EU-HENIpavirus PROTECTion via inhaled antibody solution

HENIPROTECT addresses the urgent need for effective countermeasures against Henipaviruses, in particular Nipah virus (NiV). With its high mortality rate and proven human-to-human transmission, NiV represents a global health security concern with limited treatment options. HENIPROTECT aims to deliver the first inhaled antibody(Ab)-based treatment of NiV infection, expandable to another lethal Henipavirus, Hendra virus. The project will advance the most promising humanized Ab candidate (derived from murine Nip35 specific for NiV fusion protein) to first-in-human clinical trial, and lay the foundation for an Ab cocktail combining Nip35 and another Ab that blocks NiV entry through complementary mechanism, providing a dual-target approach for a broad protection against NiV. By targeting the respiratory tract-the main site of infection and transmission-the inhaled formulation will offer direct protection, blocking viral replication and spread. To achieve this, the consortium will finalize preclinical characterization of the Ab candidates, optimize their formulation for inhaled delivery through mesh-nebulization and establish regulatory-compliant production processes, including GMP manufacturing. Pharmacokinetic and toxicology studies, supported by modelling platforms, will guide safe clinical translation. Parallel efforts will adapt a cost-effective inhalation device, establish an alternative microalgae-based production platform, and create a flexible Ab toolbox to counter emerging viral variants, ensuring affordability, scalability and long-term resilience. HENIPROTECT fully aligns with the EU work programme priorities on health security and pandemic preparedness, by supporting innovation in biomanufacturing and enabling equitable access to life-saving countermeasures. By combining cutting-edge science with scalable production and affordable delivery, the project strengthens Europe's capacity to respond swiftly to viral outbreaks, reinforcing the global health security.