Lovaltech développe une plateforme de muco-excipient de nouvelle génération, conçue pour optimiser l’administration intranasale de biomolécules complexes, qu’il s’agisse de protéines recombinantes, d’ARNm ou d’autres formats innovants.

Cette technologie propriétaire repose sur une architecture nanoparticulaire modulable capable d’augmenter l’adhésion et la persistance au niveau de la muqueuse, de protéger des entités biologiques sensibles, de favoriser leur internalisation locale et d’induire une immunité muqueuse et systémique robuste, un objectif devenu central pour les futurs vaccins respiratoires.

Totalement agnostique en termes de format vaccinal, la plateforme ouvre la voie au développement de vaccins protéiques intranasaux, déjà validés en Phase I humaine avec un excellent profil de sécurité, ainsi qu’à l’exploration de vaccins à ARNm spécifiquement formulés pour la voie nasale, un domaine encore peu adressé mais porteur de perspectives majeures. À plus long terme, ses propriétés de délivrance et d’immunomodulation permettent également d’envisager des applications dépassant les maladies infectieuses, notamment dans les champs de la vaccination thérapeutique ou de l’oncologie.

La pré-accélération IDCluster accompagnera Lovaltech dans la structuration industrielle, réglementaire et PI de cette plateforme NextGen, avec l’ambition d’en faire un socle technologique européen de référence pour les futurs candidats à administration nasale à forte valeur ajoutée.

Context and ambition: positioning France at the forefront of the fight against future pandemics 

The INNOFLU project, led by Osivax in collaboration with the Hospices Civils de Lyon (HCL) and the International Center for Infectiology Research (CIRI), is part of a proactive strategy to prepare for health crises and paves the way for a new generation of more effective vaccines against viruses with high mutation rates.

Two complementary innovations to combat influenza pandemics

1. NextGenFluVax: an innovative vaccine combining OVX836, Osivax’s universal vaccine candidate targeting all influenza A strains, with a seasonal influenza vaccine. This unique approach aims to significantly improve the effectiveness of seasonal vaccination (target >70% effectiveness compared to the current average of 38%) by mobilizing both arms of immunity (antibody and cellular responses) while providing cross-protection against pandemic strains thanks to its universal valence. The project plans to conduct a Phase 1 clinical trial on the HCL clinical trial platform to validate the feasibility and safety of NextGenFluVax.

2. VIDAS® IGRA: a rapid, automated test that measures the cellular immune response directly in whole blood in just 16 hours, and which could eventually replace the current conventional method, which takes several days and requires blood cell preparation. The development and validation of this test during the project to measure the vaccine-induced response in humans should ultimately enable robust correlates of protection to be established in future large-scale clinical trials and the rapid evaluation of the effectiveness of vaccine countermeasures against new pandemic strains in the event of a health crisis. 

Strategy and impacts: an effective first line of defense against both seasonal and pandemic influenza strains

The integration of the universal OVX836 valence into the seasonal vaccine would not only reduce the impact of seasonal influenza but also create a first line of immune defense in all vaccinated individuals in the event of the emergence of a pandemic strain, significantly reducing its initial impact.

This approach creates a virtuous circle between seasonal prevention and pandemic preparedness: the use of the vaccine for seasonal use will maintain continuous industrial production capacity, facilitating rapid deployment in emergency situations.

A consortium of excellence combining industry with academic research

Osivax, a French biotechnology company and leader in the development of universal vaccines thanks to its proprietary oligoDOM® platform, contributes its expertise in vaccine development and innovative technology. HCL will conduct the clinical trial and perform immunological analyses on samples, including validation of the VIDAS® IGRA test to measure the specific cellular response to the influenza virus. CIRI will contribute its cutting-edge expertise in immunology and virology to thoroughly characterize the antibody and cellular immune response induced during the clinical trial.

Controlling influenza A (IAV) in pigs is both a major public health issue and a crucial challenge for the pig industry. Pigs play a central role in the influenza ecosystem as an intermediate reservoir capable of reassortment of genetic segments from human, swine, and avian viruses. This mechanism can lead to the emergence of new pandemic strains, as was observed with the H1N1 virus during the 2009 pandemic. Today, control of IAV in pig farms relies mainly on the use of inactivated vaccines. However, IAV is a segmented RNA virus with a high capacity for evolution, while the vaccines currently available cannot be adapted quickly enough to keep up with the emergence of new circulating variants.

In this context, self-replicating RNA (ssRNA) vaccine technologies represent a particularly promising alternative. They make it possible to modify the sequences coding for antigens of interest, in particular hemagglutinin (HA) and neuraminidase (NA), in just a few weeks, thus providing great flexibility in the face of a constantly evolving virus. However, the development and optimization of sRNA vaccines requires the comparison of a large number of vaccine candidates in order to identify the most effective ones. Today, this phase still relies heavily on animal testing, which is time-consuming, costly, restrictive, and severely limits the number of vaccine candidates that can be tested, thereby delaying the selection of the best candidates.

The use of porcine lymphoid organoids, including lymphoid aggregates and lymphoid organs on chips, is an innovative and relevant alternative to animal testing. These ex vivo models provide a robust system for measuring complex humoral and cellular immune responses. They allow for the screening of a much larger number of vaccine candidates prior to in vivo studies, significantly reducing the risk of unsuccessful animal trials and accelerating the development phases of a new vaccine.

The FluOrganoVax project therefore aims to (i) register a saARN vaccine platform against swine flu and (ii) develop and validate two types of porcine organoids for the evaluation of saARN vaccine candidates. Led by a consortium bringing together Ceva Santé Animale, INRAE, and the Institut Pasteur, it is fully in line with a One Health approach, at the interface between animal and human health. Ceva, a leading industrial player in veterinary vaccines, is leading the development and registration of the vaccine platform. INRAE is contributing its recognized expertise in swine immunology and virology, while the Institut Pasteur is mobilizing its knowledge of immunology and organoid-on-a-chip technologies.  

Over a four-year period, FluOrganoVax will provide France with a unique strategic capability to respond rapidly to future panzootic diseases and/or pandemics. By combining an agile vaccine platform with predictive ex vivo models, the project will significantly reduce the time required to develop new vaccines, while strengthening One Health preparedness and the sustainability of the pig industry.