Tempest Therapeutics (NASDAQ: TPST) announced it delivered the TPST-2003 lentiviral vector to Cincinnati Children's Applied Gene and Cell Therapy Center, enabling manufacturing activities for the dual-targeting CD19/BCMA CAR-T therapy.

The delivery supports Tempest's plans to initiate a potentially registrational study for treating relapsed/refractory multiple myeloma patients in the fourth quarter of 2026. The manufacturing milestone follows interim data from the ongoing REDEEM-1 Phase 1/2a trial showing complete response in all six efficacy evaluable patients.

As of January 31, 2026, 36 patients with relapsed/refractory multiple myeloma received one infusion of TPST-2003 across two studies. Among 25 evaluable patients with measurable disease at baseline, the overall response rate was 100%. The investigator-initiated trial demonstrated median progression-free survival of 23.1 months across all patients.

"The delivery of lentiviral vector, which is a critical component in the manufacturing of autologous CAR-T products, has enabled us to proceed with the manufacturing activities required for the pivotal development of TPST-2003," said Dr. Matt Angel, President and Chief Executive Officer of Tempest.

TPST-2003 is an autologous CD19/BCMA dual-targeting CAR-T therapy designed for patients with relapsed/refractory multiple myeloma through a parallel dual-targeting CAR structure. Tempest developed the therapy under an agreement with partner Novatim Immune Therapeutics, with exclusive rights to develop TPST-2003 outside of China, India, Turkey, and Russia.

Cincinnati Children's Applied Gene and Cell Therapy Center, established in 2001, serves as a research, development, and manufacturing hub for cell and gene therapy treatments.