JP2010516675A - 治療薬剤のポリマー担体および疾病部位の抗体に基づく標的化のための認識部分 - Google Patents
治療薬剤のポリマー担体および疾病部位の抗体に基づく標的化のための認識部分 Download PDFInfo
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- JP2010516675A JP2010516675A JP2009546389A JP2009546389A JP2010516675A JP 2010516675 A JP2010516675 A JP 2010516675A JP 2009546389 A JP2009546389 A JP 2009546389A JP 2009546389 A JP2009546389 A JP 2009546389A JP 2010516675 A JP2010516675 A JP 2010516675A
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Abstract
Description
本出願は、35U.S.C.§119(e)に基づく2007年1月17日出願の米国特許出願第60/885,325号からの優先権を主張し、その文章全体は、それを参照することによって本明細書に組み込まれる。
DNL(ドックアンドロック)方法
DDD1
SHIQIPPGLTELLQGYTVEVLRQQPPDLVEFAVEYFTRLREARA(配列番号1)
DDD2
CGHIQIPPGLTELLQGYTVEVLRQQPPDLVEFAVEYFTRLREARA(配列番号2)
AD1
QIEYLAKQIVDNAIQQ(配列番号3)
AD2
CGQIEYLAKQIVDNAIQQAGC(配列番号4)
抗体フラグメントの生成
キメラおよびヒト化抗体
ヒト抗体
アビマー
ファージ提示法
アプタマー
共役プロトコル
実施例1:デキストランにおけるCOOH基の導入
実施例2:COOH付加のデキストラン(70kD MW)の誘導体化
実施例3:ドキソルビシン置換ポリマーに対するCOOH付加のデキストラン(40kD MW)の連続誘導体化
実施例4:「クリック化学」手法によるドキソルビシン置換ポリマーに対するCOOH付加のデキストラン(40kD MW)の逐次誘導体化
スキーム5
スキーム6
スキーム7
スキーム8
実施例11:実施例10の任意のデキストラン誘導体の、認識部分を抱合するチオール含有材料との連結
スキーム9
Claims (25)
- 複合体であって、
(a)1つ以上の治療薬部分の複製、または二官能性治療薬部分に化学選択的に連結可能であるか、または治療薬部分と非共有的に複合化できる官能基を含む官能化ポリマーと、
(b)ポリマー分子当たり1から10部分の範囲の認識構造部分と、
を含む、複合体。 - 前記ポリマーは、それぞれ異なるMWサイズのデキストラン、ポリグルタミン酸、およびデンドリマーより選択される、請求項1に記載の複合体。
- 前記ポリマーはデキストランである、請求項2に記載の複合体。
- 前記認識部分は、例えば、HSGまたはDTPA等の1つまたは2つのハプテン分子を含有するペプチド、葉酸、ソマトスタチン、VIP、ビオチン、アンチセンスオリゴヌクリド、および「ドックアンドロック」(DNL)方法の「AD」ペプチドから成る群より選択される、請求項1に記載の複合体。
- 前記治療薬部分は、化学療法薬、ビンカアルカロイド、アントラサイクリン、エピドフィロトキシン、タキサン、代謝拮抗剤、アルキル化剤、抗生物質、Cox−2阻害剤、抗有糸分裂剤、抗血管形成活性剤、アポトーシス促進剤、ドキソルビシン、メトトレキサート、タキソール、カンプトテシン、ナイトロジェンマスタード、スルホン酸アルキル、ニトロソウレア、トリアゼン、葉酸類似体、ピリミジン類似体、プリン類似体、白金配位複合体、ホルモン、毒素、リシン、アブリン、リボヌクレアーゼ(RNase)、DNase I、ブドウ球菌エンテロトキシン−A、ヤマゴボウ抗菌タンパク質、ゲロニン、ジフテリン毒素、緑膿菌外毒素、および緑膿菌内毒素から成る群より選択される、請求項1に記載の複合体。
- 前記官能基は、1つ以上のアセチレン(またはアジド)、ヒドラジド、シクロデキストリン、ビニルスルホン、マレイミド、チオール、ブロモアセトアミド、ヨードアセトアミド、イソチオシアネート、および活性カルボキシル基より選択される、請求項1に記載の複合体。
- 前記官能基はアセチレンまたはアジドであり、連結は、アジドまたはアセチレンで誘導体化された薬剤を用いて行われる、請求項6に記載の複合体。
- 前記官能基はシクロデキストリンであり、前記治療薬部分は、非共有ホストゲスト複合化によって連結される、請求項6に記載の複合体。
- 前記化学療法部分は、単一または複数の薬剤型から生じ得る、請求項1に記載の複合体。
- 前記認識部分は、DNL方法の「AD」ペプチドであり、前記DNLアセンブリは、前記ポリマーへの薬剤または治療薬部分の付着前または後のいずれかに行われる、請求項4に記載の複合体。
- 前記薬剤を前記ポリマーに連結するスペーサは、細胞内で開裂可能な結合を含有する、請求項1に記載の複合体。
- 前記開裂可能結合はヒドラゾン、カテプシン−B−開裂可能ペプチド、ジスルフィド、またはエステラーゼによって開裂可能なエステル結合である、請求項11に記載の複合体。
- 前記認識部分は、二重または多特異性抗体のアームのうちの1つに特異的であり、前記抗体の1つ以上の他のアームは、ムリン化、キメラ化、霊長類化、ヒト化、またはヒト単クローン抗体に由来する疾病標的MAbであり、前記抗体は、無傷フラグメント(Fab、Fab′、F(ab)2、F(ab′)2)、またはサブフラグメント(一本鎖組成物)形態である、請求項1に記載の複合体。
- 前記多特異性MAbは、LL1、LL2、hA20、1F5、L243、RS7、PAM−4、MN−14、MN−15、Mu−9、L19、G250、J591、CC49、およびImmu31から成る群より選択される、1つ以上の抗体を含む、二重特異性および/または二価抗体組成物である、請求項13に記載の複合体。
- 前記Mabは、癌または悪性細胞、感染性生物、自己免疫疾病、心血管疾病、または神経疾病に関連する抗原または抗原のエピトープと反応する、請求項13に記載の複合体。
- 前記癌細胞は、造血性腫瘍、癌腫、肉腫、黒色腫、またはグリア腫瘍に由来する細胞である、請求項15に記載の複合体。
- 前記MAbは、B−細胞系統抗原、T−細胞抗原、骨髄系統抗原またはHLA−DR抗原に結合する、請求項13に記載の複合体。
- 前記感染性生物は、バクテリア、ウィルス、真菌、微生物、または寄生生物である、請求項15に記載の複合体。
- 前記感染性生物は、エイズを引き起こすヒト免疫不全ウィルス(HIV)、結核菌、アガラクシア連鎖球菌、メチシリン耐性黄色ブドウ球菌、レジオネラニューモフィラ、化膿連鎖球菌、大腸菌、淋菌、髄膜炎菌、肺炎球菌sp.、血友病性B型インフルエンザ、梅毒トレポネーマ、ライム病スピロヘータ、ウエストナイルウィルス、緑膿菌、ハンセン菌、ウシ流産菌、狂犬病ウィルス、インフルエンザウィルス、サイトメガロウィルス、単純ヘルペスウィルスI型、単純ヘルペスウィルスII型、ヒト血清パルボ様ウィルス、呼吸器合胞体ウィルス、水痘帯状疱疹ウィルス、B型肝炎ウィルス、麻疹ウィルス、アデノウィルス、ヒトT−細胞白血病ウィルス、エプスタイン−バーウィルス、マウス白血病ウィルス、流行性耳下腺炎ウィルス、水疱性口内炎ウィルス、シンドビスウィルス、リンパ球性脈絡髄膜炎ウィルス、いぼウィルス、ブルータングウィルス、センダイウィルス、ネコ白血病ウィルス、レオウィルス、ポリオウィルス、シミアンウィルス40、マウス乳癌腫瘍ウィルス、デング熱ウィルス、風疹ウィルス、熱帯マラリア原虫、三日熱マラリア原虫、トキソプラズマ原虫、ランゲルトリパノソーマ、クルーズトリパノソーマ、ローデシアトリパノソーマ、ブルセイトリパノソーマ、マンソン住吸血虫、日本住吸血虫、ウシバベシア、エルメリア・テネラ、回旋糸状虫、熱帯リーシュマニア、旋毛虫、タイレリア・パルバ、胞状条虫、羊条虫、無鉤条虫、単包条虫、メソ条虫亜鋼コルチ、マイコプラズマ関節炎、マイコプラズマ・ヒオリニス、マイコプラズマ・オラール、マイコプラズマ・アルギニーニ、アコレプラズマ・レイドロウィ、マイコプラズマ・サリバリウム、およびマイコプラズマ・ニューモニエから成る群より選択される、請求項18に記載の複合体。
- 前記自己免疫疾病は、免疫媒介性血小板減少、皮膚筋炎、シェーグレン症候群、多発性硬化症、シデナム舞踏病、重症筋無力症、全身性エリテマトーデス、ループス腎炎、リウマチ熱、関節リウマチ、多腺性症候群、水疱性類天疱瘡、糖尿病、ヘノッホ−シェーンライン紫斑病、レンサ球菌感染後の腎炎、結節性紅斑、高安動脈炎、アジソン病、関節リウマチ、サルコイドーシス、潰瘍性大腸炎、多型性紅斑、IgA腎症、結節性多発性動脈炎、強直性脊椎炎、グッドパスチュア症候群、閉塞性血栓血管炎、原発性胆汁性肝硬変、橋本甲状腺炎、甲状腺亢進、強皮症、慢性活動性肝炎、多発性筋炎/皮膚筋炎、胆汁過多、尋常性天疱瘡、ヴェグナー肉芽腫症、膜性腎症、筋萎縮性側索硬化症、脊髄癆、巨大細胞動脈炎/多筋痛、悪性貧血、急速進行性糸球体腎炎、線維化性肺胞炎、および若年性糖尿病から成る群より選択される、請求項15に記載の複合体。
- 前記心血管疾病は、心筋梗塞、虚血性心疾患、動脈硬化性プラーク、フィブリン塊、塞栓、またはそれらの組み合わせを含む、請求項15に記載の複合体。
- 前記抗体は、神経疾患と関連する抗原を特異的に結合し、前記抗原は、アミロイドまたはβ−アミロイドを含む、請求項15に記載の複合体。
- 前記疾病標的抗体は、CD74、CD22、上皮糖タンパク質−1、癌胎児性抗原(CEAまたはCD66e)、大腸特異的抗原−p、α−フェトプロテイン、CC49、前立腺特異的膜抗原、炭酸脱水酵素IX、HER−2/neu、EGFR(ErbB1)、ErbB2、ErbB3、ILGF、BrE3、CD19、CD20、CD21、CD23、CD33、CD45、CD74、CD80、VEGF、ED−Bフィブロネクチン、PlGF、他の腫瘍血管形成抗原、MUC1、MUC2、MUC3、MUC4、ガングリオシド、HCG、EGP−2、CD37、HLA−DR、CD30、Ia、A3、A33、Ep−CAM、KS−I、Le(y)、S100、PSA、テネイシン、葉酸受容体、トーマス−フリードリッヒ抗原、腫瘍壊死抗原、Ga733、IL−2、IL−6、T101、MAGE、遊走阻止因子(MIF)、L243によって結合される抗原、PAM4によって結合される抗原、CD66a(BGP)、CD66b(CGM6)、66CDc(NCA)、66CDd(CGM1)、TACおよびそれらの組み合わせから成る群より選択される抗原に結合する、請求項15に記載の複合体。
- 前記抗体は、LL1、LL2、RFB4、hA20、1F5、L243、RS7、PAM−4、MN−14、MN−15、Mu−9、AFP−31、L19、G250、J591、CC49、L243、PAM4およびImmu31から成る群より選択される、請求項13に記載の複合体。
- 認識部分の数は1である、請求項1に記載の複合体。
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AU2007343610A1 (en) | 2008-07-24 |
EP2121030A2 (en) | 2009-11-25 |
WO2008088658A2 (en) | 2008-07-24 |
CA2675014C (en) | 2016-03-29 |
AU2007343610C1 (en) | 2013-11-07 |
CA2916671C (en) | 2018-01-09 |
WO2008088658A3 (en) | 2008-11-20 |
CA2675014A1 (en) | 2008-07-24 |
AU2007343610B2 (en) | 2013-07-11 |
JP2014159441A (ja) | 2014-09-04 |
EP2121030A4 (en) | 2013-06-19 |
CA2916671A1 (en) | 2008-07-24 |
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