Tempest Therapeutics, Inc. (Brisbane, California; Nasdaq: TPST) selected Cincinnati Children's Applied Gene and Cell Therapy Center (AGCTC) (Cincinnati, Ohio) as its lead contract development and manufacturing partner to conduct the formal technology transfer of TPST-2003, a dual-targeting CD19/BCMA CAR-T cell therapy under development for relapsed/refractory multiple myeloma. The TPST-2003 partnership comes as Tempest Therapeutics prepares for a planned U.S. IND filing in Q4 2026 and a subsequent registrational study, following positive interim data from the ongoing REDEEM-1 Phase 1/2a trial conducted in China by partner Novatim Immune Therapeutics. Under the arrangement, AGCTC will perform IND-enabling manufacturing and process development, with all activities other than long-term stability testing planned for completion by Q3 2026.
No financial terms were disclosed in connection with the partnership. The arrangement is structured as a CDMO and technology transfer agreement rather than a traditional licensing deal, meaning no exchange of drug rights, milestone payments, royalties, or equity components was reported. Tempest Therapeutics retains full ownership of TPST-2003 outside of China, India, Turkey, and Russia, territories where development rights are held by Novatim under a pre-existing agreement.
Deal context
TPST-2003 is an autologous CAR-T cell therapy engineered with a parallel dual-targeting CAR structure that simultaneously recognizes CD19 and BCMA on the surface of malignant B cells and plasma cells. The dual-targeting approach is designed to address tumor heterogeneity and antigen escape, two mechanisms that limit the durability of responses to single-target CAR-T therapies in multiple myeloma. By engaging both antigens, the therapy aims to eliminate mature myeloma cells expressing BCMA as well as earlier B-cell progenitors expressing CD19 that may serve as a reservoir for disease relapse.
The clinical dataset for Tempest Therapeutics TPST-2003 includes 36 patients with relapsed/refractory multiple myeloma who received a single infusion across two studies conducted in China: a Phase 1/2 investigator-initiated trial (NCT04714827) enrolling 24 patients, and the ongoing REDEEM-1 Phase 1/2a trial (NCT06223646) enrolling 12 patients as of a January 31, 2026 data cutoff. Among six efficacy-evaluable patients in REDEEM-1, all achieved complete response per International Myeloma Working Group criteria. Across both studies, the overall response rate among 25 evaluable patients with measurable disease at baseline was 100%. Tempest plans to present updated results at a scientific meeting later in 2026. A separate Phase 1 trial (NCT06518876) is evaluating TPST-2003 in POEMS syndrome, a rare plasma cell disorder.
The selection of Cincinnati Children's AGCTC as the manufacturing partner represents the operational step required to bridge the program from Chinese clinical development into U.S. regulatory territory. AGCTC, established in 2001 as part of Cincinnati Children's Cancer and Blood Diseases Institute, has experience in technology transfer of engineered cell therapy products and in preparing CAR-T programs for IND submission. The TPST-2003 clinical trial 2026 timeline envisions completion of tech transfer activities by Q3 2026, supporting a potential CAR-T cell therapy registrational study initiation thereafter.