CureVac advances ‘promising’ seasonal flu mRNA vaccine to phase 2 development

CureVac has announced that it has selected a “promising” seasonal influenza mRNA vaccine candidate after it showed positive results in the first phase of the combined phase 1/2 study conducted in collaboration with GSK.

The phase 1 part of the study assessed a range of multivalent modified mRNA seasonal flu vaccine candidates, with up to eight separate mRNA constructs per candidate, and addressing all four World Health Organization (WHO)-recommended flu strains.

The candidates were tested at different dose levels in 270 healthy adults aged 18 to 50 years old against an approved seasonal flu vaccine comparator.

Positive interim data results showed no safety concerns across all tested dose levels for the multivalent candidates.

Announced in January 2023, WHO advised protection against the two A subtypes, H1N1 and H3N2, and the influenza B Victoria and Yamagata lineages in annual flu vaccines.

According to the Centers for Disease Control and Prevention, influenza causes 12,000 to 52,000 deaths in the US each year.

The selected vaccine candidate will now be advanced to the phase 2 part of the study, with the first participant expected to be dosed in the fourth quarter of 2023. It will also be expanded to include adult adults aged 65 to 85.

博士Myriam Mendila, chief development officer at CureVac, said: "Our mRNA technology platform offers tremendous potential to overcome the current challenges associated with providing seasonally updated and highly effective influenza vaccines.

"We feel confident that our differentiated vaccine candidate has the potential to offer people broad protection and will advance us on the path to transforming public health."

First announced in July 2020, the collaboration between CureVac and GSK focuses on the development of new products based on CureVac’s mRNA technology for different targets for infectious diseases.

In 2021, the collaboration was extended to jointly develop vaccine candidates for COVID-19.