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Noile-Immune Biotech(4893 TSE Growth)

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Development of new immune cell therapy for solid tumors

Development of New Immune-Cell Therapy for Solid Tumors
Noile-Immune Biotech, a bio-venture company originating from the National Cancer Center Japan and Yamaguchi University, is developing PRIME CAR-T cell therapy. This is a cancer immunotherapy that treats solid tumors such as stomach cancers and lung cancers by enhancing the function of T cells, which are immune cells. The PRIME technology utilized in this therapy has been developed by the company president and CEO, Koji Tamada, along with his team.

PRIME Technology Responsible for Activating Immune Cells and Accumulate Them to Cancer Sites
PRIME technology is a technique that genetically modifies immune cells to generate substances that activate these cells and induce their accumulation at cancer sites. PRIME CAR-T cell therapy represents the implementation of PRIME technology in CAR-T cells, in which a gene that recognizes cancer antigens is introduced into T cells. The technique demonstrates therapeutic efficacy by accumulating immune cells in the local area of solid tumors. This had proven difficult using conventional CAR-T cell therapy, which targets blood cancers. The technique also activates the patient's own immune cells.

Promote Proprietary Drug Discovery and Joint Pipeline Development with Other Companies
The company has two types of pipelines: a proprietary drug discovery pipeline for the development of PRIME CAR-T cell therapy drugs and a collaborative pipeline for the purpose of providing PRIME technology to other companies' pipelines of cell therapy drugs that are in the process of development. Although the total revenue of the collaborative pipeline is smaller than that of proprietary drug discovery, the funds can be recovered at an early stage in the form of technology fees.

The company has three proprietary drugs in Phase I clinical trials: NIB101 for small cell lung cancer, and two drugs licensed out to Takeda Pharmaceuticals: NIB102 for hepatocellular carcinoma and NIB103 for triple-negative breast cancer (TNBC). NIB101 is expected to be eligible for the early approval system upon confirmation of the drug’s efficacy and safety in clinical trials, and derivation is anticipated at that stage.



ノイルイミューン・バイオテックの玉田耕治社長らが開発したPRIME技術を活用し、免疫細胞であるT細胞の機能を強化することで胃がんや肺がん等の固形がんの治療を行う、がん免疫療法のPRIME CAR-T細胞療法の開発を主な事業としている。






しかし、従来のCAR-T細胞療法は、がん患者の約9割を占める固形がんに対しては未だ有効性を示せておらず、承認された薬剤や療法はない。固形がんを対象とする次世代型CAR-T細胞療法の技術開発や臨床研究が各国で進められており、同社のPRIME CAR-T細胞療法もその一つになる。





ノイルイミューン・バイオテックではPRIME技術を利用したCAR-T細胞療法をPRIME CAR-T細胞療法としている。PRIME技術の根幹は、CAR-T細胞の攻撃能力を高めることに加え、患者自身の免疫細胞を活性化し、固形がんに対する多様な攻撃により、長期の治療効果を誘導することにある。






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