Tempest Therapeutics Reports Post-Transaction Strategy To Advance Dual-Targeting CAR-T Portfolio, Prioritises TPST-2003 And Expands Into In Vivo CAR-T

Tempest Therapeutics has outlined its post-transaction strategy following the acquisition of new CAR-T assets, emphasizing a capital-efficient operating model while advancing its cell therapy pipeline. The company intends to focus on progressing its clinical-stage dual-targeting CD19/BCMA CAR-T candidate, TPST-2003, while also expanding into next-generation in vivo CAR-T approaches.

TPST-2003 is currently being evaluated in an ongoing Phase 1 trial in China, with near-term clinical data expected. Tempest anticipates initiating a registrational Phase 2b study in China by the end of 2026, with interim results projected in 2027. Importantly, development activities in China are funded by a strategic partner, allowing the company to access pivotal data while preserving internal resources.

“Our strategy is to leverage partner-funded and externally supported development where possible to generate high-value clinical data before committing significant internal capital,” said Dr. Matt Angel, President and Chief Executive Officer of Tempest. “This approach allows us to advance multiple programs in parallel, expand the long-term optionality of our CAR-T portfolio and preserve flexibility as we evaluate the most compelling path forward.”

In parallel, Tempest is advancing TPST-4003, its newly disclosed in vivo CAR-T program designed to deliver the same dual-targeting CD19/BCMA construct without ex vivo cell manufacturing. This approach aims to improve scalability and patient convenience. The company plans to move the program through preclinical development and potentially into a partner-supported investigator-initiated clinical trial. Tempest is also pursuing business development opportunities for amezalpat, a Phase 3-ready candidate in first-line hepatocellular carcinoma, and preparing to initiate a National Cancer Institute-funded Phase 2 study of TPST-1495 in familial adenomatous polyposis in Q1 2026.

Beyond these programs, Tempest continues to broaden its CAR-T platform with additional dual-targeting candidates, including TPST-3003 (allogeneic CD19/BCMA), TPST-2206 (CD70-targeting), and TPST-3206 (allogeneic CD70), supporting a diversified next-generation pipeline.