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BP2301 is an autologous HER2-targeted chimeric antigen receptor T-cell (CAR-T) therapy being developed by BrightPath Biotherapeutics for the treatment of HER2-positive solid tumors, including sarcomas and gynecological malignancies. Unlike many CAR-T therapies that utilize viral vectors, BP2301 is manufactured using a non-viral PiggyBac transposon system. This approach is designed to produce a T-cell product enriched with stem cell memory-like T cells (TSCM) and central memory T cells (TCM), which are characterized by high proliferative potential, long-term persistence, and reduced exhaustion. The therapy is currently being evaluated in Phase I clinical trials, including an investigator-initiated trial for osteosarcoma.
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