Despite disappointing results for its first-generation COVID-19 vaccine, CVnCoV, German biotech CureVac is to seek EMA approval based on “a solid efficacy profile in the age group of 18 to 60”.
“Large parts of the world are still under-vaccinated against SARS-CoV-2, making effective vaccines necessary to prevent further evolution of the virus and to avoid renewed restrictions on public life,” said chief executive Franz-Werner Haas, explaining the decision.
CVnCoV offered 77% protection against moderate to severe disease and 100% protection against hospitalisation or death in people aged between 18 and 60. However, its efficacy on people over 60 has “fallen short of expectations”, said Haas, reducing its overall efficacy to 48% across all ages and all severities of disease.
The company points to the trial taking place in “the unprecedented context of 15 different virus variants circulating within the study population”.
CureVac’s second-generation vaccine, CV2CoV, will advance to phase 1 trials later this year following positive preclinical studies. The candidate features a new, optimised mRNA backbone that causes “earlier and stronger immune responses compared to CVnCoV”, the company said.
CureVac also announced that Boehringer Ingelheim had terminated a collaboration with the company to investigate treatments for lung cancer. The two companies had been working on the “legacy programme” for an mRNA cancer vaccine candidate BI1361849 in non-small cell lung cancer since 2014, when CureVac received $45m upfront and was promised $556m in milestones. A phase 1/2 combination study is still running and both companies are “assessing options” to continue collaboration, the company said.
The company continues to lose money as it invests heavily in the development of its COVID-19 vaccines and expands production capacity, with a loss of €147.8m for the three months ending in June compared with a loss of €3.2m during the same period last year.