TPST-4003 / Tempest Therap - LARVOL DELTA

Tempest Unveils Next-Generation In Vivo CAR-T Pipeline, with First Clinical Study Planned for the Fourth Quarter of 2026 (GlobeNewswire) - "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....Initial safety and pharmacodynamic data from the first patients are expected in the first half of 2027, followed by an interim clinical update including preliminary safety, pharmacodynamic and efficacy data in the second half of 2027."

New P1 trial • P1 data • Multiple Sclerosis • Myasthenia Gravis

Tempest Announces Development Collaboration with Senlang Biotechnology for TPST-4003, a CD7-Targeted Next-Generation In Vivo CAR-T (GlobeNewswire) - "Under the agreement, Tempest and Senlang will collaborate to develop Tempest’s proprietary TPST-4003 product candidate, beginning with an investigator-initiated trial ('IIT') in China evaluating TPST-4003 in approximately 10 patients with myasthenia gravis ('MG') or multiple sclerosis ('MS'). The company expects first patient enrollment and dosing to occur in the fourth quarter of 2026. The initial study is designed to generate clinical evidence of safety, pharmacodynamic ('PD') activity, and therapeutic potential of TPST-4003, building on promising findings from related pipeline preclinical and clinical research. Under the agreement, Senlang will coordinate and support trial execution in China, leveraging its extensive experience in clinical development of advanced CAR-T therapies."

Licensing / partnership • New trial • Multiple Sclerosis • Myasthenia Gravis

Tempest’s parallel CAR architecture is being applied across multiple programs (GlobeNewswire) - "(i) TPST-3003, an allogeneic CD19/BCMA dual-targeting CAR-T therapy under development for rrMM; (ii) TPST-4003, an in vivo CD19/BCMA dual-targeting CAR-T therapy under development for systemic lupus erythematosus (SLE) and other immunology disorders. Tempest expects initial clinical data from both programs later this year and believes this platform approach may allow these therapies to ultimately benefit a larger number of patients."

Clinical data • Multiple Myeloma • Systemic Lupus Erythematosus