JP2020512359A5 - - Google Patents
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- JP2020512359A5 JP2020512359A5 JP2019553183A JP2019553183A JP2020512359A5 JP 2020512359 A5 JP2020512359 A5 JP 2020512359A5 JP 2019553183 A JP2019553183 A JP 2019553183A JP 2019553183 A JP2019553183 A JP 2019553183A JP 2020512359 A5 JP2020512359 A5 JP 2020512359A5
- Authority
- JP
- Japan
- Prior art keywords
- antibody
- seq
- amino acid
- pd1ab
- antigen
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 102100040678 Programmed cell death protein 1 Human genes 0.000 claims description 244
- 101710089372 Programmed cell death protein 1 Proteins 0.000 claims description 244
- 230000027455 binding Effects 0.000 claims description 218
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- 239000000427 antigen Substances 0.000 claims description 186
- 102000036639 antigens Human genes 0.000 claims description 186
- 108091007433 antigens Proteins 0.000 claims description 186
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 163
- 230000003828 downregulation Effects 0.000 claims description 135
- 125000003275 alpha amino acid group Chemical group 0.000 claims description 112
- 102000004127 Cytokines Human genes 0.000 claims description 111
- 108090000695 Cytokines Proteins 0.000 claims description 111
- 239000008194 pharmaceutical composition Substances 0.000 claims description 106
- 230000005764 inhibitory process Effects 0.000 claims description 77
- 210000001744 T-lymphocyte Anatomy 0.000 claims description 61
- 229940127557 pharmaceutical product Drugs 0.000 claims description 43
- 238000000034 method Methods 0.000 claims description 27
- 101000611936 Homo sapiens Programmed cell death protein 1 Proteins 0.000 claims description 26
- 102000048362 human PDCD1 Human genes 0.000 claims description 26
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- 102100037850 Interferon gamma Human genes 0.000 claims description 11
- 108010074328 Interferon-gamma Proteins 0.000 claims description 11
- 102000013691 Interleukin-17 Human genes 0.000 claims description 11
- 108050003558 Interleukin-17 Proteins 0.000 claims description 11
- 108010002350 Interleukin-2 Proteins 0.000 claims description 11
- 102000000588 Interleukin-2 Human genes 0.000 claims description 11
- 229930006000 Sucrose Natural products 0.000 claims description 8
- 230000007302 negative regulation of cytokine production Effects 0.000 claims description 8
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 8
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 8
- 229920000053 polysorbate 80 Polymers 0.000 claims description 8
- 229940068968 polysorbate 80 Drugs 0.000 claims description 8
- 239000005720 sucrose Substances 0.000 claims description 8
- 210000003819 peripheral blood mononuclear cell Anatomy 0.000 claims description 7
- 235000000346 sugar Nutrition 0.000 claims description 7
- MZOFCQQQCNRIBI-VMXHOPILSA-N (3s)-4-[[(2s)-1-[[(2s)-1-[[(1s)-1-carboxy-2-hydroxyethyl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-(diaminomethylideneamino)-1-oxopentan-2-yl]amino]-3-[[2-[[(2s)-2,6-diaminohexanoyl]amino]acetyl]amino]-4-oxobutanoic acid Chemical compound OC[C@@H](C(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(O)=O)NC(=O)CNC(=O)[C@@H](N)CCCCN MZOFCQQQCNRIBI-VMXHOPILSA-N 0.000 claims description 6
- 108010017213 Granulocyte-Macrophage Colony-Stimulating Factor Proteins 0.000 claims description 6
- 102100039620 Granulocyte-macrophage colony-stimulating factor Human genes 0.000 claims description 6
- 108010002352 Interleukin-1 Proteins 0.000 claims description 6
- 102000000589 Interleukin-1 Human genes 0.000 claims description 6
- 102000013462 Interleukin-12 Human genes 0.000 claims description 6
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- 102100030703 Interleukin-22 Human genes 0.000 claims description 6
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- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 6
- 108060008682 Tumor Necrosis Factor Proteins 0.000 claims description 6
- 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims description 6
- 241000700605 Viruses Species 0.000 claims description 6
- 238000001042 affinity chromatography Methods 0.000 claims description 6
- 108010074109 interleukin-22 Proteins 0.000 claims description 6
- 101100188738 Astyanax fasciatus G103 gene Proteins 0.000 claims description 5
- 230000002238 attenuated effect Effects 0.000 claims description 5
- 150000001875 compounds Chemical class 0.000 claims description 5
- 229920005862 polyol Polymers 0.000 claims description 5
- 150000003077 polyols Chemical class 0.000 claims description 5
- 108090000623 proteins and genes Proteins 0.000 claims description 5
- 239000004094 surface-active agent Substances 0.000 claims description 5
- 241000282693 Cercopithecidae Species 0.000 claims description 4
- 238000012258 culturing Methods 0.000 claims description 4
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- 239000000203 mixture Substances 0.000 claims description 4
- 102000004169 proteins and genes Human genes 0.000 claims description 4
- 238000000746 purification Methods 0.000 claims description 4
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 4
- 239000008351 acetate buffer Substances 0.000 claims description 3
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- 239000007979 citrate buffer Substances 0.000 claims description 3
- 238000000502 dialysis Methods 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 3
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 3
- 102000004190 Enzymes Human genes 0.000 claims description 2
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- 108010021625 Immunoglobulin Fragments Proteins 0.000 claims description 2
- 102000008394 Immunoglobulin Fragments Human genes 0.000 claims description 2
- 108091028043 Nucleic acid sequence Proteins 0.000 claims description 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 2
- 241000283984 Rodentia Species 0.000 claims description 2
- 238000005571 anion exchange chromatography Methods 0.000 claims description 2
- 230000010056 antibody-dependent cellular cytotoxicity Effects 0.000 claims description 2
- 210000004369 blood Anatomy 0.000 claims description 2
- 239000008280 blood Substances 0.000 claims description 2
- 239000002738 chelating agent Substances 0.000 claims description 2
- 230000003467 diminishing effect Effects 0.000 claims description 2
- 238000001914 filtration Methods 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 229910052751 metal Inorganic materials 0.000 claims description 2
- 239000002184 metal Substances 0.000 claims description 2
- 108091033319 polynucleotide Proteins 0.000 claims description 2
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- 102000040430 polynucleotide Human genes 0.000 claims description 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 2
- 229940068977 polysorbate 20 Drugs 0.000 claims description 2
- 239000007974 sodium acetate buffer Substances 0.000 claims description 2
- 239000000126 substance Substances 0.000 claims description 2
- 239000001384 succinic acid Substances 0.000 claims description 2
- 125000000185 sucrose group Chemical group 0.000 claims description 2
- 150000005846 sugar alcohols Chemical class 0.000 claims description 2
- 150000008163 sugars Chemical class 0.000 claims description 2
- 238000000108 ultra-filtration Methods 0.000 claims description 2
- 238000011100 viral filtration Methods 0.000 claims description 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 2
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 2
- 150000001413 amino acids Chemical class 0.000 claims 1
- 239000007850 fluorescent dye Substances 0.000 claims 1
- 230000002285 radioactive effect Effects 0.000 claims 1
- 108010074708 B7-H1 Antigen Proteins 0.000 description 13
- 101100407308 Mus musculus Pdcd1lg2 gene Proteins 0.000 description 13
- 108700030875 Programmed Cell Death 1 Ligand 2 Proteins 0.000 description 13
- 102100024216 Programmed cell death 1 ligand 1 Human genes 0.000 description 13
- 102100024213 Programmed cell death 1 ligand 2 Human genes 0.000 description 13
- 238000000636 Northern blotting Methods 0.000 description 6
- 238000000684 flow cytometry Methods 0.000 description 6
- 238000003757 reverse transcription PCR Methods 0.000 description 6
- 238000001262 western blot Methods 0.000 description 6
- 230000001105 regulatory effect Effects 0.000 description 5
- 239000011230 binding agent Substances 0.000 description 4
- 229940122544 PD-1 agonist Drugs 0.000 description 3
- 230000011664 signaling Effects 0.000 description 3
- 108020004414 DNA Proteins 0.000 description 2
- 108060003951 Immunoglobulin Proteins 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 102000018358 immunoglobulin Human genes 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 230000000415 inactivating effect Effects 0.000 description 2
- 238000011534 incubation Methods 0.000 description 2
- 230000002401 inhibitory effect Effects 0.000 description 2
- 230000003834 intracellular effect Effects 0.000 description 2
- 230000007246 mechanism Effects 0.000 description 2
- 238000002703 mutagenesis Methods 0.000 description 2
- 231100000350 mutagenesis Toxicity 0.000 description 2
- 230000002829 reductive effect Effects 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 108700022150 Designed Ankyrin Repeat Proteins Proteins 0.000 description 1
- 101001027128 Homo sapiens Fibronectin Proteins 0.000 description 1
- 102000019298 Lipocalin Human genes 0.000 description 1
- 108050006654 Lipocalin Proteins 0.000 description 1
- 108091034117 Oligonucleotide Proteins 0.000 description 1
- 102000000395 SH3 domains Human genes 0.000 description 1
- 108050008861 SH3 domains Proteins 0.000 description 1
- 108010088160 Staphylococcal Protein A Proteins 0.000 description 1
- 241000191940 Staphylococcus Species 0.000 description 1
- 101000677856 Stenotrophomonas maltophilia (strain K279a) Actin-binding protein Smlt3054 Proteins 0.000 description 1
- 101000844753 Sulfolobus acidocaldarius (strain ATCC 33909 / DSM 639 / JCM 8929 / NBRC 15157 / NCIMB 11770) DNA-binding protein 7d Proteins 0.000 description 1
- 108091008874 T cell receptors Proteins 0.000 description 1
- 102000016266 T-Cell Antigen Receptors Human genes 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- 238000012867 alanine scanning Methods 0.000 description 1
- 229930193936 anticarin Natural products 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 238000012219 cassette mutagenesis Methods 0.000 description 1
- 238000012875 competitive assay Methods 0.000 description 1
- 235000018417 cysteine Nutrition 0.000 description 1
- XUJNEKJLAYXESH-UHFFFAOYSA-N cysteine Natural products SCC(N)C(O)=O XUJNEKJLAYXESH-UHFFFAOYSA-N 0.000 description 1
- 230000016396 cytokine production Effects 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 102000045725 human FYN Human genes 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 239000003446 ligand Substances 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 230000001404 mediated effect Effects 0.000 description 1
- 102000006240 membrane receptors Human genes 0.000 description 1
- 108020004084 membrane receptors Proteins 0.000 description 1
- 229940126619 mouse monoclonal antibody Drugs 0.000 description 1
- 230000011234 negative regulation of signal transduction Effects 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 238000002708 random mutagenesis Methods 0.000 description 1
- 238000002741 site-directed mutagenesis Methods 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000010186 staining Methods 0.000 description 1
- 239000008362 succinate buffer Substances 0.000 description 1
- 239000002023 wood Substances 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762478524P | 2017-03-29 | 2017-03-29 | |
| US62/478,524 | 2017-03-29 | ||
| PCT/US2018/024787 WO2018183459A1 (en) | 2017-03-29 | 2018-03-28 | Formulations comprising pd-1 binding proteins and methods of making thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2020512359A JP2020512359A (ja) | 2020-04-23 |
| JP2020512359A5 true JP2020512359A5 (https=) | 2021-07-26 |
Family
ID=63678296
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2019553183A Pending JP2020512359A (ja) | 2017-03-29 | 2018-03-28 | Ｐｄ−１結合タンパク質を含む製剤及びそれを作製する方法 |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US20180289802A1 (https=) |
| EP (1) | EP3601338A4 (https=) |
| JP (1) | JP2020512359A (https=) |
| KR (1) | KR20190141658A (https=) |
| CN (1) | CN110678482A (https=) |
| AU (1) | AU2018246252A1 (https=) |
| BR (1) | BR112019018996A2 (https=) |
| CA (1) | CA3055984A1 (https=) |
| CL (1) | CL2019002605A1 (https=) |
| CO (1) | CO2019010230A2 (https=) |
| EA (1) | EA201991912A1 (https=) |
| EC (1) | ECSP19076344A (https=) |
| IL (1) | IL268884A (https=) |
| MX (1) | MX2019010999A (https=) |
| SG (1) | SG11201907948TA (https=) |
| WO (1) | WO2018183459A1 (https=) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114591433A (zh) | 2015-07-13 | 2022-06-07 | 西托姆克斯治疗公司 | 抗pd-1抗体、可活化抗pd-1抗体及其使用方法 |
| EA201890790A1 (ru) | 2015-09-29 | 2018-10-31 | Селджин Корпорейшн | Связывающие pd-1 белки и способы их применения |
| EP3515943A4 (en) | 2016-09-19 | 2020-05-06 | Celgene Corporation | METHODS OF TREATING VITILIGO WITH PD-1 BINDING PROTEINS |
| BR112019004733A2 (pt) | 2016-09-19 | 2019-05-28 | Celgene Corp | métodos de tratamento de distúrbios imunes usando proteínas de ligação a pd-1 |
| TWI849895B (zh) | 2018-02-09 | 2024-07-21 | 日商小野藥品工業股份有限公司 | 雙特異性抗體 |
| TWI871300B (zh) * | 2019-01-28 | 2025-02-01 | 美商安進公司 | 藉由將藥物物質和藥物產品過程整體化的生物製劑製造之連續製造過程 |
| KR102735988B1 (ko) | 2019-02-18 | 2024-12-03 | 일라이 릴리 앤드 캄파니 | 치료 항체 제제 |
| US20230143066A1 (en) * | 2020-04-17 | 2023-05-11 | Ono Pharmaceutical Co., Ltd. | Method for removing color from drug substance of protein preparation |
| BR112022023989A2 (pt) | 2020-05-26 | 2023-02-07 | Boehringer Ingelheim Int | Anticorpos anti-pd-1 |
| CA3189452A1 (en) * | 2020-07-31 | 2022-02-03 | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | Anti-pd-1 antibody pharmaceutical composition and use thereof |
| EP4008345A1 (en) * | 2020-12-03 | 2022-06-08 | Hexal AG | Novel formulations for antibodies |
| US20240342083A1 (en) * | 2021-07-29 | 2024-10-17 | Shanghai Junshi Biosciences Co., Ltd. | Anti-pd-1 antibody pharmaceutical composition and use thereof |
| CN117088981B (zh) * | 2023-08-15 | 2024-09-10 | 福建医科大学附属协和医院 | 抗b7-h3的单链抗体 |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003011911A1 (fr) * | 2001-07-31 | 2003-02-13 | Ono Pharmaceutical Co., Ltd. | Substance specifique pour pd-1 |
| RU2494107C2 (ru) * | 2005-05-09 | 2013-09-27 | Оно Фармасьютикал Ко., Лтд. | Моноклональные антитела человека к белку программируемой смерти 1 (pd-1) и способы лечения рака с использованием анти-pd-1-антител самостоятельно или в комбинации с другими иммунотерапевтическими средствами |
| WO2008047914A1 (fr) * | 2006-10-20 | 2008-04-24 | Forerunner Pharma Research Co., Ltd. | Agent anticancéreux comprenant un anticorps anti-hb-egf en tant qu'ingrédient actif |
| HRP20131167T1 (hr) * | 2007-06-18 | 2014-01-03 | Merck Sharp & Dohme B.V. | Antitijela za humani receptor programirane smrti pd-1 |
| WO2009120922A2 (en) * | 2008-03-27 | 2009-10-01 | Zymogenetics, Inc. | Compositions and methods for inhibiting pdgfrbeta and vegf-a |
| NZ592420A (en) * | 2008-10-02 | 2012-12-21 | Emergent Product Dev Seattle | Cd86 antagonist multi-target binding proteins |
| TW201134488A (en) * | 2010-03-11 | 2011-10-16 | Ucb Pharma Sa | PD-1 antibodies |
| MX375378B (es) * | 2013-09-27 | 2025-03-06 | Genentech Inc | Formulaciones de anticuerpos anti-pdl1. |
| JP6701079B2 (ja) * | 2013-12-20 | 2020-05-27 | インターベット インターナショナル ベー． フェー． | ヒトｐｄ−１に対するイヌ化マウス抗体 |
| JP2016530244A (ja) * | 2013-12-31 | 2016-09-29 | ディベロップメント センター フォー バイオテクノロジーＤｅｖｅｌｏｐｍｅｎｔ Ｃｅｎｔｅｒ Ｆｏｒ Ｂｉｏｔｅｃｈｎｏｌｏｇｙ | 抗ｖｅｇｆ抗体及びその使用 |
| TWI681969B (zh) * | 2014-01-23 | 2020-01-11 | 美商再生元醫藥公司 | 針對ｐｄ-１的人類抗體 |
| TWI595006B (zh) * | 2014-12-09 | 2017-08-11 | 禮納特神經系統科學公司 | 抗ｐｄ－１抗體類和使用彼等之方法 |
| TN2017000440A1 (en) * | 2015-04-17 | 2019-04-12 | Bristol Myers Squibb Co | Compositions comprising a combination of an anti-pd-1 antibody and another antibody |
| EA201890790A1 (ru) * | 2015-09-29 | 2018-10-31 | Селджин Корпорейшн | Связывающие pd-1 белки и способы их применения |
| BR112019004733A2 (pt) * | 2016-09-19 | 2019-05-28 | Celgene Corp | métodos de tratamento de distúrbios imunes usando proteínas de ligação a pd-1 |
| EP3515943A4 (en) * | 2016-09-19 | 2020-05-06 | Celgene Corporation | METHODS OF TREATING VITILIGO WITH PD-1 BINDING PROTEINS |
-
2018
- 2018-03-28 EA EA201991912A patent/EA201991912A1/ru unknown
- 2018-03-28 EP EP18775686.1A patent/EP3601338A4/en not_active Withdrawn
- 2018-03-28 SG SG11201907948TA patent/SG11201907948TA/en unknown
- 2018-03-28 US US15/939,177 patent/US20180289802A1/en not_active Abandoned
- 2018-03-28 JP JP2019553183A patent/JP2020512359A/ja active Pending
- 2018-03-28 AU AU2018246252A patent/AU2018246252A1/en not_active Abandoned
- 2018-03-28 KR KR1020197028673A patent/KR20190141658A/ko not_active Ceased
- 2018-03-28 CN CN201880034207.7A patent/CN110678482A/zh active Pending
- 2018-03-28 MX MX2019010999A patent/MX2019010999A/es unknown
- 2018-03-28 WO PCT/US2018/024787 patent/WO2018183459A1/en not_active Ceased
- 2018-03-28 CA CA3055984A patent/CA3055984A1/en active Pending
- 2018-03-28 BR BR112019018996A patent/BR112019018996A2/pt not_active Application Discontinuation
-
2019
- 2019-08-23 IL IL26888419A patent/IL268884A/en unknown
- 2019-09-12 CL CL2019002605A patent/CL2019002605A1/es unknown
- 2019-09-20 CO CONC2019/0010230A patent/CO2019010230A2/es unknown
- 2019-10-23 EC ECSENADI201976344A patent/ECSP19076344A/es unknown
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