BP2201 / BrightPath Biotherap, Riken - LARVOL DELTA

Allogeneic induced pluripotent stem cell-derived invariant natural killer T cell therapy: A phase 1 clinical Trial (ASH 2025) - P=N/A | "We have presented safety evidence for iPSC-derived iNKT cells, which could form the foundation forfuture developments involving various iPSC-derived immune cells. Furthermore, we confirmed theunique immunological function of iPSC-iNKT cells, which activate NK cells and increase anti-cancer T cells.Additionally, we have overcome the manufacturing barrier for iNKT cells, which will accelerate thedevelopment of iNKT-cell-based immunotherapy."

Clinical • IO biomarker • P1 data • Dermatology • Head and Neck Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • CD8 • IFNG • PD-1

Allogeneic iPSC-derived iNKT cells in recurrent head and neck cancer: a phase 1 trial. (PubMed, Nat Commun) - P=N/A | "Tumor progression was suppressed in two patients, in whom clonal expansion of memory- and effector-phenotype CD8+ T cells was observed, along with activation of the IFN-γ signaling pathway. Here, we show that iPSC-iNKT cells are safe and possess therapeutic potential as an immunotherapy for solid tumors."

Journal • P1 data • Dermatology • Head and Neck Cancer • Oncology • Solid Tumor • CD8 • IFNG

Anti-tumor effect of intratumoral administration of induced pluripotent stem cell-derived NKT cells on glioblastoma through CD155/DNAM-1 interaction. (PubMed, Stem Cells Transl Med) - "We confirmed the anti-tumor effects of iPS-NKT cells on glioblastoma cells in vitro and in vivo. The anti-tumor activity was suggested to be mainly due to the interaction between CD155 and DNAM-1. Intratumoral administration of iPS-NKT cells has potential anti-tumor effects on glioblastoma in the clinic."

IO biomarker • Journal • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor • PVR

Generation of Functional BCMA CAR-iNKT Cells from Clinical-Grade iPSCs via a GMP-Compliant Manufacturing Process with Capacity for Linear Scale-Up (ASGCT 2025) - "These iPSC lines successfully differentiated into CD34+ hematopoietic progenitor cells (HPCs) and subsequently into iPSC-derived iNKT (ipsNKT) cells, achieving robust proliferation with an expansion capacity of up to 6, 000-fold...This study highlights the potential of iPSC-derived CAR-iNKT cells as a versatile and scalable platform for allogeneic cell therapies. Disease Focus of Abstract:Cancer Hematologic"

Clinical • IO biomarker • Graft versus Host Disease • Hematological Malignancies • Immunology • Multiple Myeloma • Oncology • B2M • CD34 • IL15

iPSC-derived HER2 CAR-iNKT cells enhance the activity of immune cells against cancer cells (AACR 2025) - "This study demonstrated that HER2-CAR-ipsNKT cells promote DC maturation and M1 macrophage polarization, likely due to cytokine release from HER2-CAR-ipsNKT cells as a result of CAR-stimulation, and also activate tumor antigen-specific CD8+T cells, thereby enhancing anti-tumor effect in vivo. These results suggest that administration of iPSC-derived CAR-iNKT cells to a patient can improve tumor microenvironment and activate the host endogenous tumor-specific CTLs, potentially achieving a durable therapeutic response."

Immune cell • IO biomarker • Oncology • CD8 • CD80 • CD83 • CD86 • HER-2 • IFNG • IL4 • NKG2D • TNFA

Antibody-Dependent Cellular Cytotoxicity of iPS Cell-Derived Natural Killer T Cells by Anti-GD2 mAb for Neuroblastoma. (PubMed, Cancer Sci) - "In vivo, the intratumor administration of anti-GD2 mAb and iPS-NKT cells significantly inhibited tumor growth compared with the other treatment groups: no treatment, anti-GD2 mAb alone, and iPS-NKT cells alone. In conclusion, iPS-NKT cells exhibit CD16-mediated ADCC, and the addition of iPS-NKT cells to anti-GD2 mAb therapy may be a potential approach for immunotherapy against neuroblastoma."

Journal • CNS Tumor • Neuroblastoma • Oncology • Solid Tumor • FCGR2A • FCGR2B • GZMB • IFNG • TNFA