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

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.

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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HORIZON-EIC-ACC - HORIZON EIC Accelerator

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Call for proposal

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(opens in new window) HORIZON-EIC-2025-ACCELERATOR-02

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Coordinator

STEP PHARMA
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 2 499 990,50
Address
101 RUE DE SEVRES CEDEX 06
75272 Paris
France

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Ile-de-France Ile-de-France Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

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