Tempest Announces Interim Results from Ongoing REDEEM-1 Trial of TPST-2003, Preparing for Potential U.S. Registrational Study in 2026

Core Insights - Tempest Therapeutics announced promising clinical data from the ongoing REDEEM-1 Phase 1/2a trial for TPST-2003, a dual-targeting CAR-T therapy for relapsed/refractory multiple myeloma [1][6] Clinical Data Summary - TPST-2003 is designed to enhance response depth and durability in patients with relapsed/refractory multiple myeloma through a dual-targeting CAR structure [2] - As of January 31, 2026, 36 patients with relapsed/refractory multiple myeloma have received TPST-2003, with a median of four prior lines of therapy [3] - All six evaluable patients in the REDEEM-1 trial achieved a complete response (CR), resulting in an overall response rate (ORR) of 100% among 25 evaluable patients [4][8] Safety Profile - TPST-2003 demonstrated a favorable safety profile across all dose levels, with no Grade >3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [7][9] - The prior investigator-initiated trial (IIT) showed a median progression-free survival (PFS) of 23.1 months, including patients with extramedullary disease [8][10] Future Development Plans - Tempest plans to accelerate the development of TPST-2003 and intends to submit a U.S. IND application, aiming to initiate a U.S. registrational study in 2026 [6][15] - The company is also exploring the potential of TPST-2003 for treating large B-cell lymphoma and other related indications [6][12] Treatment Landscape - Approved CAR-T therapies have shown clinical benefits in relapsed/refractory multiple myeloma, but challenges such as relapse and toxicity management remain prevalent [13] - TPST-2003's dual-targeting CAR structure aims to address tumor heterogeneity and antigen escape, which are significant factors in disease progression [14]