Brightpath Biotherapeutics Submits IND Application for BP2,202 to FDA

TOKYO, Jul 02 (Pulse News Wire) – Brightpath Biotherapeutics CO.,LTD. (4594.T) submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for BP2,202, an iPSC-derived BCMA CAR-NKT cell therapy aimed at treating multiple myeloma.

BP2,202 utilizes natural killer T (NKT) cells derived from induced pluripotent stem (iPS) cells targeting the B-cell maturation antigen (BCMA). This novel allogeneic CAR-T cell therapy was granted orphan drug designation by the FDA in July 2025 for the treatment of multiple myeloma.

The submission marks a significant milestone in the development program, paving the way for the initiation of Phase I clinical trials involving human administration. Any further developments will be disclosed promptly.

There will be no impact on the fiscal year ending March 2027 performance due to this filing.