CureVac starts Phase 1 trials for Omicron-specific vaccine

Drugs

Developed in collaboration with GSK, CV0501 is based on CureVac’s second-generation mRNA backbone and is designed to specifically protect against the Omicron variant. It is one of two second-generation candidates now in clinical trials from the German mRNA specialist, which withdrew its first-generation COVID-19 vaccine​ in 2021. Data from these two early-stage clinical trials will help CureVac select the best second-generation candidate for further development.

Licensed COVID-19 vaccines that encode for the original virus variant, continue to protect against severe disease and hospitalization, but they are increasingly challenged by immune evasion of new variants such as Omicron,”​ said CureVac interim Chief Development Officer Dr. Ulrike Gnad-Vogt. “As we extend the clinical studies of our second-generation backbone into modified mRNA, targeting the Omicron variant will further explore the full potential of our improved second-generation design as a booster vaccination for a relevant variant.”

CureVac’s two second-generation candidates

CV0501 is CureVac’s first COVID-19 vaccine candidate applying chemically modified mRNA from the COVID-19 vaccine. It encodes for the prefusion stabilized full-length spike protein of the SARS-CoV-2 Omicron variant and is formulated within lipid nanoparticles (LNPs). The vaccine was designed with specifically optimized non-coding regions to exhibit improved mRNA translation for increased and extended protein expression compared to the first-generation mRNA backbone.

The CV0501 study follows the start of a Phase 1 study in March 2022 that evaluates an unmodified second-generation COVID-19 vaccine candidate CV2CoV, encoding for the original virus variant.

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