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Dencatistat, a first-in-class, tumour-agnostic, orally available CTPS1 inhibitor to treat gynaecologic tumoursbroad

STP938 · Horizon Europe grant · 2026-06-01–2027-08-31

EC contribution

€2,499,990

Total cost

€0

Beneficiaries

1
About the data

Source: CORDIS (official EU open data), Horizon Europe. Framework HORIZON · call HORIZON-EIC-2025-ACCELERATOR-02 · scheme HORIZON-EIC-ACC · topic HORIZON-EIC-2025-ACCELERATOR-02-OPEN-01. CORDIS record →

Objective

Step Pharma is developing dencatistat (STP938), a first-in-class CTPS1 inhibitor that selectively targets CTPS2-null cancers, where tumour cells rely exclusively on CTPS1 for DNA synthesis. This represents a novel tumour-agnostic precision medicine approach that spares healthy tissue, reduces toxicity, and is suitable for oral administration. The current project focuses on advancing dencatistat in gynaecologic cancers, particularly platinum-resistant/refractory ovarian and endometrial tumours, which remain underserved despite high incidence and poor prognosis.The proposal will deliver a Phase 1b clinical trial in 10 biomarker-selected endometrial cancer patients to establish safety and early efficacy, using a validated CTPS2-loss assay. This trial follows a Phase 1a dose-escalation study already underway in ovarian cancer. If successful, a Phase 2 study will be launched with two cohorts (40 biomarker-positive, 40 biomarker-negative) to validate the predictive power of CTPS2-loss and support broader solid tumour expansion. This biomarker-guided strategy will help identify patients most likely to benefit, ensuring cost-efficient clinical development and better outcomes.The EIC grant (€2.5M) will fund critical Phase 1b activities, including patient recruitment, biomarker screening, and regulatory preparation. The requested equity (€10M) will enable Phase 2 execution across ovarian and endometrial cancers. While €37.7M in Series C1 funding has been secured for the ovarian trials, EIC support is essential to unlock the remaining €25M (Series C2) to include the endometrial trial and avoid critical delays in development. This project will lay the foundation for a European-led gynaecologic oncology franchise, with broader application across CTPS2-null solid tumours.

Beneficiaries (1)

OrganisationCountryRoleEC contributionSME
STEP PHARMA FR coordinator €2,499,990 Yes

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