JP2016518823A5 - - Google Patents
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- JP2016518823A5 JP2016518823A5 JP2016502985A JP2016502985A JP2016518823A5 JP 2016518823 A5 JP2016518823 A5 JP 2016518823A5 JP 2016502985 A JP2016502985 A JP 2016502985A JP 2016502985 A JP2016502985 A JP 2016502985A JP 2016518823 A5 JP2016518823 A5 JP 2016518823A5
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- 108091006004 Fc-tagged proteins Proteins 0.000 claims 30
- 102000000588 Interleukin-2 Human genes 0.000 claims 24
- 108010002350 Interleukin-2 Proteins 0.000 claims 24
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- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 5
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- 206010012601 Diabetes mellitus Diseases 0.000 claims 2
- 102100015541 FCGR3A Human genes 0.000 claims 2
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- 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 claims 2
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- ZDTNHRWWURISAA-UHFFFAOYSA-N 4',5'-dibromo-3',6'-dihydroxyspiro[2-benzofuran-3,9'-xanthene]-1-one Chemical compound O1C(=O)C2=CC=CC=C2C21C1=CC=C(O)C(Br)=C1OC1=C(Br)C(O)=CC=C21 ZDTNHRWWURISAA-UHFFFAOYSA-N 0.000 claims 1
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- 241000588724 Escherichia coli Species 0.000 claims 1
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- 208000009883 Joint Disease Diseases 0.000 claims 1
- 210000001503 Joints Anatomy 0.000 claims 1
- 208000003377 Juvenile-onset scleroderma 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
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- 206010038435 Renal failure Diseases 0.000 claims 1
- 206010039710 Scleroderma Diseases 0.000 claims 1
- 208000010157 Sclerosing Cholangitis Diseases 0.000 claims 1
- 206010040490 Sexually transmitted disease Diseases 0.000 claims 1
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- 208000005482 Systemic Juvenile Rheumatoid Arthritis Diseases 0.000 claims 1
- 206010043778 Thyroiditis Diseases 0.000 claims 1
- 235000004279 alanine Nutrition 0.000 claims 1
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- 235000018102 proteins Nutrition 0.000 claims 1
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- 238000002054 transplantation Methods 0.000 claims 1
Claims (49)
- V91K置換と、配列番号1に記載のアミノ酸配列と少なくとも90%同一のアミノ酸配列とを含み、前記IL−2ムテインは、制御性T細胞を選択的に刺激する、ヒトインターロイキン−2(IL−2)ムテイン。
- 125位はアラニンである、請求項1に記載のヒトIL−2ムテイン。
- 125位はシステインである、請求項1に記載のヒトIL−2ムテイン。
- Fc及び請求項1〜3のいずれかに記載のヒトIL−2ムテインを含む、Fc融合タンパク質。
- 前記Fcは、ヒトIgG1 Fcである、請求項4に記載のFc融合タンパク質。
- 前記ヒトIgG1 Fcは、前記Fcのエフェクター機能を変化させる1つ以上の変異を含む、請求項5に記載のFc融合タンパク質。
- 前記ヒトIgG1は、N297に置換を含む、請求項6に記載のFc融合タンパク質。
- N297の前記置換はN297Gである、請求項7に記載のFc融合タンパク質。
- 前記ヒトIgG FcのC末端リジンの置換または欠失を含む、請求項5〜8のいずれかに記載のFc融合タンパク質。
- 前記ヒトIgG Fcの前記C末端リジンが欠失される、請求項9に記載のFc融合タンパク質。
- リンカーが、前記タンパク質のFcとヒトIL−2ムテイン部分とを接続する、請求項4〜10のいずれかに記載のFc融合タンパク質。
- 前記リンカーは、GGGGS(配列番号5)、GGNGT、または(配列番号6)、及びYGNGT(配列番号7)である、請求項11に記載のFc融合タンパク質。
- 前記リンカーはGGGGS(配列番号5)である、請求項12に記載のFc融合タンパク質。
- 前記IL−2ムテインは、哺乳動物細胞内で発現させた時に前記Fc融合タンパク質のグリコシル化を変化させるアミノ酸の付加、置換、または欠失をさらに含む、請求項4〜13のいずれかに記載のFc融合タンパク質。
- 前記IL−2ムテインは、T3置換を含む、請求項14に記載のFc融合タンパク質。
- 前記IL−2ムテインは、T3NまたはT3A置換を含む、請求項15に記載のFc融合タンパク質。
- 前記IL−2ムテインは、T3N置換を含む、請求項16に記載のFc融合タンパク質。
- 前記IL−2ムテインは、S5変異をさらに含む、請求項17に記載のFc融合タンパク質。
- 前記IL−2ムテインは、S5T変異をさらに含む、請求項18に記載のFc融合タンパク質。
- 前記Fc融合タンパク質は、Fc二量体を含む、請求項4から19のいずれかに記載のFc融合タンパク質。
- 前記Fc融合タンパク質は、2つのIL−2ムテインを含む、請求項20に記載のFc融合タンパク質。
- 前記Fc融合タンパク質は、単一のIL−2ムテインを含む、請求項20に記載のFc融合タンパク質。
- 請求項1〜3のいずれかに記載のヒトIL−2ムテインをコードする、単離された核酸。
- 請求項4〜22のいずれかに記載のFc融合タンパク質をコードする、単離された核酸。
- 抗体の前記Fc部分及び前記ヒトIL−2ムテインは、単一のオープンリーディングフレーム内でコードされる、請求項24に記載の単離された核酸。
- プロモーターに作動可能に連結された請求項23〜25のいずれかに記載の前記単離された核酸を含む、発現ベクター。
- 請求項23〜25のいずれかに記載の単離された核酸を含む、宿主細胞。
- 前記単離された核酸は、プロモーターに作動可能に連結される、請求項27に記載の宿主細胞。
- 前記宿主細胞は、原核細胞である、請求項27または28に記載の宿主細胞。
- 前記宿主細胞は、大腸菌である、請求項29に記載の宿主細胞。
- 前記宿主細胞は、真核細胞である、請求項27または28に記載の宿主細胞。
- 前記宿主細胞は、哺乳動物細胞である、請求項31に記載の宿主細胞。
- 前記宿主細胞は、チャイニーズハムスター卵巣(CHO)細胞株である、請求項32に記載の宿主細胞。
- ヒトIL−2ムテインを作製する方法であって、前記プロモーターが発現される条件下で請求項28〜33のいずれかに記載の宿主細胞を培養することと、前記培養物から前記ヒトIL−2ムテインを回収することと、を含む、方法。
- Fc融合タンパク質を作製する方法であって、前記プロモーターが発現される条件下で請求項28〜33のいずれかに記載の宿主細胞を培養することと、前記培養物から前記Fc融合タンパク質を回収することと、を含む、方法。
- T細胞の集団を、有効量の請求項1〜3のいずれかに記載のヒトIL−2ムテインまたは請求項4〜22のいずれかに記載のFc融合タンパク質と接触させることを含む、
T細胞の集団内の非制御性T細胞に対する制御性T細胞(Treg)の比率を増加させる、
対象の末梢血中の非制御性T細胞に対する制御性T細胞(Treg)の比率を増加させる、または
対象の末梢血中のナチュラルキラー(NK)細胞に対する制御性T細胞(Treg)の比率を増加させる、方法。 - CD3+FoxP3−に対するCD3+FoxP3+細胞の比率が増加する、請求項36に記載の方法。
- CD3+FoxP3−に対するCD3+FoxP3+細胞の比率は、少なくとも50%増加する、請求項37に記載の方法。
- 有効量の請求項1〜3のいずれかに記載のヒトIL−2ムテインまたは請求項4〜22のいずれかに記載のFc融合タンパク質を投与することを含む、対象の末梢血中のナチュラルキラー(NK)細胞に対する制御性T細胞(Treg)の比率を増加させる方法。
- CD56及び/またはCD16を発現するCD3−CD19−リンパ球に対するCD3+FoxP3+細胞の比率が増加する、請求項39に記載の方法。
- CD56及び/またはCD16を発現するCD3−CD19−リンパ球に対するCD3+FoxP3+細胞の比率は、少なくとも50%増加する、請求項40に記載の方法。
- 前記対象に治療有効量の請求項1〜3のいずれかに記載のIL−2ムテインまたは請求項4〜22のいずれかに記載のFc融合タンパク質を投与することを含む、炎症性疾患または自己免疫性疾患に罹患する患者を治療する方法。
- 請求項42に記載の炎症性疾患または自己免疫性疾患に罹患する患者を治療する方法であって、投与が、前記疾患の少なくとも1つの症状の軽減をもたらす、方法。
- 対象の末梢血中の非制御性T細胞に対する制御性T細胞(Treg)の比率は、投与後に増加する、請求項43に記載の方法。
- 対象の末梢血中の非制御性T細胞に対する制御性T細胞(Treg)の比率は、投与後も本質的に同じままである、請求項43に記載の方法。
- 前記炎症性疾患または自己免疫性疾患は、炎症、アトピー性疾患、腫瘍随伴性自己免疫疾患、軟骨炎症、関節炎、関節リウマチ、若年性関節炎、若年性関節リウマチ、少関節型若年性関節リウマチ、多関節型若年性関節リウマチ、全身型若年性関節リウマチ、若年性強直性脊椎炎、若年性腸炎性関節炎、若年性反応性関節炎、若年性ライター症候群、SEA症候群(血清陰性、腱付着部症、関節症症候群)、若年性皮膚筋炎、若年性乾癬性関節炎、若年性強皮症、若年性全身性エリテマトーデス、若年性血管炎、少関節型関節リウマチ、多関節型関節リウマチ、全身型関節リウマチ、強直性脊椎炎、腸炎性関節炎、反応性関節炎、ライター症候群、SEA症候群(血清陰性、腱付着部症、関節症症候群)、皮膚筋炎、乾癬性関節炎、強皮症、血管炎、筋炎、多発性筋炎、皮膚筋炎、結節性多発動脈炎、ウェゲナー肉芽腫症、動脈炎、リウマチ性多発筋痛症、サルコイドーシス、硬化症、原発性胆汁性硬化症、硬化性胆管炎、シェーグレン症候群、乾癬、プラーク乾癬、滴状乾癬、逆性乾癬、膿胞性乾癬、乾癬性紅皮症、皮膚炎、アトピー性皮膚炎、粥状動脈硬化、狼瘡、スティル病、全身性エリテマトーデス(SLE)、重症筋無力症、炎症性腸疾患(IBD)、クローン病、潰瘍性大腸炎、セリアック病、多発性硬化症(MS)、喘息、COPD、副鼻腔炎、ポリープを伴う副鼻腔炎、好酸球性食道炎、好酸球性気管支炎、ギラン−バレー疾患、I型糖尿病、甲状腺炎(たとえばグレーブス病)、アジソン病、レイノー現象、自己免疫性肝炎、移植片対宿主病(GVHD)、移植拒絶反応、腎障害、C型肝炎誘発性血管炎および自然流産からなる群から選択される、請求項42〜45のいずれかに記載の方法。
- 疾患が、ループス、移植片対宿主病(GVHD)、C型肝炎誘発性血管炎、全身性エリテマトーデス(SLE)、関節リウマチ、乾癬、クローン病、潰瘍性大腸炎、セリアック病、多発性硬化症(MS)、I型糖尿病、自然流産、アトピー性疾患または炎症性腸疾患である、請求項46に記載の方法。
- 請求項1に記載のヒトインターロイキン−2(IL−2)ムテインまたは請求項4に記載のFc融合タンパク質を用いた治療に対する対象の反応を監視する方法であって、前記対象における変化を検出することを含み、前記変化は、
a)体温の上昇、
b)前記対象の末梢血中のCRPの上昇、
c)前記対象の末梢血中の血小板の減少、
d)前記対象の末梢血中の好中球の減少、または
e)前記対象の末梢血中のアルブミンの減少であり、
前記変化が検出された後、前記治療は、中止されるか、一時中断されるか、投与頻度が減少されるか、または投薬量が減少される、方法。 - 前記変化は、
a)少なくとも0.5℃の体温の上昇、
b)少なくとも0.2mg/mLの前記対象の末梢血中のCRPの上昇、
c)少なくとも0.8倍の前記対象の末梢血中の血小板の減少、
d)少なくとも0.8倍の前記対象の末梢血中の好中球の減少、または
e)少なくとも0.4倍の前記対象の末梢血中のアルブミンの減少を含む、請求項48に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US201361784669P | 2013-03-14 | 2013-03-14 | |
US61/784,669 | 2013-03-14 | ||
PCT/US2014/029111 WO2014153111A2 (en) | 2013-03-14 | 2014-03-14 | Interleukin-2 muteins for the expansion of t-regulatory cells |
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JP2018228769A Division JP2019058182A (ja) | 2013-03-14 | 2018-12-06 | 制御性t細胞の増殖のためのインターロイキン−2ムテイン |
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JP2016518823A JP2016518823A (ja) | 2016-06-30 |
JP2016518823A5 true JP2016518823A5 (ja) | 2017-04-20 |
JP6450365B2 JP6450365B2 (ja) | 2019-01-09 |
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JP2016502985A Active JP6450365B2 (ja) | 2013-03-14 | 2014-03-14 | 制御性t細胞の増殖のためのインターロイキン−2ムテイン |
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