HRP20201375T1 - ANTI-BCMA ANTITIJELA, BISPECIFIČNI ANTIGEN VEŽUĆE MOLEKULE KOJE SE VEŽU ZA BCMA i CD3, I NJIHOVE UPOTREBE - Google Patents
ANTI-BCMA ANTITIJELA, BISPECIFIČNI ANTIGEN VEŽUĆE MOLEKULE KOJE SE VEŽU ZA BCMA i CD3, I NJIHOVE UPOTREBE Download PDFInfo
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- BGFTWECWAICPDG-UHFFFAOYSA-N 2-[bis(4-chlorophenyl)methyl]-4-n-[3-[bis(4-chlorophenyl)methyl]-4-(dimethylamino)phenyl]-1-n,1-n-dimethylbenzene-1,4-diamine Chemical compound C1=C(C(C=2C=CC(Cl)=CC=2)C=2C=CC(Cl)=CC=2)C(N(C)C)=CC=C1NC(C=1)=CC=C(N(C)C)C=1C(C=1C=CC(Cl)=CC=1)C1=CC=C(Cl)C=C1 BGFTWECWAICPDG-UHFFFAOYSA-N 0.000 title claims 25
- 102000006942 B-Cell Maturation Antigen Human genes 0.000 title claims 25
- 108010008014 B-Cell Maturation Antigen Proteins 0.000 title claims 25
- 239000000427 antigen Substances 0.000 title claims 19
- 102000036639 antigens Human genes 0.000 title claims 19
- 108091007433 antigens Proteins 0.000 title claims 19
- 239000012634 fragment Substances 0.000 claims 29
- 125000003275 alpha amino acid group Chemical group 0.000 claims 27
- 210000004027 cell Anatomy 0.000 claims 12
- 206010028980 Neoplasm Diseases 0.000 claims 6
- 201000011510 cancer Diseases 0.000 claims 6
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 5
- 101000801255 Homo sapiens Tumor necrosis factor receptor superfamily member 17 Proteins 0.000 claims 3
- 208000034578 Multiple myelomas Diseases 0.000 claims 3
- 210000001744 T-lymphocyte Anatomy 0.000 claims 3
- 102000046935 human TNFRSF17 Human genes 0.000 claims 3
- 238000006467 substitution reaction Methods 0.000 claims 3
- 239000002246 antineoplastic agent Substances 0.000 claims 2
- 210000003719 b-lymphocyte Anatomy 0.000 claims 2
- 229940127089 cytotoxic agent Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 201000005787 hematologic cancer Diseases 0.000 claims 2
- 238000000338 in vitro Methods 0.000 claims 2
- 230000003993 interaction Effects 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 201000000050 myeloid neoplasm Diseases 0.000 claims 2
- 102000040430 polynucleotide Human genes 0.000 claims 2
- 108091033319 polynucleotide Proteins 0.000 claims 2
- 239000002157 polynucleotide Substances 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- UHDGCWIWMRVCDJ-CCXZUQQUSA-N Cytarabine Chemical group O=C1N=C(N)C=CN1[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O1 UHDGCWIWMRVCDJ-CCXZUQQUSA-N 0.000 claims 1
- 238000002965 ELISA Methods 0.000 claims 1
- 102000001706 Immunoglobulin Fab Fragments Human genes 0.000 claims 1
- 108010054477 Immunoglobulin Fab Fragments Proteins 0.000 claims 1
- 102000000588 Interleukin-2 Human genes 0.000 claims 1
- 108010002350 Interleukin-2 Proteins 0.000 claims 1
- 241000282553 Macaca Species 0.000 claims 1
- 230000004913 activation Effects 0.000 claims 1
- 239000000556 agonist Substances 0.000 claims 1
- 229940045799 anthracyclines and related substance Drugs 0.000 claims 1
- 238000011319 anticancer therapy Methods 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 229960000684 cytarabine Drugs 0.000 claims 1
- 230000003013 cytotoxicity Effects 0.000 claims 1
- 231100000135 cytotoxicity Toxicity 0.000 claims 1
- 230000001419 dependent effect Effects 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 229960004931 histamine dihydrochloride Drugs 0.000 claims 1
- PPZMYIBUHIPZOS-UHFFFAOYSA-N histamine dihydrochloride Chemical compound Cl.Cl.NCCC1=CN=CN1 PPZMYIBUHIPZOS-UHFFFAOYSA-N 0.000 claims 1
- 210000004408 hybridoma Anatomy 0.000 claims 1
- 238000004806 packaging method and process Methods 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000034190 positive regulation of NF-kappaB transcription factor activity Effects 0.000 claims 1
- 230000035755 proliferation Effects 0.000 claims 1
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 1
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- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- 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
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- 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
- C07K16/2878—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 NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- 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
- 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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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- 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
- C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
- C07K16/3061—Blood cells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
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- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
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- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
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- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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Claims (15)
1. Rekombinirano antitijelo, ili njegov fragment za vezanje antigena, koje se imunospecifično veže za BCMA, pri čemu antitijelo ima težak lanac i laki lanac, spomenuti teški lanac se sastoji iz:
a. područja 1 za određivanje komplementarnosti teškog lanca (CDR1) koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 4, CDR2 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 5, i CDR3 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 6;
b. CDR1 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 7, CDR2 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 5, i CDR3 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 6;
c. CDR1 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 4, CDR2 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 5, i CDR3 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 19;
d. CDR1 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 4, CDR2 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 8, i CDR3 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 6;
e. CDR1 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 13, CDR2 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 5, i CDR3 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 19; ili
f. CDR1 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 13, CDR2 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 8, i CDR3 teškog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 19,
pri čemu se spomenuto antitijelo dalje sastoji iz CDR1 lakog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 24, CDR2 lakog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 25, i CDR3 lakog lanca koji ima aminokiselinsku sekvencu predstavljenu u SEQ ID NO: 26.
2. Antitijelo, ili njegov fragment za vezanje antigena, prema zahtjevu 1, pri čemu težak lanac antitijela pod (a) se sastoji iz aminokiselinske sekvence koja je predstavljena u SEQ ID NO: 27; težak lanac antitijela pod (a) se sastoji iz aminokiselinske sekvence koja je predstavljena u SEQ ID NO: 57; težak lanac antitijela pod (c) se sastoji iz aminokiselinske sekvence koja je predstavljena u SEQ ID NO: 39; težak lanac antitijela pod (d) se sastoji iz aminokiselinske sekvence koja je predstavljena u SEQ ID NO: 40; ili težak lanac antitijela pod (e) se sastoji iz aminokiselinske sekvence koja je predstavljena u SEQ ID NO: 58.
3. Antitijelo ili fragment za vezanje antigena prema zahtjevu 2, pri čemu laki lanac antitijela e sastoji iz aminokiselinske sekvence koja je predstavljena u SEQ ID NO: 28.
4. Antitijelo ili fragment za vezanje antigena prema bilo kojem od zahtjeva 1 do 3 pri čemu:
i) antitijelo ili njegov fragment za vezanje antigena se veže za vanstaničnu domenu ljudskog BCMA;
ii) antitijelo ili fragment za vezanje antigena je humano antitijelo ili fragment za vezanje antigena;
iii) fragment za vezanje antigena je Fab fragment, Fab2 fragment, ili jednolančano antitijelo;
iv) antitijelo ili njegov fragment za vezanje antigena inhibira interakciju BCMA i APRIL, što pri čemu antitijelo ili fragment za vezanje antigena izlaže IC50 za interakciju BCMA i APRIL od oko 5.9 nM kao što je mjereno sa ELISA;
v) antitijelo ili njegov fragment za vezanje antigena je IgG;
vi) antitijelo ili njegov fragment za vezanje antigena je IgG4 izotipa, na primjer pri čemu IgG4 ima S228P zamjenu, L234A zamjenu i L235A zamjenu u njegovom Fc području
vii) antitijelo ili njegov fragment za vezanje antigena imunospecifično veže ljudski BCMA i unakrsno reagira sa BCMA makaki majmuna;
viii) antitijelo ili njegov fragment za vezanje antigena veže BCMA na površini stanica ljudskog mijeloma; i/ili
ix) antitijelo ili njegov fragment za vezanje antigena veže BCMA na površini stanica humanog multiplog mijeloma.
5. Rekombinirana stanica koja izražava antitijelo ili fragment za vezanje antigena prema bilo kojem od zahtjeva 1 do 4, opcionalno pri čemu je stanica hibridom ili je antitijelo rekombinirano proizvedeno.
6. Rekombinirano BCMA x CD3 bispecifično antitijelo ili njegov BCMA x CD3 bispecifičan fragment za vezanje koji se sastoji iz:
a) prvog teškog lanca (HC1);
b) drugog teškog lanca (HC2);
c) prvog lakog lanca (LC1); i
d) drugog lakog lanca (LC2),
pri čemu je HC1 povezan sa LC1 i HC2 je povezan sa LC2 i pri čemu HC1 sadrži SEQ ID NO: 59, SEQ ID NO: 60, i SEQ ID NO: 61 kao CDR1-3 teškog lanca redom, i LC1 sadrži SEQ ID NO: 62, SEQ ID NO: 63, i SEQ ID NO: 64 kao CDR1-3 lakog lanca redom, da bi se oblikovalo prvo mjesto za vezanje antigena koje imunospecifično veže CD3 i pri čemu HC2 sadrži SEQ ID NO: 4, SEQ ID NO: 5, i SEQ ID NO: 6 kao CDR1-3 teškog lanca redom, i LC2 sadrži SEQ ID NO: 24, SEQ ID NO: 25, i SEQ ID NO: 26 kao CDR1-3 lakog lanca redom, da bi se oblikovalo drugo mjesto za vezanje antigena koje imunospecifično veže BCMA.
7. Rekombinirano BCMA x CD3 bispecifično antitijelo ili njegov fragment prema zahtjevu 6 koji se sastoji iz HC1 koji sadrži SEQ ID NO: 55, LC1 koji sadrži SEQ ID NO: 56, HC2 koji sadrži SEQ ID NO: 65, i LC2 koji sadrži SEQ ID NO: 76, što pri čemu, antitijelo ili bispecifičan fragment za vezanje je IgG.
8. BCMA x CD3 bispecifično antitijelo ili bispecifičan fragment za vezanje prema zahtjevu 6 ili zahtjevu 7 pri čemu antitijelo ili bispecifičan fragment za vezanje:
i) je IgG4 izotipa;
ii) imunospecifično veže ljudski BCMA s afinitetom od najmanje 0.22 nM kao što je mjereno površinskom plazmonskom rezonancom
iii) veže BCMA na površini stanica ljudskog mijeloma;
iv) veže BCMA na površini stanica ljudskog multiplog mijeloma;
v) inducira aktivaciju ljudskih T-stanica in vitro sa EC50 manjom od oko 0.37 nM;
vi) inducira T-staničnu zavisnu citotoksičnost stanica koje izražavaju BCMA in vitro sa EC50 manjom od oko 0.45 nM;
vii) nije BCMA agonist; i/ili
viii) ne mijenja aktivaciju NF-κB u koncentracijama koje su ispod 10 nM.
9. Rekombinirana stanica koja izražava antitijelo ili bispecifičan fragment za vezanje prema bilo kojem od zahtjeva 6 do 8, što pri čemu je stanica hibridom.
10. BCMA x CD3 bispecifično antitijelo ili bispecifičan fragment za vezanje prema bilo kojem od zahtjeva 6 do 8 za upotrebu u postupku:
i) za liječenje subjekta koji ima rak, opcionalno dalje obuhvaća davanje drugog terapeutskog agensa, na primjer pri čemu drugi terapeutski agens je kemoterapeutski agens ili ciljana anti-kancerogena terapija, kao što gdje kemoterapeutski agens je citarabin, antraciklin, histamin dihidroklorid, ili interleukin 2;
ii) za inhibiciju rasta ili proliferacije stanica raka; ili
iii) preusmjeravanja T stanice ka stanici raka koja izražava BCMA.
11. BCMA x CD3 bispecifično antitijelo ili bispecifičan fragment za vezanje za upotrebu prema zahtjevu 10 pri čemu je rak hematološki rak, na primjer pri čemu hematološki rak je rak B stanica koje izražavaju BCMA, što pri čemu rak B stanica koje eksprimiraju BCMA je multipli mijelom.
12. Farmacetuski sastav koji se sastoji iz BCMA x CD3 bispecifičnog antitijela ili bispecifičnog fragmenta za vezanje prema bilo kojem od zahtjeva 6 do 8 i farmaceutski prihvatljivog nosača.
13. Postupak za dobijanje BCMA x CD3 bispecifičnog antitijela ili bispecifičnog fragmenta za vezanje prema bilo kojem od zahtjeva 6 do 8 kultivacijom stanice prema zahtjevu 9.
14. Izolirani sintetički polinukleotid koji kodira BCMA x CD3 bispecifično antitijelo ili bispecifičan fragment za vezanje prema bilo kojem od zahtjeva 6 do 8.
15. Komplet koji se sastoji iz BCMA x CD3 bispecifičnog antitijela ili bispecifičnog fragmenta za vezanje kao što je definirano u bilo kojem od zahtjeva 6 do 8 i/ili polinukleotid kako je definirano u zahtjevu 14 i pakiranje istog.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562206246P | 2015-08-17 | 2015-08-17 | |
| PCT/US2016/047146 WO2017031104A1 (en) | 2015-08-17 | 2016-08-16 | Anti-bcma antibodies, bispecific antigen binding molecules that bind bcma and cd3, and uses thereof |
| EP16754148.1A EP3337824B1 (en) | 2015-08-17 | 2016-08-16 | Anti-bcma antibodies, bispecific antigen binding molecules that bind bcma and cd3, and uses thereof |
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| Publication Number | Publication Date |
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| HRP20201375T1 true HRP20201375T1 (hr) | 2020-11-27 |
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| Application Number | Title | Priority Date | Filing Date |
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| HRP20201375TT HRP20201375T1 (hr) | 2015-08-17 | 2020-08-28 | ANTI-BCMA ANTITIJELA, BISPECIFIČNI ANTIGEN VEŽUĆE MOLEKULE KOJE SE VEŽU ZA BCMA i CD3, I NJIHOVE UPOTREBE |
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| Country | Link |
|---|---|
| US (1) | US10072088B2 (hr) |
| EP (2) | EP3337824B1 (hr) |
| JP (4) | JP2018525005A (hr) |
| KR (2) | KR20180040671A (hr) |
| CN (1) | CN108350076B (hr) |
| AR (1) | AR105724A1 (hr) |
| AU (1) | AU2016308567B2 (hr) |
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