HRP20192254T1 - Konjugat antitijela i lijeka i njegova upotreba u liječenju karcinoma - Google Patents

Konjugat antitijela i lijeka i njegova upotreba u liječenju karcinoma Download PDF

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Publication number
HRP20192254T1
HRP20192254T1 HRP20192254TT HRP20192254T HRP20192254T1 HR P20192254 T1 HRP20192254 T1 HR P20192254T1 HR P20192254T T HRP20192254T T HR P20192254TT HR P20192254 T HRP20192254 T HR P20192254T HR P20192254 T1 HRP20192254 T1 HR P20192254T1
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HR
Croatia
Prior art keywords
antibody
antigen
igf
cancer
binding
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HRP20192254TT
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English (en)
Inventor
Ian RILATT
Michel Perez
Liliane Goetsch
Matthieu BROUSSAS
Charlotte Beau-Larvor
Jean-François HAEUW
Original Assignee
Pierre Fabre Medicament
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Application filed by Pierre Fabre Medicament filed Critical Pierre Fabre Medicament
Publication of HRP20192254T1 publication Critical patent/HRP20192254T1/hr

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    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
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Claims (23)

1. Konjugat antitijela i lijeka sljedeće formule (I): Ab-(L-D)n (I) ili njegova farmaceuski prihvatljiva sol, s time da Ab jest [meta] antitijelo ili antitijelo antigena, ili [meta] njegov vezan fragment ili njegov fragment vezan na antigen; L je spojnica sljedeće formule (III): u kojoj L2 je (C4-C10)cikloalkil-karbonil, (C2-C6)alkil, ili (C2-C6)alkil-karbonil, W je aminokiselinska jedinica; w je cijeli broj između 0 i 5; Y je PAB-karbonil, a PAB jest ; y je 0 ili 1; zvjezdica pokazuje mjesto spajanja za D; valovita linija pokazuje mjesto spajanja za Ab; D je dio lijeka sljedeće formule (II): u kojoj: R1 je H ili OH; R2 je skupina: (C1-C6)alkil, COOH, COO-((C1-C6)alkil) ili tiazolil; R3 je H ili (C1-C6)alkilna skupina; A je: - skupina formule -Het-Alk- gdje Alk jest (C1-C8)alkandiilna skupina i spojena je za NR3, te je Het heterociklil opcionalno supstituiran s (C1-C6)alkilnom skupinom i sadrži najmanje jedan dušikov atom, rečeni dušikov atom vezan je za L, ili - skupina formule -Aa-Ab- u kojoj Aa je vezan za L i jest O ili NR9 s tim da R9 jest H ili (C1-C6)alkil te Ab je vezan za NR3 i jest: • (C1-C8)alkandiilna skupina, • -(CH2CH2X1)a1(CH2CH2X2)a2(CH2CH2X3)a3(CH2CH2X4)a4CH2CH2-skupina u kojoj X1, X2, X3 i X4 svaki neovisno jedan od drugog predstavlja O ili NR8; a1, a2, a3 i a4svaki neovisno jedan od drugog predstavlja 0 ili 1; te R8 predstavlja H ili (C1-C6)alkilnu skupinu, • aril-(C1-C8)alkandiilna ili heterociklil-(C1-C8)alkandiilna skupina, rečena skupina je opcionalno supstituirana s (C1-C6)alkilnom skupinom, arilni ili heterociklički dio vezan je za Aa te je (C1-C8)alkandiilni dio vezan za NR3; valovita linija pokazuje mjesto vezanja za L; te n je 1 do 12.
2. Konjugat antitijela i lijeka iz patentnog zahtjeva 1, naznačeno time da je [meta] ili antigen rečenog [meta] antitijela ili antigen antitijela prema izumu, ili [meta] ili njegov fragment vezan na antigen odabran od CD19, CD20, CD22, CD25, CD30, CD33, CD40, CD56, CD64, CD70, CD74, CD79, CD105, CD138, CD174, CD205, CD227, CD326, CD340, MUC16, GPNMB, PSMA, Cripto, ED-B, TMEFF2, EphB2, EphA2, FAP, av integrin, Mesothelin, EGFR, TAG-72, GD2, CAIX, 5T4, HER1, HER3, HER2, IGF-1R, Axl i njihov (ECD) fragment vanstanične membrane.
3. Konjugat antitijela i lijeka iz patentnog zahtjeva 1, naznačeno time da je rečena [meta] ili antigen rečenog [meta] antitijela ili antigen antitijela prema izumu, ili [meta] ili njegov fragment vezan na antigen odabran od HER2, IGF-1R te protein Axl, preferirano humani HER2, humani IGF-1R i humani protein Axl, te njihov (ECD) fragment vanstanične membrane.
4. Konjugat antitijela i lijeka iz patentnog zahtjeva 1, naznačeno time da rečeni Ab jest antitijelo, ili njegov fragment vezan na antigen, koji se može vezati na humani IGF-1R odabran od: i) antitijela 208F2, 212A11, 214F8, 219D6 te 213B10; ii) antitijela koja su u kompeticiji za vezanje na IGF-1R s antitijelima iz i); te iii) antitijela koja se vezuju na isti epitop od IGF-1R kao antitijela iz i).
5. Konjugat antitijela i lijeka iz patentnog zahtjeva 1, naznačeno time da: rečeni Ab jest antitijelo, ili njegov fragment vezan na antigen, koji se može vezati na humani IGF-1R odabran od: i) antitijela koje sadrži tri teška lanca CDRs sekvencije SEQ ID No. 1, 2, i 3 te tri laka lanca CDRs sekvencije SEQ ID No. 4, 5 i 6; ii) antitijela koje je u kompeticiji za vezanje na IGF-1R s antitijelom iz i); te iii) antitijela koje se vezuje na isti epitop od IGF-1R kao antitijelo iz i); ili rečeni Ab jest antitijelo, ili njegov fragment vezan na antigen, koji se može vezati na humani protein Axl odabran od: i) antitijela koje sadrži tri teška lanca CDRs sekvencije SEQ ID No. 59, 60 i 61 te tri laka lanca CDRs sekvencije SEQ ID No. 56, 57 i 58; ii) antitijela koje je u kompeticiji za vezanje na Axl s antitijelom iz i); te iii) antitijela koje se vezuje na isti epitop od Axl kao antitijelo iz i).
6. Konjugat antitijela i lijeka iz patentnog zahtjeva 1, naznačeno time da Ab sadrži: a) teški lanac varijabilne domene (VH) sekvencije SEQ ID No. 33 u kojoj rečena sekvencija SEQ ID No. 33 sadrži barem 1 povratnu mutaciju odabranu od ostataka 20, 34, 35, 38, 48, 50, 59, 61, 62, 70, 72, 74, 76, 77, 79, 82 ili 95; te b) laki lanac varijabilne domene (VL) sekvencije SEQ ID No. 35, u kojoj rečena sekvencija SEQ ID No. 35 sadrži barem 1 povratnu mutaciju odabranu od ostataka 22, 53, 55, 65, 71, 72, 77 ili 87.
7. Konjugat antitijela i lijeka iz patentnog zahtjeva 1, naznačeno time da rečeni Ab jest antitijelo, ili njegov fragment vezan na antigen, koji se može vezati na humani HER2 koji se sastoji od Trastuzumab.
8. Konjugat antitijela i lijeka iz bilo kojeg od patentnih zahtjeva 1 do 7, naznačeno time da je L2 sljedeće formule: u kojoj zvjezdica pokazuje točku vezanja za (W)w; te valovita linija pokazuje točku vezanja za dušikov atom maleimidnog ostatka.
9. Konjugat antitijela i lijeka iz bilo kojeg od patentnih zahtjeva 1 do 7, naznačeno time da w = 0; ili w = 2 te je (W)w odabran od: , te u kojima zvjezdica pokazuje točku vezanja za (Y)y; te valovita linija pokazuje točku vezanja za L2.
10. Konjugat antitijela i lijeka iz bilo kojeg od patentnih zahtjeva 1 do 7, naznačeno time da je L odabran od: , te , u kojima zvjezdica pokazuje točku vezanja za D, a valovita linija pokazuje točku vezanja za Ab.
11. Konjugat antitijela i lijeka iz bilo kojeg od prethodnih patentnih zahtjeva, naznačeno time da je A skupina formule -Aa-Ab- u kojoj je Aa kao što je definiran u patentnom zahtjevu 1 te Ab je skupina: - fenil-(C1-C2)alkandiil, ili - heterociklil-(C1-C2)alkandiil opcionalno supstituiran s (C1-C6)alkilnom skupinom (posebno nesupstituiran), heterociklil je zasićen, nezasićen ili aromatski peteročlani ili šesteročlani prsten koji sadrži 1 ili 2 atoma dušika, posebno odabran od piridina, piperidina i imidazola, a preferirano je piridin.
12. Konjugat antitijela i lijeka iz bilo kojeg od prethodnih patentnih zahtjeva, naznačeno time da je A skupina sljedeće formule: u kojoj: R9 jest kako je definiran u patentnom zahtjevu 1 te m je cijeli broj između 1 i 8, te preferirano gdje R9 = H ili Me i m = 1 ili 2, valovita linija pokazuje točku vezanja za L, te zvjezdica pokazuje točku vezanja za NR3.
13. Konjugat antitijela i lijeka iz bilo kojeg od prethodnih patentnih zahtjeva, naznačeno time da je (L-D) odabran od:
te gdje valovita linija pokazuje točku vezanja za Ab.
14. Konjugat antitijela i lijeka prema patentnom zahtjevu 1 ili 2 koji ima formulu odabranu od:
i njihove farmaceutski prihvatljive soli, gdje je Ab [meta] antitijelo ili antigen antitijelo, ili [meta] njegov vezan fragment ili njegov fragment vezan na antigen.
15. Konjugat antitijela i lijeka iz patentnog zahtjeva 14, naznačeno time da je [meta] od rečenog [meta] antitijela ili antigen od rečenog antitijela antigena odabran od HER2, IGF-1R i protein Axl, preferirano humani HER2, humani IGF-1R i humani protein Axl.
16. Konjugat antitijela i lijeka iz patentnog zahtjeva 14, naznačeno time da rečeni Ab jest antitijelo, ili njegov fragment vezan na antigen, te odabran od: a) Ab, ili njegov fragment vezan na antigen, koji se može vezati za humani IGF-1R odabran od: i) antitijela 208F2, 212A11, 214F8, 219D6 i 213B10; ii) antitijela koja su u kompeticiji za vezanje na IGF-1R s antitijelima iz i); te iii) antitijela koja se vezuju na isti epitop od IGF-1R kao antitijela iz i), b) Ab, ili njegov fragment vezan na antigen, koji se može vezati za humani IGF-1R odabran od: i) antitijela koje sadrži tri teška lanca CDRs sekvencije SEQ ID No. 1, 2 i 3 te tri laka lanca CDRs sekvencije SEQ ID No. 4, 5, i 6; ii) antitijela koje je u kompeticiji za vezanje na IGF-1R s antitijelom iz i); te iii) antitijela koje se vezuju na isti epitop od IGF-1R kao antitijelo iz i), c) Ab koji sadrži: i) teški lanac varijabilne domene (VH) sekvencije SEQ ID No. 33 u kojoj rečena sekvencija SEQ ID No. 33 sadrži barem 1 povratnu mutaciju odabranu od ostataka 20, 34, 35, 38, 48, 50, 59, 61, 62, 70, 72, 74, 76, 77, 79, 82 ili 95; te ii) laki lanac varijabilne domene (VL) sekvencije SEQ ID No. 35, u kojoj rečena sekvencija SEQ ID No. 35 sadrži barem 1 povratnu mutaciju odabranu od ostataka 22, 53, 55, 65, 71, 72, 77 ili 87, d) Ab, ili njegov fragment vezan na antigen, koji se može vezati za humani protein Axl odabran od: i) antitijela koje sadrži tri teška lanca CDRs sekvencije SEQ ID No. 59, 60 i 61 te tri laka lanca CDRs sekvencije SEQ ID No. 56, 57 i 58; ii) antitijela koje je u kompeticiji za vezanje na Axl s antitijelom iz i); te iii) antitijela koje se vezuju na isti epitop od Axl kao antitijelo iz i), te e) Ab, ili njegov fragment vezan na antigen, koji se može vezati na humani HER2 koji se sastoji od Trastuzumab ili Pertuzumab.
17. Konjugat antitijela i lijeka iz bilo kojeg od patentnih zahtjeva 1 do 16, naznačeno time da n jest 2 ili 4.
18. Konjugat antitijela i lijeka iz bilo kojeg od patentnih zahtjeva 1 do 17 za upotrebu kao lijek.
19. Pripravak koji sadrži najmanje jedan konjugat antitijela i lijeka iz bilo kojeg od patentnih zahtjeva 1 do 17.
20. Pripravak iz patentnog zahtjeva 19 koji dalje sadrži farmaceutski prihvatljiv vezikul.
21. Pripravak iz patentnog zahtjeva 19 ili 20 za upotrebu u liječenju karcinoma koji eksprimira [meta]- ili antigen, rečeni [meta]- ili antigen su preferirano odabrani od CD19, CD20, CD22, CD25, CD30, CD33, CD40, CD56, CD64, CD70, CD74, CD79, CD105, CD138, CD174, CD205, CD227, CD326, CD340, MUC16, GPNMB, PSMA, Cripto, ED-B, TMEFF2, EphB2, EphA2, FAP, av integrin, Mesothelin, EGFR, TAG-72, GD2, CAIX, 5T4, HER2, IGF-1R, Axl i (ECD) fragment njihovih vanstaničnih membrana.
22. Pripravak iz patentnog zahtjeva 19 ili 20 za upotrebu u liječenju karcinoma kojeg eksprimiraju HER2-, IGF-1R- ili Axl.
23. Pripravak iz jednog od patentnih zahtjeva 19 do 21, naznačeno time da karcinom koji eksprimira rečeni [meta]- ili rečeni antigen jest karcinom odabran od karcinoma dojke, karcinoma debelog crijeva, karcinoma jednjaka, hepatocelularnog karcinoma, karcinoma želuca, gliome, karcinoma pluća, melanoma, osteosarkoma, karcinoma ovarija, karcinoma prostate, rabdomiosarkoma, karcinoma bubrega, karcinoma tireoideje, karcinoma endometrija maternice, mezotelioma, oralnog skvamoznog karcinoma, Kaposijevog sarkoma, akutne leukemije, kolorektalnog karcinoma, melanoma, duktalnog adenokarcinoma gušterače i bilo kojeg karcinoma rezistentnog na lijek.
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