Noile-Immune Biotech Inc. has elucidated the mechanism by which PRIME CAR-T cells demonstrate superior therapeutic effects against solid cancers through collaborative research with the Department of Immunology, Yamaguchi University Graduate School of Medicine and hereby announces that these findings have been published in "Cancer Immunology, Immunotherapy".

 Chimeric antigen receptor T-cell (CAR-T) therapy is an advanced immunotherapy that involves genetic modification of immune cells to enable potent and selective anti-tumor activity, and has demonstrated remarkable clinical efficacy in hematological malignancies. In contrast, achieving sufficient therapeutic effects in solid tumors has been challenging, largely due to tumor heterogeneity and antigen loss. To overcome these limitations, Noile-Immune Biotech Inc. has developed “PRIME CAR-T cells,” which are engineered to co-express interleukin-7 (IL-7) and C-C motif chemokine ligand 19 (CCL19), and is advancing their clinical development and commercialization.

 Through a collaborative research program with the Department of Immunology, Yamaguchi University Graduate School of Medicine, Noile-Immune Biotech Inc. has now elucidated a key mechanism underlying the enhanced anti-tumor activity of PRIME CAR-T cells in solid tumors. Using murine solid tumor models, the study demonstrated that PRIME CAR-T cells induce epitope spreading^＊, a process by which endogenous immune responses against tumor antigens are progressively expanded in vivo. As a result, PRIME CAR-T cells exhibited therapeutic efficacy even against heterogeneous solid tumors and tumor tissues in which antigen-negative variants had emerged following loss of the CAR target. Furthermore, this epitope-spreading-mediated anti-tumor response was also observed in allogeneic CAR-T cells generated from different mouse strains. The study additionally showed that the anti-tumor effects of PRIME CAR-T cells were further enhanced when combined with immune checkpoint inhibitors.

 The research achievements have been published in "Cancer Immunology, Immunotherapy".

 Noile-Immune Biotech Inc. will continue its corporate efforts toward the practical application and commercialization of PRIME CAR-T cell therapy.

^＊： An epitope is the part of an antigen that is recognized by antibodies or T cell receptors. Epitope spreading refers to the process during the immune response where the reaction to the initially targeted epitope causes new epitopes to be presented to immune cells, leading to a continuous immune response to these new epitopes.

Noile-Immune Biotech Inc.