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Tempest Announces Interim Results from Ongoing REDEEM-1 Trial of TPST-2003, Preparing for Potential U.S. Registrational Study in 2026
100% complete response (CR) rate among all six efficacy evaluable patientsFavorable safety profile with no Grade >3 CRS or ICANSPrior investigator-initiated
About this update from Tempest Therapeutics, Inc.
[{"type":"text","content":"100% complete response (CR) rate among all six efficacy evaluable patientsFavorable safety profile with no Grade >3 CRS or ICANSPrior investigator-initiated trial (IIT) reached median progression free survival (PFS) of 23.1 months, including in patients with extramedullary disease36 patients with relapsed/refractory multiple myeloma treated to date across two studiesTempest plans to submit a U.S. IND and, subject to clearance, initiate a U.S. registrational study in 2026 BRISBANE, Calif., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing a pipeline of advanced cell therapy and small molecule product candidates to treat cancer, today 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 an autologous CD19/BCMA dual-targeting CAR-T therapy designed to improve response depth and durability in patients with relapsed/refractory multiple myeloma (“rrMM”) through a parallel dual-targeting CAR structure designed to address tumor heterogeneity and antigen escape. TPST-2003 is being developed in China by Tempest’s partner, Novatim Immune Therapeutics (“Novatim”). 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, representing one of the largest datasets evaluating a CD19/BCMA dual-targeting CAR-T therapy. As of the data cutoff, patients enrolled in the REDEEM-1 trial have received a median of four prior lines of therapy. All six patients currently evaluable for efficacy in the REDEEM-1 trial – three treated at dose level 1 (1 x 106 cells/kg) and three at dose level 2 (2 x 106 cells/kg) – achieved a CR according to the International Myeloma Working Group (IMWG) uniform response criteria. Among 25 evaluable patients with measurable disease at baseline across both studies, the overall response rate (“ORR”) was 100% (25/25). Clinical responses were observed consistently across dose levels and study settings, which Tempest believes supports the reproducibility of TPST-2003’s parallel d...