Early clinical development of first-in-class EGL-001 targeting Tregs in head and neck squamous cell carcinoma, supported by AI-based pathomics

The NEOTREG project is an SME-led, multidisciplinary initiative designed to accelerate the clinical translation of EGL-001, a first-in-class bispecific fusion antibody that selectively depletes regulatory T cells (Tregs) within the tumour microenvironment. By overcoming immune suppression, EGL-001 enhances the the efficacy of immune checkpoint inhibitors and address a major resistance mechanism in solid tumours. The project will conduct a multicentre, randomised, open-label Phase I/II neoadjuvant clinical trial in patients with head and neck squamous cell carcinoma (HNSCC), a high-incidence, high-mortality cancer with limited benefit from current immunotherapies.Beyond evaluating safety, tolerability, and early efficacy of EGL-001 in combination with pembrolizumab, NEOTREG integrates a comprehensive translational research programme including multi-omics profiling, immune monitoring, and AI-driven pathomics modelling. This will deliver predictive biomarkers for patient stratification and future companion diagnostics, supporting regulatory alignment and de-risking later-stage development.The consortium unites Egle Therapeutics (France), University College London (UK), Vall d’Hebron Institute of Oncology (Spain), Gustave Roussy (France), and Technical University of Dresden (Germany). Together, they provide cutting-edge expertise in immunology, genomics, pathology, and computational biology, alongside established clinical trial capacity across EU Member States. By delivering robust first-in-human efficacy data, novel biomarkers, and a scalable translational framework, NEOTREG not only advances EGL-001 but also creates a reproducible model for SME-driven translation of innovative biotech therapies in Europe. The project directly addresses the call’s goals by supporting the transition from preclinical to early clinical development, strengthening Europe’s competitiveness in biotechnology, and anchoring exploitation in the EU through a robust commercialisation strategy.