HRP20230154T1 - Anti-met fab-fc za liječenje tumora i/ili metastaza - Google Patents
Anti-met fab-fc za liječenje tumora i/ili metastaza Download PDFInfo
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Classifications
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- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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- C—CHEMISTRY; METALLURGY
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- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
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- C—CHEMISTRY; METALLURGY
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- C07K—PEPTIDES
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Claims (19)
1. Fragment anti-Met antitijela koji sadržava jedan krak za vezanje antigena i Fc regiju pri čemu Fc regija sadržava kompleks prvog i drugog Fc polipeptida, pri čemu fragment antitijela sadržava:
(i) prvi polipeptid koji sadržava jednu varijabilnu domenu humaniziranog lakog lanca (VL) i jednu konstantnu domenu ljudskog lakog lanca (CL), pri čemu je humanizirana VL domena spojena s ljudskom CL domenom u smjeru N- do C-terminala, i pri čemu humanizirana VL domena sadrži tri regije koje određuju komplementarnost (eng. complementarity determining regions; CDR) koje imaju sekvence aminokiselina kako je navedeno u SEQ ID br..: 1, 2 i 3, i pri čemu humanizirana VL domena ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 7;
(ii) drugi polipeptid koji sadržava jednu varijabilnu domenu humaniziranog teškog lanca (VH), jednu konstantnu CH1 domenu ljudskog teškog lanca i prvi Fc polipeptid, pri čemu prvi Fc polipeptid sadržava jednu zglobnu regiju, jednu ljudsku konstantnu CH2 domenu i jednu ljudsku CH3 konstantnu domenu, pri čemu je humanizirana VH domena spojena s ljudskom CH1 domenom, koja je spojena s ljudskom zglobnom regijom, koja je spojena s ljudskom CH2 domenom, koja je spojena s ljudskom CH3 domenom u smjeru N-do C-terminala, i pri čemu humanizirana VH domena sadrži tri regije koje određuju komplementarnost (CDR) koje imaju sekvence aminokiselina kako je navedeno u SEQ ID br.: 4, 5 i 6, i pri čemu humanizirana VH domena ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 8; i
(iii) treći polipeptid koji sadržava drugi ljudski Fc polipeptid, pri čemu drugi ljudski Fc polipeptid sadržava jednu ljudsku zglobnu regiju, jednu ljudsku CH2 konstantnu domenu i jednu ljudsku CH3 konstantnu domenu, pri čemu je ljudska zglobna regija spojena s CH2 domenom koja je spojena s ljudskom CH3 domenom u smjeru N-do C-terminala, pri čemu je ljudska zglobna regija skraćena na N-kraju.
2. Fragment anti-Met antitijela u skladu s patentnim zahtjevom 1, pri čemu je ljudska CL domena ljudska laka domena tipa kappa.
3. Fragment anti-Met antitijela u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, pri čemu su ljudska zglobna regija i ljudske konstantne domene CH1, CH2 i CH3 iz ljudskog IgG1.
4. Fragment anti-Met antitijela u skladu s bilo kojim od patentnih zahtjeva 1 do 3, pri čemu su dva Fc polipeptida povezana intermolekularnim disulfidnim vezama na zglobnoj regiji.
5. Fragment anti-Met antitijela u skladu s bilo kojim od patentnih zahtjeva 1 do 4, pri čemu se prvi Fc polipeptid i drugi Fc polipeptid susreću na sučelju, i jedan između prvog i drugog Fc polipeptida sadržava gumb na sučelju, a drugi između između prvog i drugog Fc polipeptida sadržava rupu na sučelju, pri čemu gumb može biti pozicioniran u rupu.
6. Fragment anti-Met antitijela u skladu s patentnim zahtjevom 5, pri čemu jedan između prvog i drugog Fc polipeptida sadržava mutiranu CH3 konstantnu domenu, pri čemu mutirana CH3 konstantna domena nosi mutaciju aminokiseline na položaju 389, pri čemu je izvorna aminokiselina na položaju 389 mutirana za uvoz aminokiseline koja ima veći volumen bočnog lanca od izvorne aminokiseline; i pri čemu drugi između prvog i drugog Fc polipeptida sadržava mutiranu CH3 konstantnu domenu, pri čemu mutirana CH3 konstantna domena nosi tri mutacije aminokiselina na položaju 389, 391 i 438, pri čemu su izvorne aminokiseline mutirane za uvoz aminokiselina koje imaju manji volumen bočnih lanaca od izvornih aminokiselina, pri čemu je numeriranje aminokiselina sukladno Kabatovoj shemi numeriranja u EU.
7. Fragment anti-Met antitijela u skladu s patentnim zahtjevom 6, pri čemu su izvorne aminokiseline na položajima 389, 391 i 438 treonin, leucin i tirozin redom; i pri čemu je u jednom između prvog i drugog Fc polipeptida treonin na položaju 389 mutiran u triptofan; i pri čemu je u drugom između prvog i drugog Fc polipeptida treonin na položaju 389 mutiran u serin, leucin na položaju 391 je mutiran u alanin i tirozin na položaju 438 je mutiran u valin.
8. Anti-Met fragment u skladu s bilo kojim od patentnih zahtjeva 1 do 7, pri čemu ljudska CL domena ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 9 i ljudska CH1 domena ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 10.
9. Fragment anti-Met antitijela u skladu s bilo kojim od patentnih zahtjeva 1 do 8, pri čemu prvi ljudski Fc polipeptid ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 11, i drugi ljudski Fc polipeptid ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 12.
10. Fragment anti-Met antitijela u skladu s bilo kojim od patentnih zahtjeva 1 do 9, pri čemu kad se fragment anti-Met antitijela veže na Met izaziva izbacivanje izvanstanične domene Met-a.
11. Izolirana nukleinska kiselina koja kodira fragment anti-Met antitijela iz bilo kojeg od patentnih zahtjeva 1 do 10.
12. Pripravak koji sadržava dvije ili više rekombinantnih nukleinskih kiselina koje zajedno kodiraju fragment anti-Met antitijela iz bilo kojeg od patentnih zahtjeva 1 do 10.
13. Proizvod koji sadržava, u jednoj boci ili u dvije boce, (a) fragment anti-Met antitijela u skladu s bilo kojim od patentnih zahtjeva 1 do 10, i farmaceutski prihvatljiv nosač, i (b) izvanstanični dio ljudskog Met i farmaceutski prihvatljiv nosač, pri čemu se izvanstanični dio ljudskog Met može vezati za faktor rasta hepatocita (HGF) na stabilan način i sadrži najmanje jednu mutaciju aminokiseline unutar epitopa prepoznatu od fragmenta anti-Met antitijela za sprječavanje vezanja fragmenta anti-Met antitijela na njega.
14. Proizvod u skladu s patentnim zahtjevom 13, pri čemu izvanstanični dio ljudskog Met sadrži SEMA, PSI, IPT-1, IPT-2, IPT-3 i IPT-4 domene.
15. Proizvod u skladu s patentnim zahtjevom 13 ili patentnim zahtjevom 14, pri čemu izvanstanični dio ljudskog Met ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 13, pri čemu je najmanje jedna od aminokiselina između položaja 797 i položaja 875 SEQ ID br.: 13 mutirana kako bi se spriječilo vezanje fragmenta anti-Met antitijela na njega.
16. Proizvod u skladu s bilo kojim od patentnih zahtjeva 13 do 15, pri čemu izvanstanični dio ljudskog Met ima sekvencu aminokiselina kako je navedeno u SEQ ID br.: 14.
17. Fragment anti-Met antitijela u skladu s bilo kojim od patentnih zahtjeva 1 do 10 ili proizvod u skladu s bilo kojim od patentnih zahtjeva 13 do 16 za upotrebu u liječenju tumora i/ili metastaza kod pacijenta koji nosi genetske promjene MET gena.
18. Proizvod u skladu s bilo kojim od patentnih zahtjeva 13 do 16 za upotrebu u liječenju tumora i/ili metastaza kod pacijenta koji nosi MET gen divljeg tipa.
19. Postupak za proizvodnju fragmenta anti-Met antitijela u skladu s bilo kojim od patentnih zahtjeva 1 do 10, postupak sadržava sljedeće korake: (i) sinteza cDNK sekvenci prvih, drugih i trećih polipeptida koji čine fragment anti-Met antitijela, (ii) umetanje triju cDNK sekvenci u jedan ili više plazmida, pri čemu je(su) plazmid(i) pogodan(i) za ekspresiju u staničnoj liniji sisavaca, (iii) prolazna ili stabilna ko-transfekcija stanične linije sisavaca s plazmidom(ima), (iv) skupljanje supernatanta kulture, (v) pročišćavanje pomoću afinitetne kromatografije fragmenta anti-Met antitijela.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT102018000009282A IT201800009282A1 (it) | 2018-10-09 | 2018-10-09 | Nuovo agente terapeutico per il trattamento di un tumore e/o metastasi |
| PCT/EP2019/077116 WO2020074459A1 (en) | 2018-10-09 | 2019-10-07 | Anti-met fab-fc for the treatment of a tumor and/or metastasis |
| EP19808675.3A EP3864050B1 (en) | 2018-10-09 | 2019-10-07 | Anti-met fab-fc for the treatment of a tumor and/or metastasis |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230154T1 true HRP20230154T1 (hr) | 2023-03-31 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230154TT HRP20230154T1 (hr) | 2018-10-09 | 2019-10-07 | Anti-met fab-fc za liječenje tumora i/ili metastaza |
Country Status (21)
| Country | Link |
|---|---|
| US (1) | US20210395372A1 (hr) |
| EP (2) | EP3864050B1 (hr) |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2005063816A2 (en) * | 2003-12-19 | 2005-07-14 | Genentech, Inc. | Monovalent antibody fragments useful as therapeutics |
| SI1981981T1 (sl) | 2006-02-06 | 2012-01-31 | Metheresis Translational Res Sa | Anti-met monoklonalno protitelesce, njegovi fragmenti in vektorji, za zdravljenje tumorjev in ustrezni proizvodi |
| MX2008013705A (es) * | 2006-04-28 | 2008-11-06 | Esbatech Ag | Anticuerpos que se enlazan al dominio extracelular de la cinasa de linfoma anaplastico del receptor tirosina cinasa. |
| CN106432503B (zh) * | 2008-12-19 | 2020-03-06 | 宏观基因有限公司 | 共价双抗体及其用途 |
| US8362213B2 (en) * | 2009-04-01 | 2013-01-29 | Genentech, Inc. | Anti-FcRH5 antibodies and immunoconjugates and methods of use |
| WO2012135854A2 (en) * | 2011-04-01 | 2012-10-04 | Memorial Sloan-Kettering Cancer Center | Antibodies to cytosolic peptides |
| MX2014002289A (es) * | 2011-08-26 | 2015-03-20 | Merrimack Pharmaceuticals Inc | Anticuerpos fc especificos en tandem. |
| RU2014124842A (ru) | 2011-11-21 | 2015-12-27 | Дженентек, Инк. | Очистка анти-с-мет антител |
| ITTO20130012A1 (it) | 2013-01-09 | 2014-07-10 | Metheresis Translational Res S A | Nuovi frammenti anticorpali, relative composizioni ed usi |
| GB201403875D0 (en) * | 2014-03-05 | 2014-04-16 | Cantargia Ab | Novel antibodies and uses thereof |
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| LT3864050T (lt) | 2023-03-27 |
| EP3864050A1 (en) | 2021-08-18 |
| SG11202103575RA (en) | 2021-05-28 |
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| HUE060843T2 (hu) | 2023-04-28 |
| ES2938714T3 (es) | 2023-04-14 |
| AU2019358417A2 (en) | 2021-06-24 |
| FI3864050T3 (fi) | 2023-03-14 |
| JP7371093B2 (ja) | 2023-10-30 |
| DK3864050T3 (da) | 2023-02-20 |
| WO2020074459A1 (en) | 2020-04-16 |
| US20210395372A1 (en) | 2021-12-23 |
| KR20210075121A (ko) | 2021-06-22 |
| EP4194469A1 (en) | 2023-06-14 |
| PL3864050T3 (pl) | 2023-04-11 |
| JP2022504392A (ja) | 2022-01-13 |
| CN113330032A (zh) | 2021-08-31 |
| RS63960B1 (sr) | 2023-02-28 |
| IT201800009282A1 (it) | 2020-04-09 |
| SI3864050T1 (sl) | 2023-03-31 |
| IL282033A (en) | 2021-05-31 |
| AU2019358417A1 (en) | 2021-05-27 |
| CA3115582A1 (en) | 2020-04-16 |
| PT3864050T (pt) | 2023-01-18 |
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