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A Novel Phase-2a Clinical Trial for a Next-Generation Oncolytic Immunotherapy Targeting Platinum-Resistant Ovarian Cancer

Objective

Annually 87,894 EU citizens are diagnosed with ovarian cancer (OC), with >75% at an advanced stage and poor long-term outcomes (<25% 5-year survival). Standard-of-care first-line treatments combine cytoreductive surgery, platinum-based chemotherapies, and paclitaxel. Although initially effective, most patients relapse (>70% within 3-years) and become resistant to treatment. There are no effective treatments for platinum-resistant OC (PROC) and patients have a life expectancy of <12-months.

Therapeutic challenges result from the heterogeneous and immune-suppressed nature of the tumour microenvironment, and high volume of cancer-associated fibroblasts (CAFs), that create barriers to treatment and promote tumour survival mechanisms.

THEO-260 is a next-generation oncolytic virus demonstrating:
- world-first dual efficacy, targeting both patient CAF- and cancer- cells
- high tumour selectivity (low toxicity)
- strong TME modulation (immune cell infiltration) and adaptive immune responses
- high systemic activity (intravenous delivery via standard-of-care practices and treatment of metastatic tumours)

Currently in Phase-1 trials, THEO-260 is expected to deliver a game-changer in PROC treatment, tripling patient survival, improving quality-of-life, and doubling 5-year survival rates for advanced stage disease.

The project assembles a world class consortium, comprising one of Europe’s leading SME OV Biotechs and 4 centres of excellence in the fields of gynaecological cancer, immunotherapies, and translational research. Our goals are to:
- complete a 20-patient multi-centre, open label Phase-2a trial to assess preliminary efficacy,
- undertake comprehensive translational research to assess THEO-260's pharmacokinetic, pharmacodynamic, and immune behaviour, and
- leverage our partnership and knowhow to consolidate OV clinical development capabilities and best-practice within Europe (increasing OV trial capacity and accelerating development).

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

HORIZON-RIA - HORIZON Research and Innovation Actions

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) HORIZON-HLTH-2025-01

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Coordinator

THEOLYTICS LTD
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.

€ 5 348 627,00
Address
SHERARD BUILDING, EDMUND HALLEY ROAD, OXFORD SCIENCE PARK
OX4 4DQ OXFORD
United Kingdom

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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
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
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.

€ 5 348 627,00

Participants (4)