JP6623353B2 - 抗pd−1抗体並びにその治療及び診断のための使用 - Google Patents
抗pd−1抗体並びにその治療及び診断のための使用 Download PDFInfo
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- PQYUGUXEJHLOIL-UHFFFAOYSA-N diethoxysilyl triethyl silicate Chemical compound C(C)O[SiH](O[Si](OCC)(OCC)OCC)OCC PQYUGUXEJHLOIL-UHFFFAOYSA-N 0.000 description 1
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- 230000004073 interleukin-2 production Effects 0.000 description 1
- 230000003834 intracellular effect Effects 0.000 description 1
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- 239000004310 lactic acid Substances 0.000 description 1
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- 210000002752 melanocyte Anatomy 0.000 description 1
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- 230000000869 mutational effect Effects 0.000 description 1
- 201000000050 myeloid neoplasm Diseases 0.000 description 1
- 239000013642 negative control Substances 0.000 description 1
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- 210000000056 organ Anatomy 0.000 description 1
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- 210000000496 pancreas Anatomy 0.000 description 1
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- 239000002644 phorbol ester Substances 0.000 description 1
- 238000010837 poor prognosis Methods 0.000 description 1
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- 230000003389 potentiating effect Effects 0.000 description 1
- 238000011533 pre-incubation Methods 0.000 description 1
- 210000004986 primary T-cell Anatomy 0.000 description 1
- 150000003141 primary amines Chemical class 0.000 description 1
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- 230000035755 proliferation Effects 0.000 description 1
- 125000001500 prolyl group Chemical group [H]N1C([H])(C(=O)[*])C([H])([H])C([H])([H])C1([H])[H] 0.000 description 1
- 238000004445 quantitative analysis Methods 0.000 description 1
- 108091008146 restriction endonucleases Proteins 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 102200036624 rs104893875 Human genes 0.000 description 1
- 102220169076 rs138407155 Human genes 0.000 description 1
- 102200126034 rs35874850 Human genes 0.000 description 1
- 238000012163 sequencing technique Methods 0.000 description 1
- 238000013207 serial dilution Methods 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 1
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- 210000004989 spleen cell Anatomy 0.000 description 1
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- 210000002784 stomach Anatomy 0.000 description 1
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- 239000004094 surface-active agent Substances 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
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- 238000011830 transgenic mouse model Methods 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- 230000004565 tumor cell growth Effects 0.000 description 1
- 241001515965 unidentified phage Species 0.000 description 1
- 241001430294 unidentified retrovirus Species 0.000 description 1
- 230000003827 upregulation Effects 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 239000013603 viral vector Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000012447 xenograft mouse model Methods 0.000 description 1
Classifications
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- 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
- A61K39/39591—Stabilisation, fragmentation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
- A61P31/12—Antivirals
-
- 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
-
- 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
- C07K16/2818—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
-
- 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
- C07K2317/33—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
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
-
- 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
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- 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
- C07K2317/53—Hinge
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- 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
- C07K2317/50—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
- C07K2317/567—Framework region [FR]
-
- 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
- C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
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- C07—ORGANIC CHEMISTRY
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- C07K2317/00—Immunoglobulins specific features
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- C07K2317/71—Decreased effector function due to an Fc-modification
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- C07K2317/00—Immunoglobulins specific features
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- C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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- C07K2317/00—Immunoglobulins specific features
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- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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- 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
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- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Epidemiology (AREA)
- Virology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Description
a)CDR−H1(配列番号11、17、31、又は37)、
b)CDR−H2(配列番号12、18、32、又は38)、
c)CDR−H3(配列番号13、19、33、又は39)、
d)CDR−L1(配列番号14、20、34、又は40)、
e)CDR−L2(配列番号15、21、35、又は41)、又は
f)CDR−L3(配列番号16、22、36、又は42)。
a)mu317: CDR−H1、CDR−H2、及びCDR−H3(配列番号11−13);
CDR−L1、CDR−L2、及びCDR−L3(配列番号14−16);
b)mu326: CDR−H1、CDR−H2、及びCDR−H3(配列番号17−19);
CDR−L1、CDR−L2、及びCDR−L3(配列番号20−22);
c)317−4B6: CDR−H1、CDR−H2及びCDR−H3(配列番号31−33);
CDR−L1、CDR−L2、及びCDR−L3(配列番号34−36);
d)326−4A3: CDR−H1、CDR−H2、及びCDR−H3(配列番号37−39);
CDR−L1、CDR−L2、及びCDR−L3(配列番号40−42);
e)317−1H: CDR−H1、CDR−H2、及びCDR−H3(配列番号11、59、13);
CDR−L1、CDR−L2、及びCDR−L3(配列番号14−16);
f)317−4B2: CDR−H1、CDR−H2、及びCDR−H3(配列番号11、60、13);
CDR−L1、CDR−L2、及びCDR−L3(配列番号61、15、16);
g)317−4B5: CDR−H1、CDR−H2、及びCDR−H3(配列番号11、60、13);
CDR−L1、CDR−L2、及びCDR−L3(配列番号61、15、16);
h)317−4B6: CDR−H1、CDR−H2、及びCDR−H3(配列番号11、32、13);
CDR−L1、CDR−L2、及びCDR−L3(配列番号61、15、16);
i)326−1: CDR−H1、CDR−H2、及びCDR−H3(配列番号17、62、19);
CDR−L1、CDR−L2、及びCDR−L3(配列番号20−22);
j)326−3B1: CDR−H1、CDR−H2、及びCDR−H3(配列番号17、62、19);
CDR−L1、CDR−L2、及びCDR−L3(配列番号20−22);
k)326−3G1 CDR−H1、CDR−H2、及びCDR−H3(配列番号17、62、19);又は
CDR−L1、CDR−L2、及びCDR−L3(配列番号20−22)。
(a) CDR−H1(配列番号31)、CDR−H2(配列番号12、32、59又は60)、及びCDR−H3(配列番号33)、
CDR−L1(配列番号14、34、又は61)、CDR−L2(配列番号35)、及びCDR−L3(配列番号36);又は
(b) CDR−H1(配列番号37)、CDR−H2(配列番号18、38、又は62)、及びCDR−H3(配列番号39)、
CDR−L1(配列番号40)、CDR−L2(配列番号41)、及びCDR−L3(配列番号42)。
a)mu317(配列番号4又は6);
b)mu326(配列番号8又は10);
c)317−4B6(配列番号24又は26);
d)326−4A3(配列番号28又は30);
e)317−4B2(配列番号43又は44);
f)317−4B5(配列番号45又は46);
g)317−1(配列番号48又は50);
h)326−3B1(配列番号51又は52);
i)326−3G1(配列番号53又は54);
j)326−1(配列番号56又は58);
k)317−3A1(配列番号64);
l)317−3C1(配列番号65);
m)317−3E1(配列番号66);
n)317−3F1(配列番号67);
o)317−3G1(配列番号68);
p)317−3H1(配列番号69);
q)317−3I1(配列番号70);
r)317−4B1(配列番号71);
s)317−4B3(配列番号72);
t)317−4B4(配列番号73);
u)317−4A2(配列番号74);
v)326−3A1(配列番号75);
w)326−3C1(配列番号76);
x)326−3D1(配列番号77);
y)326−3E1(配列番号78);
z)326−3F1(配列番号79);
aa)326−3B N55D(配列番号80);
ab)326−4A1(配列番号81);又は
ac)326−4A2(配列番号82)。
a)mu317(配列番号4及び6);
b)mu326(配列番号8及び10);
c)317−4B6(配列番号24及び26);
d)326−4A3(配列番号28及び30);
e)317−4B2(配列番号43及び44);
f)317−4B5(配列番号45及び46);
g)317−1(配列番号48及び50);
h)326−3B1(配列番号51又は52);
i)326−3G1(配列番号53及び54);
j)326−1(配列番号56及び58);
k)317−3A1(配列番号64及び26);
l)317−3C1(配列番号65及び26);
m)317−3E1(配列番号66及び26);
n)317−3F1(配列番号67及び26);
o)317−3G1(配列番号68及び26);
p)317−3H1(配列番号69及び26);
q)317−3I1(配列番号70及び26);
r)317−4B1(配列番号71及び26);
s)317−4B3(配列番号72及び26);
t)317−4B4(配列番号73及び26);
u)317−4A2(配列番号74及び26);
v)326−3A1(配列番号75及び30);
w)326−3C1(配列番号76及び30);
x)326−3D1(配列番号77及び30);
y)326−3E1(配列番号78及び30);
z)326−3F1(配列番号79及び30);
aa)326−3B N55D(配列番号80及び30);
ab)326−4A1(配列番号28及び81);又は
ac)326−4A2(配列番号28及び82)。
(a)K45及びI93(文献[2008 PNAS、105:10483]に基づくアミノ酸番号付け;配列番号2におけるK58およびI106に相当する);又は
(b)I93、L95及びP97(文献[2008 PNAS、105:10483]に基づくアミノ酸番号付け;配列番号2におけるI106、L108およびP110のに相当する)。
実施例
Claims (7)
- 以下の3つの相補性決定領域(CDR)を含む重鎖可変領域(Vh):配列番号31のアミノ酸配列を有するCDR−H1、配列番号32のアミノ酸配列を有するCDR−H2、及び配列番号33のアミノ酸配列を有するCDR−H3;及び
以下の3つの相補性決定領域(CDR)を含む軽鎖可変領域(Vk):配列番号34のアミノ酸配列を有するCDR−L1、配列番号35のアミノ酸配列を有するCDR−L2、及び配列番号36のアミノ酸配列を有するCDR−L3;
を含む、1.47×10 −10 M以下の平均解離定数(K D )でヒトPD−1に結合する抗体抗原結合ドメインを含む抗体。 - 配列番号24のアミノ酸配列を有する重鎖可変領域(Vh)を含む、請求項1に記載の抗体。
- 配列番号26のアミノ酸配列を有する軽鎖可変領域(Vk)を含む、請求項1に記載の抗体。
- それぞれ、配列番号24のアミノ酸配列、及び配列番号26のアミノ酸配列を有する、重鎖可変領域(Vh)及び軽鎖可変領域(Vk)を含む、ヒトPD−1に結合する抗体抗原結合ドメインを含む抗体。
- PD1残基:K45及びI93(配列番号2におけるK58およびI106に相当する)に結合する、請求項1に記載の抗体。
- 請求項1から5のいずれかに記載の抗体の、F(ab)又はF(ab)2。
- 癌又はウイルス感染症の判定を受けた個体、又は、PD−1拮抗作用を必要とする個体において、癌又はウイルス感染症の治療のために用いられる請求項1から5のいずれかに記載の抗体。
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