CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have launched a Phase 1 dose-escalation study to test the performance of CV2CoV, a COVID-19 vaccine candidate based on CureVac’s second-generation mRNA backbone.
In late morning trading, CureVac’s stock ticked up 0.10% to $19.22.
CVAC shares were trading above $100 before announcing in mid-June 2021 that the interim vaccine efficacy of its first mRNA COVID-19 vaccine candidate was 47% in a Phase 2b/3 study.
Tübingen, Germany–based CureVac believes that its second-generation mRNA could prove to be broadly efficacious against SARS-CoV-2 variants and other pathogens.
Nature published a preclinical study involving cynomolgus macaques last year, indicating that the immunogenicity of CV2CoV was superior to its first-generation vaccine candidate, CVnCoV. The paper concluded that CV2CoV was “comparably immunogenic to the BNT162b2 (Pfizer) vaccine in macaques.”
The dose of the CV2CoV vaccine used in the study was 12 µg compared with a 30 µg dose of the Pfizer-BioNTech COVID-19 vaccine, which is the same dose used in humans.
After announcing disappointing results from the Phase 2b/3 study, CureVac ramped up development efforts of its CV2CoV and decided to not seek U.S. authorization of its first-generation vaccine. CureVac also withdrew its application for authorization in the European Union.
“Our second-generation mRNA backbone was engineered to enable faster and stronger immune responses than our first-generation vaccine,” said Dr. Klaus Edvardsen, Chief Development Officer of CureVac, in a news release.
The Phase 1 study will be conducted at sites in the U.S., enrolling up to 210 healthy adults.
Investigators will test vaccine doses between 2 and 20µg.
CureVac also has a Phase 1 study underway for a multivalent influenza vaccine candidate known as CVSQIV that it jointly developed with GSK.
Filed Under: clinical trials, Drug Discovery, Infectious Disease