HRP20211418T1 - Čestice polimera i njihova uporaba - Google Patents

Čestice polimera i njihova uporaba Download PDF

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HRP20211418T1
HRP20211418T1 HRP20211418TT HRP20211418T HRP20211418T1 HR P20211418 T1 HRP20211418 T1 HR P20211418T1 HR P20211418T T HRP20211418T T HR P20211418TT HR P20211418 T HRP20211418 T HR P20211418T HR P20211418 T1 HRP20211418 T1 HR P20211418T1
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antigen
binding
domain capable
binding domain
rv3615c
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HRP20211418TT
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Bernd Helmut Adam Rehm
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Polybatics Limited
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    • C07K14/195Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/35Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Mycobacteriaceae (F)
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K38/44Oxidoreductases (1)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/51Lyases (4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/04Mycobacterium, e.g. Mycobacterium tuberculosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00Preparations for testing in vivo
    • A61K49/0004Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
    • A61K49/0006Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • A61P31/06Antibacterial agents for tuberculosis
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    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/10Transferases (2.)
    • C12N9/1025Acyltransferases (2.3)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • G01N33/6866Interferon
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • GPHYSICS
    • G01MEASURING; TESTING
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    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/35Assays involving biological materials from specific organisms or of a specific nature from bacteria from Mycobacteriaceae (F)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/52Assays involving cytokines
    • G01N2333/555Interferons [IFN]
    • G01N2333/57IFN-gamma
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00Detection or diagnosis of diseases
    • G01N2800/26Infectious diseases, e.g. generalised sepsis

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Claims (15)

1. Polimerna čestica sadrži jedan ili više polipeptida fuzije, pri čemu jedan ili više polipeptida fuzije sadrži: (A) proteinom stvorenu česticu i dvije ili više iz te skupine koja sadrži a. ESAT6 antigen ili veznu domenu sposobnu vezati ESAT6 antigen, b. CFP10 antigen ili veznu domenu sposobnu vezati CFP10 antigen, c. Rv3615c antigen ili veznu domenu sposobnu vezati Rv3615c antigen, i d. Rv3020c antigen ili veznu domenu sposobnu vezati Rv3020c antigen, ili (B) proteinom stvorenu česticu i tri ili više iz te skupine koja sadrže a. ESAT6 antigen ili veznu domenu sposobnu vezati ESAT6 antigen; b. CFP10 antigen ili veznu domenu sposobnu vezati CFP10 antigen, c. Rv3615c antigen ili veznu domenu sposobnu vezati Rv3615c antigen, d. Rv3020c antigen ili veznu domenu sposobnu vezati Rv3020c antigen, i e. Rv2346c antigen ili veznu domenu sposobnu vezati Rv2346c antigen, ili (C) proteinom stvorenu česticu, ESAT6 antigen, CFP10 antigen, i Rv3615c antigen, ili (D) proteinom stvorenu česticu, ESAT6 antigen, CFP10 antigen, i Rv3615c antigen, pri čemu spomenuti polipeptid fuzije ima najmanje oko 95% jednakost sekvence sa sekvencom aminokiseline prikazanom na SEK. ID. BR. 10, ili (E) protein stvarajuća čestica i i. ESAT6 antigen ili veznu domenu sposobnu vezati ESAT6 antigen; i ii. CFP10 antigen ili veznu domenu sposobnu vezati CFP10 antigen; i iii. Rv3615c antigen ili veznu domenu sposobnu vezati Rv3615c antigen, i iv. Rv3020c antigen ili veznu domenu sposobnu vezati Rv3020c antigen, ili (F) protein stvarajuća čestica, ESAT6 antigen, CFP10 antigen, i Rv3615c antigen, i Rv3020c antigen.
2. Polimerna čestica sukladno patentnom zahtjevu 1, pri čemu ta čestica polimera sadrži najmanje jedan polipeptid fuzije koja koja sadrži proteinom stvorenu česticu i dvije ili više skupina koje sadrže i. ESAT6 antigen ili veznu domenu sposobnu vezati ESAT6 antigen; ii. CFP10 antigen ili veznu domenu sposobnu vezati CFP10 antigen; iii. Rv3615c antigen ili veznu domenu sposobnu vezati Rv3615c antigen; iv. Rv3020c antigen ili veznu domenu sposobnu vezati Rv3020c antigen; i v. Rv2346c antigen ili veznu domenu sposobnu vezati Rv2346c antigen; i najmanje jedan polipeptid fuzije koja sadrži proteinom stvorenu česticu i jednu ili više skupina koje sadrže vi. ESAT6 antigen ili veznu domenu sposobnu vezati ESAT6 antigen; vii. CFP10 antigen ili veznu domenu sposobnu vezati CFP10 antigen; viii. Rv3615c antigen ili veznu domenu sposobnu vezati Rv3615c antigen; ix. Rv3020c antigen ili veznu domenu sposobnu vezati Rv3020c antigen; i x. Rv2346c antigen ili veznu domenu sposobnu vezati Rv2346c antigen.
3. Čestica polimera sukladno patentnom zahtjevu 2., pri čemu polipeptid fuzije sadrži jedan ili više antigena koja skupina (vi) do (x) je različita u odnosu na polipeptid fuzije koja sadrži dva ili više antigena iz skupine (i) do (v).
4. Čestica polimera sukladno bilo kojem od patentnih zahtjeva 1. do 3., pri čemu kada je prisutan ESAT6 antigen sadrži 10. ili više dodirnih aminokiselina iz sekvence aminokiselina sukladno SEK. ID. br. 1., i kada je prisutan CFP10 antigen sadrži 10. ili više dodirnih aminokiselina iz sekvence aminokiselina sukladno SEK. ID. br. 2., i kada je prisutan Rv3615c antigen sadrži 10. ili više dodirnih aminokiselina iz sekvence aminokiselina sukladno SEK. ID. br. 3., i kada je prisutan Rv3020c antigen sadrži 10 ili više dodirnih aminokiselina iz sekvencije aminokiselina sukladno SEK. ID. br. 4., i kada je prisutan Rv2346c antigen sadrži 10 ili više dodirnih aminokiselina iz sekvencije aminokiselina SEK. ID. br. 5.
5. Čestica polimera sukladno patentnom zahtjevu 4., pri čemu kada je prisutan ESAT6 antigen sadrži sekvencu aminokiseline SEK. ID. br. 1., i kada je prisutan CFP10 antigen sadrži sekvencu aminokiselina sukladno SEK. ID. br. 2., i kada je prisutan Rv3615c antigen sadrži sekvencu aminokiselina sukladno SEK. ID. br. 3., i kada je prisutan Rv3020c antigen sadrži sekvencu aminokisleina SEK. ID. br. 4., i kada je prisutan Rv2346c antigen sadrži sekvencu aminokiselina SEK. ID. br. 5.
6. Pripravak koja sadrži jednu ili više čestica polimera sukladno bilo kojem od patentnih zahtjeva 1. do 5., i nosač.
7. Pripravak sukladno patentnom zahtjevu 6. pri čemu taj pripravak sadrži dvije ili više populacija čestica polimera, pri čemu jedna populacija čestica polimera sadrži jedan ili više polipeptida fuzije sadrži proteinom stvorenu česticu i dvije ili više skupina koje sadrže i. ESAT6 antigen ili veznu domenu sposobnu vezati ESAT6 antigen; ii. CFP10 antigen ili veznu domenu sposobnu vezati CFP10 antigen; iii. Rv3615c antigen ili veznu domenu sposobnu vezati Rv3615c antigen; iv. Rv3020c antigen ili veznu domenu sposobnu vezati Rv3020c antigen; i v. Rv2346c antigen ili veznu domenu sposobnu vezati Rv2346c antigen; i jedna populacija čestica polimera sadrži jedan ili više polipeptida fuzije sadrži proteinom stvorenu česticu i jednu ili više skupina koja sadrži vi. ESAT6 antigen ili veznu domenu sposobnu vezati ESAT6 antigen; vii. CFP10 antigen ili veznu domenu sposobnu vezati CFP10 antigen; viii. Rv3615c antigen ili veznu domenu sposobnu vezati Rv3615c antigen; ix. Rv3020c antigen ili veznu domenu sposobnu vezati Rv3020c antigen; i x. Rv2346c antigen ili veznu domenu sposobnu vezati Rv2346c antigen; pri čemu je jedan ili više polipeptida fuzije prisutnih na jednoj populaciji čestica polimera drugačiji na jednom ili više polipeptida fuzije prisutnih na jednoj drugoj populaciji čestica polimera.
8. Dijagnostički reagens koja sadrži jednu ili više čestica polimera sukladno bilo kojem od patentnih zahtjeva 1. do 5. ili pripravak za koju se zaštita patentom traži u patentnim zahtjevima 6. ili 7., poželjno za topikalnu primjenu pacijentu.
9. Dijagnostički reagens sukladno patentnog zahtjeva 8., pri čemu dijagnostički reagens (A) je stvoren da bi osigurao manje od 10 mikrograma ukupnog antigena po dozi, (B) sadrži manje od 5 µg ukupnog antigena po dozi, (C) se stvara da bi se osiguralo manje od 5 µg jednog ili više antigena prisutnih po dozi, (D) se stvara da bi se osiguralo manje od 1 µg jednog ili više antigena prisutnih po dozi, (E) se stvara da bi se osiguralo manje od 5 µg svakog antigena prisutnog po dozi, (F) sadrži manje od 5 µg svakog antigena prisutnog po dozi, (G) sadrži manje od 1 µg svakog antigena prisutnog po dozi, (H) sadrži manje od 0,5 µg jednog ili više antigena prisutnih po dozi, (I) sadrži manje od 0,5 µg svakog antigena prisutnog po dozi, (J) sadrži manje od 50 ng svakog antigena prisutnog po dozi, (K) je stvoren da osigura manje od 50 ng ukupnog antigena po dozi, ili (L) je stvoren da osigura manje od 10 ng ukupnog antigena po dozi.
10. Najmanje jedna čestica polimera sukladno bilo kojem od patentnih zahtjeva 1. do 5., pripravak sukladno patentnom zahtjevu 6. ili 7., ili reagens sukladno patentnom zahtjevu 8. ili 9., za uporabu u postupku dijagnosticiranja tuberkuloze kod subjekta, taj postupak sadrži isporuku subjektu učinkovite količine najmanje jedne čestice polimera sukladno bilo kojem od patentnih zahtjeva 1. do 5., pripravka sukladno patentnom zahtjevu 6. ili 7., ili reagensa sukladno patentnom zahtjevu 8. ili 9., i utvrđivanje odgovora imunosnog sustava kod subjekta, pri čemu je prisutnost odgovora imunosnog sustava indikativno za tuberkulozu.
11. Najmanje jedna čestica polimera, pripravak, ili reagens za uporabu sukladno patentnom zahtjevu 10, pri čemu je primjena topikalna, poželjno putem uboda u kožu.
12. Postupak dijagnosticiranja M. tuberculosis ili M. bovis u uzorku od subjekta, taj postupak sadrži osiguravanje uzorka iz subjekta, dovođenje u dodir uzorka s najmanje jednom česticom polimera sukladno bilo kojem od patentnih zahtjeva 1. do 5., pripravkom sukladno patentnom zahtjevu 6. ili 7., ili reagensom sukladno patentnom zahtjevu 8. ili 9., i otkrivanje odgovora indikativnog za prisutnost jednog ili više M. tuberculosis antigena u tome uzorku, pri čemu je taj odgovor indikativan na prisutnost jednog ili više M. tuberculosis ili M. bovis antigena je indikativan za M. tuberculosis ili M. bovis kod tog subjekta.
13. Postupak sukladno patentnom zahtjevu 12., pri čemu je odgovor indikativan na prisutnost jednog ili više M. tuberculosis ili M. bovis antigena je (A) otkrivanje prisutnosti antitijela na M. tuberculosis ili M. bovis u navedenom uzorku, ili (B) otkrivanje prisutnosti imunosne stanice koja reagira na M. tuberculosis ili M. bovis u navedenom uzorku.
14. Postupak sukladno patentnom zahtjevu 12 ili 13, pri čemu je to otkrivanje putem imunoogleda, putem ELISA, radioimunoogleda, ili Western Blot putem ogleda citokina, ili je gama interferonom.
15. Postupak sukladno patentnom zahtjevu 13, pri čemu prisutnost imunosne stanice koja reagira na Mycobacterium tuberculosis ili M. bovis se otkriva ogledom proliferacije stanice, ogledom sortiranja stanice uključujući FACS, ili ogledom hibridsukladnoacije in situ.
HRP20211418TT 2014-02-04 2015-02-04 Čestice polimera i njihova uporaba HRP20211418T1 (hr)

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NZ62068214 2014-02-04
EP15746012.2A EP3102613B1 (en) 2014-02-04 2015-02-04 Polymer particles and uses thereof
PCT/NZ2015/050008 WO2015119512A1 (en) 2014-02-04 2015-02-04 Polymer particles and uses thereof

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WO2018111536A1 (en) 2016-12-14 2018-06-21 Becton, Dickinson And Company Methods and compositions for obtaining a tuberculosis assessment in a subject
CN109776661B (zh) * 2019-03-13 2022-08-09 中国动物卫生与流行病学中心 一种牛结核病γ-干扰素ELISA检测用鸡尾酒刺激抗原
CN109776662B (zh) * 2019-03-13 2022-05-17 中国动物卫生与流行病学中心 一种用于牛结核病变态反应检测的鸡尾酒抗原
CN109813884A (zh) * 2019-03-25 2019-05-28 中国动物卫生与流行病学中心 一种牛结核病γ-干扰素快速检测制品
CN109813576B (zh) * 2019-03-25 2021-04-02 中国动物卫生与流行病学中心 一种牛结核病刺激上清制备用采血器
CN111269297B (zh) * 2020-01-23 2021-11-30 郑州伊美诺生物技术有限公司 一种结核分枝杆菌刺激抗原的制备方法
EP4132952A4 (en) * 2020-04-08 2024-10-02 Nanopin Tech Inc MONOCLONAL ANTIBODIES AND USES THEREOF

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US7037510B2 (en) 1997-04-18 2006-05-02 Statens Serum Institut Hybrids of M. tuberculosis antigens
US20060024332A1 (en) * 2004-08-02 2006-02-02 Waters Wade R Recombinant ESAT-6:CFP-10 fusion protein useful for specific diagnosis of tuberculosis
DK1929010T3 (en) * 2005-09-27 2014-03-10 Polybatics Ltd Use of the polymer particles
JP2013500329A (ja) * 2009-07-29 2013-01-07 ヘルムート アダム レフム ベルン ポリマー粒子およびその使用
WO2012104791A1 (en) * 2011-02-01 2012-08-09 Bernd Helmut Adam Rehm Fusion polypeptides and uses thereof
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PL3102613T3 (pl) 2021-12-13
EP3102613A4 (en) 2017-12-20
EP3102613B1 (en) 2021-06-09
CY1124491T1 (el) 2022-07-22
ES2891973T3 (es) 2022-02-01
SI3102613T1 (sl) 2021-11-30
WO2015119512A1 (en) 2015-08-13
RS62375B1 (sr) 2021-10-29
HUE056108T2 (hu) 2022-01-28
US20170008938A1 (en) 2017-01-12
US10501505B2 (en) 2019-12-10

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