GSK and CureVac will 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.
The tested vaccine candidates produced promising immunogenicity and reactogenicity profiles in ongoing phase 1 clinical programmes for COVID-19 and seasonal flu, assessing both modified and unmodified mRNA technology.
“The positive results from this preliminary data analysis strongly validate the power of our proprietary mRNA-technology platform, opening the door to new opportunities in the development of effective prophylactic vaccines and also for advancement of our robust oncology strategy,” said Franz-Werner Haas, chief executive officer of CureVac.
Each clinical programme assessed the vaccine candidates based on CureVac’s second-generation mRNA backbone to ‘achieve improved mRNA translation and strong immune responses at low doses’, the company explained.
While the COVID-19 programme tested two monovalent candidates, the flu programme included an unmodified multivalent and a modified monovalent vaccine.
The monovalent modified mRNA COVID-19 vaccine candidate CV0501, encoding Omicron variant BA.1, was shown to successfully boost antibody levels against BA.1 and ancestral variants in healthy adults and was generally well tolerated across all tested dose groups.
The monovalent modified mRNA flu vaccine candidate Flu-SV-mRNA also successfully boosted antibody levels against matching flu strain and was well tolerated across all tested dose groups.
The companies plan to start the second phase of their COVID-19 clinical programme later this year, assessing candidates designed to target clinically relevant variants, while a seasonal flu study to target four different strains should begin towards the middle of the year.
“The data derived from CureVac’s mRNA technology platform and second-generation mRNA backbone implemented in the current clinical compounds demonstrates the potential of our portfolio, not just in COVID-19 and influenza, but across the spectrum of RNA therapies,” said Igor Splawski, chief scientific officer of CureVac. “This includes oncology, where CureVac’s second-generation mRNA backbone is applied.”
The infectious disease collaboration between CureVac and GSK was first announced in July 2020, focusing 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.