BiGEN, a strategic partner of Noile Immune Biotech, Inc (herein, Noile), is pleased to share the news, "CTN submission of NIB101 phase 1 clinical trial", released by Noile today. We hope Noile will be able to obtain successful clinical outputs through this clinical study, thereby providing wonderful medical benefits for all the patients and their family suffering from solid cancers in a relatively short period of time. For more details, please refer to official news release of Noile below;
September 14, 2021
Noile-Immune Biotech, Inc.
Announcement of Clinical Trial Notification (CTN) submission of NIB101 Phase 1 Clinical Trial for Solid Tumors in Japan
Noile-Immune Biotech Inc. announces the CTN submission of NIB101 Phase 1 Clinical Trial to the Pharmaceuticals and Medical Devices Agency (PMDA).
NIB101 is a CAR-T cell (chimeric antigen receptor-T cell) derived from autologous T cells equipped with PRIME technology and targets GM2, a type of glycolipid expressed on certain types of cancer cells.
PRIME technology was developed by Dr. Koji Tamada, a scientific founder of the company and President & CEO. The company owns exclusive license of the technology, which enhances the function of genetically modified immune cells such as CAR-T cells and activates the host’s own cells.1) GM2 is known to be expressed on malignant pleural mesothelioma, small cell lung cancer, pancreatic cancer, and other cancers2)3). These cancer types are usually aggressive cancers with a poor prognosis4) , and there are significant unmet medical needs.
This study is a phase I clinical trial, targeting patients with GM2 positive solid cancers that are refractory or intolerant of standard-of-care therapies and plans primarily to evaluate the tolerability and safety of NIB101 for approximately 42 subjects, aiming to complete the registration in the second half of 2023.
A type of lymphocyte, which expresses T cell receptor (TCR) on their surface and plays an important role in immune response against cancer.
CAR-T cells stand for chimeric antigen receptor T cells, generated by genetic modification of T cells to express an artificial chimeric antigen receptor composed of single-chain antibodies 2 / 2 specific for cell-surface antigens of cancer and molecular signaling domains for T cell activation.
Noile-Immune Biotech, Inc.
Noile-Immune Biotech, Inc. is a venture company derived from Yamaguchi University and National Cancer Center with the mission of contributing to the creation of a society which is able to overcome cancer. The company aims to develop new therapies for solid cancers using genetically modified immune cell therapies, mainly CAR-T cells equipped with PRIME (proliferation inducing and migration enhancing) technology.
1) Adachi K et al. Nat Biotechnol, 2018;36(4):346-351.
2) Miyake M et al. Cancer Res. 1988;48(21):6154-6160.
3) Sasaki N et al. Sci Rep. 2019;9(1):19369.
4) National Cancer Institute Cancer Information Service
https://ganjoho.jp/reg_stat/index.html (accessed in September, 2021)