Crispr-armed PHAGE therapeutics for Response and Emergency Preparedness - Yersinia pestis

PHAGE-PREP aims to establish a versatile platform for designing and manufacturing engineered phage cocktails as next-generation medical countermeasures (MCMs) against CBRN (Chemical, biological, radiological, and nuclear) threats. The project will demonstrate platform flexibility through a prototype phage cocktail targeting Yersinia pestis (SNIPR013), advancing the main product from TRL3 to TRL6. Key activities include phage engineering, preclinical validation in high-containment animal models, Good Manufacturing Practices (GMP)-compliant manufacturing, and safety testing in humans, paving the way for regulatory approval and market readiness. Central to the project is SNIPR Biome's proprietary phage engineering platform, integrating CRISPR/Cas and multi-effector arming strategies to enhance phage potency, specificity, and resilience. Led by SNIPR Biome, the consortium brings together leading European expertise in phage engineering, Yersinia phage biology, in vitro & in vivo testing at high-containment level, and industrial-scale GMP manufacturing. Key partners across Europe include Fraunhofer (recombinant and reporter phages for rapid susceptibility testing), the University of Helsinki (extensive Yersinia phage collections and animal facilities), and Jafral (European CDMO for GMP production). Sofpromed will manage the Phase I clinical trial to establish product safety. Collaboration with national public health agencies and defense institutes such as the Bundeswehr Institute of Microbiology ensures alignment with security priorities and establishes a robust framework for CBRN-relevant countermeasure development. By creating a scalable, adaptable platform, PHAGE-PREP will deliver a validated countermeasure against Y. pestis and lay the foundation for rapid responses to broad spectrum of natural and engineered potential CBRN threats, reinforcing EU resilience and global health security.