JP6862499B2 - ヒトの腫瘍のための腫瘍溶解性ポリオウイルス - Google Patents
ヒトの腫瘍のための腫瘍溶解性ポリオウイルス Download PDFInfo
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Description
本発明は、抗腫瘍治療の領域に関連する。特に、本発明は腫瘍溶解性ウイルスによる抗腫瘍治療に関連する。
PVS-RIPOは、腫瘍溶解性ポリオウイルス(PV)の組換体である。PVS-RIPOは、2型ヒトライノウイルス(HRV2)の外来内部リボソーム進入部位(IRES)を含有する、減弱化生1型(Sabin)PVワクチンからなる。IRESは、PVゲノムの5'非翻訳領域内に位置するシス作用性遺伝要素であり、ウイルス性のm7G-キャップ非依存性翻訳を仲介する。
[本発明1001]
以下の工程を含む、NECL5(ネクチン様タンパク質5)を発現する固形腫瘍を有するヒトを治療する方法:
ポリオウイルスSabin I型株を含むキメラポリオウイルス構築物であって、該ポリオウイルスが、該ポリオウイルスのクローバーリーフと該ポリオウイルスのオープンリーディングフレームとの間の該ポリオウイルスの5'非翻訳領域にヒトライノウイルス2(HRV2)内部リボソーム進入部位(IRES)を有する、構築物を、該ヒトにおける該腫瘍に直接投与する工程。
[本発明1002]
前記キメラポリオウイルス構築物を投与するために対流増加送達が用いられる、本発明1001の方法。
[本発明1003]
前記固形腫瘍が神経膠芽腫である、本発明1001の方法。
[本発明1004]
前記固形腫瘍が前立腺腫瘍である、本発明1001の方法。
[本発明1005]
前記投与が脳内投与である、本発明1001の方法。
[本発明1006]
前記固形腫瘍が髄芽腫である、本発明1001の方法。
[本発明1007]
前記固形腫瘍が乳腺腫瘍である、本発明1001の方法。
[本発明1008]
前記固形腫瘍が肺腫瘍である、本発明1001の方法。
[本発明1009]
前記固形腫瘍が結腸直腸腫瘍である、本発明1001の方法。
[本発明1010]
前記投与が、対流増加送達による脳内注入である、本発明1001の方法。
[本発明1011]
前記投与が定位的に誘導される、本発明1010の方法。
[本発明1012]
前記ヒトが成人である、本発明1001の方法。
[本発明1013]
前記ヒトが小児である、本発明1001の方法。
[本発明1014]
同時または連続化学療法が前記ヒトに施される、本発明1012の方法。
[本発明1015]
同時または連続放射線療法が前記ヒトに施される、本発明1013の方法。
[本発明1016]
前記固形腫瘍が、非病原性の腫瘍溶解性ポリオウイルスの投与前または投与後に外科切除される、本発明1001の方法。
[本発明1017]
前記固形腫瘍が、前記投与する工程の前に、NECL5の発現について試験される、本発明1001の方法。
[本発明1018]
以下の工程を含む、NECL5(ネクチン様タンパク質5)を発現する固形腫瘍を有するヒトを治療する方法:
固形腫瘍がNECL5を発現していることを確認するために該固形腫瘍を試験する工程;
ポリオウイルスSabin I型株を含むキメラポリオウイルス構築物であって、該ポリオウイルスが、該ポリオウイルスのクローバーリーフと該ポリオウイルスのオープンリーディングフレームとの間の該ポリオウイルスの5'非翻訳領域にヒトライノウイルス2(HRV2)内部リボソーム進入部位(IRES)を有する、構築物を、該ヒトにおける該腫瘍に直接投与する工程であって、該投与が、定位的に誘導される、対流増加送達による脳内注入である、工程。
本発明者らは、ヒトにおいて使用するためのウイルス構築物を開発した。以前より、ウイルス構築物の実験室グレードの標品が細胞培養モデル及び動物モデルで試験されてきた。しかし、これらの試験は、如何なる効果も、未精製の実験室グレードの標品中の他の要素ではなく、ウイルス構築物自身に起因すると考えるには不十分である。さらに、当分野において周知なように、細胞培養モデル及び動物モデルは、ヒトにおける効能を予測させるものではない。
動物腫瘍モデル。 PVS-RIPOのIND用有効性試験を、胸腺欠損マウスのHTB-15 GBM異種移植モデルで行った。(臨床ロットからの)PVS-RIPOを、「マウス用に調整された」FDAにより承認された最大開始用量で投与した[FDAにより承認された最大開始用量(10e8 TCID)を、マウスにおけるより小さい腫瘍サイズ用に(6.7×10e6 TCIDに)調節した]。送達は、所期の臨床経路、即ち、ゆっくりとした腫瘍内注入を模した。これらの条件下で、PVS-RIPOは、15日後に全ての動物において完全な腫瘍退縮を誘導した(図8A)。10日目までは、処置された腫瘍からウイルスが回収されたものの、その量は最高でも中程度であり、ウイルスによる直接的な腫瘍細胞死滅だけではこの処置の効果を説明できないことが示唆された(図8B)。
臨床試験。 IND番号14,735の「再発性神経膠芽腫に対するPVSRIPOの用量決定及び安全性研究」は、2011年6月19日にFDAに承認され、2011年10月27日にIRBに承認された。再発性神経膠芽腫(GBM)(NCT01491893)の患者におけるフェーズI/II臨床試験について現在患者を登録している。
第一のヒト対象での予備的発見。 当該患者は、右前頭葉のGBM(WHOグレードIV)と診断された21歳の女性看護学生である。当該患者は重篤な頭痛の病歴、及び、副鼻腔感染の疑いによる失敗に終わった治療の後、20歳の2011年6月に初めて診断された。2011年6月17日に脳イメージングが得られ、右前頭葉に約5×6cmと測定された大きな腫瘤が見られた。当該患者は、2011年6月22日に右前頭葉の腫瘤の部分切除を受け、病理学的にGBM(WHOグレードIV)と確認された。当該患者の若さ、抜群のパフォーマンスステータス及び部分腫瘍切除を考慮し、6週間の放射線治療、および、毎日の経口での75mg/m2のテモダール化学療法と2週間毎のベバシズマブ(血管新生抑制剤)投与との併用の組合せで、当該患者を積極的に処置することが決定された。当該患者は2011年9月18日に、6週間の処置を終えた。当該患者は2011年10月3日に、2週間毎のベバシズマブ10mg/kgに加えて、毎月5日間のテモダール化学療法による補助療法を開始した。
対流注入。 術前にBrainLab iPlan Flowシステムを用いて、術前MRIから得られる情報を用いて予測される分布に基づいてカテーテルの経路を設計する。
Claims (19)
- ポリオウイルスSabin I型株のクローバーリーフと該ポリオウイルスのオープンリーディングフレームとの間の該ポリオウイルスの5'非翻訳領域にヒトライノウイルス2(HRV2)内部リボソーム進入部位(IRES)を有するポリオウイルスSabin I型株を含むキメラポリオウイルス構築物を含み、前記キメラポリオウイルス構築物がNECL5(ネクチン様タンパク質5)を発現する再発性神経膠芽腫に直接投与されるように用いられることを特徴とする、外科的切除、外科的縮小、化学療法、生物学的療法および放射線療法からなる群から選択される神経膠芽腫の標準的なケアを受けたことのある患者における再発性神経膠芽腫を治療するための医薬。
- 前記キメラポリオウイルス構築物が、対流増加送達により再発性神経膠芽腫に直接投与される、請求項1に記載の医薬。
- 前記神経膠芽腫が、WHOグレードIVの神経膠芽腫である、請求項1または2に記載の医薬。
- 前記キメラポリオウイルス構築物が、対流増加送達による脳内注入により再発性神経膠芽腫に直接投与される、請求項1乃至3のいずれか一項に記載の医薬。
- 前記投与が定位的に誘導される、請求項4に記載の医薬。
- 前記患者が、成人である、請求項1乃至5のいずれか一項に記載の医薬。
- 前記患者が、小児である、請求項1乃至5のいずれか一項に記載の医薬。
- 前記医薬が、外科的切除、外科的縮小、化学療法、生物学的療法および放射線療法からなる群から選択される神経膠芽腫の標準的なケアと組み合わせて用いられることを特徴とする、請求項1乃至7のいずれか一項に記載の医薬。
- 前記キメラポリオウイルス構築物の投与の前に、患者における神経膠芽腫が、NECL5の発現について試験される、請求項1乃至8のいずれか一項に記載の医薬。
- ポリオウイルスSabin I型株のクローバーリーフと該ポリオウイルスのオープンリーディングフレームとの間の該ポリオウイルスの5'非翻訳領域にヒトライノウイルス2(HRV2)内部リボソーム進入部位(IRES)を有するポリオウイルスSabin I型株を含むキメラポリオウイルス構築物を含み、前記キメラポリオウイルス構築物がNECL5(ネクチン様タンパク質5)を発現する再発性神経膠芽腫に定位的に誘導される、対流増加送達による脳内注入により直接投与されるように用いられることを特徴とする、外科的切除、外科的縮小、化学療法、生物学的療法および放射線療法からなる群から選択される神経膠芽腫の標準的なケアを受けたことのある患者における再発性神経膠芽腫を治療するための医薬。
- 前記患者が、成人である、請求項10に記載の医薬。
- 前記患者が、小児である、請求項10に記載の医薬。
- 前記医薬が、外科的切除、外科的縮小、化学療法、生物学的療法および放射線療法からなる群から選択される神経膠芽腫の標準的なケアと組み合わせて用いられることを特徴とする、請求項10乃至12のいずれか一項に記載の医薬。
- 前記キメラポリオウイルス構築物の投与の前に、患者における神経膠芽腫が、NECL5の発現について試験される、請求項10乃至13のいずれか一項に記載の医薬。
- ガドリニウムをさらに含む、請求項1乃至14のいずれか一項に記載の医薬。
- 前記ガドリニウムが、Gd-DTPAである、請求項15に記載の医薬。
- ヒト血清アルブミンをさらに含む、請求項15または16に記載の医薬。
- 前記ヒト血清アルブミンが、放射標識されている、請求項17に記載の医薬。
- 前記ヒト血清アルブミンが、 124 Iで放射標識されている、請求項18に記載の医薬。
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AU2013347945B2 (en) | 2012-11-21 | 2017-02-02 | Duke University | Oncolytic poliovirus for human tumors |
WO2016201224A1 (en) | 2015-06-10 | 2016-12-15 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Processes for production and purification of nucleic acid-containing compositions |
CN108026567B (zh) * | 2015-07-31 | 2021-10-22 | 美国政府(由卫生和人类服务部的部长所代表) | 分析病毒来源治疗剂的方法 |
JP6850290B2 (ja) * | 2015-10-15 | 2021-03-31 | デューク ユニバーシティー | 併用療法 |
MX2018007423A (es) | 2015-12-17 | 2018-11-09 | Novartis Ag | Moleculas de anticuerpo que se unen a pd-1 y usos de las mismas. |
DK3432901T3 (da) * | 2016-03-21 | 2021-10-11 | Univ Duke | Sekventiel antikræftbehandling |
AU2017263543A1 (en) * | 2016-05-11 | 2018-12-13 | Ohio State Innovation Foundation | Oncolytic viruses comprising esrage and methods of treating cancer |
CN109414023A (zh) * | 2016-06-29 | 2019-03-01 | 杜克大学 | 用嵌合脊髓灰质炎病毒激活抗原呈递细胞的组合物和方法 |
WO2018067446A1 (en) | 2016-10-06 | 2018-04-12 | Duke University | Detection of cd-155, the poliovirus receptor |
WO2018075357A1 (en) | 2016-10-17 | 2018-04-26 | Duke University | PRODUCTION OF IMMUNOTOXIN D2C7-(scdsFv)-PE38KDEL |
CN109276580B (zh) * | 2017-07-21 | 2021-08-24 | 厦门大学 | 一种用于治疗肿瘤的病毒 |
CA3095591A1 (en) * | 2018-04-02 | 2019-10-10 | Duke University | Neoadjuvant cancer treatment |
CN110387353B (zh) * | 2018-04-16 | 2023-07-18 | 厦门大学 | 一种用于治疗肿瘤的柯萨奇b组病毒 |
US20220387529A1 (en) * | 2019-11-04 | 2022-12-08 | Duke University | Treatment for primary and metastatic cancer |
US20210196813A1 (en) * | 2019-12-27 | 2021-07-01 | Rush University Medical Center | Utilizing Vaccines to Treat Cancer and Enhance the Success Rate of Cancer Immunotherapy |
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US5541100A (en) * | 1990-09-12 | 1996-07-30 | Rutgers University | Chimeric rhinoviruses |
US6264940B1 (en) * | 1998-08-05 | 2001-07-24 | The Research Foundation Of State University Of New York | Recombinant poliovirus for the treatment of cancer |
US6518033B1 (en) | 1998-08-05 | 2003-02-11 | The Research Foundation Of State University Of New York | Method of detecting the presence of CD155 for diagnosis of cancer and to determine treatment |
US8066983B2 (en) * | 2008-03-14 | 2011-11-29 | The Research Foundation Of State University Of New York | Attenuated poliovirus |
US8076070B2 (en) | 2008-08-06 | 2011-12-13 | University Of Southern California | Genome-wide chromosome conformation capture |
EP2629803A2 (en) * | 2010-10-20 | 2013-08-28 | Mount Sinai School Of Medicine | Methods and compositions for treating tumors using myeloid derived suppressor cells |
BR112013017096A2 (pt) * | 2011-01-04 | 2020-09-01 | Jennerex Inc. | composição e métodos de indução de resposta citotóxica dependente de complemento mediado por anticorpo específico de tumor em animal tendo tumor, de geração de anticorpos in vivo, de inibição do crescimento ou morte de célula de câncer, para tratar indivíduo com câncer, para adaptar de terapia de câncer para indivíduo com câncer e para identificar antígeno específico de tumor |
AU2013347945B2 (en) | 2012-11-21 | 2017-02-02 | Duke University | Oncolytic poliovirus for human tumors |
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CA2892183A1 (en) | 2014-05-30 |
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US11406677B2 (en) | 2022-08-09 |
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AU2013347945A1 (en) | 2015-06-04 |
HK1211487A1 (en) | 2016-05-27 |
ES2688653T3 (es) | 2018-11-06 |
CN104936608A (zh) | 2015-09-23 |
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US10799543B2 (en) | 2020-10-13 |
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EP2922564B1 (en) | 2018-07-04 |
US20160030497A1 (en) | 2016-02-04 |
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