Tempest Therapeutics, Inc. (NASDAQ: TPST) is engaged as a clinical-stage oncology company, which is focused on the research and development of first-in-class therapies that aim to combine targeted and immune-mediated mechanisms. Shares of the clinical-stage oncology company are rallying 25% through early trading on Friday, April 28, 2023. Over the past three months, Tempest Therapeutics has seen average daily volume of 32,490 shares. However, volume of 9.48 million shares or dollar volume of around $20.86 million, has already exchanged hands through early trading.

Shares of Tempest Therapeutics are gaining after the company announced encouraging early results from a global randomized Phase 1b/2 clinical study on TPST-1120, its small molecule PPAR⍺ antagonist. When combined with standard-of-care atezolizumab and bevacizumab, TPST-1120 demonstrated substantial improvement in treating unresectable or metastatic hepatocellular carcinoma (HCC). The study involved 40 patients in the TPST-1120 arm and 30 in the control arm.

Key findings from the study include a 74.4% relative improvement in objective response rate (ORR) and a 69.9% relative improvement in confirmed ORR for the TPST-1120 triplet arm compared to the control arm. Moreover, 47.5% of patients in the TPST-1120 arm were on treatment, and 80% were on study, compared to 23.3% and 50%, respectively, in the control arm. The addition of TPST-1120 was well tolerated, with safety data consistent with the control regimen.

Secondary endpoints, including duration of response, progression-free survival, and overall survival, will potentially be available later this year or next year. TPST-1120 has demonstrated tumor reduction and biomarker modulation in a Phase 1 clinical trial, both as a monotherapy and in combination with the PD-1 inhibitor nivolumab.

Hepatocellular carcinoma is an aggressive cancer with increasing mortality, expected to become the third leading cause of cancer death by 2030. It affects over 900,000 people worldwide each year and is mainly caused by chronic liver disease.

“These randomized data in first-line HCC are exciting and support the promise of TPST-1120 as an active small molecule for patients,” said Stephen Brady, chief executive officer of Tempest. “HCC is a common and aggressive cancer where significant unmet need remains to improve care in the first line and beyond. We believe the improvements shown in the TSPT-1120 arm validate the hypothesis of targeting HCC with TPST-1120, as well as the mechanistic basis for combination with both a checkpoint inhibitor and VEGF inhibitor. We look forward to receiving more data this year, including with respect to potential biomarkers, and to the potential next steps of this program in HCC and other cancers of interest.”

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