JP6759326B2 - 細胞結合分子の共役のための架橋連結体 - Google Patents
細胞結合分子の共役のための架橋連結体 Download PDFInfo
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- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
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- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
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- A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
- A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
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- A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
- A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
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- A—HUMAN NECESSITIES
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- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
- A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
- C07D207/44—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having three double bonds between ring members or between ring members and non-ring members
- C07D207/444—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having three double bonds between ring members or between ring members and non-ring members having two doubly-bound oxygen atoms directly attached in positions 2 and 5
- C07D207/448—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having three double bonds between ring members or between ring members and non-ring members having two doubly-bound oxygen atoms directly attached in positions 2 and 5 with only hydrogen atoms or radicals containing only hydrogen and carbon atoms directly attached to other ring carbon atoms, e.g. maleimide
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- C07D213/02—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
- C07D213/04—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
- C07D213/60—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D213/62—Oxygen or sulfur atoms
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Description
「アルキル」とは、直鎖状又は分岐でもよい、鎖中に1〜8の炭素原子を有する脂肪族炭化水素基を意味する。「分岐」とは、直鎖状のアルキル基に1つ又は複数の低級アルキル、例えば、メチル、エチル、又はプロピル基が結合していることを指す。アルキル基の具体例としては、メチル、エチル、n−プロピル、イソプロピル、n−ブチル、t−ブチル、n−ペンチル、3−ペンチル、オクチル、ノニル、デシル、シクロペンチル、シクロヘキシル、2,2−ジメチルブチル、2,3−ジメチルブチル、2,2−ジメチルペンチル、2,3−ジメチルペンチル、3,3−ジメチルペンチル、2,3,4−トリメチルペンチル、3−メチルヘキシル、2,2−ジメチルヘキシル、2,4−ジメチルヘキシル、2,5−ジメチルヘキシル、3,5−ジメチルヘキシル、2,4−ジメチルペンチル、2−メチルヘプチル、3−メチルヘプチル、n−ヘプチル、イソヘプチル、n−オクチル、及びイソオクチルが含まれる。C1〜C8アルキル基は未置換でもよく、1つ又は複数の置換基(但し、次の置換基に制限されない)で置換されてもよい。前記置換基としては、C1〜C8アルキル、−O−(C1〜C8のアルキル)、アリール、−C(O)R’、−OC(O)R’、−C(O)OR’、−C(O)NH2、−C(O)NHR’、−C(O)N(R’)2、−NHC(O)R’、−SR’、−S(O)2R’、−S(O)R’、−OH、−ハロゲン、−N3、−NH2、−NH(R’)、−N(R’)2、及び−CNが挙げられ、尚、R’はそれぞれ独立にC1〜C8アルキル及びアリールから選択される。
本発明の細胞結合分子に対する薬剤の共役体の調製と同様に、架橋連結体を得る合成経路を図1〜11に示す。架橋連結体は、3つの要素を有する:a)同一の又は独立した2つの置換基、細胞結合剤上の一対のチオールと反応することが可能であり、これらに限定されないが、N−ヒドロキシスクシンイミドエステル、マレイミド、ジスルフィド、ハロアセチル、エテンスルホニル、ハロゲン化アシル(酸ハライド)、アクリル(アクリロイル)、及び/又は酸無水物等である;b)中間の架橋が、官能基と連結するヒドラジンである;c)同一の又は独立した2つの置換基、薬剤と反応することが可能であり、これらに限定されないが、ジスルフィド、マレイミド、ハロアセチル、アルデヒド、ケトン、アジド、アミン、アルコキシアミン、及びヒドラジド等である。ヒドラジンを含む架橋連結体は、細胞結合剤及び薬剤との反応が可能な官能基の導入に続いて、酸、酸ハロゲン化物、又は酸無水物とヒドラジンとを直接縮合することにより導入することができる。これらの架橋連結体の合成は、図1〜11及び実施例の項に例示されている。
本発明の共役体及び修飾された細胞結合分子を構成する細胞結合分子は、治療的に又は他の生物学的に修飾されようとする細胞群の残基と結合、複合化、又は反応する、現在知られている、あるいは判明する如何なる分子でもよい。
(別名:Stelara、抗IL−12、IL−23抗体)、バパリキシマブ(Vapaliximab)(抗AOC3(VAP−1)抗体)、ベドリズマブ(Vedolizumab)、(抗インテグリンα4β7抗体)、ベルツズマブ(抗CD20抗体)、ベパリモマブ(Vepalimomab)(抗AOC3(VAP−1))抗体)、ビシリズマブ(別名:Nuvion、抗CD3抗体)、ビタキシン(抗血管新生インテグリンavb3抗体)、ボロシキシマブ(Volociximab)(抗インテグリンα5β1)、ボツムマブ(Votumumab)(別名:HumaSPECT、抗腫瘍抗原CTAA16.88抗体)、ザルツムマブ(別名:HuMax-EGFr、(抗EGFR抗体)、ザノリムマブ(別名:HuMax-CD4、抗CD4抗体)、ジラリムマブ(Ziralimumab)(抗CD147(基本免疫グロブリン)抗体)、ゾリモマブ(zolimomab)(抗CD5抗体)、エタネルセプト(登録商標「Enbrel」)、アレファセプト(Alefacept)(登録商標「Amevive」)、アバタセプト(登録商標「Orencia」)、リロナセプト(Rilonacept)(Arcalyst)、14F7[抗IRP−2(鉄調節タンパク質2)抗体]、14G2a(Nat.Cancer Inst.から黒色腫及び固形腫瘍のための抗ガングリオシドGD2抗体)、J591(Weill Cornell Medical Schoolから前立腺癌を治療するための抗PSMA抗体、)、225.28S[黒色腫のための抗HMW−MAA(高分子量黒色腫関連抗原)抗体、Sorin Radiofarmaci S.R.L.(ミラノ、イタリア)]、COL−1(Nat. Cancer Inst.から大腸癌及び胃癌のための抗CEACAM3抗体、CGM1)、CYT−356(登録商標「Oncoltad」、前立腺癌)、HNK20(Ora Vax Inc.からRSウイルスのための)、ImmuRAIT(IMMUNOMEDICSから非ホジキンリンパ腫のための)、Lym−1(抗HLA−DR10抗体、Peregrine Pharmから腫瘍のため)、MAK−195F[Abbott/Knollから敗血症、毒素ショックのための抗TNF(腫瘍壊死因子;TNFA、TNF−α;TNFSF2)抗体]、MEDI−500[別名:T10B9、MedImmune Incから移植片対宿主病のための抗CD3抗体、TRαβ(T細胞受容体α/β)、]、RING SCAN[Neoprobe Corp.から乳癌、結腸癌及び結腸直腸癌のための抗TAG72(腫瘍関連糖タンパク質72)抗体)]、Avicidin(抗EPCAM(上皮細胞接着分子)抗体)、抗TACSTD1(腫瘍関連カルシウムシグナルトランスデューサー1)抗体、抗GA733−2(胃腸腫瘍関連タンパク質2)抗体、抗EGP−2(上皮糖タンパク質2)抗体;抗KSA抗体;KS1/4抗原;M4S;腫瘍抗原17−1A;NeoRx Corp.から結腸癌、卵巣癌、前立腺癌、及び非ホジキンリンパ腫のためのCD326;LYMPHOCIDE(IMMUNOMEDICS、NJ)、スマートID10(Protein Design Labs)、Oncolym(Techniclone Inc、CA)、Allomune(BioTransplant、CA)、抗VEGF抗体(ジェネンテック、CA);CEAcide(Immunomedics、NJ)、IMC−1C11(ImClone Systems、NJ)、並びにセツキシマブ(ImClone、NJ)が含まれるが、これらに限られない。
本発明において細胞結合分子と連結することができる薬物は、細胞毒性剤を含む小分子薬物であり、直接又は修飾後に細胞結合分子に連結することができる。ここで、「小分子薬物」は、分子量が例えば100〜1800、より好ましくは120〜1400の有機、無機又は有機金属化合物が広く用いられる。小分子薬物のより良い定義について、WO05058367A2及び米国特許第4,956,303号、並びに他の文献を参考することができ、これらはその全体が参照として組み込まれる。上記薬物には、既知の薬物及び薬物になる可能性のあるものが含まれる。
細胞毒性アッセイのため細胞株として、ヒト白血病細胞株HL−60、ヒト胃癌細胞株NCI−N78、及びヒト卵巣癌細胞株SKOV3を使用した。HL−60及びN87細胞のために、これらの細胞を10%FBS含有RPMI−1640で培養した。SKOV3細胞については、10%FBS含有マッコイの5A培地で培養した。アッセイを実行するために、細胞(180μl、6000細胞)を96ウェルプレートのウェルにそれぞれ加え、37℃、5%CO2で24時間インキュベートした。次いで、適切な細胞培養培地(総量、0.2mL)中で、細胞を種々の濃度の試験用化合物(20μl)で処理した。コントロールウェルは、細胞と培地を含むが、試験化合物を欠いている。プレートを37℃、5%CO2で120時間インキュベートした。MTT(5mg/ml)をウェル(20μl)に添加し、プレートを37℃で1.5時間インキュベートした。その後、培地を注意深く除去し、DMSO(180μl)を加えた。15分間振とうした後、620nmの基準フィルタを用いて490nmと570nmで吸光度を測定した。阻害率%は次の式に従って計算された:阻害率抑%=[1−(分析値−ブランク)/(コントロール−ブランク)]×100
Claims (26)
- 式(II)の細胞結合剤−薬剤共役化合物:
Cbは、細胞結合剤を表す;
「Drug1」及び「Drug2」は、同一の又は異なる、それぞれアルキレン、アルケニレン、アルキニレン、エーテル、ポリオキシアルキレン、エステル、アミン、イミン、ポリアミン、ヒドラジン、ヒドラゾン、アミド、尿素、セミカルバジド、カルバジド、アルコキシアミン、ウレタン、アミノ酸、ペプチド、アシルオキシルアミン、ヒドロキサム酸、ジスルフィド、チオエーテル、チオエステル、カルバメート、カーボネート、複素環、ヘテロアルキル、ヘテロ芳香環、若しくはアルコキシム結合、又はその組み合わせによって、架橋連結体を介して前記細胞結合剤と連結した、細胞毒性剤又は薬物を表し;
nは1〜20であり;
R1、R2、R3、及びR4は、同じか又は異なり、且つ、不存在、炭素数1〜8の直鎖状アルキル、炭素数3〜8の分岐若しくはシクロアルキル、炭素数2〜8の直鎖、分岐若しくはシクロアルケニル若しくはアルキニル、炭素数2〜8のエステル、エーテル若しくはアミド、若しくは構造式(OCH2CH2)pである(p;1〜12の整数)ポリエチレンオキシ単位、又はこれらの組み合わせである。 - Drug1及びDrug2が、同一であるか又は異なる、以下からなる群から独立に選択されている、請求項1に記載の式(II)の細胞結合剤−薬剤共役化合物:
1)化学療法剤:a)アルキル化剤:ナイトロジェンマスタード:クロラムブシル、クロルナファジン、シクロホスファミド、ダカルバジン、エストラムスチン、イホスファミド、メクロレタミン、塩酸メクロレタミンオキサイド、マンノムスチン、ミトブロニトール、メルファラン、ピポブロマン、ノベンビチン、フェネステリン、プレドニムスチン、チオテパ、トロホスファミド、ウラシルマスタード;アドゼレシン、カルゼレシン及びビゼレシンの合成類似体を含むCC−1065;合成類似体、KW−2189及びCBI−TMIを含むデュオカルマイシン;ピロロベンゾジアゼピン又はトマイマイシン、インドリノベンゾジアゼピン類、イミダゾベンゾチアヂアゼピン類、又はオキサゾリジノベンゾジアゼピン類の二量体を含むベンゾジアゼピン二量体;カルムスチン、ロムスチン、クロロゾトシン、フォテムスチン、ニムスチン、及びラニムスチンを含むニトロソ尿素化合物;ブスルファン、トレオスルファン、イムプロスルファン及びピポスルファンを含むアルキルスルホネート;トリアゼン;カルボプラチン・シスプラチン・オキサリプラチンを含む白金含有化合物;ベンゾドパ・カルボクオン・メツレドパ・ウレドパを含むアジリジン類;エチレンイミン類、並びにアルトレタミン、トリエチレンメラミン、トリエチレンホスホルアミド及びトリエチレンチオホスホルアミンを含むメチラメラミン類;b)植物アルカロイド:ビンクリスチン・ビンブラスチン・ビンデシン・ビノレルビン・ナベルビンを含むビンカアルカロイド類; パクリタキセル及びドセタキセル並びにこれらの類似体を含むタキソイド類、DM1・DM2・DM3・DM4・メイタンシン・アンサマイトシン及びこれらの類似体を含むメイタンシノイド類、クリプトフィシン1及びクリプトフィシン8を含むクリプトフィシン類;エポチロン類、エリュテロビン類、ディスコデルモライド、ブリオスタチン類、ドロスタチン類、オーリスタチン類、チューブリシン類、セファロスタチン類;パンクラチスタチン;サルコジクチイン;スポンジスタチン;c)DNAトポイソメラーゼ阻害剤:9−アミノカンプトテシン、カンプトテシン、クリスナトール、ダウノマイシン、エトポシド、リン酸エトポシド、イリノテカン、ミトキサントロン、ノバントロン、及びレチノイン酸を含むエピポドフィリン類、テニポシド、トポテカン、9−ニトロカンプトテシン;マイトマイシン類;d)代謝拮抗剤:抗葉酸:メトトレキサート、トリメトレキサート、デノプテリン、プテロプテリン、アミノプテリン、又はその他の葉酸類似体を含むジヒドロ葉酸レダクターゼ阻害剤;ミコフェノール酸、チアゾフリン、リバビリン、及びEICARを含むIMPデヒドロゲナーゼ阻害剤;ヒドロキシウレア及びデフェロキサミンを含むリボヌクレオチド還元酵素阻害薬;ピリミジン類似体:アンシタビン、アザシチジン、6−アザウリジン、カペシタビン、カルモフール、シタラビン、ジデオキシウリジン、ドキシフルリジン、エノシタビン、5−フルオロウラシル、フロクスウリジン、及びラルチトレキセドを含むウラシル類似体;シタラビン、シトシンアラビノシド、及びフルダラビンを含むシトシン類似体;アザチオプリン、フルダラビン、メルカプトプリン、チアミプリン、及びチオグアニンを含むプリン類似体;フォリン酸;e)ホルモン療法剤:受容体拮抗薬:メゲストロール、ラロキシフェン、及びタモキシフェンを含む抗エストロゲン;ゴセレリン及び酢酸リュープロリドを含むLHRHアゴニスト;ビカルタミド、フルタミド、カルステロン、プロピオン酸ドロモスタノロン、エピチオスタノール、ゴセレリン、リュープロリド、メピチオスタン、ニルタミド、テストラクトン、トリロスタン、及び他のアンドロゲン阻害剤を含む抗アンドロゲン;レチノイド類/三角筋:CB1093、EB1089、KH1060、コレカルシフェロール、及びエルゴカルシフェロールを含むビタミンD3類似体;ベルテポルフィン、フタロシアニン、光増感剤Pc4、及びデメトキシ−ヒポクレリンAを含む光線力学的療法剤;インターフェロンα、インターフェロンγ、腫瘍壊死因子、及びTNFドメイン含有ヒトタンパク質を含むサイトカイン類;f)キナーゼ阻害剤:BIBW2992、イマチニブ、ゲフィチニブ、ペガプタニブ、ソラフェニブ、ダサチニブ、スニチニブ、エルロチニブ、ニロチニブ、ラパチニブ、アキシチニブ、パゾパニブ、バンデタニブ、E7080、ムブリチニブ、ポナチニブ、バフェチニブ、ボスチニブ、カボザンチニブ、ビスモデギブ、イニパリブ、ルキソリチニブ、CYT387、アキシチニブ、チボザニブ、ソラフェニブ、ベバシズマブ、セツキシマブ、トラスツズマブ、ラニビズマブ、パニツムマブ、イスピネシブ;g)抗生物質:カリケアマイシンγ1、δ1、α1及びβ1を含むエンジイン系抗生物質;ダイネミシンA及びデオキシダイネミシンを含むダイネミシン;エスペラミシン、ケダルシジン、C−1027、マズロペプチン、並びにネオカルジノスタチンクロモフォア及び関連する色素タンパク質エンジイン抗生物質クロモフォア、アクラシノマイシン類、アクチノマイシン、アンスラマイシン、アザセリン、ブレオマイシン類、カクチノマイシン(cactinomycin)、カラビシン(carabicin)、カルミノマイシン、カルジノフィリン;クロモマイシン類、ダクチノマイシン、ダウノルビシン、デトルビシン、6−ジアゾ−5−オキソ−L−ノルロイシン、ドキソルビシン、モルホリノ−ドキソルビシン、シアノモルホリノ−ドキソルビシン、2−ピロリノ−ドキソルビシン及びデオキシドキソルビシン、エピルビシン、イダルビシン、マルセロマイシン、マイトマイシン類、ミコフェノール酸、ノガラマイシン、オリボマイシン類、ペプロマイシン、ポトフィロマイシン、ピューロマイシン、クエラマイシン、ロドルビシン、ストレプトニグリン、ストレプトゾシン、ツベルシジン、ウベニメクス、ジノスタチン、ゾルビシン;f)その他のカテゴリー:ブラタシン及びブラタシノンを含むポリケチド;ゲムシタビン、エポキソミシン類、ボルテゾミブ、サリドマイド、レナリドミド、ポマリドマイド、トセドスタット、ザイブレスタット、PLX4032、STA−9090、スチムバックス、アロベクチン−7、ザイゲバ、プロベンジ、エルボイ、イソプレニル化阻害剤、ドーパミン作動性神経毒、細胞周期阻害剤、アクチノマイシン類(アクチノマイシンD及びダクチノマイシンを含むアクチノマイシン類、ブレオマイシンA2・ブレオマイシンB2・ペプロマイシンを含むブレオマイシン類、ダウノルビシン・ドキソルビシン・イダルビシン・エピルビシン・ピラルビシン・ゾルビシンを含むアントラサイクリン類、ミトキサントロン、MDR阻害剤、Ca2+ATP阻害剤、ボリノスタット・ロミデプシン・パノビノスタット・バルプロ酸・モセチノスタット・ベリノスタット・PCI−24781・エンチノスタット・SB939・レスミノスタット・ギビノスタット・AR−42・CUDC−101・スルフォラファン・トリコスタチンAを含むヒストン脱アセチル化酵素阻害剤;タプシガルギン、セレコキシブ、グリタゾン類、エピガロカテキンガレート、ジスルフィラム、サリノスポラミドA、抗副腎薬、アミノグルテチミド、ミトタン、トリロスタン;アセグラトン;アルドホスファミドクリコシド;アミノレブリン酸;アラビノシド、ベストラブシル;ビサントレン;エダトレキサート;デフォファミン、デメコルシン、ジアジコン、エルフォルニチン、酢酸エリプチニウム、エトクルシド、硝酸ガリウム、ガシトシン、ヒドロキシ尿素;イバンドロネート、レンチナン;ロニダミン;ミトグアゾン;モピダモール;ニトラエリン;ペントスタチン;フェナメット;ピラルビシン;ポドフィリン酸;2−エチルヒドラジド;プロカルバジン;PSK(登録商標);ラゾキサン;リゾキシン;シゾフィラン;スピロゲルマニウム;テニュアゾン酸;トリアジコン;2,2’,2’’−トリクロロトリエチルアミン;T2トキシン・ベルカリンA・ロリジンA・アングイジンを含むトリコテセン類;ウレタン、siRNA、アンチセンス医薬、並びに核酸分解酵素;
2)抗自己免疫疾患薬:シクロスポリン、シクロスポリンA、アザチオプリン、アミノカプロン酸、ブロモクリプチン、クロラムブシル、クロロキン、シクロホスファミド、ホルモン剤・ベタメタゾン・ブデソニド・フルニソリド・フルチカゾンプロピオン酸エステル・ヒドロコルチゾン・デキサメタゾン・フルオコルトダナゾール・トリアムシノロンアセトニド・ジプロピオン酸ベクロメタゾンを含むコルチコイド、デヒドロエピアンドロステロン、エタネルセプト、ヒドロキシクロロキン、インフリキシマブ、メロキシカム、メトトレキサート、ミコフェノール酸モフェチル、シロリムス、タクロリムス、プレドニゾン;
3)抗感染薬:a)アミノグリコシド類:アミカシン、アストロマイシン、ネチルマイシン・シソマイシン・イセパマイシンを含むゲンタマイシン、ハイグロマイシン、アミカシン・アルベカシン・アミノデオキシカナマイシン・ジベカシン・トブラマイシンを含むカナマイシン、ネオマイシンB・パロモマイシン・リボスタマイシンを含むネオマイシン、ネチルマイシン, スペクチノマイシン、ストレプトマイシン、トブラマイシン、ベルダミシン;b)アンフェニコール類:アジダムフェニコール、クロラムフェニコール、フロルフェニコール、チアンフェニコール;c)アンサマイシン類:ゲルダナマイシン、ハービマイシン;d)カルバペネム類:ビアペネム、ドリペネム、エルタペネム、イミペネム/シラスタチン、メロペネム、パニペネム;e)セフェム類:カルバセフェム、セファセトリル、セファクロル、セフラジン、セファドロキシル、セファロニウム、セファロリジン、セファロチン又はセファロスポリン、セファレキシン、セファログリシン、セファマンドール、セファピリン、セファトリジン、セファザフル、セファゼドン、セファゾリン、セフブペラゾン、セフカペン、セフダロキシム、セフェピム、セフミノックス、セフォキシチン、セフプロジル、セファロスポリン、セフテゾル、セフロキシム、セフィキシム、セフジニル、セフジトレン、セフェピム、セフェタメト、セフメノキシム、セフォジジム、セフォニシド、セフォペラゾン、セホラニド、セフォタキシム、、セフォチアム、セフォゾプラン、セファレキシン、セフピミゾール、セフピラミド、セフピロム、セフポドキシム、セフプロジル、セフキノム、セフスロジン、セフタジジム、セフテラム、セフチブテン、セフチオレン、セフチゾキシム、セフタジジム、セフトリアキソン、セフロキシム、セファゾリンフラン、セフォキシチン・セフォテタン・セフメタゾールを含むセファマイシン、フロモキセフ及びラタモキセフを含むオキサセフェム;f)糖ペプチド類:ブレオマイシン、オリタバンシン及びテラバンシンを含むバンコマイシン、テイコプラニン、ラモプラニン、キュービシン;g)グリシルサイクリン類;h)β−ラクタマーゼ阻害剤:スルバクタム及びタゾバクタムを含むペナム、クラバム;i)リンコサミド類:クリンダマイシン、リンコマイシン;j)リポペプチド類:ダプトマイシン、A54145、カルシウム依存性抗生物質;k)マクロライド類:アジスロマイシン、セスロマイシン、クラリスロマイシン、ジリスロマイシン、エリスロマイシン、フルリスロマイシン、ジョサマイシン、テリスロマイシン及びエセスロマイシンを含むケトライド、ミデカマイシン、ミオカマイシン、オレアンドマイシン、リファンピシンン・リファンピン・リファブチン・リファペンチンを含むリファマイシン、ロキタマイシン、ロキシスロマイシン、スペクチノマイシン、スピラマイシン、タクロリムス、トロレアンドマイシン、テリスロマイシンン;l)モノバクタム類:アズトレオナム、チゲモナム;M)オキサゾリジノン類;N)ペニシリン類:アモキシシリン、ピバンピシリン・ヘタシリン・バカンピシリン・メタンピシリン・タランピシリンを含むアンピシリン、アジドシリン、アズロシリン、ペニシリン、ベンザチンペニシリン、フェノキシベンザチンペニシリン、クロメトシリン、プロカインペニシリン、カルベニシリン、クロキサシリン、ジクロキサシリン、セファロスポリン、フルクロキサシリン、メシリナム、メズロシリン、メチシリン、ナフシリン、オキサシリンナトリウム、フェネチシリン、ペニシリン、フェネチシリン、ペニシリン、ピペラシリン、プロピシリン、スルベニシリン、テモシリン、チカルシリン;o)ポリペプチド類:バシトラシン、ポリミキシンE、ポリミキシンB; p)キノロン類:アラトロフロキサシン、バロフロキサシン、シプロフロキサシン、クリナフロキサシン、ダノフロキサシン、ジフロキサシン、エノキサシン、エンロフロキサシン、オフロキサシン、ガレノキサシン、ガチフロキサシン、ゲミフロキサシン、グレパフロキサシン、カノトロバフロキサシン(kanotroafloxacin)、レボフロキサシン、ロメフロキサシン、マルボフロキサシン、モキシフロキサシン、ナジフロキサシン、ノルフロキサシン、オルビフロキサシン、オフロキサシン、ペフロキサシン、トロバフロキサシン、グレパフロキサシン、シタフロキサシン、スパルフロキサシン、テマフロキサシン、トスフロキサシン、トロバフロキサシン;q)ストレプトゾトシン類:プリスチナマイシン、キヌプリスチン/ダルホプリスチン;r)スルホンアミド類:マフェニド、プロントジル、スルファセタミド、スルファメトキサゾール、スルファニルアミド、スルファサラジン、スルファフラゾール、トリメトプリム、トリメトプリム - スルファメトキサゾール;s)ステロイド系抗菌薬;t)テトラサイクリン類:ドキシサイクリン、クロルテトラサイクリン、クロモサイクリン、デメクロサイクリン、リメサイクリン、メクロサイクリン、メタサイクリン、ミノサイクリン、オキシテトラサイクリン、ペニメピサイクリン、ロリテトラサイクリン、テトラサイクリン、グリシルサイクリン;u)他のタイプの抗生物質:アンノナシン、アルスフェナミン、バクトプレノール阻害剤、DADAL/AR阻害剤、ジクチオスタチン、ディスコデルモライド、エレウテロビン、エポチロン、エタンブトール、エトポシド、ファロペネム、フシジン酸、フラゾリドン、イソニアジド、ラウリマリド、メトロニダゾール、ムピロシン、マイコラクトン、NAM合成阻害剤、ニトロフラントイン、パクリタキセル、プラテンシマイシン、ピラジナミド、キヌプリスチン/ダルホプリスチン、リファンピシン、タゾバクタムチニダゾール、ウバリシン;
4)抗ウイルス薬:a)侵入/融合阻害剤:アプラビロック、マラビロク、ビクリビロック、gp41、PRO140、CD4;b)インテグラーゼ阻害剤:ラルテグラビル、エルビテグラビル、グロボイドナンA;c)成熟阻害剤:ベビリマット、ヴィヴィコン;d)ノイラミニダーゼ阻害剤:オセルタミビル、ザナミビル、ペラミビル;e)ヌクレオシド及びヌクレオチド:アバカビル、アシクロビル、アデフォビル、アムドキソビル、アプリシタビン、ブリブジン、シドフォビル、クレブジン、デキセルブシタビン、ジダノシン、エルブシタビン、エムトリシタビン、エンテカビル、ファムシクロビル、フルオロウラシル、3’−フルオロ−2’,3’−ジデオキシチミジン及び3’−フルオロ−2’,3’−ジデオキシグアノシンを含む3’−フルオロ置換2’,3’−デオキシヌクレオシド類似体、ホミビルセン、ガンシクロビル、イドクスウリジン、ラミブジン、β−L−チミジン及びβ−L−2’−デオキシシチジンを含むL−ヌクレオシド、ペンシクロビル、ラシビル、リバビリン、スタンピジン、スタブジンセット、タリバビリン、テルビブジン、テノホビル、トリフルリジン、バラシクロビル、バルガンシクロビル、ザルシタビン、ジドブジン;f)非ヌクレオシド:アマンタジン、アテビリジン、カプラビリン、エトラビリン及びリルピビリンを含むジアリールピリミジン、デラビルジン、ドコサノール、エミビリン、エファビレンツ、ホスカルネット、イミキモド、インターフェロンα、ロビリド、ロデノシン、メチサゾン、ネビラピン、NOV−205、ペグインターフェロンα、ポドフィロトキシン、リファンピシン、リマンタジン、レシキモド、トロマンタジン;g)プロテアーゼ阻害剤:アンプレナビル、アタザナビル、ボセプレビル、ダルナビル、ホスアンプレナビル、インジナビル、ロピナビル、ネルフィナビル、プレコナリル、リトナビル、サキナビル、テラプレビル、チプラナビル;H)抗ウイルス薬の他のタイプ:アブザイム、アルビドール、カラノリドA、セラゲニン、シアノビリン−N、DAPY、没食子酸エピガロカテキン、ホスカルネット、グリフィスシン、タリバビリン、ヒドロキシカルバミド、KP−1461、プレコナリル、ポートマントー阻害剤、リバビリン、及びセリシクリブ;
5)3H、11C、14C、18F、32P、35S、64Cu、68Ga、86Y、99Tc、111In、123I、124I、125I、131I、133Xe、177Lu、211At、及び213Biからなる群から選択される放射性同位元素;
6)UV光、蛍光光、IR光、近IR光、視覚光のようなある種の光を吸収する能力を有する発色団分子;黄色素胞、赤色素胞、虹色素胞、白色素胞、黒色素胞、青色素胞、及び蛍光体のクラス又はサブクラスであって、前記蛍光体は、光で光を再放射する蛍光性化学物質、視覚的光感受性分子、発光分子、ルミネッセンス分子、ルシフェリン化合物のクラスまたはサブクラス、可視光伝達分子、発光分子、ルミネセンス分子、ルシフェリン化合物;以下の非タンパク質有機蛍光体:フルオレセイン、ローダミン、オレゴングリーン、エオシン、及びテキサスレッドを含むキサンテン誘導体;シアニン、インドカルボシアニン、オキサカルボシアニン、チアカルボシアニン、及びメロシアニンを含むシアニン誘導体;Seta、SeTau、及びSquare色素を含むスクアレン誘導体及び環置換スクアライン;ダンシル及びプロダン誘導体を含むナフタレン誘導体;クマリン誘導体;ピリジルオキサゾール、ニトロベンゾキサジアゾール、及びベンゾオキサジアゾールを含むオキサジアゾール誘導体;DRAQ5、DRAQ7、及びCyTRAK Orangeを含むアントラキノン類を含むアントラセン誘導体;ピレン誘導体;ナイルレッド・ナイルブルー・クレシルバイオレット・オキサジン170を含むオキサジン誘導体;プロフラビン・アクリジンオレンジ・アクリジンイエローを含むアクリジン誘導体;オーラミン・クリスタルバイオレット・マラカイトグリーンを含むアリールメチン誘導体;ポルフィン・フタロシアニン・ビリルビンを含むテトラピロール誘導体; 以下の蛍光体化合物の任意の類縁体及び誘導体:CF色素、DRAQ及びCyTRAKプローブ、BODIPY、Alexa Fluor、DyLight Fluor、Atto及びTrancy、FluoProbes、Abberior色素、DY及びMegaStokes色素、SulfoCy色素、HiLyte Fluor、Seta、SeTau及びSquare色素、Quasar及びCal Flour色素、SureLight色素、APC、APCXL、RPE、BPE、アロフィコシアニン、アミノクマリン、APC−Cy7共役体、BODIPY−FL、カスケードブルー、Cy2、Cy3、Cy3.5、Cy3B、Cy5、Cy5.5、Cy7、フルオレセイン、FluorX、ヒドロキシクマリン、リサミンローダミンB、ルシファーイエロー、メトキシクマリン、NBD、Pacific Blue、Pacific Orange、PE−Cy5共役体、PE−Cy7共役体、PerCP、R−フィコエリトリン、Red613、Seta−555−アジド、Seta−555−DBCO、Seta−555−NHS、Seta−580−NHS、Seta−680−NHS、Seta−780−NHS、Seta−APC−780、Seta−PerCP−680、Seta−R−PE−670、SeTau380−NHS、SeTau405−マレイミド、SeTau405−NHS、SeTau425−NHS、SeTau647−NHS、テキサスレッド、TRITC、TruRed、X−ローダミン、7−AAD、アクリジンオレンジ、クロモマイシンA3、CyTRAKオレンジ、DAPI、DRAQ5、DRAQ7、エチジウムブロマイド、ヘキスト33258、ヘキスト33342、LDS751、ミスラマイシン、ヨウ化プロピジウム、SYTOXブルー、SYTOXグリーン、SYTOXオレンジ、チアゾールオレンジ、TO−PRO:シアニン単量体、TOTO−1、TO−PRO−1、TOTO−3、TO−PRO−3、YOseta−1、YOYO−1。前記蛍光色素は、以下の化合物又はその誘導体から選択される:DCFH、DHR、Fluo−3、Fluo−4、Indo−1、SNARF、アロフィコシアニン、AmCyan1、AsRed2、Azamiグリーン、アズライト、B−フィコエリトリン、セルリアン、CyPet、DsRed単量体、DsRed2、EBFP、EBFP2、ECFP、EGFP、エメラルド、EYFP、GFP、GFPのS65C変異体、GFPのS65L変異体、GFPのS65T変異体、GFPのY66F変異体、GFPのY66H変異体、GFPのY66W変異体、GFPuv、HcRed1、J−Red、カチューシャ、Kusabira Orange、mCFP、mCherry、mCitrine、Midriishi Cyan、mKate、mKeima−Red、mKO、mOrange、mPlum、mRaspberry、mRFP1、mStrawberry、mTFP1、mTurquoise2、P3、Peridinin Chlorophyll、R−フィコエリトリン、T−Sapphire、TagCFP、TagGFP、TagRFP、TagYFP、tdTomato、トパーズ、TurboFP602、TurboFP635、TurboGFP、TurboRFP、TurboYFP635、ビーナス、天然型GFP、YPet、Zsグリーン1、Zsイエロー1、及びこれらの誘導体;
7)薬学的に許容される、上記の任意の薬物の塩、酸、又は誘導体。 - 前記「Drug1」及び「Drug2」は発色団である、請求項1に記載の式(II)の細胞結合剤−薬剤共役化合物。
- 前記「Drug1」及び「Drug2」は、チューブリシン類、カリケアマイシン類、オーリスタチン類、メイタンシノイド類、CC−1065類縁体、ダウノルビシン及びドキソルビシン化合物、タキサノイド類、クリプトフィシン類、エポチロン類、並びにピロロベンゾジアゼピン、トマイマイシン、アントラマイシン、インドリノベンゾジアゼピン類、イミダゾベンゾチアジアゼピン、及びオキサゾリジノベンゾジアゼピン類の二量体を含むベンゾジアゼピン二量体、カリケアマイシン類及びエンジイン類抗生物質、アクチノマイシン、アザセリン類、ブレオマイシン類、エピルビシン、タモキシフェン、イダルビシン、並びにモノメチルオーリスタチンE、MMAE、MMAF、オーリスタチンPYE、オーリスタチンTP、オーリスタチン2−AQ、6−AQ、EB、及びEFPを含むドラスタチン類/オーリスタチン類、デュオカルマイシン類、チオテパ、ビンクリスチン類、ヘミアステリン類、ナズマミド類(nazumamides)、ミクロギニン類(microginins)、ラジオスミン類(radiosumins)、アルテロバクチン類(alterobactins)、ミクロスクレロデルミシン類(microsclerodermins)、テネラミド類(thenellamides)、エスペラミシン類(esperamicins)、siRNA、核酸分解酵素、並びに上記分子のいずれかの薬学的に許容される塩、酸、及びそれらの類縁体及び誘導体から選択される、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記細胞結合剤は、抗体、タンパク質、ビタミン、ペプチド、ポリマーミセル、リポソーム、リポタンパク系薬物担体、ナノ粒子薬物担体、及びデンドリマーで、各々任意に細胞結合リガンドで被覆され、並びにそれらの組み合わせからなる群から選択される、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記細胞結合剤は、抗体、単鎖抗体、標的細胞と結合する抗体断片、モノクローナル抗体、単鎖モノクローナル抗体、標的細胞と結合するモノクローナル抗体断片、キメラ抗体、標的細胞と結合するキメラ抗体断片、ドメイン抗体、標的細胞と結合するドメイン抗体断片、表面再構成型抗体、単鎖表面再構成型抗体、標的細胞と結合する表面再構成型抗体断片、ヒト化抗体、表面再構成型ヒト化抗体、単鎖ヒト化抗体、標的細胞と結合するヒト化抗体断片、リンホカイン、ホルモン、ビタミン、成長因子、コロニー刺激因子、又は栄養輸送因子である、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記細胞結合剤は、腫瘍細胞、ウイルス感染細胞、微生物感染細胞、寄生虫感染細胞、自己免疫疾患細胞、活性化腫瘍細胞、骨髄細胞、活性化T細胞、影響されているB細胞、又はメラニン細胞を標的とすることができる細胞結合剤である、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記細胞結合剤は、CD3、CD4、CD5、CD6、CD7、CD8、CD9、CD10、CD11a、CD11b、CD11c、CD12w、CD14、CD15、CD16、CDw17、CD18、CD19、CD20、CD21、CD22、CD23、CD24、CD25、CD26、CD27、CD28、CD29、CD30、CD31、CD32、CD33、CD34、CD35、CD36、CD37、CD38、CD39、CD40、CD41、CD42、CD43、CD44、CD45、CD46、CD47、CD48、CD49b、CD49c、CD51、CD52、CD53、CD54、CD55、CD56、CD58、CD59、CD61、CD62E、CD62L、CD62P、CD63、CD66、CD68、CD69、CD70、CD72、CD74、CD79、CD79a、CD79b、CD80、CD81、CD82、CD83、CD86、CD87、CD88、CD89、CD90、CD91、CD95、CD96、CD98、CD100、CD103、CD105、CD106、CD109、CD117、CD120、CD125、CD126、CD127、CD133、CD134、CD135、CD138、CD141、CD142、CD143、CD144、CD147、CD151、CD147、CD152、CD154、CD156、CD158、CD163、CD166、CD168、CD174、CD180、CD184、CDw186、CD194、CD195、CD200、CD200a、CD200b、CD209、CD221、CD227、CD235a、CD240、CD262、CD271、CD274、CD276(B7−H3)、CD303、CD304、CD309、CD326、 4−1BB、5AC、5T4、腺癌抗原、AGS−5、AGS−22M6、アクチビン受容体様キナーゼ1、AFP、AKAP−4、ALK、αインテグリン、αvβ6、アミノペプチダーゼN、アミロイドβ、アンドロゲン受容体、アンジオポイエチン2、アンジオポイエチン3、アネキシンA1、炭疽菌トキシン防御抗原、抗トランスフェリン受容体、AOC3、B7−H3、炭疽菌、BAFF、B−リンパ腫細胞、bcr−abl、ボンベシン、BORIS、C5、C242抗原、CA125、CA−IX、CALLA、CanAg、イヌIL31、炭酸脱水酵素IX、心筋ミオシン、CCL11、CCR4、CCR5、CD3E、CEA、CEACAM3、CEACAM5、CFD、Ch4D5、コレシストキニン2、CLDN18、クランピング因子A、CRIPTO、FCSF1R、CSF2、CTLA4、CTAA16.88腫瘍抗原、CXCR4、CXCケモカイン受容体4型、cADPリボースヒドロラーゼ、Cyclin B1、CYP1B1、サイトメガロウイルス、サイトメガロウイルス糖タンパク質B、ダビガトラン、DLL4、DPP4、DR5、大腸菌志賀毒素2型、ED−B、EGFL7、EGFR、EGFRII、EGFRvIII、エンドグリン(CD105)、エンドセリンB受容体、エンドトキシン、EpCAM、EphA2、エピシアリン、ERBB2、ERBB3、ERG、大腸菌、ETV6−AML、FAP、FCGR1、α−フェトプロテイン、フィブリンII、β鎖、フィブロネクチン外部ドメインB、FOLR、葉酸受容体α、葉酸ヒドロラーゼ、Fos関連抗原1、RSウイルスのFタンパク質、Frizzled受容体、フコシルGM1、GD2ガングリオシド、G−28、GD3イディオタイプ、GloboH、グリピカン3、N−グリコリルノイラミン酸、GM3、GMCSF受容体α鎖、成長分化因子8、GP100、GPNMB、グアニル酸シクラーゼ2C、グアニル酸シクラーゼC(GC−C)、腸グアニル酸シクラーゼ、グアニル酸シクラーゼ−C受容体、及び熱安定性エンテロトキシン受容体を含むGUCY2C、熱ショックタンパク質、血球凝集素、B型肝炎表面抗原、B型肝炎ウイルス、HER1、HER2、HER2/neu、HER3、IgG4、HGF/SF、HHGFR、HIV−1、ヒストン複合体、HLA−DR、HLA−DR10、HLA−DRB、HMWMAA、ヒト絨毛性ゴナドトロピン、HNGF、ヒト細胞散乱因子受容体キナーゼ、HPV E6/E7、Hsp90、hTERT、ICAM−1、イディオタイプ、IGF1R、IGHE、IFN−γ、インフルエンザ赤血球凝集素、IgE、IgE Fc領域、IGHE、IL−1、IL−2受容体、IL−4、IL−5、IL−6、IL−6R、IL−9、IL−10、L−12、IL−13、IL−17、IL−17A、IL−20、IL−22、IL−23、IL−31RA、ILGF2、α4、αIIIbβ3、αvβ3、α4β7、α5β1、α6β4、α7β7、αIIβ3、α5β5、及びαvβ5を含むインテグリン、インターフェロンγ誘導タンパク質、ITAGA2、ITGB2、KIR2D、LCK、Le、レグマイン、ルイス−Y抗原、LFA−1、LHRH、LINGO−1、リポタイコ酸、LIV1A、LMP2、LTA、MAD−CT−1、MAD−CT−2、MAGE−1、MAGE−2、MAGE−3、MAGEA1、MAGEA3、MAGEA4、MART1、MCP−1、MIF、MS4A1、MSLN、MUC1、MUC1−KLH、MUC16、MCP1、MelanA/MART1、ML−IAP、MPG、MS4A1、MYCN、ミエリン関連糖タンパク質、ミオスタチン、NA17、NARP−1、NCA−90、Nectin−4、NGF、神経アポトーシス制御プロテイナーゼ1、NOGO−A、Notch受容体、ヌクレオリン、Neu癌遺伝子産物、NY−BR−1、NY−ESO−1、OX−40、OxLDL、OY−TES1、P21、p53非変異体、P97、Page4、PAP、抗(N−グリコリルノイラミン酸)のパラトープ、PAX3、PAX5、PCSK9、PDCD1、PDGF−Rα、PDGFR−β、PDL−1、PLAC1、PLAP様精巣アルカリホスファターゼ、血小板由来成長因子受容体β、リン酸ナトリウム共輸送体、PMEL17、ポリシアル酸、プロテイナーゼ3、前立腺癌、PS、前立腺癌細胞、緑膿菌、PSMA、PSA、PSCA、狂犬病ウイルス糖タンパク質、RHD、アカゲザル因子、RANKL、PhoC,Ras変異体、RG55、ROBO4、RSウイルス、RON、肉腫転移ブレイクポイント、SART3、スクレロスチン、SLAMF7、セレクチンP、SDC1、sLe(a)、ソマトメジンC、SIP、ソマトスタチン、精子タンパク質17、SSX2、STEAP1、STEAP2、STn、TAG−22、サバイビン、T細胞受容体、T細胞膜貫通タンパク質、TEM1、TENB2、テナスシンC、TGF−α、TGF−β、TGF−β1、TGF−β2、Tie、Tie2、TIM−1、TN、TNF、TNF−α、TNFRSF8、TNFRSF10B、TNFRSF13B、TPBG、TRAIL−R1、TRAILR2、主要関連カルシウムシグナルトランスデューサー2、MUC1の腫瘍特異的グリコシル化、TWEAK受容体、TYRP1、TRP−2、チロシナーゼ、VCAM−1、VEGF、VEGF−A、VEGF−2、VEGFR−1、VEGFR2、又はビメンチン、WT1、XAGE1、及び任意のインスリン成長因子受容体を発現する細胞、又は任意の上皮増殖因子受容体を含むいずれかの抗原又は受容体に対して標的化が可能な細胞結合剤である、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記腫瘍細胞は、リンパ腫細胞、骨髄腫細胞、腎細胞、乳癌細胞、前立腺癌細胞、卵巣癌細胞、大腸癌細胞、胃癌細胞、扁平上皮癌細胞、小細胞肺癌細胞、非小細胞肺癌細胞、精巣癌細胞、及び無秩序に成長及び分裂し、癌を引き起こすペースを促進する任意の細胞からなる群から選択される、請求項8に記載の細胞結合剤−薬剤共役化合物。
- 前記連結体成分R1、R2、R3、及び/又はR4は、6−マレイミドカプロイル、マレイミドプロパノイル、バリン−シトルリン、アラニン−フェニルアラニン、リジン−フェニルアラニン、p−アミノベンジルオキシカルボニル、4−チオ−ペンタン酸エステル、4−(N−マレイミドメチル)シクロヘキサン−1−カルボン酸エステル、4−チオ−酪酸エステル、マレイミドエチル、4−チオ−2−ヒドロキシスルホニル−酪酸エステル、ピリジニル−ジチオール、アルコキシアミノ、エチレンオキシ、4−メチル−4−ジチオエステル−ペンタン酸、アジド、アルキニル、ジチオ、ペプチド、及び(4−アセチル)アミノ安息香酸の連結体成分の一種又は二種以上にて構成される、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 「Drug1」及び「Drug2」がチューブリシン(Tubulysin)類縁体であり、前記式(II)の共役体化合物が、以下のT01、T02、T03、T04、T05、T06、及びT07の構造のうちの1つである、請求項1に記載の細胞結合剤−薬剤共役化合物:
式中:及び
mAbは抗体であり;
Z3及びZ’3はそれぞれ独立して、H、R1、OP(O)(OM1)(OM2)、OCH2OP(O)(OM1)(OM2)、OSO3M1、又はグルコシド, ガラクトシド、マンノシド、グルクロノシド、アロシド、及びフルクトシドからなる群から選択されるO−配糖体、NH−配糖体、S−配糖体若しくはCH2−配糖体であり;
M1及びM2は独立してH、Na、K、Ca、Mg、NH4、NR1R2R3R4であり;
nは1〜20であり;並びに
R1、R2、R3、及びR4は、請求項1で定義されているものと同じである。 - 「Drug1」及び「Drug2」がCC−1065類縁体又はデュオカルマイシン類縁体であり、前記式(II)の共役体化合物が、以下のCC01、CC02、及びCC03の構造のうちの1つである、請求項1に記載の細胞結合剤−薬剤共役化合物:
式中:
mAbは抗体であり;
nは1〜20であり;並びに
Z4及びZ’4はそれぞれ独立して、H、PO(O)(OM1)(OM2)、SO3M1、CH2PO(O)(OM1)(OM2)、CH3N(CH2CH2)2NC(O)−、O(CH2CH2)2NC(O)−、又は配糖体であり;
X3及びX’3はそれぞれ独立して、O、NH、NR1、NHC(O)、OC(O)、CO、若しくはR1であるか、又は存在しない;
M1及びM2は独立して、Na、K、H、Ca、Mg、NH4、NR1R2R3R4であり;
R1、R2、R3、及びR4は、請求項1で定義されているものと同じである。 - 「Drug1」及び「Drug2」がオーリスタチン又はドラスタチン(dolastatin)類縁体であり、前記式(II)の共役体化合物が、以下のAu01、Au02、Au03、Au04、及びAu05の構造のうちの1つである、請求項1に記載の細胞結合剤−薬剤共役化合物:
式中:
mAbは抗体であり;
nは1〜20であり;
X3及びX’3はそれぞれ独立して、CH2、O、NH、NR1、NHC(O)、NHC(O)NH、C(O)、OC(O)、若しくはR1であるか、又は存在せず;
X4及びX’4はそれぞれ独立して、CH2、C(O)、C(O)NH、C(O)N(R1)、R1、又はC(O)Oであり;
Z3及びZ’3はそれぞれ独立して、H、R1、OP(O)(OM1)(OM2)、OCH2OP(O)(OM1)(OM2)、OSO3M1、又はO−配糖体(グルコシド, ガラクトシド、マンノシド、グルクロノシド、アロシド、フルクトシド)、NH−配糖体、S−配糖体若しくはCH2−配糖体であり;
M1及びM2は独立して、H、Na、K、H、Ca、Mg、NH4、又はNR1R2R3R4であり;並びに
R1、R2、R3、及びR4は、請求項1で定義されているものと同じである。 - 「Drug1」及び「Drug2」がベンゾジアゼピン二量体類縁体であり、前記式(II)の共役体化合物が、以下のPB01、PB02、PB03、PB04、PB05、PB06、PB07、PB08、PB09、PB10、及びPB11の構造のうちの1つである、請求項1に記載の細胞結合剤−薬剤共役化合物:
式中:
mAbは抗体であり;
nは1〜20であり;
X3及びX’3はそれぞれ独立して、CH2、O、NH、NR1、NHC(O)、NHC(O)NH、C(O)、C(O)R1、OC(O)、C(O)N(R1)、若しくはR1であるか、又は存在せず;
X4及びX’4はそれぞれ独立して、CH2、C(O)、C(O)NH、C(O)N(R1)、C(O)O、若しくはR1であるか、又は存在せず;並びに
R1、R2、R3、及びR4は、請求項1で定義されているものと同じである。 - 治療有効量の請求項1に記載の細胞結合剤−薬剤共役化合物、並びに薬学的に許容される塩類、担体、希釈剤、又は賦形剤を含む、医薬組成物。
- インビトロ(in vitro)、インビボ(in vivo)、又はエクスビボ(ex vivo)で細胞殺傷活性を有する、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記連結体成分R1、R2、R3、又はR4 は、1〜20単位の天然若しくは非天然のアミノ酸のペプチド、p−アミノベンジル単位、6−マレイミドカプロイル単位、ジスルフィド単位、チオエーテル単位、ヒドラゾン単位、トリアゾール単位、又はアルコキシム単位を含む、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記連結体成分R1、R2、R3、又はR4がプロテアーゼにより開裂可能である、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 前記連結された一対の硫黄原子が、前記共役部位としての前記一対のチオールを生成するためにTCEP及び/又はDTT分子により還元される、抗体の鎖間ジスルフィド結合からのものである、請求項1に記載の細胞結合剤−薬剤共役化合物。
- 化学療法薬、放射性療法、免疫治療薬、自己免疫性疾患薬、及び抗感染症薬からなる群から選択される、相乗的に有効量の治療剤と共に投与される、相乗的に癌、自己免疫性疾患、又は感染疾患に有効な治療又は予防のための、請求項19に記載の医薬組成物。
- 前記治療剤は、以下からなる群から選択される、請求項24に記載の医薬組成物:アバタセプト、酢酸アビラテロン、アセトアミノフェン/ヒドロコドン、アダリムマブ、アファチニブ ジマレエート、アレムツズマブ、アリトレチオニン、アド−トラスツズマブエムタンシン、アンフェタミン混合塩、アナストロゾール、アリピプラゾール、アタザナビル、アテゾリズマブ、アトルバスタチン、アキシチニブ、ベリノスタット、ベバシズマブ、カバジタキセル、カボザチニブ、ベキサロテン、ブリナツモマブ、ボルテゾミブ、ボスチニブ、ブレンツキマブ ベドチン、ブデソニド、ブデソニド/ホルモテロール、ブプレノルフィン、カペシタビン、カルフィルゾミブ、、セレコキシブ、セリチニブ、セツキシマブ、シクロスポリン、シナカルセット、クリゾチニブ、ダビガトラン、ダブラフェニブ、ダルベポエチンα、ダルナビル、メシル酸イマチニブ、ダサチニブ、デニロイキン ジフチトクス、デノスマブ、デパコテ、デキスランソプラゾール、デキスメチルフェニデート、ジヌツキシマブ、ドキシサイクリン、デュロキセチン、エムトリシタビン/リルピビリン/フマル酸テノホビルジソプロキシル、エムトリシタビン/テノホビル/エファビレンツ、エノキサパリン、エンザルタミド、エポエチンα、エルロチニブ、エソメプラゾール、エスゾピクロン、エタネルセプト、エベロリムス、エキセメスタン、エベロリムス、エゼチミブ、エゼチミブ/シンバスタチン、フェノフィブラート、フィルグラスチム、フィンゴリモド、プロピオン酸フルチカゾン、フルチカゾン/サルメテロール、フルベストラント、ゲフィチニブ、グラチラマー、酢酸ゴセレリン、イマチニブ、イブリツモマブチウキセタン、イブルチニブ、イデラリシブ、インフリキシマブ、インスリン アスパルト、インスリンデテミル、インスリングラルギン、インスリンリスプロ、インターフェロンβ1a、インターフェロンβ1b、ラパチニブ、イピリムマブ、臭化イプラトロピウム/サルブタモール、酢酸ランレオチド、レナリオミド、メシル酸レンバチニブ、レトロゾール、レボチロキシン、レボチロキシン、リドカイン、リネゾリド、リラグルチド、リスデキサムフェタミン、MEDI4736、メマンチン、メチルフェニデート、メトプロロール、モダフィニル、モメタゾン、ニロチニブ、ニボルマブ、オファツムマブ、オビヌツズマブ、オラパリブ、オルメサルタン、オルメサルタン/ヒドロクロロチアジド、オマリズマブ、ω3脂肪酸エチルエステル、オセルタミビル、オキシコドン、パルボシクリブ、パリビズマブ、パニツムマブ、パノビノスタット、パゾパニブ、ペムブロリズマブ、ペメトレキセド、ペルツズマブ、肺炎球菌共役ワクチン、ポマリドミド、プレガバリン、クエチアピン、ラベプラゾール、ラジウム223塩化物、ラロキシフェン、ラルテグラビル、ラムシルマブ、ラニビズマブ、レゴラフェニブ、リツキシマブ、リバロキサバン、ロミデプシン、ロスバスタチン、ルキソリチニブ、サルブタモール、セベラマー、シルデナフィル、シルツキシマブ、シタグリプチン、シタグリプチン/メトホルミン、ソリフェナシン、ソラフェニブ、スニチニブ、タダラフィル、タモキシフェン、テラプレビル、テムシロリムス、テノホビル/エムトリシタビン、テストステロンゲル、サリドマイド、チオトロピウムブロマイド、トレミフェン、trametinib、トラスツズマブ、トレチノイン、ウステキヌマブ、バルサルタン、バンデタニブ、ベムラフェニブ、ボリノスタット、ジバフリベルセプト、及びゾスタバックス、並びにこれらの類縁体、誘導体、薬学的に許容される塩、これらのための担体、希釈剤若しくは賦形剤、又はこれらの組み合わせ。
- 細胞結合剤−薬剤共役化合物と標的細胞との相互作用又は機能を検出又はモニタリングするための、請求項3に記載の式(II)の細胞結合剤−薬剤共役化合物の使用。
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EP3319936A4 (en) | 2019-02-06 |
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PH12018500285A1 (en) | 2018-08-29 |
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CA2991973A1 (en) | 2015-10-08 |
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