113164762A (zh) | 2018-05-09 | 2021-07-23 | 生物马林药物股份有限公司 | 苯丙酮尿症的治疗方法 |
| TW202005978A (zh) | 2018-05-14 | 2020-02-01 | 美商拜奧馬林製藥公司 | 新穎肝靶向腺相關病毒載體 |
| WO2019241132A1 (en) | 2018-06-12 | 2019-12-19 | Codexis, Inc. | Engineered tyrosine ammonia lyase |
| CN112672989A (zh) * | 2018-07-12 | 2021-04-16 | 科德克希思公司 | 工程化苯丙氨酸氨裂合酶多肽 |
| SG11202105668PA (en) | 2018-12-14 | 2021-06-29 | Codexis Inc | Engineered tyrosine ammonia lyase |
| CA3123598A1 (en) | 2018-12-20 | 2020-06-25 | Codexis, Inc. | Human alpha-galactosidase variants |
| CN110456056A (zh) * | 2019-07-22 | 2019-11-15 | 浙江大学 | 一种新生儿苯丙酮尿症无创筛查试纸的制备方法 |
| MX2022002473A (es) | 2019-08-30 | 2022-08-02 | Codexis Inc | Variantes de lipasa modificadas geneticamente. |
| BR112022011760A2 (pt) | 2019-12-20 | 2022-08-30 | Codexis Inc | Fragmento de alfa glicosidase ácida recombinante e/ou de alfa glicosidase ácida recombinante biologicamente ativa, alfa glicosidase ácida recombinante, composição, sequência polinucleotídica recombinante, vetor de expressão, vetor de expressão pdh, célula hospedeira, método para produzir uma variante de alfa glicosidase ácida recombinante, variante de alfa glicosidase ácida recombinante, composição farmacêutica para o tratamento da doença de pompe, composição farmacêutica, método para tratar e/ou prevenir os sintomas da doença de pompe em um indivíduo, e, uso das composições |
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