Tempest Announces Publication of Positive Data from Phase 1 Trial of TPST-1120 in Patients with Advanced Solid Tumors in Journal of Cancer Research Communications

• TPST-1120, a first-in-class, oral, selective PPAR⍺ antagonist, demonstrates clinical activity in PD-1 inhibitor refractory and immune compromised cancers
• Based on subsequent positive randomized data, Company preparing to move TPST-1120 into pivotal Phase 3 trial in HCC

BRISBANE, Calif., April 04, 2024 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classⁱ targeted and immune-mediated therapeutics to fight cancer, today announced that Cancer Research Communications published positive clinical data from the dose-escalation Phase 1 trial of TPST-1120 in an article titled “First-in-Human Phase I Trial of TPST-1120, an inhibitor of PPARα, as Monotherapy or in Combination with Nivolumab, in Patients with Advanced Solid Tumors.” The data showed that TPST-1120 demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor refractory and immune compromised cancers, and was well tolerated both as monotherapy and in combination with nivolumab. These earlier Phase 1 data complement the positive Phase 1b/2 data reported in October 2023 from a global randomized study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, which showed clinical superiority of the TPST-1120 arm across multiple study endpoints and relevant biomarker-defined patient subpopulations.

“In this Phase 1 study of TPST-1120, we saw the first evidence of anti-tumor activity in multiple cancer types, affirming our belief that PPARα inhibition is an exciting and novel approach for cancer treatment,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. “These early-phase data are supported by the positive top line results of the ongoing randomized Phase 1b/2 trial in first-line HCC. We believe there is tremendous potential for TPST-1120 to make a meaningful impact for patients and we look forward to providing updated data this year.”

About the TPST-1120 Phase 1 Study

In this first-in-human Phase 1 study, 35 patients were treated with escalating doses of TPST-1120 either as monotherapy (20 patients) or in combination with the anti-PD-1 therapy, nivolumab (15 patients). TPST-1120 was well-tolerated as monotherapy and in combination, with a maximum tolerated dose not identified and predominantly low-grade toxicity. Notwithstanding the late-line stage of these patients and difficult to treat tumor types, clinical benefit was observed as both a monotherapy and combination.² In monotherapy, a best response of stable disease (SD) was observed in 53% (10/19) of evaluable patients, with 5 of those patients staying on treatment for more than 5 months. Tumor shrinkage of target lesions on treatment occurred in 21% (4 patients) and a best response of no target lesion growth was seen in 3 additional patients.