JP6674543B2 - 抗体に基づく薬物のコンパニオン診断としての細胞結合補体活性化産物アッセイ - Google Patents
抗体に基づく薬物のコンパニオン診断としての細胞結合補体活性化産物アッセイ Download PDFInfo
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Description
本願は、2015年7月31日出願の「Cell‐Bound Complement Activation Products Assays as Companion Diagnostics for Antibody‐Based Drugs」と題する米国仮特許出願第62/199,713号の利益を主張し、その開示内容全体を参照によって本明細書に援用する。
C4d標識Bリンパ球を、事前に規定されたプロトコルを用いてインビトロで生成した。Bリンパ球に結合しているC4dのレベルを、マルチカラーフローサイトメトリアッセイを用いて測定した。簡潔に述べると、抹消血白血球(PBL)を、Ficoll Plus(GE ヘルスケア)を用いた勾配遠心分離によって調製した。低張性溶解によって混入赤血球を除去した後、PBLをリン酸緩衝食塩水(PBS)で洗浄し、1%のウシ血清を含むPBSに再懸濁し、抗体染色のために小分けした。リンパ球を、特徴的な表面分子の発現及び前方(サイズ)/側方(粒度)散乱のそれら独自の特徴に基づいて、単球及び顆粒球から区別した。Zenon抗体標識キット(Invitrogen社、カリフォルニア、カールスバッド)を用いてAlexa Fluor 488により標識された抗ヒトC4d(マウスIgG1;C4のC4d含有分画と反応;Quidel社、カリフォルニア、サンディエゴ)と併用して、系統特異的細胞表面マーカ(Bリンパ球用CD19;BD Biosciences社、カリフォルニア、サンディエゴ)と反応するフィコエリトリン‐又はフィコエリトリンCy5‐結合マウスモノクローナル抗体(mAb)を使用した。
Claims (10)
- 被検者について、Bリンパ球抗原に対する潜在的治療用抗体の結合を評価する方法において、前記被検者からの白血球細胞を含む血液試料について、
前記試料中のBリンパ球の表面上の少なくとも1つのバイオマーカの存在レベルを定量化する工程であって、前記バイオマーカは、C4d、C3d、C4b、iC4b、C3b、iC3b、及びC3dgからなる群から選択される、工程と、
前記被検者の前記バイオマーカの存在レベルを対照試料のBリンパ球の表面上の前記バイオマーカの存在レベルと比較することで、前記被検者の前記バイオマーカの存在レベルが前記対照試料における存在レベルに比べて上昇しているか否かを判定する工程と、
前記対照試料における存在レベルと比較した前記被検者からの前記血液試料中の前記バイオマーカの存在レベルの増加を、前記被検者のBリンパ球上の前記Bリンパ球抗原に対する前記潜在的治療用抗体の結合の減少と関連付ける工程と、
を含んでおり、
前記バイオマーカの存在レベルの増加は、前記潜在的治療用抗体の前記被検者への投与前に、且つ、前記潜在的治療用抗体が標的とする前記Bリンパ球抗原の発現に関連付けられることなく検出される、方法。 - 前記バイオマーカはC4dである、請求項1に記載の方法。
- 前記Bリンパ球抗原は、CD5、CD19、CD20、CD21、CD22、CD23、CD25、CD40、CD69、CD70、CD79、CD80、CD85、CD86、CD137、CD138、CD252、及びCD268からなる群から選択される、請求項1に記載の方法。
- 前記対照試料が、より早い時期に前記被検者から得られた試料である、請求項1に記載の方法。
- 前記被検者のBリンパ球上の前記Bリンパ球抗原に対する前記潜在的治療用抗体の結合の減少は、前記被検者が前記潜在的治療用抗体による治療に有利に反応する可能性が低いことを意味する、請求項1に記載の方法。
- 前記被検者は、自己免疫疾患又は自己免疫障害を有する疑いがある、或いは、自己免疫疾患又は自己免疫障害について検査されており、前記対照試料は、前記自己免疫疾患又は自己免疫障害を患っていない1又は複数の個体を含む対照セットから得られる、請求項1に記載の方法。
- 前記自己免疫疾患または自己免疫障害は、全身性エリテマトーデス(SLE)、関節リウマチ、シェーグレン症候群、全身性硬化症、血管炎、混合型クリオグロブリン血症、及び炎症性ミオパチーからなる群より選択される、請求項6に記載の方法。
- 前記被検者は、自己免疫疾患又は自己免疫障害を有する疑いがある、或いは、自己免疫疾患又は自己免疫障害について検査されており、前記対照試料は、前記自己免疫疾患又は自己免疫障害を有するが、前記自己免疫疾患又は自己免疫障害の急性期を経験していない1又は複数の個体を含む対照セットから得られる、請求項1に記載の方法。
- 前記自己免疫疾患または自己免疫障害は、全身性エリテマトーデス(SLE)、関節リウマチ、シェーグレン症候群、全身性硬化症、血管炎、混合型クリオグロブリン血症、及び炎症性ミオパチーからなる群より選択される、請求項8に記載の方法。
- 前記被検者は、B細胞リンパ腫を有する疑いがある、或いは、B細胞リンパ腫について検査されており、前記対照試料は、B細胞リンパ腫を患っていない1又は複数の個体の対照セットから得られる、請求項1に記載の方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201562199713P | 2015-07-31 | 2015-07-31 | |
US62/199,713 | 2015-07-31 | ||
PCT/US2016/044779 WO2017023781A1 (en) | 2015-07-31 | 2016-07-29 | Cell-bound complement activation product assays as companion diagnostics for antibody-based drugs |
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JP2018528439A JP2018528439A (ja) | 2018-09-27 |
JP2018528439A5 JP2018528439A5 (ja) | 2019-09-05 |
JP6674543B2 true JP6674543B2 (ja) | 2020-04-01 |
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US (1) | US10067128B2 (ja) |
EP (1) | EP3329278A4 (ja) |
JP (1) | JP6674543B2 (ja) |
AU (1) | AU2016303499B2 (ja) |
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