Tempest Therapeutics, Inc., headquartered in Brisbane, California, is a clinical-stage biotechnology company developing small-molecule therapeutics that combine tumor-targeted and immune-mediated mechanisms to treat cancer.
In March 2025, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Tempest's investigational therapy TPST-1495 for the treatment of familial adenomatous polyposis (FAP), a hereditary condition associated with a high risk of colorectal cancer. TPST-1495 is a dual antagonist of the EP2 and EP4 prostaglandin receptors, aiming to inhibit tumor-promoting pathways while sparing other prostaglandin receptors. The FDA also issued a "Study May Proceed" letter, enabling the initiation of a Phase II clinical trial to evaluate TPST-1495's efficacy in reducing duodenal polyp burden in FAP patients. This trial is being conducted by the Cancer Prevention Clinical Trials Network and is funded by the National Cancer Institute's Division of Cancer Prevention.
Tempest's pipeline also includes amezalpat (TPST-1120), an oral PPARα antagonist that has received both Orphan Drug and Fast Track designations from the FDA for the treatment of hepatocellular carcinoma (HCC). Following positive Phase II data, amezalpat is poised to enter a pivotal Phase III trial in combination with atezolizumab and bevacizumab.
As of April 2025, Tempest is exploring strategic alternatives to advance its clinical programs and maximize shareholder value. The company has engaged MTS Health Partners to assist in evaluating options, which may include mergers, acquisitions, partnerships, or licensing arrangements.
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