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Development of a completely new antibody-cell complex advanced technology that overcomes the limitations of allogeneic CAR-T therapy.

Research Project

Project/Area Number 21K19529
Research Category

Grant-in-Aid for Challenging Research (Exploratory)

Allocation TypeMulti-year Fund
Review Section Medium-sized Section 55:Surgery of the organs maintaining homeostasis and related fields
Research InstitutionKyushu University

Principal Investigator

Yonemitsu Yoshikazu  九州大学, 薬学研究院, 教授 (40315065)

Project Period (FY) 2021-07-09 – 2023-03-31
Project Status Completed (Fiscal Year 2022)
Budget Amount *help
¥3,900,000 (Direct Cost: ¥3,000,000、Indirect Cost: ¥900,000)
Fiscal Year 2022: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2021: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
KeywordsNK細胞 / 抗体医薬 / 固形腫瘍 / CAR-T / がん免疫 / 他家細胞 / CAR / 架橋 / 非遺伝子改変 / 抗体細胞複合体
Outline of Research at the Start

難治性悪性腫瘍に対し、期待されながらも製剤化の困難に直面する他家CAR-Tの限界を突破するため、独自特許技術であるNK細胞製剤GAIA-102の機能を更に高度化するための、遺伝子導入技術を用いず既存抗体医薬品の全てに適応可能な「抗体・細胞複合体」高度化技術を開発する。高度な結合能を持ち、低抗原性のものを絞り込んだ上で、動物にて確認する。現在世界中が困難に直面しているCAR-Tの製剤化の問題点を一気に解決可能であるポテンシャルを有する。

Outline of Final Research Achievements

We have selected NKp46, 2B4, and NKp30 as target molecules on GAIA-102 and conducted selection of monobodies that specifically bind to these target molecules. All clones were confirmed to bind to GAIA-102. In addition, we designed scFv based on known antibody sequences and fusion proteins with monobody for functional evaluation of GAIA-102 binding monobodies. These research results provide valuable data for the development of advanced "antibody-cell complex" technology as intended and will now move on to the practical development steps for standardization and manufacturing towards clinical development.

Academic Significance and Societal Importance of the Research Achievements

難治性悪性腫瘍に対し、期待されながらも製剤化の困難に直面する他家CAR-T(キメラ遺伝子導入T細胞治療)の限界を突破するために、独自特許技術であるNK細胞製剤GAIA-102 (AMEDの支援にて開発中)の機能を更に高度化するための遺伝子導入技術を用いず既存抗体医薬品の全てに適応可能な「抗体・細胞複合体」高度化技術を開発することで、未だ治療成果が十分では無い広範な悪性腫瘍に有効な治療法を提供する。

Report

(3 results)
  • 2022 Annual Research Report   Final Research Report ( PDF )
  • 2021 Research-status Report
  • Research Products

    (4 results)

All 2022

All Presentation (4 results) (of which Int'l Joint Research: 2 results,  Invited: 2 results)

  • [Presentation] 再生医療等製品を取り巻く諸問題:特に薬価について2022

    • Author(s)
      米満吉和
    • Organizer
      琉球大学AMED再生事業シンポジウム
    • Related Report
      2022 Annual Research Report
  • [Presentation] MANUFACTURING: Optimizing Cell Expansion Protocols for High Quality Product Yeild GAIA-NK: Off-the-shelf ‘NK-like’ cell product that can eliminate solid tumors2022

    • Author(s)
      Yoshikazu Yonemitsu
    • Organizer
      7th Innate Killer Summit
    • Related Report
      2022 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] GAIA-NK: Off-the-shelf ‘NK-like’ cell product that can eliminate solid tumors2022

    • Author(s)
      Yoshikazu Yonemitsu
    • Organizer
      Oncology Immunotherapy Webinar Virtual Conference
    • Related Report
      2022 Annual Research Report
    • Int'l Joint Research / Invited
  • [Presentation] 固形がんを破壊可能な新しいNK細胞様フェノタイプGAIA-NKの臨床開発2022

    • Author(s)
      米満吉和
    • Organizer
      第28回 日本遺伝子細胞治療学会(JSGCT2022)
    • Related Report
      2022 Annual Research Report

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Published: 2021-07-13   Modified: 2024-01-30  

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