Tempest Therapeutics Secures Lentiviral Vector, Readies TPST-2003 for Q4 2026 Registrational Study
Tempest Therapeutics delivered TPST-2003 lentiviral vector to Cincinnati Children’s AGCTC, enabling manufacturing activities required for a pivotal registrational study planned for Q4 2026. Interim data from REDEEM-1 showed 100% complete response in six evaluable RRMM patients and 100% overall response rate in 25 measurable disease patients.
1. Manufacturing Milestone Achieved
Tempest delivered the TPST-2003 lentiviral vector to Cincinnati Children’s AGCTC, enabling the manufacturing activities needed for its dual-targeting CD19/BCMA CAR-T therapy. This delivery marks a critical step toward producing clinical-grade TPST-2003.
2. Registrational Study Timeline
The manufacturing milestone aligns with plans to launch the first registrational study of TPST-2003 in patients with relapsed/refractory multiple myeloma, including those with extramedullary disease, in Q4 2026.
3. Interim Efficacy Data
As of January 31, 2026, all six efficacy-evaluable patients in the REDEEM-1 trial achieved complete responses, and 25 of 25 patients with measurable disease across studies attained overall responses, demonstrating promising early activity.