Tempest Plans Phase 2b in China for Dual-Targeting CD19/BCMA CAR-T by 2026
Tempest plans registrational Phase 2b initiation in China for its dual-targeting CD19/BCMA CAR-T program TPST-2003 by end-2026 with interim Phase 1 data expected in 2027, leveraging partner funding to preserve capital. The company also disclosed an in vivo CAR-T candidate TPST-4003 entering preclinical development through a partner-funded investigator trial.
1. Strategic Plan Overview
Tempest outlined a capital-efficient post-transaction strategy to advance its newly acquired dual-targeting CAR-T assets by prioritizing partner-funded and externally supported development to generate clinical data before deploying significant internal capital.
2. TPST-2003 Development Timeline
The company will advance TPST-2003, a dual-targeting CD19/BCMA CAR-T therapy, with interim Phase 1 data expected in 2027 from its ongoing trial in China and plans to initiate a registrational Phase 2b in China by end-2026, fully funded by its strategic partner.
3. In Vivo CAR-T Candidate TPST-4003
Tempest disclosed TPST-4003, its first in vivo dual-targeting CD19/BCMA CAR-T program designed to bypass ex vivo manufacturing, slated for preclinical development and an investigator-initiated clinical trial supported by a partner.
4. Other Pipeline Programs
Beyond CAR-T, Tempest aims to position amezalpat for Phase 3 in hepatocellular carcinoma through business development, initiate a partner-funded Phase 2 study of TPST-1495 in familial adenomatous polyposis in Q1 2026, and progress additional dual-targeting allogeneic and CD70-based CAR-T candidates.