Tempest Therapeutics, Inc. Reports Strong New Clinical Results For TPST-2003, Its CD19/BCMA Dual-Targeting CAR-T Therapy, In Ongoing REDEEM-1 Phase 1/2a Study

Tempest Therapeutics, Inc., a clinical-stage biotechnology company developing advanced cell therapies and small-molecule treatments for cancer, announced new clinical results from the ongoing REDEEM-1 Phase 1/2a study evaluating TPST-2003, its CD19/BCMA dual-targeting CAR-T therapy. TPST-2003 is designed to strengthen and prolong treatment responses for patients with relapsed or refractory multiple myeloma by using a parallel dual-targeting structure intended to overcome tumor heterogeneity and reduce the risk of antigen escape. The therapy is being developed in China by Tempest’s partner, Novatim Immune Therapeutics, while Tempest holds exclusive rights to pursue development outside China, India, Turkey, and Russia.

As of the January 31, 2026 cutoff, a total of 36 patients with relapsed or refractory multiple myeloma had been treated with TPST-2003—24 from an earlier Phase 1/2 investigator-initiated trial and 12 from the ongoing REDEEM-1 study. This represents one of the largest data collections to date for a CD19/BCMA dual-targeting CAR-T therapy. Patients in REDEEM-1 had received a median of four prior lines of treatment before entering the trial.

Among the six patients currently evaluable for efficacy in REDEEM-1—three treated at dose level 1 and three at dose level 2—all achieved a complete response according to IMWG criteria. Across both studies, 25 patients with measurable disease at baseline were evaluable for response, and all achieved an overall response, resulting in a 100% response rate. These consistent results across doses and study settings reinforce the potential of TPST-2003's parallel dual-targeting architecture and support Tempest’s plan to present the full REDEEM-1 dataset, along with updated IIT results, at a scientific meeting later this year.

Dr. Matt Angel, President and Chief Executive Officer of Tempest, noted that these findings could represent a meaningful advance for patients with relapsed or refractory multiple myeloma. He stated that TPST-2003’s emerging profile suggests it may differentiate itself from currently approved CAR-T therapies by offering strong clinical activity with a favorable safety profile. Based on these outcomes, Tempest is accelerating development of the therapy and exploring expansion into other cancers such as large B-cell lymphoma, as well as additional related disease areas.

Updated safety findings from REDEEM-1 as of January 15, 2026 showed a positive safety profile across all dose levels. No patients experienced Grade 3 or higher cytokine release syndrome. Only one patient at the highest dose level reported low-grade ICANS, and no cases of Grade 3 or higher ICANS were observed. This combination of manageable safety and strong early efficacy supports the company’s plan to meet with the U.S. FDA to discuss initiating a registrational study later this year.

Tempest also reviewed results from the earlier Phase 1/2 investigator-initiated trial, which demonstrated deep and durable responses. Among 19 evaluable patients, the overall response rate was again 100%, with an 89.5% complete response rate. At the highest dose level, all treated patients achieved a complete response. Median progression-free survival was 23.1 months across all patients, including those with extramedullary disease—a group typically associated with poorer outcomes. All evaluable patients remained MRD-negative at 12 months, supporting the therapy’s potential durability.

Novatim’s proprietary parallel dual-targeting CAR structure is a key component of TPST-2003’s design. Dr. Guoxiang Wu, Chairman and General Manager of Novatim, explained that the architecture is intended to overcome limitations seen with other approaches, including relapse due to insufficient target coverage. He noted that TPST-2003 has shown promising activity not only in multiple myeloma but also in POEMS syndrome and may have potential utility in autoimmune diseases, supported by its safety and efficacy profile.

Within the broader treatment landscape, CAR-T therapies have become an important option for patients with relapsed or refractory multiple myeloma, though challenges such as relapse, complex manufacturing, and safety concerns remain. TPST-2003’s structure was specifically engineered to address these limitations by targeting two antigens in parallel, which may improve consistency of response even in patients with highly heterogeneous disease.

Tempest is also applying its dual-targeting architecture to additional programs. TPST-3003, an allogeneic CD19/BCMA therapy for relapsed or refractory multiple myeloma, and TPST-4003, an in vivo CD19/BCMA therapy for systemic lupus erythematosus and other immunology disorders, are advancing in development. Initial clinical data from these programs are expected later this year. The company plans to share full REDEEM-1 results and updated IIT findings in 2026. Based on the data collected so far, Tempest intends to submit a U.S. IND application and, pending regulatory clearance, begin a registrational trial of TPST-2003 in 2026.