From Research Excellence to Industrial Scale-Up: enabling Europe’s biotech competitiveness – the Lovaltech experience

Europe’s ambition for health sovereignty will be judged on its ability to transform scientific excellence into industrial capacity that remains on European soil. As Lovaltech, our trajectory – from an academic discovery in Tours (France) to a first-in-human intranasal COVID-19 vaccine trial and an emerging mucosal vaccine platform – illustrates both Europe’s strengths and its structural bottlenecks.

We created Lovaltech in 2022 to take over an innovative intranasal protein vaccine developed by the BioMAP research team (INRAE / University of Tours), designed to induce both mucosal and systemic immunity and block SARS-CoV-2 replication at the respiratory entry site. Our vaccine is built on a unique multivalent fusion protein associated with biocompatible muco-excipient, and in preclinical models it has shown the capacity to protect against disease and reduce transmission across variants, making it one of the few candidates in the world explicitly targeting sterilising immunity against current and future SARS-CoV-2 strains.

Thanks to early public support (MESRI, ANRS-MIE, Bpifrance DeepTech, and the 2022 i-Lab competition), we have financed GMP production of our vaccine antigen and mucosal excipient through European CDMOs, including GTP Bioways and Stanipharm, and we have launched the MUCOBOOST Phase I/II clinical trial in France. This first-in-human study, registered as NCT06821126, compares an intranasal booster dose of our LVT-001 vaccine with a standard intramuscular mRNA COVID-19 booster, and will enroll 36 participants in Phase I and 202 participants in Phase II. The trial is co-sponsored by ANRS-MIE and the Tours University Hospital under the new European framework that allows shared sponsorship, which demonstrates how updated EU rules can directly support innovative clinical models.

Our journey captures Europe’s core advantage: dense and excellent academic ecosystems, strong public research organizations and hospitals, and targeted innovation instruments that allow a deep-tech start-up to emerge rapidly around a breakthrough. It also exposes the “valley of scale-up” that the European Biotech Act must now address if Europe wants to translate such successes into enduring industrial leadership.

First, we experience every day how clinical and regulatory pathways for novel modalities remain complex and fragmented. Our intranasal recombinant protein vaccine sits at the intersection of biologics, mucosal delivery and combination products (vaccine plus device). Navigating scientific advice, trial approval, and device-vaccine alignment across national authorities and the EMA is highly resource-intensive for a small company, even when we run a single-country trial. We believe that a more integrated European approach to innovative vaccines and mucosal products – with shared evaluation frameworks, predictable timelines, and early dialogue platforms – would reduce uncertainty, accelerate time-to-clinic, and make Europe a more attractive location for first-in-human trials.

Second, we feel directly the fragility of the financing continuum.

We have been able to fund early development through French and European public instruments and non-dilutive grants, complemented by seed equity. The next step – progressing LVT-001 through full Phase II, preparing pivotal development, and advancing pipeline assets such as a universal intranasal flu vaccine and a nasal malaria candidate – requires a level of capital and risk appetite that Europe is only starting to build.

Without stronger late-stage European biotech funds and catalytic public-private vehicles aligned with the Biotech Act, companies like Lovaltech will inevitably be pushed to seek strategic capital and listing venues outside the EU, with the well-known consequences for ownership, decision-making and manufacturing location.

Third, we are convinced that health sovereignty must be understood in terms of platforms, not only products. Our proprietary platform combines recombinant “smart antigens” engineered for breadth of protection, a mucosal excipient system designed for stability and delivery, and scalable bioprocesses that are compatible with European GMP facilities. This combination is applicable to multiple respiratory pathogens beyond COVID-19: influenza, RSV, and other viruses where blocking transmission at the mucosal surface can prevent both disease and the emergence of new variants. By nurturing such cross-pathogen platforms and linking them to European epidemiological and pandemic-preparedness strategies, the Biotech Act can turn individual start-ups like ours into strategic assets for long-term health security.

Finally, our story shows the power of European collaboration when it works well. A public-private network spanning INRAE, the University of Tours, CHU de Tours, ANRS-MIE, industrial partners such as GTP Bioways, Stanipharm and Aptar Pharma, and national and European funding bodies has brought an academic mucosal vaccine from the laboratory to clinical trial in just a few years. We would welcome a European Biotech Act that systematises these success factors: incentives for co-sponsorship models, simplified access to transnational clinical networks, and mechanisms to prioritise projects that both address unmet medical needs and reinforce European manufacturing capacity.

If Europe wants to lead in next-generation vaccines and mucosal immunology – key pillars of future pandemic preparedness and respiratory-virus control – it must ensure that companies like Lovaltech can not only emerge, but scale and stay in Europe.

That means aligning regulatory innovation with industrial policy, coupling research funding with manufacturing incentives, and mobilising growth capital to keep strategic IP, skills and production within the Union.

Our contribution to Europe’s quest for health sovereignty is specific: a new generation of intranasal protein vaccines capable of inducing robust mucosal and systemic immunity, produced and developed in Europe, with the potential to reduce transmission and protect against current and future variants. The European Biotech Act can turn this type of pioneering project from an exception into a model – ensuring that European research excellence systematically leads to European industrial champions.