Brightpath Biotherapeutics Receives FDA Approval for Phase I Clinical Trial

TOKYO, Aug 03 (Pulse News Wire) – Brightpath Biotherapeutics CO.,LTD. (4594.T) received approval from the U.S.

Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for BP2,202. The trial focuses on treating relapsed and refractory multiple myeloma patients through off-the-shelf CAR-NKT cells targeting B-cell maturation antigen (BCMA). BP2,202 B (BCMA) iPS T(NKT) utilizes pre-manufactured natural killer (NKT) cells as effectors, aiming to reduce patient-specific manufacturing time and enable rapid treatment initiation. With approximately 30,000 estimated cases of multiple myeloma diagnosed annually in the U.S., there is a growing need for innovative therapeutic options. The upcoming Phase I clinical trial will involve open-label, non-randomized, multi-center dose escalation studies. Participants will undergo lymphodepletion conditioning followed by administration of BP2,202 B (BCMA) iPS T(NKT) cells over three weeks.

Safety, tolerability, and clinical activity will be evaluated post-administration. BrightPath Biotherapeutics plans to establish trial infrastructure in U.S. facilities while concurrently transferring manufactured investigational drugs from contract development and manufacturing organizations (CDMOs) to respective sites. The company aims to initiate dosing within the year. This milestone marks significant progress in advancing the company's proprietary induced pluripotent stem cell (iPS)-derived cellular therapy platform towards clinical development. Further evaluation of BP2,202's safety and initial clinical efficacy will pave the way for broader applications of this technology.

There will be no impact on fiscal results for the period ending March 2027.