TPST News & Events

Tempest Therapeutics announced the selection of Cincinnati Children's Applied Gene and Cell Therapy Center as the lead contract development and manufacturing partner to conduct the formal technology transfer of TPST-2003, Tempest's dual-targeting CD19/BCMA CAR-T therapy under development for the treatment of relapsed/refractory multiple myeloma. Tempest recently announced that, as of a 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 investigator-initiated trial and 12 patients in the ongoing REDEEM-1 trial, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy. As of the data cutoff, all six efficacy evaluable patients enrolled in the REDEEM-1 trial had achieved a complete response according to the International Myeloma Working Group uniform response criteria. Among 25 evaluable patients with measurable disease at baseline across both studies, the overall response rate was 100%. Tempest plans to present the results of the REDEEM-1 trial and updated results from the IIT at a scientific meeting later this year.

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.

Tempest Therapeutics files to sell 1.17M shares of common stock for holders