BP2202 / BrightPath Biotherap - LARVOL DELTA

BP2202: An Off-The-Shelf Ipsc-Derived Bcma-Targeted Cellular Therapy for Multiple Myeloma (IMS 2026) - "BP2202 is an off-the-shelf iPSC-derived BCMA-targeted iNKT cell therapy that demonstrates promising preclinical antitumor activity, favorable genetic safety profiles, and highly reproducible manufacturing. These findings support the clinical development of BP2202 as a novel allogeneic cell therapy for multiple myeloma."

First-in-human • IO biomarker • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Lymphoma • Multiple Myeloma

A Phase I, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: BrightPath Biotherapeutics Co., Ltd. | Trial completion date: Dec 2043 ➔ Dec 2028 | Trial primary completion date: Dec 2029 ➔ Dec 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

BP2202 is the subject of an regulatory application (IND) submitted by the U.S. Food and Drug Administration (FDA). [Google translation] (BrightPath Biotherapeutics Press Release) - "The submission of this application is a procedural step toward initiating a Phase I clinical trial—the first-in-human administration of BP2202—and represents a significant development milestone for this program."

IND • New P1 trial • Multiple Myeloma

A Phase I, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BP2202 in Patients With Relapsed/Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: BrightPath Biotherapeutics Co., Ltd.

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

U.S. FDA Orphan Drug Designation Granted to BP2202 for the Treatment of Multiple Myeloma (BrightPath Biotherapeutics Press Release) - "BrightPath Biotherapeutics...announced that its iPS cell-derived BCMA CAR-NKT cell therapy candidate, BP2202 (the 'Drug'), has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma, as of July 2, 2025 (U.S. EST)...'We are planning to initiate a clinical trial of BP2202 in the U.S. The ODD granted by the FDA underscores the significant unmet medical need for off-the-shelf, allogeneic CAR-T cell therapies that are readily available when needed for patients with multiple myeloma...'"

Orphan drug • Multiple Myeloma