HRP20200164T1 - Bispecifična protutijela koja se vežu na cd38 i cd3 - Google Patents
Bispecifična protutijela koja se vežu na cd38 i cd3 Download PDFInfo
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- HRP20200164T1 HRP20200164T1 HRP20200164TT HRP20200164T HRP20200164T1 HR P20200164 T1 HRP20200164 T1 HR P20200164T1 HR P20200164T T HRP20200164T T HR P20200164TT HR P20200164 T HRP20200164 T HR P20200164T HR P20200164 T1 HRP20200164 T1 HR P20200164T1
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- Prior art keywords
- nucleic acid
- heavy chain
- domain
- heterodimeric antibody
- acid encoding
- Prior art date
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- 150000007523 nucleic acids Chemical class 0.000 claims 12
- 102000039446 nucleic acids Human genes 0.000 claims 12
- 108020004707 nucleic acids Proteins 0.000 claims 12
- 239000013604 expression vector Substances 0.000 claims 7
- 102100031585 ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 Human genes 0.000 claims 2
- 101000777636 Homo sapiens ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 Proteins 0.000 claims 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
Classifications
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- 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
-
- 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
- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
-
- 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
- C07K16/30—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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/46—Hybrid immunoglobulins
- C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
- C07K2317/622—Single chain antibody (scFv)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
- C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Cell Biology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
Claims (11)
1. Heterodimerno protutijelo koje sadrži:
a) prvi teški lanac koji sadrži:
i) prvu varijantu domene Fc;
ii) jednolančanu Fv regiju (scFv) koja veže CD3; i
b) drugi teški lanac koji sadrži:
i) drugu varijantu domene Fc; i
ii) prvu varijabilnu tešku domenu; i
c) prvi laki lanac koji sadrži prvu varijabilnu laku domenu i prvu konstantnu laku domenu;
pri čemu se navedena prva varijabilna teška domena i navedena prva varijabilna laka domena vežu na CD38, i
pri čemu su navedeni drugi teški lanac i navedeni prvi laki lanac odabrano između parova koji sadrže
2. Heterodimerno protutijelo prema patentnom zahtjevu 1 naznačeno time što navedeni drugi teški lanac i navedeni prvi laki lanac su
H1: EVQLVESGGG LVQPGGSLRLSCAASG FDFSRSWM NWVRQAPG KG LEWVSEIN PDSSTINYATSVKGRFTISRDNSKNTLYLQM NSLRAE DTAVYYCARYG NWFPYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTF PAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSDTKVDKKVEPKSCDKTHTCPPCPAPPVAGPSVFL FPPKPKDTLMISRTPEVTCVWDVKH EDPEVKFNWYVDGVEVH NAKTKPREEEYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRE EMTKNQVSLTCDVSGFYPSDIAVEWESDGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWEQGDVFSC SVMHEALHNHYTQKSLSLSPGK i L1.24:
3. Heterodimerno protutijelo prema patentnom zahtjevu 1 ili zahtjevu 2 naznačeno time što navedena scFv ima nabijenu scFv poveznicu.
4. Heterodimerno protutijelo prema patentnom zahtjevu 3 naznačeno time što navedena nabijena scFv poveznica ima pozitivni naboj od 3 do 8 i izabrana je iz skupine koju čine IRPRAIGGSKPRVA, GKGGSGKGGSGKGGS, GGKGSGGKGSGGKGS, GGGKSGGGKSGGGKS, GKGKSGKGKSGKGKS, GGGKSGGKGSGKGGS, GKPGSGKPGSGKPGS, GKPGSGKPGSGKPGSGKPGS, i GKGKSGKGKSGKGKSGKGKS.
5. Heterodimerno protutijelo prema bilo kojem od patentnih zahtjeva 1-4, naznačeno time što prvi teški lanac obuhvaća sekvencu
6. Pripravak nukleinske kiseline naznačen time što sadrži:
a) prvu nukleinsku kiselinu koja kodira prvi teški lanac prema zahtjevu 1;
b) drugu nukleinsku kiselinu koja kodira drugi teški lanac prema zahtjevu 1; i
c) treću nukleinsku kiselinu koja kodira prvi laki lanac prema zahtjevu 1;
ili
a) prvi ekspresijski vektor koji sadrži prvu nukleinsku kiselinu koja kodira prvi teški lanac prema zahtjevu 1;
b) drugi ekspresijski vektor koji sadrži drugu nukleinsku kiselinu koja kodira drugi teški lanac prema zahtjevu 1; i
c) treći ekspresijski vektor koji sadrži treću nukleinsku kiselinu koja kodira prvi laki lanac prema zahtjevu 1.
7. Stanica domaćina naznačena time što sadrži pripravak nukleinske kiseline prema patentnom zahtjevu 7.
8. Postupak za proizvodnju heterodimernog protutijela prema bilo kojem od patentnih zahtjeva 1 do 5 naznačen time što sadrži:
a) osiguravanje prvog ekspresijskog vektora koji sadrži prvu nukleinsku kiselinu koja kodira drugi teški lanac koji sadrži:
i) drugu varijantu domene Fc;
ii) prvi varijabilni teški lanac; i
b) osiguravanje drugog ekspresijskog vektora koji sadrži drugu nukleinsku kiselinu koja kodira prvi teški lanac koji sadrži:
i) prvu varijantu domene Fc; i
ii) jednolančanu Fv regiju (scFv) koja veže CD3;
i
c) osiguravanje trećeg ekspresijskog vektora koji sadrži treću nukleinsku kiselinu koja kodira prvi laki lanac; pri čemu navedena prva varijabilna teška domena i varijabilna laka domena navedenog prvog lakog lanca veže CD38;
d) pri čemu su navedeni prvi, drugi i treći ekspresijski vektori transfektirani u stanicama domaćina omjeru odabranom iz skupine koja se sastoji od 1:1.5:1.5, 1:2:1.5, 1:0.667:2, 1:1:2, 1:1.5:2, i 1:2:2 ;
e) eksprimiranje navedene prve, druge i treće nukleinske kiseline u navedenim stanicama domaćina da bi se stvorila odgovarajuća prva, druga i treća sekvenca aminokiselina, ako da prva, druga i treća amino sekvenca aminokiselina tvore navedeno heterodimerno protutijelo.
9. Postupak prema patentnom zahtjevu 8, naznačen time što nadalje obuhvaća (f) formuliranje heterodimernog protutijela u farmaceutski pripravak.
10. Heterodimerno protutijelo prema bilo kojem od patentnih zahtjeva 1 do 5 naznačeno time što je za uporabu u terapiji.
11. Farmaceutski pripravak, naznačen time što sadrži heterodimerno protutijelo prema bilo kojem od patentnih zahtjeva 1 do 5.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461972172P | 2014-03-28 | 2014-03-28 | |
| US201462025931P | 2014-07-17 | 2014-07-17 | |
| US201462025974P | 2014-07-17 | 2014-07-17 | |
| EP15720820.8A EP3122781B1 (en) | 2014-03-28 | 2015-03-30 | Bispecific antibodies that bind to cd38 and cd3 |
| PCT/US2015/023411 WO2015149077A1 (en) | 2014-03-28 | 2015-03-30 | Bispecific antibodies that bind to cd38 and cd3 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200164T1 true HRP20200164T1 (hr) | 2020-05-01 |
Family
ID=53053074
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200164TT HRP20200164T1 (hr) | 2014-03-28 | 2020-01-31 | Bispecifična protutijela koja se vežu na cd38 i cd3 |
Country Status (31)
| Country | Link |
|---|---|
| US (3) | US9822186B2 (hr) |
| EP (3) | EP3954713A3 (hr) |
| JP (3) | JP6775422B2 (hr) |
| KR (3) | KR102327996B1 (hr) |
| CN (2) | CN106471009B (hr) |
| AP (1) | AP2016009475A0 (hr) |
| AU (2) | AU2015237184B2 (hr) |
| BR (1) | BR112016022385A2 (hr) |
| CA (1) | CA2943621A1 (hr) |
| CL (1) | CL2016002460A1 (hr) |
| CR (1) | CR20160506A (hr) |
| CY (1) | CY1123236T1 (hr) |
| DK (1) | DK3122781T3 (hr) |
| EA (1) | EA201691925A1 (hr) |
| ES (1) | ES2775431T3 (hr) |
| HR (1) | HRP20200164T1 (hr) |
| HU (1) | HUE048734T2 (hr) |
| IL (1) | IL248007B (hr) |
| LT (1) | LT3122781T (hr) |
| ME (1) | ME03666B (hr) |
| MX (2) | MX2016012578A (hr) |
| PE (1) | PE20161431A1 (hr) |
| PH (1) | PH12016501908A1 (hr) |
| PL (1) | PL3122781T3 (hr) |
| PT (1) | PT3122781T (hr) |
| RS (1) | RS59907B1 (hr) |
| SG (2) | SG11201607983YA (hr) |
| SI (1) | SI3122781T1 (hr) |
| TN (1) | TN2017000532A1 (hr) |
| UA (1) | UA119167C2 (hr) |
| WO (1) | WO2015149077A1 (hr) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9493578B2 (en) | 2009-09-02 | 2016-11-15 | Xencor, Inc. | Compositions and methods for simultaneous bivalent and monovalent co-engagement of antigens |
| AU2011283694B2 (en) | 2010-07-29 | 2017-04-13 | Xencor, Inc. | Antibodies with modified isoelectric points |
| TW202323302A (zh) | 2010-11-30 | 2023-06-16 | 日商中外製藥股份有限公司 | 細胞傷害誘導治療劑 |
| US10851178B2 (en) | 2011-10-10 | 2020-12-01 | Xencor, Inc. | Heterodimeric human IgG1 polypeptides with isoelectric point modifications |
| US10131710B2 (en) | 2013-01-14 | 2018-11-20 | Xencor, Inc. | Optimized antibody variable regions |
| US9701759B2 (en) | 2013-01-14 | 2017-07-11 | Xencor, Inc. | Heterodimeric proteins |
| US10487155B2 (en) | 2013-01-14 | 2019-11-26 | Xencor, Inc. | Heterodimeric proteins |
| US9605084B2 (en) | 2013-03-15 | 2017-03-28 | Xencor, Inc. | Heterodimeric proteins |
| EP3620473A1 (en) | 2013-01-14 | 2020-03-11 | Xencor, Inc. | Novel heterodimeric proteins |
| US11053316B2 (en) | 2013-01-14 | 2021-07-06 | Xencor, Inc. | Optimized antibody variable regions |
| US10968276B2 (en) | 2013-03-12 | 2021-04-06 | Xencor, Inc. | Optimized anti-CD3 variable regions |
| US9738722B2 (en) | 2013-01-15 | 2017-08-22 | Xencor, Inc. | Rapid clearance of antigen complexes using novel antibodies |
| EP2970486B1 (en) | 2013-03-15 | 2018-05-16 | Xencor, Inc. | Modulation of t cells with bispecific antibodies and fc fusions |
| US10858417B2 (en) | 2013-03-15 | 2020-12-08 | Xencor, Inc. | Heterodimeric proteins |
| US10106624B2 (en) | 2013-03-15 | 2018-10-23 | Xencor, Inc. | Heterodimeric proteins |
| US10519242B2 (en) | 2013-03-15 | 2019-12-31 | Xencor, Inc. | Targeting regulatory T cells with heterodimeric proteins |
| US9822186B2 (en) | 2014-03-28 | 2017-11-21 | Xencor, Inc. | Bispecific antibodies that bind to CD38 and CD3 |
| JP6629187B2 (ja) | 2014-04-07 | 2020-01-15 | 中外製薬株式会社 | 免疫活性化抗原結合分子 |
| EA201692287A1 (ru) | 2014-05-13 | 2017-06-30 | Чугаи Сеияку Кабушики Каиша | Антигенсвязывающая молекула, перенаправляющая т-клетки на клетки, обладающие иммуносупрессорной функцией |
| US11773166B2 (en) | 2014-11-04 | 2023-10-03 | Ichnos Sciences SA | CD3/CD38 T cell retargeting hetero-dimeric immunoglobulins and methods of their production |
| EA201791139A1 (ru) | 2014-11-26 | 2018-04-30 | Ксенкор, Инк. | Гетеродимерные антитела, которые связывают cd3 и опухолевые антигены |
| US10259887B2 (en) | 2014-11-26 | 2019-04-16 | Xencor, Inc. | Heterodimeric antibodies that bind CD3 and tumor antigens |
| JP2017536830A (ja) | 2014-11-26 | 2017-12-14 | ゼンコー・インコーポレイテッドＸｅｎｃｏｒ、 Ｉｎｃ． | Ｃｄ３及びｃｄ３８に結合するヘテロ二量体抗体 |
| WO2016105450A2 (en) | 2014-12-22 | 2016-06-30 | Xencor, Inc. | Trispecific antibodies |
| WO2016141387A1 (en) | 2015-03-05 | 2016-09-09 | Xencor, Inc. | Modulation of t cells with bispecific antibodies and fc fusions |
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| TWI829617B (zh) | 2015-07-31 | 2024-01-21 | 德商安美基研究（慕尼黑）公司 | Ｆｌｔ３及ｃｄ３抗體構築體 |
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