SG11201809388SA - Relative potency assay for viral vector encoding isomerohydrolases - Google Patents

Relative potency assay for viral vector encoding isomerohydrolases

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Publication number
SG11201809388SA
SG11201809388SA SG11201809388SA SG11201809388SA SG11201809388SA SG 11201809388S A SG11201809388S A SG 11201809388SA SG 11201809388S A SG11201809388S A SG 11201809388SA SG 11201809388S A SG11201809388S A SG 11201809388SA SG 11201809388S A SG11201809388S A SG 11201809388SA
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SG
Singapore
Prior art keywords
international
rule
applicant
assay
lots
Prior art date
Application number
SG11201809388SA
Inventor
Linda Couto
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Spark Therapeutics Inc
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Publication date
Application filed by Spark Therapeutics Inc filed Critical Spark Therapeutics Inc
Publication of SG11201809388SA publication Critical patent/SG11201809388SA/en

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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/32—Bonded phase chromatography
    • B01D15/325—Reversed phase
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • B01D15/3819—Affinity chromatography of the nucleic acid-nucleic acid binding protein type
    • 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)
    • 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)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • C12N9/18—Carboxylic ester hydrolases (3.1.1)
    • 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
    • C12Q1/44—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving esterase
    • 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
    • C12Q1/533—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving isomerase
    • 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
    • C12N15/85—Vectors or expression systems specially adapted for eukaryotic hosts for animal cells
    • C12N15/86—Viral vectors
    • 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
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/14011—Parvoviridae
    • C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14141—Use of virus, viral particle or viral elements as a vector
    • 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
    • C12N2750/00—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssDNA viruses
    • C12N2750/00011—Details
    • C12N2750/14011—Parvoviridae
    • C12N2750/14111—Dependovirus, e.g. adenoassociated viruses
    • C12N2750/14141—Use of virus, viral particle or viral elements as a vector
    • C12N2750/14143—Use of virus, viral particle or viral elements as a vector viral genome or elements thereof as genetic vector
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y203/00—Acyltransferases (2.3)
    • C12Y203/01—Acyltransferases (2.3) transferring groups other than amino-acyl groups (2.3.1)
    • C12Y203/01135—Phosphatidylcholine--retinol O-acyltransferase (2.3.1.135)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/01—Carboxylic ester hydrolases (3.1.1)
    • C12Y301/01064—Retinoid isomerohydrolase (3.1.1.64)
    • 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)
    • G01N2333/916—Hydrolases (3) acting on ester bonds (3.1), e.g. phosphatases (3.1.3), phospholipases C or phospholipases D (3.1.4)
    • G01N2333/918—Carboxylic ester hydrolases (3.1.1)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/16—Ophthalmology
    • G01N2800/164—Retinal disorders, e.g. retinopathy

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Virology (AREA)
  • Plant Pathology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Information Retrieval, Db Structures And Fs Structures Therefor (AREA)

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 02 November 2017 (02.11.2017) WI P0 I PC T IiiimmomiolollmolommolommoilommuniovoimIE (10) International Publication Number WO 2017/190081 Al (51) International Patent Classification: A61K 31/07 (2006.01) Cl 2N 15/86 (2006.01) C12N 9/18 (2006.01) C12Q 1/00 (2006.01) (21) International Application Number: PCT/US2017/030254 (22) International Filing Date: 28 April 2017 (28.04.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/328,916 28 April 2016 (28.04.2016) US (71) Applicant: SPARK THERAPEUTICS, INC. [US/US]; 3737 Market Street, Suite 1300, Philadelphia, PA 19104 (US). (72) Inventor: COUTO, Linda; 7814 Oak Creek Drive, Pleasanton, CA 94588 (US). (74) Agent: BEDGOOD, Robert, M.; Pillsbury Winthrop Shaw Pittman LLP, P.O. Box 10500, McLean, VA 22102 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (54) Title: RELATIVE POTENCY ASSAY FOR VIRAL VECTOR ENCODING ISOMERHYDROLASES Figure 7 Use of assay to demonstrat. different Assay tiesigin 3 HEK293/tRAT cells transduced with two different lOts AAV,ii+Ei6 a Five MOIS (3S1(r, 1%10 4 , 3X10, 11410, 3x10' vector genomesicell) • Cell lysates analyzed for RPE65 activity w 4 Parameter Logistic Model used to Compare two lots of steam Conclusion: The hotor and ProlwOUSci (enmities) are. both 'cos, Indicattribbhat there amino differences between the curves. Thus, two lots d : re simila, pas...1m.y 1-1 GC N (57) : Methods for assaying function and/or activity and/or potency of isomerohydrolase proteins are provided. [Continued on next page] O WO 2017/190081 Al MIDEDIMOMMIMOIDEMOMOHMONEHHINEVOIMIE Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(H)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) of inventorship (Rule 4.17(iv)) Published: — with international search report (Art. 21(3))
SG11201809388SA 2016-04-28 2017-04-28 Relative potency assay for viral vector encoding isomerohydrolases SG11201809388SA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662328916P 2016-04-28 2016-04-28
PCT/US2017/030254 WO2017190081A1 (en) 2016-04-28 2017-04-28 Relative potency assay for viral vector encoding isomerhydrolases

Publications (1)

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SG11201809388SA true SG11201809388SA (en) 2018-11-29

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US (1) US20210348210A1 (en)
EP (1) EP3448371A4 (en)
JP (1) JP7067843B2 (en)
KR (1) KR20190020661A (en)
CN (1) CN109689033A (en)
AU (2) AU2017258776B2 (en)
BR (1) BR112018072268A2 (en)
CA (1) CA3022386A1 (en)
CL (1) CL2018003079A1 (en)
CO (1) CO2018012509A2 (en)
IL (1) IL262583B2 (en)
MX (1) MX2018013205A (en)
MY (1) MY194096A (en)
PE (1) PE20190393A1 (en)
PH (1) PH12018502291A1 (en)
RU (1) RU2756403C2 (en)
SG (1) SG11201809388SA (en)
WO (1) WO2017190081A1 (en)

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Publication number Priority date Publication date Assignee Title
US20240060989A1 (en) 2019-10-04 2024-02-22 Novartis Ag Methods for measuring cralbp activity
WO2023099793A1 (en) * 2021-12-03 2023-06-08 Dsm Ip Assets B.V. Novel compositions comprising retinoids
WO2023099791A1 (en) * 2021-12-03 2023-06-08 Dsm Ip Assets B.V. Novel compositions comprising trans retinol

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU873121A1 (en) * 1979-08-20 1981-10-15 Институт биохимии АН ЛитССР Hydrolasa activity determination method
AU714271B2 (en) * 1996-09-27 1999-12-23 Unilever Plc Skin care compositions containing combinations of compounds for mimicking the effect on skin of retinoic acid
US6071410A (en) * 1998-11-16 2000-06-06 Varian, Inc. Recovery of organic solutes from aqueous solutions
CN1997359A (en) * 2004-02-17 2007-07-11 哈佛大学校长及研究员协会 Management of ophthalmologic disorders, including macular degeneration
KR20140140616A (en) * 2004-06-18 2014-12-09 유니버시티 오브 워싱톤 스루 이츠 센터 포 커머셜리제이션 Retinal derivatives and methods for the use thereof for the treatment of visual disorders
JP2008518586A (en) * 2004-09-09 2008-06-05 ユニバーシティ オブ ワシントン All-trans retinol, or all-trans 13,14-dihydroretinol saturase and method of use
MX2012003220A (en) * 2009-09-15 2012-08-03 Quadra Logic Tech Inc PHARMACEUTICAL FORMULATIONS COMPRISING 9-<i>CIS</i>-RETINYL ESTERS IN A LIPID VEHICLE.
US20140357611A1 (en) * 2009-12-08 2014-12-04 Case Western Reserve University Compounds and methods of treating ocular disorders
JP6600624B2 (en) * 2013-05-31 2019-10-30 ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア Adeno-associated virus mutant and method of use thereof
WO2015184453A1 (en) 2014-05-30 2015-12-03 Case Western Reserve University Retinylamine derivitives for treatment of ocular disorders
JP2017522895A (en) * 2014-07-31 2017-08-17 ザ ボード オブ リージェンツ オブ ザ ユニヴァーシティ オブ オクラホマ High isomerohydrolase activity mutant of mammalian RPE65
GB201502137D0 (en) * 2015-02-09 2015-03-25 Ucl Business Plc Treatment

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MY194096A (en) 2022-11-11
RU2756403C2 (en) 2021-09-30
CA3022386A1 (en) 2017-11-02
CO2018012509A2 (en) 2019-04-30
JP2019514375A (en) 2019-06-06
WO2017190081A1 (en) 2017-11-02
JP7067843B2 (en) 2022-05-16
PE20190393A1 (en) 2019-03-13
US20210348210A1 (en) 2021-11-11
IL262583B2 (en) 2023-10-01
AU2023203939A1 (en) 2023-09-14
RU2018141675A (en) 2020-05-29
AU2017258776B2 (en) 2023-07-13
RU2018141675A3 (en) 2020-09-14
EP3448371A1 (en) 2019-03-06
KR20190020661A (en) 2019-03-04
IL262583B1 (en) 2023-06-01
PH12018502291A1 (en) 2019-07-08
MX2018013205A (en) 2019-06-24
EP3448371A4 (en) 2019-09-11
BR112018072268A2 (en) 2019-02-12
CN109689033A (en) 2019-04-26
CL2018003079A1 (en) 2019-03-29
AU2017258776A1 (en) 2018-11-29
IL262583A (en) 2018-12-31

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