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Description
詳細には、本発明は、ＰＤ‐１のエピトープ及びＬＡＧ‐３のエピトープに対して免疫特異的に結合できる二重特異性Ｆｃダイアボディに関し、上記ダイアボディは、アミノ末端及びカルボキシ末端をそれぞれ有する４つのポリペプチド鎖（第１乃至第４のポリペプチド鎖）を含み：
（Ａ）上記第１及び第２のポリペプチド鎖は互いに共有結合し、上記第１及び第３のポリペプチド鎖は互いに共有結合し、また上記第３及び第４のポリペプチド鎖は互いに共有結合し；
（Ｂ）上記ダイアボディの上記第１及び第３のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端への方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、ＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメイン、ヘテロ二量体促進ドメイン及びＣＨ２‐ＣＨ３ドメインを含み、上記軽鎖可変ドメイン及び重鎖可変ドメインは、ＰＤ‐１のエピトープ又はＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
（Ｃ）上記ダイアボディの上記第２及び第４のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端の方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、ＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメイン、及びヘテロ二量体促進ドメインを含み、上記軽鎖可変ドメイン及び重鎖可変ドメインは、ＰＤ‐１のエピトープ又はＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
（Ｉ）（１）上記第１のポリペプチド鎖の軽鎖可変ドメイン及び上記第２のポリペプチド鎖の重鎖可変ドメインは、連結して第１のエピトープ結合部位を形成し、上記第１のポリペプチド鎖の重鎖可変ドメイン及び上記第２のポリペプチド鎖の軽鎖可変ドメインは、連結して第２のエピトープ結合部位を形成し；
（２）上記第３のポリペプチド鎖の軽鎖可変ドメイン及び上記第４のポリペプチド鎖の重鎖可変ドメインは、連結して第３のエピトープ結合部位を形成し、上記第３のポリペプチド鎖の重鎖可変ドメイン及び上記第４のポリペプチド鎖の軽鎖可変ドメインは、連結して第４のエピトープ結合部位を形成し；
形成された上記エピトープ結合部位のうちの２つは、ＰＤ‐１のエピトープに免疫特異的に結合でき、形成された上記エピトープ結合部位のうちの２つは、ＬＡＧ‐３のエピトープに免疫特異的に結合でき；
（ＩＩ）上記第１のポリペプチド鎖の上記ヘテロ二量体促進ドメインは上記第２のポリペプチド鎖の上記ヘテロ二量体促進ドメインと異なっており、配列番号１６及び配列番号１７からなる群から選択されるアミノ酸配列を有し；
（ＩＩＩ）上記第１及び第３のポリペプチド鎖の上記ＣＨ２‐ＣＨ３ドメインは、連結してＦｃドメインを形成する。
（Ａ）上記第１及び第２のポリペプチド鎖は互いに共有結合し、上記第１及び第３のポリペプチド鎖は互いに共有結合し、また上記第３及び第４のポリペプチド鎖は互いに共有結合し；
（Ｂ）上記ダイアボディの上記第１及び第３のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端への方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、ＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメイン、ヘテロ二量体促進ドメイン及びＣＨ２‐ＣＨ３ドメインを含み、上記軽鎖可変ドメイン及び重鎖可変ドメインは、ＰＤ‐１のエピトープ又はＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
（Ｃ）上記ダイアボディの上記第２及び第４のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端の方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、ＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメイン、及びヘテロ二量体促進ドメインを含み、上記軽鎖可変ドメイン及び重鎖可変ドメインは、ＰＤ‐１のエピトープ又はＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
（Ｉ）（１）上記第１のポリペプチド鎖の軽鎖可変ドメイン及び上記第２のポリペプチド鎖の重鎖可変ドメインは、連結して第１のエピトープ結合部位を形成し、上記第１のポリペプチド鎖の重鎖可変ドメイン及び上記第２のポリペプチド鎖の軽鎖可変ドメインは、連結して第２のエピトープ結合部位を形成し；
（２）上記第３のポリペプチド鎖の軽鎖可変ドメイン及び上記第４のポリペプチド鎖の重鎖可変ドメインは、連結して第３のエピトープ結合部位を形成し、上記第３のポリペプチド鎖の重鎖可変ドメイン及び上記第４のポリペプチド鎖の軽鎖可変ドメインは、連結して第４のエピトープ結合部位を形成し；
形成された上記エピトープ結合部位のうちの２つは、ＰＤ‐１のエピトープに免疫特異的に結合でき、形成された上記エピトープ結合部位のうちの２つは、ＬＡＧ‐３のエピトープに免疫特異的に結合でき；
（ＩＩ）上記第１のポリペプチド鎖の上記ヘテロ二量体促進ドメインは上記第２のポリペプチド鎖の上記ヘテロ二量体促進ドメインと異なっており、配列番号１６及び配列番号１７からなる群から選択されるアミノ酸配列を有し；
（ＩＩＩ）上記第１及び第３のポリペプチド鎖の上記ＣＨ２‐ＣＨ３ドメインは、連結してＦｃドメインを形成する。
Claims (17)
- ＰＤ‐１のエピトープ及びＬＡＧ‐３のエピトープに対して免疫特異的に結合できる二重特異性Ｆｃダイアボディであって、
前記ダイアボディは、アミノ末端及びカルボキシ末端をそれぞれ有する４つの第１乃至第４のポリペプチド鎖を含み：
（Ａ）前記第１のポリペプチド鎖及び前記第２のポリペプチド鎖は互いに共有結合し、前記第１のポリペプチド鎖及び前記第３のポリペプチド鎖は互いに共有結合し、また前記第３のポリペプチド鎖及び前記第４のポリペプチド鎖は互いに共有結合し；
（Ｂ）前記ダイアボディの前記第１のポリペプチド鎖及び前記第３のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端への方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、ＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメイン、及びＣＨ２‐ＣＨ３ドメインを含み、前記軽鎖可変ドメイン及び前記重鎖可変ドメインは、前記ＰＤ‐１のエピトープ又は前記ＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
（Ｃ）前記ダイアボディの前記第２のポリペプチド鎖及び前記第４のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端の方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、及びＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメインを含み、前記軽鎖可変ドメイン及び前記重鎖可変ドメインは、前記ＰＤ‐１のエピトープ又は前記ＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
（Ｉ）（１）前記第１のポリペプチド鎖の前記軽鎖可変ドメイン及び前記第２のポリペプチド鎖の前記重鎖可変ドメインは、連結して第１のエピトープ結合部位を形成し、前記第１のポリペプチド鎖の前記重鎖可変ドメイン及び前記第２のポリペプチド鎖の前記軽鎖可変ドメインは、連結して第２のエピトープ結合部位を形成し；
（２）前記第３のポリペプチド鎖の前記軽鎖可変ドメイン及び前記第４のポリペプチド鎖の前記重鎖可変ドメインは、連結して第３のエピトープ結合部位を形成し、前記第３のポリペプチド鎖の前記重鎖可変ドメイン及び前記第４のポリペプチド鎖の前記軽鎖可変ドメインは、連結して第４のエピトープ結合部位を形成し；
形成された前記エピトープ結合部位のうちの２つは、前記ＰＤ‐１のエピトープに免疫特異的に結合でき、形成された前記エピトープ結合部位のうちの２つは、前記ＬＡＧ‐３のエピトープに免疫特異的に結合でき；
（ＩＩ）前記第１のポリペプチド鎖及び前記第３のポリペプチド鎖の前記ＣＨ２‐ＣＨ３ドメインは、連結してＦｃドメインを形成する、二重特異性Ｆｃダイアボディ。 - （Ａ）前記ダイアボディの前記第１のポリペプチド鎖及び前記第３のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端への方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、ＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメイン、ヘテロ二量体促進ドメイン及びＣＨ２‐ＣＨ３ドメインを含み、前記軽鎖可変ドメイン及び前記重鎖可変ドメインは、前記ＰＤ‐１のエピトープ又は前記ＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
（Ｂ）前記ダイアボディの前記第２のポリペプチド鎖及び前記第４のポリペプチド鎖はそれぞれ、Ｎ末端からＣ末端の方向に、ＰＤ‐１又はＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、ＬＡＧ‐３又はＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメイン、及びヘテロ二量体促進ドメインを含み、前記軽鎖可変ドメイン及び前記重鎖可変ドメインは、前記ＰＤ‐１のエピトープ又は前記ＬＡＧ‐３のエピトープに結合できるエピトープ結合部位を形成するために連結できず；
前記第１及び第３のポリペプチド鎖の前記ヘテロ二量体促進ドメインは前記第２及び第４のポリペプチド鎖の前記ヘテロ二量体促進ドメインと異なる、請求項１に記載の二重特異性Ｆｃダイアボディ。 - （１）前記第１及び第３のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１４のアミノ酸配列を含み、前記第２及び第４のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１５のアミノ酸配列を含むか；
（２）前記第１及び第３のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１５のアミノ酸配列を含み、前記第２及び第４のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１４のアミノ酸配列を含むか；
（３）前記第１及び第３のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１６のアミノ酸配列を含み、前記第２及び第４のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１７のアミノ酸配列を含むか；又は
（４）前記第１及び第３のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１７のアミノ酸配列を含み、前記第２及び第４のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１６のアミノ酸配列を含む、請求項２に記載の二重特異性Ｆｃダイアボディ。 - 前記第１のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１４を含み、前記第２のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１５を含む、請求項２又は３に記載の二重特異性Ｆｃダイアボディ。
- 前記第１のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１６を含み、前記第２のポリペプチド鎖の前記ヘテロ二量体促進ドメインは配列番号１７を含む、請求項２又は３に記載の二重特異性Ｆｃダイアボディ。
- 前記第１のポリペプチド鎖及び前記第３のポリペプチド鎖の前記ＣＨ２‐ＣＨ３ドメインはそれぞれ、配列番号２４のアミノ酸配列を含む、請求項１〜５のいずれか１項に記載の二重特異性Ｆｃダイアボディ。
- ＬＡＧ‐３に対して免疫特異的である抗体の前記重鎖可変ドメインは、配列番号１１のアミノ酸配列を含み、
ＬＡＧ‐３に対して免疫特異的である抗体の前記軽鎖可変ドメインは、配列番号１２のアミノ酸配列を含む、請求項１〜６のいずれか１項に記載の二重特異性Ｆｃダイアボディ。 - ＰＤ‐１に対して免疫特異的である抗体の前記重鎖可変ドメインは、配列番号２のアミノ酸配列を含み、
ＰＤ‐１に対して免疫特異的である抗体の前記軽鎖可変ドメインは、配列番号３のアミノ酸配列を含む、請求項１〜７のいずれか１項に記載の二重特異性Ｆｃダイアボディ。 - （Ａ）前記第１のポリペプチド鎖及び前記第３のポリペプチド鎖はそれぞれ、ＰＤ‐１に対して免疫特異的である抗体の軽鎖可変ドメイン、及びＬＡＧ‐３に対して免疫特異的である抗体の重鎖可変ドメインを含み；
（Ｂ）前記第２のポリペプチド鎖及び前記第４のポリペプチド鎖はそれぞれ、ＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、及びＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメインを含む、請求項１〜８のいずれか１項に記載の二重特異性Ｆｃダイアボディ。 - （Ａ）前記第１のポリペプチド鎖及び前記第３のポリペプチド鎖はそれぞれ、ＬＡＧ‐３に対して免疫特異的である抗体の軽鎖可変ドメイン、及びＰＤ‐１に対して免疫特異的である抗体の重鎖可変ドメインを含み；
（Ｂ）前記第２のポリペプチド鎖及び前記第４のポリペプチド鎖はそれぞれ、ＰＤ‐１に対して免疫特異的である抗体の軽鎖可変ドメイン、及びＬＡＧ‐３に対して免疫特異的である抗体の重鎖可変ドメインを含む、請求項１〜８のいずれか１項に記載の二重特異性Ｆｃダイアボディ。 - 有効量の請求項１〜１０のいずれか１項に記載のＦｃダイアボディと、薬学的に許容可能なキャリアとを含む、医薬組成物。
- 前記二重特異性Ｆｃダイアボディの前記有効量は、治療を必要とするレシピエント個体の癌を治療するために有効な量である、請求項１１に記載の医薬組成物。
- 前記癌は：副腎癌；ＡＩＤＳ関連癌；胞巣状軟部肉腫；星細胞腫瘍；膀胱癌；骨癌；脳及び脊髄癌；転移性脳腫瘍；乳癌；頸動脈球腫瘍；子宮頸癌；軟骨肉腫；脊索腫；発色性腎細胞癌；明細胞癌；大腸癌；結腸直腸癌；皮膚良性線維性組織球腫；線維形成性小円形細胞腫瘍；上衣腫；ユーイング腫瘍；骨外性粘液型軟骨肉腫；骨性線維形成不全症；線維性骨異形成症；胆嚢若しくは胆管癌；消化器癌；妊娠性絨毛性疾患；胚細胞腫瘍；頭頸部癌；肝細胞癌；膵島細胞腫；カポジ肉腫；腎臓癌、白血病、脂肪腫／良性リポソーム腫瘍、脂肪肉腫／悪性リポソーム腫瘍、肝臓癌；リンパ腫；肺癌；髄芽腫；黒色腫；髄膜腫；多発性内分泌腫瘍；多発性骨髄腫；骨髄異形成症候群；神経芽細胞腫；神経内分泌腫瘍；卵巣癌；膵臓癌；乳頭状甲状腺癌；副甲状腺腫瘍；小児癌；末梢神経鞘腫瘍；褐色細胞腫；下垂体腫瘍；前立腺癌；後部ブドウ膜黒色腫；希少な血液学的障害；腎転移性癌；ラブドイド腫瘍；横紋筋肉腫；肉腫；皮膚癌；軟組織肉腫；扁平上皮細胞癌；胃癌；滑膜肉腫；精巣癌；胸腺癌；胸腺腫；甲状腺転移性癌；又は子宮癌である、請求項１２に記載の医薬組成物。
- 前記二重特異性Ｆｃダイアボディの前記有効量は、治療を必要とするレシピエント個体の、病原体の存在に関連する疾患を治療するために有効な量である、請求項１１に記載の医薬組成物。
- 前記病原体は、細菌、真菌又はウイルスである、請求項１４に記載の医薬組成物。
- 癌の治療のための薬剤の製造における、請求項１〜１０のいずれか１項に記載の二重特異性Ｆｃダイアボディ、又は請求項１２又は１３に記載の医薬組成物の使用。
- 病原体の存在に関連する疾患の治療のための薬剤の製造における、請求項１〜１０のいずれか１項に記載の二重特異性Ｆｃダイアボディ、又は請求項１４又は１５に記載の医薬組成物の使用。
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