Tempest Therapeutics Announces Clinical Data for TPST-2003

Tempest Therapeutics announced clinical data from the ongoing REDEEM-1 Phase 1/2a trial evaluating TPST-2003, a CD19/BCMA dual-targeting CAR-T therapy. TPST-2003 is being developed in China by Tempest's partner, Novatim Immune Therapeutics. Under its agreement with Novatim, Tempest has the exclusive right to develop TPST-2003 outside of China, India, Turkey, and Russia. As of the January 31, 2026 data cutoff, a total of 36 patients with rrMM had received one infusion of TPST-2003, including 24 patients in a prior Phase 1/2 IIT and 12 patients in the ongoing REDEEM-1 trial. As of the January 15, 2026 data cutoff, TPST-2003 demonstrated a favorable safety profile across all dose levels evaluated in REDEEM-1. As of the data cutoff, patients in the REDEEM-1 trial experienced: No Grade three or higher cytokine release syndrome; One patient treated at the highest dose level experienced low-grade immune effector cell-associated neurotoxicity syndrome; No Grade three or higher ICANS. Tempest believes the results of the ongoing REDEEM-1 study are consistent with prior clinical results, including a 24-patient Phase 1/2 IIT. In the IIT, among 19 evaluable patients with measurable disease at baseline: ORR was 100%; CR rate was 89.5%; At the highest dose level, CR was observed in 100% of patients. The IIT also demonstrated durable disease control, with: Median progression-free survival of 23.1 months across all patients; Median PFS of 23.1 months in patients with extramedullary disease; All evaluable patients remained MRD-negative at month 12.