On March 12, 2024 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Spring Scientific Meeting highlighting preclinical data showing potent anti-tumor activity in several cancer models treated with TPST-1120 alone or with immune checkpoint inhibitors (Press release, Tempest Therapeutics, MAR 12, 2024, View Source [SID1234641073]). The presentation covered experimental results that corroborated clinical biomarker data from patients with advanced solid tumor cancers treated in a Phase 1 trial with TPST-1120 showing increased expression of select immune-related genes and elevated plasma Free Fatty Acid (FFA) levels associated with clinical response. TPST-1120 is an oral, selective PPAR⍺ antagonist in clinical development that has shown promising results, including positive data from a randomized study in first-line hepatocellular carcinoma (HCC) patients compared to the standard of care.

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"Data presented at the SITC (Free SITC Whitepaper) Spring Scientific Meeting bolster our mechanistic understanding of PPARα blockade in cancer patients and reinforce a basis for the ongoing late-stage clinical development of TPST-1120," said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D at Tempest. "Based on positive Phase 1 and 2 data, we are planning a pivotal study in patients with first-line liver cancer, and we also look forward to evaluating the potential of TPST-1120 in additional cancer indications."

In preclinical models of liver, colon and pancreatic cancer, TPST-1120 elicited a greater than 50% inhibition of tumor growth with enhanced inhibition observed in liver and colon cancer models when co-administered with anti-PD-1. In addition, biomarker results from the Phase 1 clinical trial of TPST-1120 in multiple solid tumor indications showed statistically significant, exposure-dependent elevations in expression levels of multiple immune-related genes, and patients exhibiting objective responses displayed increased circulating free fatty acids (FFA), both of which are in-line with the proposed TPST-1120 mechanism of action. Clinical response and biomarker findings support that inhibition of PPARα may be an effective therapeutic strategy for the treatment of cancer.

These findings complement positive data reported in October 2023 from a global randomized phase 1b/2 study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC. The differentiating data showed clinical superiority of the TPST-1120 arm across multiple study endpoints and relevant biomarker-defined patient subpopulations when compared to atezolizumab and bevacizumab alone, the standard of care in first-line HCC.

About TPST-1120

TPST-1120 is an oral, small molecule, selective PPAR⍺ antagonist. Tempest’s data suggest that TPST-1120 treats cancer by targeting tumor cell metabolism directly, as well as by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In a Phase 1 clinical trial in patients with heavily-pretreated advanced solid tumors, TPST-1120 as monotherapy and in combination with the PD-1 inhibitor nivolumab demonstrated tumor reduction (including RECIST responses) and biomarker modulation. In a global randomized phase 1b/2 study of TPST-1120 in combination with atezolizumab and bevacizumab in first-line patients with advanced hepatocellular carcinoma (HCC), the TPST-1120 arm showed clinical superiority across multiple study endpoints when compared to atezolizumab and bevacizumab alone, the standard of care. TPST-1120 is wholly-owned by Tempest.