2023 Fiscal Year Final Research Report
Basic research for the development of companion diagnostics for immunotherapy targeting the HPVE7 cancer protein
| Project/Area Number |
20K09656
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Review Section |
Basic Section 56040:Obstetrics and gynecology-related
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| Research Institution | Nihon University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
川名 敬 日本大学, 医学部, 教授 (60311627)
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| Project Period (FY) |
2020-04-01 – 2024-03-31
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| Keywords | 子宮頸癌 / HPV / 癌ワクチン / 粘膜免疫 / 子宮頸部高度上皮内腫瘍 / 第I/II相医師主導治験 / E7発現乳酸菌製剤 / コンパニオン診断 |
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| Outline of Final Research Achievements |
We have developed a therapeutic HPV vaccine, IGMKK16E7, as an immunotherapy (cancer vaccine) targeting HPV cancer protein E7, which is highly expressed in the precancerous lesion CIN2/3 of cervical cancer.
Results of a phase I/II investigator-initiated trial using this showed poor effector cell efficacy in patients with high CD86 expression and enhanced efficacy in patients with low CD86 expression.
CD86 and CTLA-4 expression were positively correlated, presumably suppressing T cells.Patients with low CD86 expression were found to have high efficacy for IGMKK16E7.Therefore, finding patients with low CD86 expression may lead to the development of this companion diagnosis.
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| Free Research Field |
産婦人科、婦人科腫瘍学
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| Academic Significance and Societal Importance of the Research Achievements |
我々は、世界初の治療的HPVワクチンの開発を行っている。
第I/II相ランダム化比較試験の結果、プラセボ群と比べてIGMKK16E7（高用量群）において、有意なCIN2/3の治癒効果を示した。本研究によって、治療前のCIN2/3患者の子宮頸部でCD86低発現の症例を選択することがIGMKK16E7の治療をより効果的にすることがわかった。CD86低発現の症例の選択が、この治療薬のコンパニオン診断になりうると考えられる。この治療薬によって、CIN2/3に対する子宮頸部円錐切除術後の早産リスクが回避できる点は社会的意義が大きい。
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