HRP20230237T1 - Anti-psma antitijela, bispecifične molekule za vezanje antigena koje vežu psma i cd3, i njihova uporaba - Google Patents
Anti-psma antitijela, bispecifične molekule za vezanje antigena koje vežu psma i cd3, i njihova uporaba Download PDFInfo
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- HRP20230237T1 HRP20230237T1 HRP20230237TT HRP20230237T HRP20230237T1 HR P20230237 T1 HRP20230237 T1 HR P20230237T1 HR P20230237T T HRP20230237T T HR P20230237TT HR P20230237 T HRP20230237 T HR P20230237T HR P20230237 T1 HRP20230237 T1 HR P20230237T1
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- antigen
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- 239000000427 antigen Substances 0.000 title claims 23
- 102000036639 antigens Human genes 0.000 title claims 23
- 108091007433 antigens Proteins 0.000 title claims 23
- 206010060862 Prostate cancer Diseases 0.000 claims 7
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 7
- 102100041003 Glutamate carboxypeptidase 2 Human genes 0.000 claims 6
- 101000892862 Homo sapiens Glutamate carboxypeptidase 2 Proteins 0.000 claims 6
- 125000003275 alpha amino acid group Chemical group 0.000 claims 6
- 229920001481 poly(stearyl methacrylate) Polymers 0.000 claims 6
- 241000699670 Mus sp. Species 0.000 claims 4
- 206010028980 Neoplasm Diseases 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 4
- 230000004614 tumor growth Effects 0.000 claims 4
- 238000000338 in vitro Methods 0.000 claims 3
- 206010061598 Immunodeficiency Diseases 0.000 claims 2
- 210000001744 T-lymphocyte Anatomy 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 230000001404 mediated effect Effects 0.000 claims 2
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 2
- 210000004881 tumor cell Anatomy 0.000 claims 2
- 206010005003 Bladder cancer Diseases 0.000 claims 1
- 206010009944 Colon cancer Diseases 0.000 claims 1
- 208000001333 Colorectal Neoplasms Diseases 0.000 claims 1
- 208000008839 Kidney Neoplasms Diseases 0.000 claims 1
- 241000282567 Macaca fascicularis Species 0.000 claims 1
- 206010038389 Renal cancer Diseases 0.000 claims 1
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 1
- 238000003556 assay Methods 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
- 230000022534 cell killing Effects 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 206010017758 gastric cancer Diseases 0.000 claims 1
- 210000005260 human cell Anatomy 0.000 claims 1
- 201000010982 kidney cancer Diseases 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 238000000159 protein binding assay Methods 0.000 claims 1
- 201000011549 stomach cancer Diseases 0.000 claims 1
- 230000005909 tumor killing Effects 0.000 claims 1
- 201000005112 urinary bladder cancer Diseases 0.000 claims 1
Classifications
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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
-
- 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
- C07K16/30—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
-
- 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
-
- 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
-
- 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
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
-
- 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
-
- 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
- C07K2317/70—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
- C07K2317/70—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
- C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
-
- 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
- C07K2317/734—Complement-dependent cytotoxicity [CDC]
-
- 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
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
-
- 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
Claims (10)
1. Bispecifična molekula za vezivanje antigena koja sadrži prvu domenu za vezivanje antigena koji specifično vezuje humani CD3, i drugu domenu za vezivanje antigena koji specifično vezuje humani PSMA,
pri čemu se prva domena koja se vezuje za antigen koji se specifično vezuje za humani CD3 obuhvaća varijabilnu regiju teškog lanca (HCVR) koji sadrži aminokiselinsku sekvencu SEQ ID NO: 1514 ili SEQ ID NO: 1618, i varijabilna regija lakog lanca (LCVR) koja sadrži aminokiselinsku sekvencu SEQ ID NO: 1386, i
pri čemu druga domena za vezivanje antigena koji se specifično vezuje za humani PSMA obuhvaća varijabilnu regiju teškog lanca (HCVR) koji sadrži aminokiselinsku sekvencu SEQ ID NO: 66, i varijabilnu regiju lakog lanca (LCVR) koji sadrži aminokiselinsku sekvencu SEQ ID NO: 1386.
2. Bispecifična molekula za vezivanje antigena prema zahtjevu 1, gdje prva domena za vezivanje antigena koji specifično vezuje humani CD3 obuhvaća HCVR koji sadrži aminokiselinsku sekvencu SEQ ID NO: 1514.
3. Bispecifična molekula za vezivanje antigena prema zahtjevu 1, gdje prva domena za vezivanje antigena koji specifično vezuje humani CD3 obuhvaća HCVR koji sadrži aminokiselinsku sekvencu SEQ ID NO: 1618.
4. Bispecifična molekula koja vezuje antigen prema bilo kojem od zahtjeva 1 do 3, gdje:
(i) druga domena za vezivanje antigena vezuje humane stanice koje eksprimiraju humani PSMA i stanice cynomolgus majmuna koje eksprimiraju cynomoglus PSMA;
(ii) molekula koja vezuje antigen inhibira rast tumora kod imunokompromitiranih miševa koji nose ksenotransplantate humanog raka prostate;
(iii) molekula koja veže antigen inhibira rast tumora kod imunokompetentnih miševa koji nose ksenotransplantate humanog raka prostate;
(iv) molekula koja vezuje antigen suzbija rast tumora kod tumora ustanovljenih kod imunokompromitiranih miševa koji nose ksenotransplantate humanog raka prostate; ili
(v) molekula koja vezuje antigen smanjuje rast tumora kod tumora ustanovljenih kod imunokompetentnih miševa koji nose ksenotransplantate humanog raka prostate.
5. Bispecifična molekula koja vezuje antigen prema bilo kojem od zahtjeva 1 do 4, gdje:
(i) molekula koja se vezuje za antigen inducira ubijanje tumorskih stanica posredovano T stanicama s vrijednošću EC50 manjom od oko 1,3 nM, kako je izmjereno u in vitro testu ubijanja tumorskih stanica posredovano sa T stanicama; i/ili
(ii) druga domena za vezivanje antigena specifično vezuje humani PSMA sa KD vrijednošću manjom od oko 80 nM, kako je izmjereno u in vitro testu vezivanja površinskom plazmenom rezonancom; i/ili
(iii) druga domena za vezivanje antigena specifično vezuje svaki od humanih PSMA s vrijednošću KD manjom od oko 5 nM, manjom od oko 2 nM, manjom od oko 1 nM, manjom od oko 800 pM ili manjom od oko 600 pM, kako je izmjeren ou in vitro testu vezivanja površinskom plazmenom rezonancom.
6. Bispecifična molekula koja se vezuje za antigen prema bilo kojem od zahtjeva 1 do 5 koji je bispecifično antitijelo ili njegov bispecifični fragment koji vezuje antigen.
7. Farmaceutski sastav koji sadrži bispecifičnu molekulu koja vezuje antigen prema bilo kojem od zahtjeva 1 do 6 i farmaceutski prihvatljiv nosač ili razrjeđivač.
8. Farmaceutski sastav prema zahtjevu 7, naznačen time, da se koristi u postupku liječenja raka kod subjekta
9. Farmaceutski sastav za upotrebu prema zahtjevu 8, gdje je rak izabran iz grupe koju čine rak prostate, rak bubrega, rak mjehura, kolorektalni karcinom i rak želuca.
10. Farmaceutski sastav za upotrebu prema zahtjevu 8, naznačen time, da je rak prostate, opcionalno rak prostate otporan na kastraciju.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562199823P | 2015-07-31 | 2015-07-31 | |
| US201562222590P | 2015-09-23 | 2015-09-23 | |
| US201662351823P | 2016-06-17 | 2016-06-17 | |
| PCT/US2016/044732 WO2017023761A1 (en) | 2015-07-31 | 2016-07-29 | Anti-psma antibodies, bispecific antigen-binding molecules that bind psma and cd3, and uses thereof |
| EP16748023.5A EP3328888B1 (en) | 2015-07-31 | 2016-07-29 | Anti-psma antibodies, bispecific antigen-binding molecules that bind psma and cd3, and uses thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20230237T1 true HRP20230237T1 (hr) | 2023-04-14 |
Family
ID=56610023
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230237TT HRP20230237T1 (hr) | 2015-07-31 | 2016-07-29 | Anti-psma antitijela, bispecifične molekule za vezanje antigena koje vežu psma i cd3, i njihova uporaba |
Country Status (24)
| Country | Link |
|---|---|
| US (3) | US10179819B2 (hr) |
| EP (2) | EP4183805A1 (hr) |
| JP (2) | JP6975707B2 (hr) |
| KR (1) | KR20180042272A (hr) |
| CN (1) | CN108137700B (hr) |
| AR (1) | AR106570A1 (hr) |
| AU (1) | AU2016302928B2 (hr) |
| CA (1) | CA2994245A1 (hr) |
| DK (1) | DK3328888T3 (hr) |
| EA (1) | EA038603B1 (hr) |
| ES (1) | ES2935120T3 (hr) |
| FI (1) | FI3328888T3 (hr) |
| HK (1) | HK1255971A1 (hr) |
| HR (1) | HRP20230237T1 (hr) |
| HU (1) | HUE061419T2 (hr) |
| JO (1) | JOP20160154B1 (hr) |
| LT (1) | LT3328888T (hr) |
| MD (1) | MD3328888T2 (hr) |
| PL (1) | PL3328888T3 (hr) |
| PT (1) | PT3328888T (hr) |
| RS (1) | RS63991B1 (hr) |
| SI (1) | SI3328888T1 (hr) |
| TW (1) | TWI728990B (hr) |
| WO (1) | WO2017023761A1 (hr) |
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