Optimization and Validation a of Personalized Automated Viral-Vectored Vaccines Manufacturing for Scalable and Cost-Effective Clinical Applications

Personalized cancer vaccines targeting patient-specific neoantigens have transformative potential. Nouscom’s platform (NOUS-PEV), based on proprietary viral vectors, has demonstrated safety, feasibility, and strong immunogenicity in a completed Phase I trial.  However, clinical adoption remains limited by complex manual manufacturing, high costs, and challenges in scalability, quality control and integration, particularly in large-scale studies. To addresses these barriers, this project will optimize and validate a modular, automated and GMP-compliant platform for personalized vaccine production, building on clinically tested viral vector technology and on the availability of a non-GMP prototype integrating upstream and downstream manufacturing steps. Successful feasibility testing of the prototype in a controlled lab environment position NOUS-PEV at TRL 6, alongside clinical evidence from the completed Phase I trial. The approach will combine automated generation of personalized vector genomes, closed-system manufacturing process based on the prototype, and a scalable quality control framework. Development will be guided by key performance indicators, including production time, cost per patient, reproducibility and scalability. This will lay the groundwork for readiness to GMP translation and clinical development. To maximize impact, the project will integrate early health technology assessment (HTA), payer perspectives and sustainable business models for ATMP manufacturing within European healthcare systems. A key objective is identifying optimal clinical applications, combining high medical need with suitable mutational burden, including non-canonical neoantigens.  Collaborators with expertise in advanced NGS, immunopeptidomics, bioinformatics, and access to relevant tumor samples are encouraged to join. The project will establish a fully integrated process enabling parallel production of multiple patient-specific batches for clinical trials readiness, contributing to a strong European ecosystem for scalable, cost-effective personalized cancer vaccines, strengthening EU leadership in advanced therapies.