HRP20160506T1 - Neutralizirajuće prolaktin receptorsko protutijelo mat3 i njegova terapijska uporaba - Google Patents

Neutralizirajuće prolaktin receptorsko protutijelo mat3 i njegova terapijska uporaba Download PDF

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HRP20160506T1
HRP20160506T1 HRP20160506TT HRP20160506T HRP20160506T1 HR P20160506 T1 HRP20160506 T1 HR P20160506T1 HR P20160506T T HRP20160506T T HR P20160506TT HR P20160506 T HRP20160506 T HR P20160506T HR P20160506 T1 HRP20160506 T1 HR P20160506T1
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antigen
antibody
host cell
binding
binding fragment
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Christoph Freiberg
Christiane Otto
Lars Linden
Axel Harrenga
Mark Trautwein
Simone Greven
Andreas Wilmen
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Bayer Intellectual Property Gmbh
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    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
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    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3015Breast
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Claims (22)

1. Protutijelo Mat3 ili njegovi fragmenti koji vežu antigen, koje antagonizira signalizaciju prolaktinom posredovanog receptora, naznačeno time da protutijelo ili njegovi fragmenti koji vežu antigen sadrže a. promjenjivo teško područje sa sekvencom amino kiseline u skladu sa SEQ ID NO: 1, i b. promjenjivo lako područje sa sekvencom amino kiseline u skladu sa SEQ ID NO: 2.
2. Protutijelo ili njegovi fragmenti koji vežu antigen prema zahtjevu 1, naznačeno time da protutijelo ili njegovi fragmenti koji vežu antigen sadrže regiju koja veže antigen koja se specifično veže na jednu ili više regija izvanstanične domene prolaktin receptora (PRLR) iz čovjeka, majmuna i miša, te pri čemu su sekvence amino kiseline za ljudski PRLR prikazane sa sekvencom amino kiseline od položaja 1 do 210 iz SEQ ID NO: 12 i ljudske polimorfne varijante iz SEQ ID NO: 12, sa sekvencom amino kiseline od položaja 1 do 210 majmunskog PRLR u skladu sa SEQ ID NO: 11 i mišjeg PRLR u skladu sa SEQ ID NO: 13.
3. Protutijelo ili njegovi fragmenti koji vežu antigen prema zahtjevu 2, naznačeno time da afinitet za izvanstaničnu domenu PRLR iz čovjeka, majmuna i miša je 100 nM, manje od 30 nM, ili s afinitetom od 10 nM, te pri čemu je afinitet izmjeren površinskom plazmonskom rezonancijom, na primjer sa Biacore.
4. Protutijelo ili njegovi fragmenti koji vežu antigen prema zahtjevu 1, naznačeno time da protutijelo sadrži regiju koja veže antigen koja se veže specifično na jednu ili više regija izvanstanične domene ljudske PRLR i pri čemu je afinitet 10 nM ili 1 nM, te pri čemu je afinitet izmjeren površinskom plazmonskom rezonancijom, na primjer sa Biacore.
5. Protutijelo ili njegovi fragmenti koji vežu antigen prema bilo kojem od zahtjeva 1 do 4 naznačeno time da konstantne domene teškog lanca su modificirani ili nemodificirani IgG1, IgG2, IgG3 ili IgG4.
6. Izolirana sekvenca nukleinske kiseline naznačena time da kodira protutijelo ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5.
7. Izolirana sekvenca nukleinske kiseline prema zahtjevu 6, naznačena time da su izolirane sekvence nukleinske kiseline u skladu sa SEQ ID NO: 3 i 4.
8. Ekspresijski vektor naznačen time da sadrži sekvencu nukleinske kiseline prema zahtjevu 6 ili 7.
9. Stanica domaćin koja sadrži vektor prema zahtjevu 8 ili molekulu nukleinske kiseline prema zahtjevu 6 ili 7, naznačena time da je stanica domaćin viša eukariotska stanica domaćin, niža eukariotska stanica domaćin, ili prokariotska stanica.
10. Stanica domaćin prema zahtjevu 9, naznačena time da viša eukariotska stanica domaćin je stanica sisavca.
11. Stanica domaćin prema zahtjevu 9, naznačena time da niža eukariotska stanica domaćin je stanica kvasca.
12. Stanica domaćin prema zahtjevu 9, naznačena time da prokariotska stanica je bakterijska stanica.
13. Postupak korištenja stanice domaćina prema bilo kojem od zahtjeva 9 do 12 za proizvodnju protutijela ili fragmenta koji veže antigen, naznačen time da sadrži kultiviranje stanice domaćina prema zahtjevu 9 pod pogodnim uvjetima i prikupljanje navedenih protutijela.
14. Protutijelo ili fragment koji veže antigen naznačeno time da se proizvodi postupkom prema zahtjevu 13.
15. Protutijelo ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5 naznačeno time da se pročišćava do najmanje 95% homogenosti po težini.
16. Protutijelo ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5 naznačeno time da je za uporabu kao lijek.
17. Farmaceutski pripravak naznačen time da sadrži protutijelo ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5 i farmaceutski prihvatljiv nosač koji sadrži ekscipijente i pomoćna sredstva.
18. Komplet koji sadrži protutijelo prema zahtjevu 1 do 5 naznačen time da sadrži terapeutski učinkovitu količinu protutijela Mat3, pakiranu u spremnik, navedeni komplet proizvoljno sadrži i drugo terapeutsko sredstvo, te nadalje sadrži oznaku pričvršćenu ili pakiranu sa spremnikom, oznaka opisuje sadržaj spremnika i pruža navode i/ili upute o korištenju sadržaja spremnika za liječenje endometrioze, adenomioze, benigne bolesti dojke i mastalgije, inhibiciju laktacije, hiper- i normo-prolaktinemijskog gubitka kose, benigne hiperplazije prostate, fibroida ili za primjenu za ne-hormonsku žensku kontracepciju ili za liječenje žena koje su pod kombiniranom hormonskom terapijom, estrogen plus progestin terapijom, za inhibiciju proliferacije stanica epitela dojke ili za liječenje i prevenciju raka dojke otpornog na terapiju antiestrogenom.
19. Protutijelo ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5 naznačeno time da je za uporabu u lijeku za liječenje i/ili prevenciju endometrioze i adenomioze, interne endometrioze.
20. Protutijelo ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5 naznačeno time da je za uporabu u lijeku za liječenje benigne bolesti dojke i mastalgije.
21. Protutijelo ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5 naznačeno time da je za uporabu u lijeku za liječenje ili prevenciju raka dojke otpornog na terapiju antiestrogenom.
22. Farmaceutski pripravak prema zahtjevu 17 naznačen time da sadrži PRLR protutijela ili fragment koji veže antigen prema bilo kojem od zahtjeva 1 do 5, u kombinaciji s najmanje jednim drugim sredstvom.
HRP20160506TT 2011-06-03 2016-05-12 Neutralizirajuće prolaktin receptorsko protutijelo mat3 i njegova terapijska uporaba HRP20160506T1 (hr)

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EP11168644A EP2530089A1 (en) 2011-06-03 2011-06-03 Neutralising prolactin receptor antibody Mat3 and its therapeutical use
EP12729030.2A EP2714740B1 (en) 2011-06-03 2012-05-31 Neutralizing prolactin receptor antibody mat3 and its therapeutic use
PCT/EP2012/060078 WO2012163932A1 (en) 2011-06-03 2012-05-31 Neutralizing prolactin receptor antibody mat3 and its therapeutic use

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US (2) US9353186B2 (hr)
EP (2) EP2530089A1 (hr)
JP (1) JP5859641B2 (hr)
KR (1) KR101920521B1 (hr)
CN (1) CN103764679B (hr)
AP (1) AP2013007266A0 (hr)
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