JP7198083B2 - Cd47遮断及び免疫同時刺激アゴニストを用いた標的細胞の枯渇亢進 - Google Patents
Cd47遮断及び免疫同時刺激アゴニストを用いた標的細胞の枯渇亢進 Download PDFInfo
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Description
抗CD47薬。CD47は、単一のIg様ドメイン及び5つの膜貫通領域を有する広範に発現する膜貫通糖タンパク質であり、SIRPαのNH2 末端V様ドメインを通じて仲介される結合を用いてSIRPαに対する細胞リガンドとして機能する。SIRPαは主として、マクロファージ、顆粒球、骨髄系樹状細胞(DC)、肥満細胞、及び造血幹細胞を含めてこれらの前駆細胞を含む、骨髄系細胞に発現する。CD47結合を仲介するSIRPαに対する構造的な決定因子は、Lee et al.(2007)J.Immunol.179:7741-7750;Hatherley et al.(2008)Mol Cell.31(2):266~277;Hatherley et al.(2007)J.B.C.282:14567-75によって考察されており、CD47結合におけるSIRPαシス二量体化の役割は、Lee et al.(2010)J.B.C.285:37953-37963によって考察されている。正常細胞の食作用を阻害するCD47の役割を踏まえて、当該役割は造血幹細胞(HSC)及び前駆細胞の遊走相の直前及び間に当該細胞に関して一過性に上方調節され、これらの細胞に関するCD47のレベルは、インビボで貪食される確率を決定するという証拠がある。
標的細胞を、免疫調節シグナル伝達を調節する薬剤の組み合わせと接触させることを含む治療計画によって、原発性癌または転移性癌としてリンパ腫、白血病、黒色腫、膠芽腫、肉腫、骨髄腫などを含むがこれらに限定されない癌を治療、低下または予防するための方法が提供される。免疫調節薬には、(i)CD47活性を遮断する薬剤、及び(ii)免疫同時刺激分子、例えばCD137を刺激する薬剤を含み、これにより、腫瘍細胞のインビボでの食作用を高める。当該治療計画はさらに、標的細胞へ特異的に結合する薬剤、例えば、抗体またはその生物活性フラグメントもしくは誘導体を含み得る。このような方法には、当該試薬と化学療法薬、腫瘍特異的抗体、またはESAとの組み合わせを含むがこれに限定されない、本発明の組み合わされた治療有効量または有効量の薬剤を、治療を必要とする対象へ投与することが含まれる。
免疫枯渇のために細胞を標的とする上でのCD47遮断及びCD137アゴニズムの組み合わせ
インビトロ相乗性実験
ADCCアッセイを、マウスまたはヒトNK細胞(エフェクター)及びマウスまたはヒト癌細胞(標的細胞)を用いて実施する。マウスNK細胞を末梢血、骨髄、または脾臓から分離し、ヒトNK細胞を末梢血から分離する。ヒト癌細胞株または初代試料を標的細胞としての使用のために標識する(例えば、クロムまたは蛍光色素を用いる)。
・ビヒクル対照(例えば、PBS)
・CD137アゴニスト単独
・CD47アンタゴニスト単独
・CD47アンタゴニストプラスCD137アゴニスト
・腫瘍結合抗体単独
・腫瘍結合抗体+CD137アゴニスト単独
・腫瘍結合抗体+CD47アンタゴニスト単独
・腫瘍結合抗体+CD47アンタゴニストプラスCD137アゴニスト
インビボでの実験プロトコル
癌細胞をマウスへ、皮下、後腹膜、または末梢血注射を介して注射し、移植させておく。当該動物を4つの処置群へと無作為に分ける。
1.ビヒクル対照(例えば、PBS)
2.CD137アゴニスト単独
3.CD47アンタゴニスト単独
4.CD47アンタゴニストプラスCD137アゴニスト
腫瘍特異的モノクローナル抗体との相乗性についてのインビボでの実験プロトコル
癌細胞をマウスへ、皮下、後腹膜、または末梢血注射を介して注射し、移植させておく。当該動物を4つの処置群へ無作為に分ける。
1.腫瘍結合抗体単独
2.腫瘍結合抗体+CD137アゴニスト単独
3.腫瘍結合抗体+CD47アンタゴニスト単独
4.腫瘍結合抗体+CD47アンタゴニストプラスCD137アゴニスト
・マウス肥満細胞腫P815細胞をDBA/2マウスへ移植し、ACK2(抗マウスc-キット抗体)CD47/CD137標的化療法を用いて処置する。
・TUBO-EGFR細胞を野生型マウスへ移植し、セツキシマブ(抗ヒトEGFR)及びCD47/CD137標的化療法を用いて処置する。
・ヒト黒色腫SK-Mel-3細胞をRAG-/-マウスへ移植し、SR-1(抗ヒトc-キット)及びCD47/CD137標的化療法を用いて処置する。
・B16黒色腫細胞を野生型マウスへ移植し、TA99(マウスB16細胞を標的とする抗体)及びCD47/CD137標的化療法を用いて処置する。
・A20マウスリンパ腫細胞を野生型マウスへ移植し、抗マウスCD20抗体及びCD47/CD137標的化療法を用いて処置する。
米国特許法第119条(e)項に従って、本出願は、出願の開示が参照により本明細書に組み込まれる2015年8月26日出願の米国仮特許出願番号第62/210,279号の出願日に対する優先権を請求する。
Claims (8)
- 腫瘍細胞と免疫細胞の集団とを含む細胞の集団に接触させる組み合わされた薬剤であって、
前記腫瘍細胞の枯渇を亢進するための有効量で、(i)CD47活性を遮断する抗CD47抗体と、(ii)アゴニストである抗CD-137抗体と、(iii)腫瘍特異的抗体とを含む、組み合わされた薬剤。 - 前記免疫細胞は、NK細胞及び食細胞のうちの1つまたは両方を含む、請求項1に記載の組み合わされた薬剤。
- 前記免疫細胞は、NK細胞及びマクロファージを含む、請求項2に記載の組み合わされた薬剤。
- 前記腫瘍細胞の枯渇は、(i)CD47活性を遮断する薬剤による、または(ii)アゴニストである抗CD-137抗体による単一療法で観察される枯渇に対して高い、請求項1~3のいずれか一項に記載の組み合わされた薬剤。
- 前記抗CD47抗体は、IgG4 Fc領域を含む、請求項1~4のいずれか一項に記載の組み合わされた薬剤。
- 前記抗CD47抗体は、5F9-G4である、請求項5に記載の組み合わされた薬剤。
- 腫瘍細胞を含む前記細胞の集団は、マウスの細胞である、請求項1~6のいずれか一項に記載の組み合わされた薬剤。
- 腫瘍細胞を含む前記細胞の集団は、ヒトの細胞である、請求項1~6のいずれか一項に記載の組み合わされた薬剤。
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JP2021098639A JP7313398B2 (ja) | 2015-08-26 | 2021-06-14 | 腫瘍細胞の枯渇を亢進するための薬剤の組み合わせ |
JP2023113879A JP2023126368A (ja) | 2015-08-26 | 2023-07-11 | 腫瘍細胞の枯渇を亢進するための薬剤の組み合わせ |
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US201562210279P | 2015-08-26 | 2015-08-26 | |
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PCT/US2016/049016 WO2017035480A1 (en) | 2015-08-26 | 2016-08-26 | Enhanced depletion of targeted cells with cd47 blockade and an immune costimulatory agonist |
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AU2016310348B2 (en) * | 2015-08-26 | 2023-01-05 | The Board Of Trustees Of The Leland Stanford Junior University | Enhanced depletion of targeted cells with CD47 blockade and an immune costimulatory agonist |
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PL2477648T3 (pl) * | 2009-09-15 | 2022-11-07 | The Board Of Trustees Of The Leland Stanford Junior University | Synergistyczna terapia anty-cd47 dla nowotworów hematologicznych |
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RS62151B1 (sr) † | 2015-08-07 | 2021-08-31 | Alx Oncology Inc | Konstrukti koji sadrže sirp-alfa domen ili njegovu varijantu |
AU2016310348B2 (en) | 2015-08-26 | 2023-01-05 | The Board Of Trustees Of The Leland Stanford Junior University | Enhanced depletion of targeted cells with CD47 blockade and an immune costimulatory agonist |
CN115569192A (zh) * | 2015-12-11 | 2023-01-06 | 小利兰·斯坦福大学托管委员会 | 以双重靶向cd47和egfr来治疗癌症 |
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US10894831B2 (en) | 2021-01-19 |
EP3341015A1 (en) | 2018-07-04 |
SI3341015T1 (sl) | 2021-11-30 |
WO2017035480A1 (en) | 2017-03-02 |
PT3341015T (pt) | 2021-10-12 |
JP7313398B2 (ja) | 2023-07-24 |
AU2016310348A1 (en) | 2018-03-15 |
US20230257464A1 (en) | 2023-08-17 |
EP3341015A4 (en) | 2018-07-11 |
JP2023126368A (ja) | 2023-09-07 |
JP2018525421A (ja) | 2018-09-06 |
CA2996167A1 (en) | 2017-03-02 |
PL3341015T3 (pl) | 2021-12-13 |
ES2894335T3 (es) | 2022-02-14 |
EP3341015B2 (en) | 2023-12-27 |
SI3341015T2 (sl) | 2024-03-29 |
AU2016310348B2 (en) | 2023-01-05 |
JP2021138756A (ja) | 2021-09-16 |
US20210095034A1 (en) | 2021-04-01 |
PL3341015T5 (pl) | 2024-04-08 |
US20200223923A1 (en) | 2020-07-16 |
HK1257824A1 (zh) | 2019-11-01 |
EP3341015B1 (en) | 2021-07-28 |
AU2023201987A1 (en) | 2023-05-04 |
US11608377B2 (en) | 2023-03-21 |
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