HRP20210448T1 - Monoklonsko antitijelo protiv ctla4 ili njegov antigen-vezujući fragment, medicinski pripravak i uporaba - Google Patents
Monoklonsko antitijelo protiv ctla4 ili njegov antigen-vezujući fragment, medicinski pripravak i uporaba Download PDFInfo
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- HRP20210448T1 HRP20210448T1 HRP20210448TT HRP20210448T HRP20210448T1 HR P20210448 T1 HRP20210448 T1 HR P20210448T1 HR P20210448T T HRP20210448T T HR P20210448TT HR P20210448 T HRP20210448 T HR P20210448T HR P20210448 T1 HRP20210448 T1 HR P20210448T1
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- 239000000427 antigen Substances 0.000 title claims 18
- 102000036639 antigens Human genes 0.000 title claims 18
- 108091007433 antigens Proteins 0.000 title claims 18
- 239000012634 fragment Substances 0.000 title claims 18
- 238000000034 method Methods 0.000 claims 11
- 101000889276 Homo sapiens Cytotoxic T-lymphocyte protein 4 Proteins 0.000 claims 10
- 102000043321 human CTLA4 Human genes 0.000 claims 9
- 210000001744 T-lymphocyte Anatomy 0.000 claims 4
- 150000007523 nucleic acids Chemical class 0.000 claims 4
- 102000039446 nucleic acids Human genes 0.000 claims 4
- 108020004707 nucleic acids Proteins 0.000 claims 4
- 210000004027 cell Anatomy 0.000 claims 3
- 101000914484 Homo sapiens T-lymphocyte activation antigen CD80 Proteins 0.000 claims 2
- 206010062016 Immunosuppression Diseases 0.000 claims 2
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- 230000000694 effects Effects 0.000 claims 2
- 230000001506 immunosuppresive effect Effects 0.000 claims 2
- 201000007270 liver cancer Diseases 0.000 claims 2
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- 229930182817 methionine Natural products 0.000 claims 2
- 206010005003 Bladder cancer Diseases 0.000 claims 1
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- 102100039498 Cytotoxic T-lymphocyte protein 4 Human genes 0.000 claims 1
- 206010017993 Gastrointestinal neoplasms Diseases 0.000 claims 1
- 206010073069 Hepatic cancer Diseases 0.000 claims 1
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims 1
- AGPKZVBTJJNPAG-WHFBIAKZSA-N L-isoleucine Chemical compound CC[C@H](C)[C@H](N)C(O)=O AGPKZVBTJJNPAG-WHFBIAKZSA-N 0.000 claims 1
- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims 1
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
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- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 1
- KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Natural products CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 claims 1
- 230000004913 activation Effects 0.000 claims 1
- 235000004279 alanine Nutrition 0.000 claims 1
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- 150000001413 amino acids Chemical class 0.000 claims 1
- 230000000903 blocking effect Effects 0.000 claims 1
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- 238000004113 cell culture Methods 0.000 claims 1
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- 238000000338 in vitro Methods 0.000 claims 1
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- AGPKZVBTJJNPAG-UHFFFAOYSA-N isoleucine Natural products CCC(C)C(N)C(O)=O AGPKZVBTJJNPAG-UHFFFAOYSA-N 0.000 claims 1
- 125000001909 leucine group Chemical group [H]N(*)C(C(*)=O)C([H])([H])C(C([H])([H])[H])C([H])([H])[H] 0.000 claims 1
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- 230000001105 regulatory effect Effects 0.000 claims 1
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 1
- 201000005112 urinary bladder cancer Diseases 0.000 claims 1
- 239000004474 valine Substances 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
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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
- 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
- C07K16/2818—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 CD28 or CD152
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- A—HUMAN NECESSITIES
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- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39541—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against normal tissues, cells
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- C—CHEMISTRY; METALLURGY
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- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- C—CHEMISTRY; METALLURGY
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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
- C07K16/2896—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
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- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
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- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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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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- C07K2317/70—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
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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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- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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Claims (14)
1. Antitijelo ili njegov antigen-vezujući fragment koji se veže za ljudski CTLA4, izabran iz grupe koja se sastoji od:
(a) antitijela ili njegovog antigen-vezujućeg fragmenta koji sadrži varijabilnu regiju teškog lanca sekvence SEQ ID NO: 14 i varijabilnu regiju lakog lanca sekvence SEQ ID NO: 16; i
(b) antitijela ili njegovog antigen-vezujućeg fragmenta koji sadrži varijabilnu regiju teškog lanca sekvence SEQ ID NO: 14 i varijabilnu regiju lakog lanca sekvence SEQ ID NO: 16, pri čemu u sekvenci SEQ ID NO: 14 na poziciji 18, metionin može biti supstituiran aminokiselinom izabranom iz grupe koja se sastoji od: leucina, valina, izoleucina i alanina.
2. Antitijelo ili antigen-vezujući fragment prema patentnom zahtjevu 1, naznačeno time što je metionin na poziciji 18 u SEQ ID NO: 14 supstituiran leucinom, a varijabilna regija lakog lanca ima sekvencu SEQ ID NO: 16.
3. Antitijelo ili njegov antigen-vezujući fragment prema patentnim zahtjevima 1 ili 2, koje predstavlja humanizirano antitijelo ili njegov antigen-vezujući fragment.
4. Antitijelo ili njegov antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-3, naznačeno time što se antitijelo ili njegov antigen-vezujući fragment veže za ljudski CTLA4 sa KD manjom od oko 10-5 M, određeno rezonancom površinskog plazmona.
5. Antitijelo ili njegov antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-4, naznačeno time što antitijelo ili njegov antigen-vezujući fragment:
(a) blokira vezanje ljudskog CTLA4 za ljudski B7;
(b) regulira aktivnost ljudskog CTLA4;
(c) ublažava imunosupresiju na tijelo ljudskim CTLA4;
(d) aktivira T limfocite, i/ili
(e) povećava ekspresiju IL-2 u T limfocitima.
6. Jedna ili više izoliranih molekula nukleinske kiseline koje kodiraju antitijelo ili antigen-vezujući fragment prema patentnom zahtjevu 1.
7. Jedna ili više izoliranih molekula nukleinske kiseline prema patentnom zahtjevu 6, naznačene time što jedna ili više izoliranih molekula nukleinske kiseline imaju nukleotidnu sekvencu kako je navedeno u SEQ ID NO: 13 ili SEQ ID NO: 15.
8. Vektor koji sadrži izoliranu molekulu nukleinske kiseline prema patentnom zahtjevu 6.
9. Stanica-domaćin koja sadrži vektor prema patentnom zahtjevu 9.
10. Postupak za pripremu antitijela ili njegovog antigen-vezujućeg fragmenta prema bilo kojem od patentnih zahtjeva 1 do 4, koji obuhvaća korake kultivacije stanice-domaćina prema patentnom zahtjevu 8 pod pogodnim uvjetima i izdvajanje antitijela ili njegovog antigen-vezujućeg fragmenta iz stanične kulture.
11. Farmaceutski pripravak koji sadrži antitijelo ili njegov antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-5 i farmaceutski prihvatljiv nosač i/ili ekscipijent.
12. Antitijelo ili njegov antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1 do 5 za uporabu u postupku za liječenje raka, kao što je melanom, tumor bubrega/renalni tumor, rak prostate, rak mjehura, rak debelog crijeva, rak gastrointestinalnog trakta, i/ili rak jetre/hepatični rak kod ljudskog subjekta.
13. Antitijelo ili njegov antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1 do 5 za uporabu u postupku za liječenje limfoma.
14. In vitro postupak koji obuhvaća korake primjene na stanice efikasne količine antitijela ili njegovog antigen-vezujućeg fragmenta prema bilo kojem od patentnih zahtjeva 1 do 5, naznačen time što je postupak odabran od sljedećeg:
(a) postupka za detekciju nivoa CTLA4 u uzorku,
(b) postupka za blokiranje vezanja ljudskog CTLA4 za ljudski B7,
(c) postupka za reguliranje aktivnosti ljudskog CTLA4 ili nivoa ljudskog CTLA4,
(d) postupka za ublažavanje imunosupresije na tijelu ljudskim CTLA4,
(e) postupka za aktivaciju T limfocita, ili
(f) postupka za povećanje ekspresije IL-2 u T limfocitima.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410377352.9A CN105296433B (zh) | 2014-08-01 | 2014-08-01 | 一种ctla4抗体、其药物组合物及其用途 |
| EP15827441.5A EP3176181B1 (en) | 2014-08-01 | 2015-07-31 | Anti-ctla4 monoclonal antibody or antigen binding fragment thereof, medicinal composition and use |
| PCT/CN2015/085721 WO2016015675A1 (zh) | 2014-08-01 | 2015-07-31 | 抗ctla4的单克隆抗体或其抗原结合片段、药物组合物及用途 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210448T1 true HRP20210448T1 (hr) | 2021-05-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210448TT HRP20210448T1 (hr) | 2014-08-01 | 2021-03-17 | Monoklonsko antitijelo protiv ctla4 ili njegov antigen-vezujući fragment, medicinski pripravak i uporaba |
Country Status (39)
| Country | Link |
|---|---|
| US (3) | US10449251B2 (hr) |
| EP (2) | EP3858861A1 (hr) |
| JP (2) | JP6514774B2 (hr) |
| KR (1) | KR102017396B1 (hr) |
| CN (3) | CN105296433B (hr) |
| AP (1) | AP2017009762A0 (hr) |
| AU (2) | AU2015295936C1 (hr) |
| CA (1) | CA2956000C (hr) |
| CL (1) | CL2017000250A1 (hr) |
| CO (1) | CO2017000754A2 (hr) |
| CR (1) | CR20170033A (hr) |
| CY (1) | CY1124190T1 (hr) |
| DK (1) | DK3176181T3 (hr) |
| DO (1) | DOP2017000031A (hr) |
| EA (1) | EA036396B1 (hr) |
| EC (1) | ECSP17012781A (hr) |
| ES (1) | ES2857509T3 (hr) |
| GE (1) | GEP20207166B (hr) |
| HR (1) | HRP20210448T1 (hr) |
| HU (1) | HUE053719T2 (hr) |
| IL (1) | IL250321B (hr) |
| LT (1) | LT3176181T (hr) |
| MA (2) | MA55868A (hr) |
| MD (1) | MD4795C1 (hr) |
| MX (2) | MX2017001446A (hr) |
| MY (1) | MY192822A (hr) |
| NI (1) | NI201700008A (hr) |
| NZ (1) | NZ729158A (hr) |
| PE (1) | PE20170772A1 (hr) |
| PH (1) | PH12017500190A1 (hr) |
| PL (1) | PL3176181T3 (hr) |
| PT (1) | PT3176181T (hr) |
| RS (1) | RS61590B1 (hr) |
| SG (1) | SG11201700819QA (hr) |
| SI (1) | SI3176181T1 (hr) |
| TN (1) | TN2017000010A1 (hr) |
| UA (1) | UA119570C2 (hr) |
| WO (1) | WO2016015675A1 (hr) |
| ZA (1) | ZA201700528B (hr) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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