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

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).