A French nasal vaccine against COVID-19

blocking all contagiousness and effective against variants

A nasal subunit vaccine against COVID-19 has been developed by the BioMAP research team from the "Infectiology and Public Health" unit – a joint research unit between INRAE and the University of Tours – with the support of a network of academic and industrial collaborations.
This vaccine, composed of a unique multivalent fusion protein combined with biocompatible mucosal nanocarriers, has demonstrated in relevant preclinical models its ability to induce both systemic and mucosal immune responses, particularly at the level of the respiratory tract, the main entry site for the virus. This protective immune response blocks viral replication at an early stage and:
1/ protects individuals against symptomatic forms of COVID-19;
2/ stops the contagiousness of infected individuals, thus contributing to the reduction of viral circulation and the emergence of new variants.
Furthermore, thanks to its innovative design in terms of protein composition, this vaccine has a unique ability to offer protection against current and future variants.
Today, this vaccine is positioned as one of the few in the world capable of ensuring complete protection against infection with SARS-CoV-2.
In order to bring this innovative vaccine to market, Lovaltech, a biotech company based in Tours and labelled DeepTech by BPI France, was created in January 2022 to take over from academic research and continue the industrial development of the nasal vaccine until its commercialization.
With initial financial support from MESRI and ANRS-MIE, Lovaltech led the GMP development phase of the vaccine protein and the mucosal excipient (production and pharmaceutical release) via CDMOs GTP Bioways and Stanipharm.
Winner of the 2022 i-Lab national competition for the creation of innovative businesses, the start-up accelerated the development of its vaccine by launching regulatory studies on toxicity and immunogenicity to demonstrate the safety and effectiveness of the vaccine candidate in animals before its administration to humans. These studies, conducted since October 2022 by C-Ris Pharma (a French CRO specialized in non-clinical studies), have now been completed and validated the vaccine's safety.
Regarding the medical device – with its unprecedented design – its development follows a specifications document established by LoValTech in collaboration with Aptar Pharma, a world leader in the manufacture of sprays and aerosols for the pharmaceutical market. Aptar Pharma has committed to developing a dedicated production line for this device for LoValTech’s vaccines in France as part of the #France2030 project call, of which Lovaltech is a winner.

2020

Submission of the first COVID project.

Preclinical tests conducted in the laboratory demonstrated the effectiveness of the concept for a vaccine candidate, consisting of the Spike protein and the non-mutating nucleoprotein, after two nasal immunizations spaced 3 weeks apart, both in terms of immune response and protection against the original virus and its variants.

2021

Grant of €1.5 million has been allocated by the MESRI (Ministry for Higher Education, Research and Innovation) to the project delivered through the University of Tours.

Late 2021

New preclinical trials on the hamster reference model demonstrate the vaccine's effectiveness in blocking contagiousness and inter-individual transmission.

2022

Support from the French Agency for Research on AIDS and Emerging infectious diseases (ANRS-MIE) up to €900,000 and CREATION OF LOVALTECH.

DEVELOPMENT PHASE

These 2 grants were awarded for the development and production of our vaccine in a GMP (Good Manufacturing Practice) environment, mandatory for use in humans in the context of clinical phases.

2024

Submission of regulatory IMPD file to ANSM.

2025

Phase I and II multicenter clinical trials (FIH).

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