CureVac has announced that the first participant has been dosed in the initial phase of a combined phase 1/2 study of its multivalent mRNA seasonal influenza vaccine candidates, developed in collaboration with GSK.
Influenza causes 12,000 to 52,000 deaths in the US every year, according to the Centers for Disease Control and Prevention, but the strains used in vaccines have to be changed continually ahead of the flu season as circulating viruses keep evolving.
Dr Myriam Mendila, chief development officer of CureVac, explained: “The flexibility, speed and scalability of CureVac’s end-to-end mRNA capabilities position us well to develop and deliver seasonal flu vaccines together with GSK that combat dominant strains of the season as they emerge.”
The combined study will evaluate the candidates, which address all four World Health Organization-recommended flu strains, for safety, reactogenicity and immune responses.
The first phase 1 dose selection part is being conducted in the US and Belgium, CureVac said, and will feature a licensed flu comparator vaccine.
The partners have previously reported positive results from an ongoing phase 1 trial of their monovalent mRNA seasonal flu vaccine candidate in older and younger adults.
Preliminary data indicated strong immune responses in line with a licensed flu vaccine, and the candidate showed a favourable tolerability profile and no concerning safety signals
“Our clinically validated technology platform and second-generation mRNA backbone give us great confidence as we continue clinical development of novel vaccine candidates to address seasonal flu,” Mendila said.
The infectious disease collaboration between CureVac and GSK was first announced in July 2020 and focused on the development of new products based on CureVac’s mRNA technology for different targets in the field of infectious diseases.
The collaboration was extended in February 2021 to also include jointly developed vaccine candidates for COVID-19, with the companies broadening their development strategy to test modified mRNA technologies in addition to unmodified mRNA last year.
In January, the partners said they would be advancing their jointly developed mRNA COVID-19 and flu vaccine candidates to the next stage of clinical testing after announcing positive preliminary results from early stage trials.
Image used with permission. Copyright held by CureVac AG