ME02296B - Postupak za liječenje kancera dll4 antagonistom i hemoterapijskim agensom - Google Patents

Postupak za liječenje kancera dll4 antagonistom i hemoterapijskim agensom

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Publication number
ME02296B
ME02296B MEP-2015-185A MEP18515A ME02296B ME 02296 B ME02296 B ME 02296B ME P18515 A MEP18515 A ME P18515A ME 02296 B ME02296 B ME 02296B
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antigen
binding fragment
cancer
seq
antibody
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MEP-2015-185A
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English (en)
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Irene Noguera-Troise
Gavin Thurston
Alain Thibault
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Regeneron Pharma
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    • A61K33/24Heavy metals; Compounds thereof
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    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
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    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
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    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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    • A61K31/7064Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
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    • A61K39/39558Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K2317/00Immunoglobulins specific features
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    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding

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Claims (14)

1.Izolovane antitijela čoveka ili fragment za vezivanje antigena koji se specifično vezuje na ljudskom delta-sličnom ligandu 4 (hDII4) za upotrebu u lečenju kancera ili smanjenje ili zaustavljanje rasta tumora kod subjekta primenom u kombinaciji sa hemoterapijskim agensom, pri čemu ljudsko antitelo ili njegov fragment za vezivanje antigena obuhvata promenljivi region teškog lanca (HCVR) koji obuhvata CDR1, CDR2 i CDR3 teškog lanca sekvenci ID BR SEK:22, 24 i 26, respektivno, i promenljivi region lakog lanca (LCVR) koji obuhvata CDR1, CDR2 i CDR3 sekvence lakog lanca ID BR SEK:30, 32 l 34, respektivno, hemoterapijski agens je hemoterapijski agens na bazi platine ili analoga pirimidina, i kancer ili tumor je čvrst malignitet.
2.Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu prema patentnom zahtjevu 1, pri čemu antitelo ili fragment za vezivanje antigena obuhvata HCVR sekvence ID BR SEK: 20 ili ID BR SEK: 116,ili LCVR sekvenca ID BR SEK: 28 ili ID BR SEK:118.
3.Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu prema patentnom zahtjevu 1, pri čemu antitelo ili fragment za vezivanje antigena obuhvata HCVR /LCVR kombinaciju ID BR SEK: 20 /28 ili 116/118.
4.Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu prema bilo kom patentnom zahtjevu 1-3, pri čemu: a) hemoterapijski agens na bazi platine jeste cisplatin, karboplatin, iproplatin, ili oksaliplatin; ili njihova farmaceutski prihvatljiva so; b) analog pirimidina je gemcitabin, 5-FU, ili kapecitabin; ili njihova farmaceutski prihvatljiva so.
5.Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu prema patentnom zahtjevu 4, pri čemu je hemoterapijski agens cisplatin ili 5-FU.
6.Upotreba ljudskog antitijela ili fragmenta za vezivanje antigena obuhvata promenljivi region teškog lanca (HCVR) koji obuhvata teški lanac CDR1, CDR2 i CDR3 sekvence SEQ ID N0:22, 24 i 26, respektivno, i promenljivi region lakog lanca (LCVR) koji obuhvata laki lanac CDR1, CDR2 i CDR3 sekvence ID BR SEK:30, 32 i 34, respektivno u proizvodnji leka za lečenje kancera ili smanjenje ili zaustavljanje rasta tumora kod subjekta kome se primenjuje u kombinaciji sa hemoterapijskim agensom, pri čemu je hemoterapijski agens je hemoterapijski agens na bazi platine ili analoga pirimidina, i kancer ili tumor je čvrsti malignitet.
7. Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu prema jednom od patentnih zahtjeva 1 do 5 ili upotrebu prema patentnom zahtevu 6, pri čemu se kancer bira iz grupe koja obuhvata kancer jajnika, kancer materice, kancer dojke, kancer pluća, kancer jetre, kolorektalni kancer, kancer bešike, kancer bubrega, kancer prostate, kancer pankreasa, kancer želuca, kancer kostiju, kancer kože, i maligni sarkom mekog tkiva.
8.Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu ili za upotrebu prema patentnom zahtjevu 7, pri čemu se kancer bira iz kancera pluća, kolorektalnog kancera ili kancera bešike.
9.Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu prema jednom od patentnih zahtjeva 1 do 5 i 7 do 8, ili upotreba prema jednom od patentnih zahteva 6 do 8, pri čemu se antitelo ili fragment za vezivanje antigena i hemoterapijski agens primenjuju istovremeno ili u sledu.
10.Ljudsko antitijela ili fragment za vezivanje antigena za upotrebu prema jednom od patentnih zahtjeva 1 do 5 i 7 do 8, ili upotreba prema jednom od patentnih zahteva 6 do 8, pri čemu se pomenuto antitelo ili fragment za vezivanje antigena primenjuje na ljudskom subjektu u kombinaciji sa pomenutim hemoterapijskim agensom.
11.Farmaceutsko jedinjenje koje obuhvata antitijela ili njegov fragment za vezivanje antigena obuhvata promenljivi region teškog lanca (HCVR) koji obuhvata CDR1, CDR2 i CDR3 teškog lanca sekvenci ID BR SEK:22, 24 i 26, respektivno, i promenljivi region lakog lanca (LCVR) koji obuhvata CDR1, CDR2 i CDR3 lakog lanca sekvenci ID BR SEK:30, 32 i 34, respektivno, hemoterapijski agens izabran iz hemoterapijskog agensa na bazi platine ili analoga pirimidina, opciono pri čemu hemoterapijski agens jeste cisplatin ili 5-FU , i farmaceutski prihvatljiv nosač.
12.Komplet koji u sebi sadrži posudu u kojoj se nalazi antitijela ili njegov fragment za vezivanje antigena obuhvata promenljivi region teškog lanca (HCVR) koji obuhvata CDR1, CDR2 i CDR3 teškog lanca sekvenci ID BR SEK:22, 24 i 26, respektivno, i promenljivi region lakog lanca (LCVR) koji obuhvata CDR1, CDR2 i CDR3 lakog lanca sekvenci ID BR SEK:30, 32 i 34, respektivno, i jednu ili više dodatnih posuda koje u sebi sadrže najmanje jedan hemoterapijski agens izabran iz hemoterapijskog agensa na bazi platine ili analoga pirimidina, opciono pri čemu hemoterapijski agens jeste cisplatin ili 5-FU.
13. Antitijela ili fragment za vezivanje antigena za upotrebu u postupku liječenja za smanjenje količine hemoterapijskog agensa neophode da se postigne željeno dejstvo lečenja kod subjekta koji ima kancer ili tumor, koji obuhvata primenu pomenutog antitela ili fragmenta za vezivanje antigena subjektu u kombinaciji sa hemoterapijskim agensom; pri čemu antitijela ili fragment za vezivanje antigena obuhvata promjenljivi region teškog lanca (HCVR) koji obuhvata CDR1, CDR2 i CDR3 teškog lanca sekvenci ID BR SEK:22, 24 i 26, respektivno, i promenljivi region lakog lanca (LCVR) koji obuhvata CDR1, CDR2 i CDR3 lakog lanca sekvenci ID BR SEK:30, 32 i 34, respektivno, pri čemu je hemoterapijski agens hemoterapijski agens na bazi platine ili analoga pirimidina, opciono pri čemu hemoterapijski agens jeste cisplatin ili 5-FU; i pri čemu je količina hemoterapijskog agensa smanjena u poređenju sa količinom potrebnom za isti terapijski agens u odsustvu antitela ili fragmenta za vezivanje antigena.
14.Antitijela ili fragment za vezivanje antigena za upotrebu prema patentnom zahtjevu 13, pri čemu je količina hemoterapijskog agensa neophodna da se postigne željeno terapijsko dejstvo smanjena za najmanje 20%, ili 30% do 50%. /// / 7 " --·----·· - .. ·-- - - D V 0 l< A -,- _ , Vido Đako n ov1c Mob. te l : 067/9 0 1 .. 0 1 4 1 email : ad v.djakonovic@gm a d .com BAJO\IA br .9, 81250 CET INJ E
MEP-2015-185A 2009-06-25 2010-06-25 Postupak za liječenje kancera dll4 antagonistom i hemoterapijskim agensom ME02296B (me)

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US22046509P 2009-06-25 2009-06-25
US30188110P 2010-02-05 2010-02-05
EP10728555.3A EP2445528B1 (en) 2009-06-25 2010-06-25 Method of treating cancer with dll4 antagonist and chemotherapeutic agent
PCT/US2010/039999 WO2010151770A1 (en) 2009-06-25 2010-06-25 Method of treating cancer with dll4 antagonist and chemotherapeutic agent

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