HRP20220133T1 - Optimizirana anti-cd3 bispecifična antitijela i njihove upotrebe - Google Patents
Optimizirana anti-cd3 bispecifična antitijela i njihove upotrebe Download PDFInfo
- Publication number
- HRP20220133T1 HRP20220133T1 HRP20220133TT HRP20220133T HRP20220133T1 HR P20220133 T1 HRP20220133 T1 HR P20220133T1 HR P20220133T T HRP20220133T T HR P20220133TT HR P20220133 T HRP20220133 T HR P20220133T HR P20220133 T1 HRP20220133 T1 HR P20220133T1
- Authority
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- Croatia
- Prior art keywords
- bispecific antibody
- cancer
- antigen
- use according
- cytotoxic
- Prior art date
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Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
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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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- 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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- 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
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
-
- 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
- C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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Claims (15)
1. Citotoksično bispecifično antitijelo za upotrebu u liječenju raka kod subjekta, gdje se bispecifično antitijelo sastoji iz prvog kraka koji vezuje antigen koji očituje slabo do nedetektibilno vezivanje za humani CD3 i CD3 cinomolgusa, i drugog kraka koji vezuje antigen koji se veže za antigen koji je povezan sa tumorom, pri čemu se svaki od prvog kraka koji vezuje antigen i drugog kraka koji vezuje antigen sastoji iz teškog lanca i lakog lanca, pri čemu je laki lanac zajednički za oba, prvi krak koji vezuje antigen i drugi krak koji vezuje antigen, i pri čemu težak lanac prvog kraka koji vezuje antigen sadrži varijabilni dio teškog lanca (HCVR) koji se sastoji iz dijela koji određuju komplementarnost HCDR1, HCDR2 i HCDR3 koji se sastoje iz aminokiselinskih sekvenci, redom, SEQ ID NOs: 36, 38, i 40 SEQ ID NOs: 140, 142 i 144.
2. Citotoksično bispecifično antitijelo za upotrebu prema zahtjevu 1, pri čemu bispecifično antitijelo očituje aktivaciju T stanica in vitro.
3. Citotoksično bispecifično antitijelo za upotrebu prema zahtjevu 1 ili 2, pri čemu je antigen povezan sa tumorom izražen na humanoj tumorskoj stanici.
4. Citotoksično bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1-3, gdje bispecifično antitijelo inducira ubijanje tumorskih stanica posredstvom T stanica sa vrijednošću EC50 manjom od oko 1.3 nM, kao što je mjereno u in vitro testu ubijanja tumorskih stanica posredstvom T stanica.
5. Citotoksično bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1-4, pri čemu ciljna stanica tumora izražava antigen povezan sa tumorom izabran iz grupe koja se sastoji iz AFP, ALK, BAGE proteina, BIRC5 (survivin), BIRC7, β-katenina, brc-abl, BRCA1, BORIS, CA9, karbonatne dehidrataze IX, kaspaza-8, CALR, CCR5, CD19, CD20 (MS4A1), CD22, CD30, CD40, CDK4, CEA, CTLA4, ciklin-B1, CYP1B1, EGFR, EGFRvIII, ErbB2/Her2, ErbB3, ErbB4, ETV6-AML, EpCAM, EphA2, Fra-1, FOLR1, GAGE proteina (npr., GAGE-1, -2), GD2, GD3, GloboH, glipikan-3, GM3, gp100, Her2, HLA/B-raf, HLA/k-ras, HLA/MAGE-A3, hTERT, LMP2, MAGE proteina (npr., MAGE-1, -2, -3, -4, -6, i -12), MART-1, mezotelina, ML-IAP, Muc1, Muc2, Muc3, Muc4, Muc5, Muc16 (CA-125), MUM1, NA17, NY-BR1, NY-BR62, NY-BR85, NY-ESO1, OX40, p15, p53, PAP, PAX3, PAX5, PCTA-1, PLAC1, PRLR, PRAME, PSMA (FOLH1), RAGE proteina, Ras, RGS5, Rho, SART-1, SART-3, STEAP1, STEAP2, TAG-72, TGF-β, TMPRSS2, Thompson-nouvelle antigena (Tn), TRP-1, TRP-2, tirozinaze, i uroplakina-3.
6. Citotoksično bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1-5, pri čemu se laki lanac sastoji od varijabilnog dijela lakog lanca (LCVR) koji se sastoji od područja koji određuju komplementarnost LCDR1, LCDR2 i LCDR3 koji se sastoje iz aminokiselinskih sekvenci, redom, SEQ ID NOs: 164, 166 i 168.
7. Citotoksično bispecifično antitijelo za upotrebu prema zahtjevu 6, gdje LCVR sadrži aminokiselinsku sekvencu SEQ ID NO: 162.
8. Citotoksično bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1-5, pri čemu je laki lanac srodni laki lanac teškog lanca drugog kraka koji se vezuje za antigen koji vezuje antigen povezan sa tumorom.
9. Citotoksično bispecifično antitijelo za upotrebu prema zahtjevu 6, gdje prvi krak koji vezuje antigen sadrži područja koja određuju komplementarnost HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 koji se sastoje iz aminokiselinskih sekvenci, redom, SEQ ID NOs: 36, 38, 40, 164, 166 i 168.
10. Citotoksično bispecifično antitijelo za upotrebu prema zahtjevu 6, gdje prvi krak koji vezuje antigen sadrži područja koja određuju komplementarnost HCDR1, HCDR2, HCDR3, LCDR1, LCDR2 i LCDR3 koji se sastoje iz aminokiselinskih sekvenci, redom, SEQ ID NOs: 140, 142, 144, 164, 166 i 168.
11. Citotoksično bispecifično antitijelo za upotrebu prema zahtjevu 7, gdje bispecifično antitijelo sadrži par HCVR i LCVR aminokiselinskih sekvenci (HCVR/LCVR) koje se sastoje iz aminokiselinskih sekvenci SEQ ID NOs: 34/162.
12. Citotoksično bispecifično antitijelo za upotrebu prema zahtjevu 7, gdje bispecifično antitijelo sadrži par HCVR and LCVR aminokiselinskih sekvenci (HCVR/LCVR) koje se sastoje iz aminokiselinskih sekvenci SEQ ID NOs: 138/162.
13. Farmaceutski sastav koji se sastoji iz (i) bispecifičnog antitijela prema bilo kojem od zahtjeva 1-12, i (ii) farmaceutski prihvatljivog nosača ili razblaživača.
14. Farmaceutski sastav prema zahtjevu 13 za upotrebu u postupku liječenja raka kod subjekta, postupak obuhvaća davanje subjektu farmaceutskog sastava.
15. Farmaceutski sastav za upotrebu prema zahtjevu 14, pri čemu je rak izabran iz grupe koja se sastoji iz: raka gušterače, melanoma, glioblastoma, raka glave i vrata, raka prostate, malignih glioma, osteosarkoma, kolorektalnog raka, raka želuca, malignog mezotelioma, multiplog mijeloma, raka jajnika, raka malih stanica pluća, raka ne-malih stanica pluća, sinovijalnog sarkoma, raka tireoidee, raka dojke, melanoma glioma, raka dojke, raka skvamoznih stanica, raka jednjaka, raka bubrežnih bistrih stanica, kromofobnog raka stanica bubrega, onkocitoma bubrega, prijelaznog raka stanica bubrega, urotelnog karcinoma, adenokarcinoma, ili karcinoma malih stanica, opcionalno kada je subjekt pogođen sa tumorom koji je otporan na, ili nepotpuno reagira samo na monspecifičnu terapiju.
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