Advancing a pipeline of in vivo CAR-T product candidates for oncology and immunology applications differentiated by CD7-targeted mRNA/LNP delivery approach
Lead candidate TPST-4003 combines proprietary CD7-targeted mRNA/LNP delivery with a clinically validated dual-targeting CD19/BCMA CAR construct to support broad B-cell lineage reset across multiple indications
First investigator-initiated trial expected to enroll approximately 10 patients with nervous system autoimmune diseases, including MG and MS, with first patient dosing anticipated in the fourth quarter of 2026 and initial clinical data expected in the first half of 2027
BRISBANE, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) ("Tempest"), a clinical-stage biotechnology company developing a pipeline of advanced chimeric antigen receptor T-cell ("CAR-T") product candidates, today announced details of its next-generation in vivo CAR-T platform. The company plans to advance TPST-4003, its lead in vivo CAR-T product candidate, into a first investigator-initiated clinical trial in patients with nervous system autoimmune diseases, initially focusing on myasthenia gravis ("MG") and multiple sclerosis ("MS"). The study is expected to enroll approximately 10 patients, with first patient dosing anticipated in the fourth quarter of 2026.
TPST-4003 combines Tempest's next-generation CD7-targeted mRNA lipid nanoparticle ("CD7-tLNP") delivery platform with the same dual-targeting CD19 B-cell maturation antigen ("CD19/BCMA") chimeric antigen receptor ("CAR") architecture used in TPST-2003, the company's clinical-stage CAR-T program. Interim Phase 1/2a clinical data generated with TPST-2003 demonstrating the achievement of a 100% complete response rate, together with its successful U.S. manufacturing, provide important support of the underlying CAR construct, establishing a foundation for TPST-4003.
"We are excited to announce the strategic prioritization of our next-generation in vivo CAR-T pipeline and our plan to advance TPST-4003 toward an anticipated first patient dosing later this year," said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. "We believe our differentiated in vivo CAR-T platform may enable broader addressable T-cell coverage and support scalable repeat dosing once developed and commercialized, supporting future commercial attractiveness of in vivo CAR-T therapy. The lead product candidate in our pipeline, TPST-4003, is being designed to enable broad B-cell lineage depletion and reset with its dual CD19/BCMA targeting architecture, with the goal of potentially delivering improved efficacy and durability compared with single-target CAR approaches. We look forward to advancing TPST-4003 into clinical development later this year."