Cynbiose and Virnext congratulate HIPRA upon Covid-19 vaccine’s, Bimervax®, approval by the European Medicines Agency (EMA).

26 April 2023

At the time the SARS-CoV-2 pandemic was at its peak, HIPRA, a biotechnological pharmaceutical company, initiated a preclinical evaluation of its vaccine candidate to confirm its safety and efficacy in a translational model.

The active component of the HIPRA Covid-19 vaccine is an heterologous recombinant heterodimer protein that emulates the receptor binding domain (RBD) of the Spike (S) protein of the Alpha and Beta variants of the SARS-Cov-2 virus. The antigen, which is the active component of the vaccine, requires an adjuvant to amplify and enhance the immune response. The preclinical trials were completed in 2021. The European Commission announced in August 2022 it had signed a pre-purchase agreement with HIPRA to supply its Covid-19 vaccine, subject to approval by the European Medicines Agency (EMA). The agreement involves 13 countries and should allow the purchase of up to 250 million doses, said the European executive in a statement.

CYNBIOSE and VIRNEXT were selected to perform the preclinical studies in a SARS-CoV-2 large animal efficacy model. Indeed, thanks to their synergistically complementarity, they had developed a non-human primate efficacy model from the first half of 2020 thanks to the COVIBIOSE project labeled by the French Health cluster Lyonbiopôle and supported by an exceptional grant provided by the Région Auvergne-Rhône-Alpes.

The efficacy, safety, and immunogenicity of HIPRA’s vaccine (PHH-1V) in cynomolgus macaques showed that PHH-1V prime-boost vaccination induces high levels of RBD-specific IgG and IgA binding and neutralizing antibodies against several SARS-CoV-2 variants of concern, as well as a balanced Th1/Th2 cellular immune response. Remarkably, PHH-1V vaccination prevents SARS-CoV-2 replication in the lower respiratory tract and significantly reduces infectious viral load in the upper respiratory tract after an experimental infection challenge. This highlighted the potential use of the PHH-1V vaccine in humans.

These results were presented in three scientific congresses in 2022 and a scientific publication has been submitted.

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