Tempest folds in the storm
Last year Tempest Therapeutics was talking up plans for a phase 3 trial of its PPAR⍺ antagonist amezalpat despite a lack of cash; now the group has had to face reality. Tempest said on Wednesday that it was “exploring strategic alternatives” after failing to find funds for the 700-patient study, which is listed on clinicaltrials.gov with a start date of 29 March, but is described as not yet recruiting. The group had planned to test amezalpat alongside Roche’s Tecentriq and Avastin in first-line liver cancer, following promising data from Morpeus-Liver, a phase 1/2 Roche-sponsored platform trial. However, these plans always looked in doubt given Tempest’s cash balance of around $30m. Now amezalpat’s future depends on Tempest finding a partner or buyer. The company is also developing the EP2/4 inhibitor TPST-1495 for familial adenomatous polyposis, a genetic disorder that causes polyps in the colon that eventually become cancerous. A phase 2 NCI-sponsored trial of TPST-1495 is slated to begin in May. Tempest could provide a cautionary tale to other small biotechs, notably Imunon, which has just $6m in the bank but still plans to take its IL-12 gene therapy IMNN-001 into phase 3.
Up for grabs: Tempest’s pipeline
| Project | Description | Status | Trial design |
|---|---|---|---|
| Amezalpat (TPST-1120) | PPAR⍺ inhibitor | Ph3 in 1st-line HCC, listed on ct.gov but not yet recruiting | 740 pts; amezalpat + Tecentriq + Avastin, vs Tecentriq + Avastin; primary endpoint OS; primary completion Mar 2028 |
| TPST-1495 | EP2/EP4 inhibitor | Ph2 in FAP, to begin May 2025* | 38 pts; single arm, TPST-1495 + esophagogastroduodenoscopy + biopsy; primary endpoint change in polyp burden/safety; primary completion Dec 2026 |
Note: *NCI-sponsored; FAP= familial adenomatous polyposis. Source: OncologyPipeline & clinicaltrials.gov.
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