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HRP20211626T1 - Spojevi cikličkog peptidtirozina tirozina vezani na protutijelo kao modulatori receptora za neuropeptid y - Google Patents

Spojevi cikličkog peptidtirozina tirozina vezani na protutijelo kao modulatori receptora za neuropeptid y Download PDF

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Publication number
HRP20211626T1
HRP20211626T1 HRP20211626TT HRP20211626T HRP20211626T1 HR P20211626 T1 HRP20211626 T1 HR P20211626T1 HR P20211626T T HRP20211626T T HR P20211626TT HR P20211626 T HRP20211626 T HR P20211626T HR P20211626 T1 HRP20211626 T1 HR P20211626T1
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HR
Croatia
Prior art keywords
cyclic peptide
image
seq
monoclonal antibody
side chain
Prior art date
Application number
HRP20211626TT
Other languages
English (en)
Inventor
Mark Macielag
Raymond J. Patch
Rui Zhang
Martin A. CASE
Shamina M. Rangwala
James N. Leonard
Raul C. Camacho
Michael J. Hunter
Katharine E. D'aquino
Wilson EDWARDS
Ronald V. Swanson
Wenying Jian
Yue-Mei Zhang
Mark Wall
Ellen Chi
Original Assignee
Janssen Pharmaceutica Nv
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=62020814&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20211626(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Janssen Pharmaceutica Nv filed Critical Janssen Pharmaceutica Nv
Publication of HRP20211626T1 publication Critical patent/HRP20211626T1/hr

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/57545—Neuropeptide Y
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    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
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Claims (20)

1. Konjugat koji sadrži monoklonsko protutijelo ili njegov fragment koji veže antigen, spojen na ciklički peptid PYY, naznačen time, da je ciklički peptid PYY predstavljen Formulom I, ili derivat ili njegova farmaceutski prihvatljiva sol: [image] gdje p je 0 ili 1; m je 0, 1, 2, 3, 4 ili 5; n je 1, 2, 3 ili 4; q je 0 ili 1; uz uvjet da q je 1 samo onda kada je Z30 odsutan; MOST je -Ph-CH2-S-, -triazolil-, -NHC(O)CH2S-, SCH2C(O)NH-, -(OCH2CH2)2NHC(O)CH2S, -NHC(O)- ili -CH2S-; Z4 je K, A, E, S ili R; Z7 je A ili K; Z9 je G ili K; Z11 je D ili K; Z22 je A ili K; Z23 je S ili K; Z26 je A ili H; Z30 je L, W, odsutan ili K; uz uvjet da je Z30 odsutan samo onda kada q jest 1; Z34 je [image] Z35 je [image] gdje derivat je spoj Formule I koji je modificiran putem jednog ili više postupaka odabranih iz skupine koja se sastoji od amidacije, glikozilacije, karbamilacije, sulfatacije, fosforilacije, ciklizacije, lipidacije i pegilacije.
2. Konjugat prema patentnom zahtjevu 1, naznačen time, da ciklički peptid PYY je spoj Formule I ili derivat cikličkog peptida PYY Formule I koji je modificiran putem jednog ili više postupaka odabranih iz skupine koja se sastoji od amidacije, lipidacije i pegilacije, ili njegova farmaceutski prihvatljiva sol.
3. Konjugat prema patentnom zahtjevu 1, naznačen time, da je ciklički peptid PYY predstavljen Formulom I, ili derivat ili njegova farmaceutski prihvatljiva sol, gdje: p je 0 ili 1; m je 0, 1, 2, 3, 4 ili 5; n je 1, 2, 3 ili4; q je 0 ili 1; uz uvjet da q je 1 samo onda kada je Z30 odsutan; MOST je -Ph-CH2-S-, -triazolil-, -NHC(O)CH2S-, -SCH2C(O)NH2-, -(OCH2CH2)2NHC(O)CH2S, -NHC(O)- ili -CH2S-; Z4 je K, A, E, S ili R; Z7 je A ili K, pri čemu je amino bočni lanac od navedenog K opcionalno supstituiran s [image] gdje i je cijeli broj od 0 do 24, i X = Br, I ili Cl, -C(O)CH2Br, -C(O)CH2I, ili -C(O)CH2Cl; Z9 je G ili K, pri čemu je amino bočni lanac od navedenog K opcionalno supstituiran s [image] gdje i je cijeli broj od 0 do 24, i X = Br, I ili Cl, -C(O)CH2Br, -C(O)CH2I, ili -C(O)CH2Cl; Z11 je D ili K, pri čemu je amino bočni lanac od navedenog K opcionalno supstituiran s [image] gdje i je cijeli broj od 0 do 24, i X = Br, I ili Cl, -C(O)CH2Br, -C(O)CH2I, ili -C(O)CH2Cl; Z22 je A ili K, pri čemu je amino bočni lanac od navedenog K opcionalno supstituiran s [image] gdje i je cijeli broj od 0 do 24, i X = Br, I ili Cl, -C(O)CH2Br, -C(O)CH2I, ili -C(O)CH2Cl; Z23 je S ili K, pri čemu je amino bočni lanac od navedenog K opcionalno supstituiran s [image] gdje i je cijeli broj od 0 do 24, i X = Br, I ili Cl, -C(O)CH2Br, -C(O)CH2I, ili -C(O)CH2Cl; Z26 je A ili H; Z30 je L ili K, pri čemu je amino bočni lanac od navedenog K supstituiran s [image] Z34 je [image] i Z35 je [image]
4. Konjugat prema patentnom zahtjevu 1, naznačen time, da je ciklički peptid PYY predstavljen Formulom I, ili derivat ili njegova farmaceutski prihvatljiva sol, gdje: p je 0 ili 1; m je 0, 1, 2, 3, 4 ili 5; n je 1, 2 ili 4; q je 0 ili 1; uz uvjet da q može biti 1 samo onda kada je Z30 odsutan; MOST je -Ph-CH2-S-, -triazolil-, -NHC(O)CH2S-, -(OCH2CH2)2NHC(O)CH2S, -NHC(O)- ili -CH2S-; Z4 je K, A, E, S ili R; Z7 je A ili K, pri čemu je amino bočni lanac od navedenog K supstituiran s [image] Z9 je G ili K; Z11 je D ili K, pri čemu je amino bočni lanac od navedenog K supstituiran s [image] [image] -C(O)CH2Br, Z22 je A ili K, pri čemu je amino bočni lanac od navedenog K supstituiran s [image] Z23 je S ili K, pri čemu je amino bočni lanac od navedenog K supstituiran s [image] Z26 je A ili H; Z30 je L ili K, pri čemu je amino bočni lanac od navedenog K supstituiran s [image] Z34 je [image] Z35 je [image]
5. Konjugat prema patentnom zahtjevu 1, naznačen time, da se ciklički peptid PYY bira iz skupine koja se sastoji od SEQ ID NO: 1, 73-100 i 147-156, ili njegova farmaceutski prihvatljiva sol.
6. Konjugat prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time, da se monoklonsko protutijelo ili njegov fragment koji veže antigen kovalentno veže na ciklički peptid PYY na lizinskom ostatku cikličkog peptida PYY putem veznika; dok opcionalno pritom veznik sadrži jedan odabran iz skupine koja se sastoji od polietilen glikola (PEG)8-triazolil-CH2CH2CO-PEG4, PEG lanca od 2-24 PEG jedinica, alkilnog lanca koji sadrži 2-10 ugljikovih atoma, (Gly4Ser)j gdje j = 1-4, (AlaPro)u gdje u = 1-10, i veze.
7. Konjugat prema patentnom zahtjevu 6, naznačen time, da samo jedan od Z7, Z9, Z11, Z22, i Z23, u Formuli I, jest lizin, i lizin je kovalentno vezan na cisteinski ostatak monoklonskog protutijela konstruiran inženjeringom ili njegovog fragmenta koji veže antigen, putem veznika.
8. Konjugat, naznačen time, da sadrži molekulu u skladu sa sljedećom formulom: cPYY-L]2-mAb gdje: cPYY je ciklički peptidni PYY slijed odabran iz skupine koju čine SEQ ID NO: 102- 127 ili njegova farmaceutski prihvatljiva sol; L je veznik; mAb je monoklonsko protutijelo ili njegov fragment koji veže antigen i koji je spojen sa cikličkim peptidom PYY putem veznika; i ]2 predstavlja to da su 1 ili 2 ciklička peptida PYY kovalentno konjugirani na mAb.
9. Konjugat prema bilo kojem od patentnih zahtjeva 1 do 8, naznačen time, da monoklonsko protutijelo ili njegov fragment koji veže antigen sadrži regiju 1 koja određuje komplementarnost teškog lanca (HCDR1), HCDR2, HCDR3, i regiju 1 koja određuje komplementarnost lakog lanca (LCDR1), LCDR2, LCDR3, koje imaju polipeptidne sljedove SEQ ID NO: 141, 142, 143, 144, 145 i 146, za svaku posebno, dok opcionalno pritom izolirano monoklonsko protutijelo sadrži varijabilnu domenu teškog lanca (VH) koja ima polipeptidni slijed SEQ ID NO: 137, i varijabilnu domenu lakog lanca (VL) koja ima polipeptidni slijed SEQ ID NO: 139.
10. Konjugat prema patentnom zahtjevu 9, naznačen time, da nadalje sadrži Fc odlomak koji opcionalno sadrži teški lanac (HC) koji ima polipeptidni slijed SEQ ID NO: 138 i laki lanac (LC) koji ima polipeptidni slijed SEQ ID NO: 140.
11. Konjugat koji sadrži monoklonsko protutijelo ili njegov fragment koji veže antigen, spojen na ciklički peptid PYY, naznačen time, da: monoklonsko protutijelo ili njegov fragment koji veže antigen sadrži regiju 1 koja određuje komplementarnost teškog lanca (HCDR1), HCDR2, HCDR3, i regiju 1 koja određuje komplementarnost lakog lanca (LCDR1), LCDR2, LCDR3, koje imaju polipeptidne sljedove SEQ ID NO: 141, 142, 143, 144, 145 i 146, za svaku posebno, dok poželjno pritom monoklonsko protutijelo ili njegov fragment koji veže antigen sadrži varijabilnu domenu teškog lanca (VH) koja ima polipeptidni slijed SEQ ID NO: 137, i varijabilnu domenu lakog lanca (VL) koja ima polipeptidni slijed SEQ ID NO: 139, te još poželjnije, monoklonsko protutijelo sadrži teški lanac (HC) koji ima polipeptidni slijed SEQ ID NO: 138 i laki lanac (LC) koji ima polipeptidni slijed SEQ ID NO: 140; ciklički peptid PYY sadrži polipeptidni slijed odabran iz skupine koja se sastoji od SEQ ID NO: 1, 73-100 i 147-156, ili njegova farmaceutski prihvatljiva sol; i monoklonsko protutijelo ili njegov fragment koji veže antigen, konjugirano je na ciklički peptid PYY na ostatku 7, 9, 11, 22 ili 23 od cikličkog peptida PYY, poželjno na lizinskom ostatku 11 cikličkog peptida PYY, izravno ili putem veznika.
12. Postupak proizvodnje konjugata prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da obuhvaća reakciju elektrofila, poželjno bromoacetamida ili maleimida, koji se uvodi na bočni lanac cikličkog peptida PYY, poželjno na bočni lanac lizinskog ostatka cikličkog peptida PYY, sa sulfhidrilnom skupinom cisteinskog ostatka od SEQ ID NO: 143 monoklonskog protutijela ili njegovog fragmenta koji veže antigen, čime se stvara kovalentna veza između cikličkog peptida PYY i monoklonskog protutijela ili njegovog fragmenta koji veže antigen.
13. Farmaceutski pripravak, naznačen time, da sadrži konjugat prema bilo kojem od patentnih zahtjeva 1 do 11, i farmaceutski prihvatljiv nosač.
14. Farmaceutski pripravak prema patentnom zahtjevu 13, naznačen time, da je za uporabu u postupku liječenja ili prevencije bolesti ili poremećaja kod pojedinca kojemu je to potrebno, pri čemu se navedena bolest ili spomenuti poremećaj biraju iz skupine koju čine pretilost, dijabetes tipa I ili tipa II, metabolički sindrom, otpornost na inzulin, smanjena tolerancija na glukozu, hiperglikemija, hiperinzulinemija, hipertrigliceridemija, hipoglikemija uslijed kongenitalnog hiperinzulinizma (CHI), dislipidemija, ateroskleroza, dijabetička nefropatija, i ostali kardiovaskularni faktori rizika kao što su hipertenzija i kardiovaskularni faktori rizika koji se odnose na neuravnotežene razine kolesterola i/ili lipida, osteoporoza, upala, nealkoholna bolest masne jetre (NAFLD), nealkoholni steatohepatitis (NASH), bubrežna bolest, i ekcem, gdje postupak obuhvaća davanje učinkovite količine farmaceutskog pripravaka pojedincu kojemu je to potrebno.
15. Farmaceutski pripravak prema patentnom zahtjevu 13, naznačen time, da je za uporabu u postupku redukcije unosa hrane kod pojedinca kojemu je to potrebno, pri čemu postupak obuhvaća davanje učinkovite količine farmaceutskog pripravka pojedincu kojemu je to potrebno.
16. Farmaceutski pripravak prema patentnom zahtjevu 13, naznačen time, da je za uporabu u postupku modulacije djelovanja receptora Y2 kod pojedinca kojemu je to potrebno, pri čemu postupak obuhvaća davanje učinkovite količine farmaceutskog pripravka pojedincu kojemu je to potrebno.
17. Farmaceutski pripravak za uporabu prema bilo kojem od patentnih zahtjeva 14 do 16, naznačen time, da se farmaceutski pripravak daje putem injekcije i/ili u kombinaciji s najmanje jednim antidijabetskim sredstvom.
18. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 17, naznačen time, da je spomenuto antidijabetsko sredstvo modulator receptora peptida-1 nalik na glukagon ili se farmaceutski pripravak daje u kombinaciji s liraglutidom.
19. Komplet, naznačen time, da sadrži konjugat prema bilo kojem od patentnih zahtjeva 1 do 11, te poželjno nadalje sadrži liraglutid i uređaj za injekciju.
20. Postupak proizvodnje farmaceutskog pripravka koji sadrži konjugat prema bilo kojem od patentnih zahtjeva 1 do 11, naznačen time, da obuhvaća miješanje konjugata s farmaceutski prihvatljivim nosačem kako bi se dobio farmaceutski pripravak.
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