Naobios, Nuvonis and European Vaccine Initiative collaborate on manufacturing influenza challenge agent

(MENAFN- ALA Group) Working with the Inno4Vac consortium coordinated by European Vaccine Initiative, Naobios will leverage Nuvonis’s Vero Cell Bank to support development of a controlled human infection model based on the influenza virus A(H3N2)

Nantes (France), Vienna (Austria) and Heidelberg (Germany), September 2, 2025 – Naobios, a Contract Development and Manufacturing Organisation (CDMO) providing bioprocess development and good manufacturing practices (GMP) production of clinical batches of virus-based products, Nuvonis, a biotechnological company providing innovative cell banks for the production of vaccines and other biologicals, and European Vaccine Initiative (EVI), a leading European non-profit Product Development Partnership (PDP), today announce a joint effort with the Inno4Vac consortium to develop an influenza A(H3N2) Human Viral Challenge Agent with the long-term goal of addressing the low effectiveness of seasonal influenza vaccines in fighting influenza A(H3N2).

To address the ongoing need for more rapid and efficient vaccine development, the Inno4Vac consortium, a public-private partnership coordinated by EVI, is advancing the development of an innovative Controlled Human Infection Model (CHIM) for influenza A(H3N2). Controlled Human Infection Models involve the deliberate, safe exposure of healthy adult volunteers to a well-characterised virus under tightly controlled clinical conditions, enabling the fast generation of data on vaccine protection, immunogenicity and immune responses. A critical prerequisite for such studies is the availability of a robust, GMP-compliant Human Viral Challenge agent.

For this project, Naobios will leverage Nuvonis’s well-characterised GMP Vero Working Cell Bank. This approach eliminates the need for time-consuming cell bank development and enables Naobios to proceed directly to GMP production of the Human Viral Challenge Agent using a fully tested, regulatory-compliant cell substrate manufactured to industrial standards.

Vero cells are widely accepted by national and international regulatory authorities, including the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and are used in commercial vaccine production.

"Nuvonis is thrilled to partner with Naobios and EVI on this groundbreaking project to develop an influenza A(H3N2) Human Viral Challenge Agent,” said Christina Nicolodi, CEO of Nuvonis. “Our GMP Vero Working Cell Bank will play a crucial role in accelerating the GMP manufacturing process by eliminating the need for time-consuming cell bank production and reducing the associated risks and costs. We are proud to contribute to the Inno4Vac consortium and look forward to the successful completion of this important initiative."

“Previously, Naobios has successfully completed the development, manufacturing and filling of more than 30 GMP batches of Human Viral Challenge Agents. This includes the successful delivery of a Respiratory Syncytial Virus (RSV) challenge agent, in collaboration with Inno4Vac, represented by EVI,” said Eric Le Forestier, general manager of Naobios. “This new project on influenza further strengthens our partnership with EVI and reinforces our reputation as a global leader in the manufacturing of Human Viral Challenge Agents.”

“We are pleased to collaborate with Naobios on this influenza challenge agent and to leverage Nuvonis’s high-performance Vero cell bank. This is an important step towards the success of the Inno4Vac project,” said Ole Olesen, Executive Director of EVI. “This collaboration brings together exceptional partners - leaders in their respective fields - ensuring the highest level of expertise for this critical project."

“As an EVI partner and Inno4Vac consortium member, we encourage collaboration and expertise from leading experts to address scientific bottlenecks in vaccine development. Together with Naobios and Nuvonis, we believe Inno4Vac can now progress the development of a high-quality controlled influenza virus infection model with confidence,” said Othmar Engelhardt, head of seasonal influenza, research & development, Medicines and Healthcare products Regulatory Agency (MHRA), UK, and member of the Inno4Vac consortium.

Following manufacturing, the next step will involve conducting a Controlled Human Infection Model (CHIM) study, led by the Inno4Vac consortium, targeted for Q3/Q4 2026.

About European Vaccine Initiative and Inno4Vac
European Vaccine Initiative (EVI) is supporting global efforts to develop effective and affordable vaccines and is promoting innovative solutions in vaccine research and development (R&D). It supports global efforts to develop safe, effective and affordable vaccines against diseases that disproportionately affect low- and middle-income countries; through constructive collaboration and exchange with academia, pharmaceutical and biotechnology companies, policy makers, donors and other Product Development Partnerships (PDPs). EVI helps them to advance and accelerate their vaccine candidates by openly providing its expertise and supporting vaccine R&D.
Inno4Vac is a public-private partnership coordinated by EVI aiming to address scientific bottlenecks in vaccine development including Controlled Human Infection Models (CHIM).
Inno4Vac has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 101007799 (Inno4Vac). This joint undertaking is supported by the European Union’s Horizon 2020 research and innovation programme and the EFPIA.
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About Nuvonis Technologies
Nuvonis Technologies is a biotechnological company specializing in innovative cell banks for the production of vaccines and other biologicals. The company provides GMP Master and GMP Working Cell Banks, produced under serum and animal-free media conditions, and has developed new avian cell lines as modern alternatives to traditional egg-based manufacturing. Nuvonis also offers process development services, including vaccine process optimization and virus purification. Founded in 2016, Nuvonis is based in Vienna, Austria.

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