Ethris, based in Planegg/Munich, Germany, together with the European consortium NOFLU, has received initial funding of EUR 13 million to advance an innovative mRNA-based mucosal vaccine against pandemic influenza. The total program could grow to up to EUR 148 million in several phases.
The European Health and Digital Executive Agency (HaDEA) has awarded the European vaccine consortium NOFLU initial funding of EUR 13 million as part of a competitive tender. Subject to further evaluation, the total volume of the contract could reach up to EUR 148 million. The aim is to develop novel vaccine approaches to better prepare for influenza pandemics.
NOFLU is one of three programs selected within this EU-wide pre-commercial procurement process. The consortium brings together seven partners from Europe and pools expertise across the entire value chain - from mRNA design and formulation to preclinical research and clinical development to immunological analysis. The participants are Ethris and Evonik (Germany), NIVI Development (Novo Nordisk Foundation Initiative for Vaccines and Immunity), Statens Serum Institut and Bavarian Nordic (Denmark), ECRAID (Netherlands), and VisMederi (Italy).
The program focuses on the further development of Ethris' proprietary mRNA technology as a mucosal vaccine against pandemic influenza. Unlike traditional systemic vaccines, this approach aims to trigger an immune response directly at the virus's point of entry – the respiratory tract. This is intended to prevent virus replication at an early stage and reduce transmission. A stabilized, non-immunogenic RNA formulation is used, which is designed to optimize both safety and efficacy. Earlier clinical proof-of-concept studies have already delivered positive results.
The funding program is scheduled to run for a total of 98 months and follows a phased development model from the preclinical phase to potential market approval activities. The initial funding of EUR 13 million will enable the start of a Phase 1 study to investigate safety, feasibility, and immune response. Intramuscular and intranasal routes of administration will be evaluated comparatively. The clinical trial will be conducted at Gentofte Hospital in Copenhagen.
If successful, the project can move on to two further competitive phases: up to EUR 35 million is available for a Phase 2 study and up to EUR 100 million for a Phase 3 study.
With NOFLU, the consortium is responding to the HaDEA call for proposals for the development of next-generation influenza vaccines. The integrated development approach underscores the partners' shared goal of combining scientific excellence with operational implementation expertise and making a sustainable contribution to European pandemic prevention.