HRP20240102T1 - Monoklonsko protutijelo koje antagonizira i inhibira vezanje između humanog pd-1 antigena i njegovog liganda, postupak njegove priprave i primjena - Google Patents

Monoklonsko protutijelo koje antagonizira i inhibira vezanje između humanog pd-1 antigena i njegovog liganda, postupak njegove priprave i primjena Download PDF

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HRP20240102T1
HRP20240102T1 HRP20240102TT HRP20240102T HRP20240102T1 HR P20240102 T1 HRP20240102 T1 HR P20240102T1 HR P20240102T T HRP20240102T T HR P20240102TT HR P20240102 T HRP20240102 T HR P20240102T HR P20240102 T1 HRP20240102 T1 HR P20240102T1
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Croatia
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antibody
variable region
seq
human
cdr
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HRP20240102TT
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English (en)
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Hongqun Hu
Zui CHEN
Xiaoqi SONG
Shiping Luo
Mingwen CAI
Jinling FAN
Yiqing Xu
Qunmin Zhou
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Acroimmune Biopharmaceutical Co., Ltd.
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Publication of HRP20240102T1 publication Critical patent/HRP20240102T1/hr

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • C07K16/2818Immunoglobulins [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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/522CH1 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

Claims (11)

1. Monoklonsko protutijelo koje antagonizira i inhibira vezanje humanog PD-1 antigena na njegov ligand, naznačeno time da sadrži prvu i drugu varijabilnu regiju: prva varijabilna regija je varijabilna regija lakog lanca protutijela, od kojih su aminokiselinske sekvence CDR 1, CDR 2 i CDR 3 prikazane u SEQ ID BR.: 3, SEQ ID BR: 4 i SEQ ID BR: 5, dok je druga varijabilna regija varijabilna regija teškog lanca protutijela, od kojih su aminokiselinske sekvence CDR 1, CDR 2 i CDR 3 prikazane u SEQ ID BR: 8, SEQ ID BR: 9 i SEQ ID BR: 10, respektivno i gdje je prva navedena varijabilna regija varijabilna regija lakog lanca protutijela, sa sekvencom aminokiselina prikazanom u SEQ ID BR: 11, dok je navedena druga varijabilna regija varijabilna regija teškog lanca protutijela, sa sekvencom aminokiselina prikazanom u SEQ ID NO: 12.
2. Protutijelo ili njegov derivat prema zahtjevu 1, naznačeno time da sadrži spomenutu varijabilnu regiju lakog lanca protutijela i konstantnu regiju lakog lanca ljudskog protutijela, kao i zglobnu regiju, CH1, CH2 i CH3 spomenutog varijabilnog teškog lanca protutijela. regija i konstantna regija teškog lanca ljudskog protutijela.
3. Protutijelo ili njegov derivat prema zahtjevu 2, naznačeno time da je navedena konstantna regija lakog lanca ljudskog protutijela iz kapa lanca ljudskog protutijela ili lambda lanca protutijela, a navedena teška konstantna regija ljudskog protutijela je iz humanog podtipa IgG1, IgG2, IgG3 ili IgG4.
4. DNA molekula ili gen koji kodira protutijelo ili njegov derivat prema zahtjevu 1, naznačen time što je nukleotidna sekvenca varijabilne regije lakog lanca protutijela prikazana u SEQ ID BR: 13, a nukleotidna sekvenca varijabilne regije teškog lanca protutijela prikazana je u SEQ ID BR: 14.
5. Ekspresijski vektor, naznačen time što sadrži DNA molekularni slijed prema zahtjevu 4 i slijed regulacije ekspresije operativno povezan s njim.
6. Rekombinantna stanica domaćina, naznačena time da je transformirana iz ekspresijskog vektora navedenog u zahtjevu 5.
7. Rekombinantna stanica domaćina prema zahtjevu 6, naznačena time da navedena rekonstitucijska stanica domaćin eksprimira protutijelo ili njegov derivat prema zahtjevu 1.
8. Farmaceutski pripravak, naznačen time da sadrži farmaceutski učinkovitu količinu protutijela prema zahtjevu 1 i farmaceutski prihvatljiv nosač.
9. Farmaceutski pripravak prema zahtjevu 8, naznačen time da se koristi u liječenju raka.
10. Farmaceutski pripravak za upotrebu prema zahtjevu 9, naznačen time da je to rak debelog crijeva.
11. Metoda za pripremu protutijela ili njegovog derivata prema zahtjevu 1, naznačena time da metoda uključuje sljedeće korake: a) Osigurati ekspresijski vektor koji sadrži DNA molekularni slijed prema Zahtjevu 4 i slijed regulacije ekspresije operativno povezan s njim; b) Transformirajte stanice domaćina ekspresijskim vektorom navedenim u koraku a); c) Kultura stanica domaćina dobivenih iz koraka b) pod uvjetima prikladnim za ekspresiju navedenog protutijela; i d) Nabavite navedena protutijela odvajanjem i pročišćavanjem tekućine kulture stanica domaćina afinitetnom kromatografijom.
HRP20240102TT 2017-04-20 2017-06-21 Monoklonsko protutijelo koje antagonizira i inhibira vezanje između humanog pd-1 antigena i njegovog liganda, postupak njegove priprave i primjena HRP20240102T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201710262053.4A CN106939049B (zh) 2017-04-20 2017-04-20 拮抗抑制人pd-1抗原与其配体结合的单克隆抗体及其制备方法与应用
EP17906230.2A EP3613768B1 (en) 2017-04-20 2017-06-21 Monoclonal antibody antagonizing and inhibiting binding between human pd-1 antigen and ligand thereof, preparation method therefor and application thereof
PCT/CN2017/089282 WO2018192089A1 (zh) 2017-04-20 2017-06-21 拮抗抑制人pd-1抗原与其配体结合的单克隆抗体及其制备方法与应用

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EP (1) EP3613768B1 (hr)
JP (1) JP6928971B2 (hr)
CN (1) CN106939049B (hr)
HR (1) HRP20240102T1 (hr)
RS (1) RS64987B1 (hr)
WO (1) WO2018192089A1 (hr)

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CN106939049B (zh) 2019-10-01
WO2018192089A1 (zh) 2018-10-25
EP3613768A1 (en) 2020-02-26
EP3613768C0 (en) 2023-11-22
EP3613768A4 (en) 2020-06-17
JP6928971B2 (ja) 2021-09-01
JP2020517264A (ja) 2020-06-18
RS64987B1 (sr) 2024-01-31
CN106939049A (zh) 2017-07-11
EP3613768B1 (en) 2023-11-22
US11345754B2 (en) 2022-05-31
US20200277376A1 (en) 2020-09-03

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