TPST · Tempest Therapeutics, Inc.

Tempest Therapeutics reported highly positive clinical data for its lead asset TPST-2003, a dual-targeting CD19/BCMA CAR-T therapy, at the ISCT 2026 Annual Meeting. The data update more than doubled the previous dataset, demonstrating a 100% complete response (CR) rate among all 15 CAR-T-naïve efficacy evaluable patients across the ongoing REDEEM-1 and POEMS-1 Phase 1 trials. In REDEEM-1, all 10 evaluable patients achieved CR per IMWG criteria, while all 5 evaluable patients in POEMS-1 achieved CR VEGF. The safety profile remained favorable with no Grade > 3 CRS or ICANS observed in REDEEM-1 and no dose-limiting toxicities in POEMS-1. These results reinforce the potential of the parallel-structure dual-targeting CAR architecture to address tumor heterogeneity. Supporting these findings, data from a prior Phase 1/2 investigator-initiated trial showed a 100% overall response rate in 29 CAR-T-naïve patients and a median progression-free survival of 23.1 months, including in patients with extramedullary disease. Based on these results, management stated plans to meet with the FDA to discuss initiating a U.S. registrational study later this year.