HRP20192170T1 - Pripravci antitijela za liječenje tumora - Google Patents
Pripravci antitijela za liječenje tumora Download PDFInfo
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- HRP20192170T1 HRP20192170T1 HRP20192170TT HRP20192170T HRP20192170T1 HR P20192170 T1 HRP20192170 T1 HR P20192170T1 HR P20192170T T HRP20192170T T HR P20192170TT HR P20192170 T HRP20192170 T HR P20192170T HR P20192170 T1 HRP20192170 T1 HR P20192170T1
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- 206010028980 Neoplasm Diseases 0.000 title claims 5
- 239000000203 mixture Substances 0.000 title 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 25
- 239000000427 antigen Substances 0.000 claims 7
- 102000036639 antigens Human genes 0.000 claims 7
- 108091007433 antigens Proteins 0.000 claims 7
- 210000003719 b-lymphocyte Anatomy 0.000 claims 4
- 101100495232 Homo sapiens MS4A1 gene Proteins 0.000 claims 3
- 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims 3
- 230000010056 antibody-dependent cellular cytotoxicity Effects 0.000 claims 3
- 201000011510 cancer Diseases 0.000 claims 3
- 210000004027 cell Anatomy 0.000 claims 3
- 230000004540 complement-dependent cytotoxicity Effects 0.000 claims 3
- 238000000338 in vitro Methods 0.000 claims 3
- 108010087819 Fc receptors Proteins 0.000 claims 2
- 102000009109 Fc receptors Human genes 0.000 claims 2
- 210000001744 T-lymphocyte Anatomy 0.000 claims 2
- 238000002784 cytotoxicity assay Methods 0.000 claims 2
- 231100000263 cytotoxicity test Toxicity 0.000 claims 2
- 210000002540 macrophage Anatomy 0.000 claims 2
- 230000001404 mediated effect Effects 0.000 claims 2
- 210000000822 natural killer cell Anatomy 0.000 claims 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 1
- 102100022005 B-lymphocyte antigen CD20 Human genes 0.000 claims 1
- 208000011691 Burkitt lymphomas Diseases 0.000 claims 1
- 108010021472 Fc gamma receptor IIB Proteins 0.000 claims 1
- 208000017604 Hodgkin disease Diseases 0.000 claims 1
- 208000021519 Hodgkin lymphoma Diseases 0.000 claims 1
- 208000010747 Hodgkins lymphoma Diseases 0.000 claims 1
- 101000897405 Homo sapiens B-lymphocyte antigen CD20 Proteins 0.000 claims 1
- 101000913074 Homo sapiens High affinity immunoglobulin gamma Fc receptor I Proteins 0.000 claims 1
- 101000917826 Homo sapiens Low affinity immunoglobulin gamma Fc region receptor II-a Proteins 0.000 claims 1
- 101000917858 Homo sapiens Low affinity immunoglobulin gamma Fc region receptor III-A Proteins 0.000 claims 1
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 1
- 102100029205 Low affinity immunoglobulin gamma Fc region receptor II-b Human genes 0.000 claims 1
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 1
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 238000009175 antibody therapy Methods 0.000 claims 1
- 238000003556 assay Methods 0.000 claims 1
- 230000022534 cell killing Effects 0.000 claims 1
- 230000006037 cell lysis Effects 0.000 claims 1
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 1
- 230000003013 cytotoxicity Effects 0.000 claims 1
- 231100000135 cytotoxicity Toxicity 0.000 claims 1
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 1
- 201000003444 follicular lymphoma Diseases 0.000 claims 1
- 201000011649 lymphoblastic lymphoma Diseases 0.000 claims 1
- 230000004044 response Effects 0.000 claims 1
- 229960004641 rituximab Drugs 0.000 claims 1
- 238000009097 single-agent therapy Methods 0.000 claims 1
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
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- 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
- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
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- A61P35/00—Antineoplastic agents
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
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- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2809—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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- C07K2317/524—CH2 domain
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- C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
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Claims (14)
1. Bispecifično antitijelo za primjenu u liječenju ili ublažavanju raka B stanica u subjekta, naznačeno time, što bispecifično antitijelo sadrži prvu domenu koja se vezuje za antigen koja vezuje ljudski CD3, drugu domenu koja se vezuje za antigen koja vezuje ljudski CD20 i kimernu Fc domenu ograničenu prvom i drugom domenom koja se vezuje za antigen, naznačeno time, što kimerna Fc domena sadrži:
(a) aminokiselinsku sekvencu gornje spojne regije ljudskog IgG1 ili ljudskog IgG4 od položaja 216 do 227 (EU numeriranje);
(b) aminokiselinsku sekvencu donje spojne regije ljudskog IgG2 koja obuhvaća PCPAPPVA (SEQ ID NO: 52) od položaja 228 do 236 (EU numeriranje);
(c) CH1 domenu ljudskog IgG1 i CH3 domenu ljudskog IgG1 ili CH1 domenu ljudskog IgG4 i CH3 domenu ljudskog IgG4; i
(d) aminokiselinsku sekvencu CH2 domene ljudskog IgG4 od položaja 237 do 340 (EU numeriranje);
naznačeno time, što bispecifično antitijelo ispoljava viši afinitet vezivanja za ljudski FcγRIIA u odnosu na ljudski FcγRIIB te ispoljava nizak ili nemjerljiv afinitet vezivanja za ljudski FcγRI i ljudski FcγRIII, kada se mjeri testom rezonancije površinskih plazmona.
2. Bispecifično antitijelo za primjenu prema patentnom zahtjevu 1, naznačeno time, što je rak B stanica odabran iz skupine koja se sastoji od: folikularnog limfoma, kronične limfocitne leukemije B stanica, limfoblastičnog limfoma B stanica, Hodgkinovog limfoma, ne-Hodgkinovog limfoma, difuznog limfoma velikih b stanica, limfoma stanica rubne zone, limfoma stanica plašta, triholeukemije i Burkittovog limfoma.
3. Bispecifično antitijelo za primjenu prema patentnom zahtjevu 2, naznačeno time, što je rak B stanica ne-Hodgkinov limfom.
4. Bispecifično antitijelo za primjenu prema patentnom zahtjevu 1 ili 3, naznačeno time što subjekt boluje od tumora koji je rezistentan na ili ne postiže potpun odgovor na (a) samostalnu terapiju protiv CD20 monospecifičnog antitijela ili (b) monoterapiju rituksimabom;
i/ili naznačeno time, što je subjekt primao terapiju protiv CD20 monospecifičnog antitijela najmanje 1 dan do 1 godinu prije primjene bispecifičnog antitijela.
5. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 4, naznačeno time, što antitijelo:
(a) ispoljava smanjenju staničnu citotoksičnost ovisnu o antitijelu (engl. antibody-dependent-celllular cytotoxicity, ADCC) u usporedbi s antitijelom koje sadrži Fc domenu divljeg tipa, kada se mjeri in vitro testom citotoksičnosti;
(b) ispoljava zanemariv ili nemjerljiv ADCC;
(c) ispoljava smanjenu citotoksičnost ovisnu o komplementu (engl. complement dependent cytotoxicity, CDC) u usporedbi s antitijelom koje sadrži Fc domenu divljeg tipa, kada se mjeri in vitro testom citotoksičnosti;
(d) ispoljava citotoksičnost manju od 50 %, što se detektira mjerenjem lize stanica u in vitro testu;
(e) ispoljava zanemariv ili nemjerljiv CDC;
(f) izaziva smanjeno uništavanje stanica koje nose Fc receptor posredovano T stanicama, kao što su NK stanice ili makrofagi, u usporedbi s antitijelom koje sadrži Fc domenu divljeg tipa; ili
(g) izaziva smanjeno uništavanje T stanica posredovano stanicama koje nose Fc receptor, kao što su NK stanice ili makrofagi, u usporedbi s antitijelom koje sadrži Fc domenu divljeg tipa.
6. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 4, naznačeno time, što bispecifično antitijelo sadrži
(a) kimernu aminokiselinsku sekvencu spojne regije EPKSCDKTHTCPPCPAPPVA (SEQ ID NO: 53); ili
(b) kimernu aminokiselinsku sekvencu spojne regije ESKYGPPCPPCPAPPVA (SEQ ID NO: 54).
7. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 6, naznačeno time, što prva domena koja se vezuje za antigen koja specifično vezuje ljudski CD3 sadrži aminokiselinsku sekvencu varijabilne regije teškog lanca (HCVR) koja sadrži SEQ ID NO: 10 i aminokiselinsku sekvencu varijabilne regije lakog lanca (LCVR) koja sadrži SEQ ID NO: 18.
8. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 7, naznačeno time, što druga domena koja se vezuje za antigen koja specifično vezuje ljudski CD20 sadrži aminokiselinsku sekvencu varijabilne regije teškog lanca (HCVR) koja sadrži SEQ ID NO: 2 i aminokiselinsku sekvencu varijabilne regije lakog lanca (LCVR) koja sadrži SEQ ID NO: 18.
9. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 6, naznačeno time, što prva domena koja se vezuje za antigen (A1) koja specifično vezuje ljudski CD3 sadrži tri regije teškog lanca koje određuju komplementarnost (HCDR1, HCDR2, HCDR3) i tri regije lakog lanca koje određuju komplementarnost (LCDR1, LCDR2, LCDR3), naznačeno time, što
(i) A1-HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 12;
(ii) A1-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 14;
(iii) A1-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 16;
(iv) A1-LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 20;
(v) A1-LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 22; i
(vi) A1-LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 24.
10. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 6 ili 9, naznačeno time, što druga domena koja se vezuje za antigen (A2) koja specifično vezuje ljudski CD20 sadrži tri regije teškog lanca koje određuju komplementarnost (HCDR1, HCDR2, HCDR3) i tri regije lakog lanca koje određuju komplementarnost (LCDR1, LCDR2, LCDR3), naznačeno time, što
(i) A2-HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 4;
(ii) A2-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 6;
(iii) A2-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 8;
(iv) A2-LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 20;
(v) A2-LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 22; i
(vi) A2-LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 24.
11. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 10, naznačeno time, što bispecifično antitijelo sadrži kimernu Fc domenu koja sadrži aminokiselinsku sekvencu SEQ ID NO: 26.
12. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 10, naznačeno time, što bispecifično antitijelo sadrži kimernu Fc domenu koja sadrži aminokiselinsku sekvencu SEQ ID NO: 28.
13. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 10, naznačeno time, što bispecifično antitijelo sadrži kimernu Fc domenu koja sadrži aminokiselinsku sekvencu SEQ ID NO: 30.
14. Bispecifično antitijelo za primjenu prema bilo kojem patentnom zahtjevu od 1 do 10, naznačeno time, što bispecifično antitijelo sadrži kimernu Fc domenu koja sadrži aminokiselinsku sekvencu SEQ ID NO: 32.
Applications Claiming Priority (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461955663P | 2014-03-19 | 2014-03-19 | |
| US201461981641P | 2014-04-18 | 2014-04-18 | |
| US201462007385P | 2014-06-03 | 2014-06-03 | |
| US201462033460P | 2014-08-05 | 2014-08-05 | |
| PCT/US2015/021322 WO2015143079A1 (en) | 2014-03-19 | 2015-03-18 | Antibody compositions for tumor treatment |
| EP15714116.9A EP3119808B1 (en) | 2014-03-19 | 2015-03-18 | Antibody compositions for tumor treatment |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20192170T1 true HRP20192170T1 (hr) | 2020-02-21 |
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| RU2016129517A (ru) | 2013-12-20 | 2018-01-25 | Ф. Хоффманн-Ля Рош Аг | Биспецифические антитела к her2 и способы применения |
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