CureVac (CVAC) Announces Positive Data on COVID-19 Vaccine
Clinical-stage biopharmaceutical company, CureVac N.V. CVAC, announced that its phase IIb/III study on COVID-19 vaccine candidate, CVnCoV, will continue following the first interim analysis in 59 eligible COVID-19 cases.
The independent Data Safety Monitoring Board (DSMB) confirmed that the phase IIb/III study (HERALD) for CVnCoV has passed the first interim analysis in 59 adjudicated COVID-19 cases with no safety concerns.
Consequently, the trial will continue to collect sufficient data in order to conduct a statistically significant efficacy analysis.
We note that the HERALD study has enrolled approximately 40,000 participants in ten countries in Latin America and Europe. The primary objective of the study is to demonstrate the efficacy of a two-dose administration of 12µg of CVnCoV in preventing COVID-19 infection of any severity in participants without prior exposure to SARS-CoV-2.
It is being conducted in an environment characterized by the spread of multiple virus strains. COVID-19 cases within the trial are currently being sequenced to provide critical complementary data to the efficacy readout.
CureVac has no access to the trial data.
We note that the company began the development of mRNA-based COVID-19 vaccine candidates in January 2020. CVnCoV is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs).
In December 2020, CureVac initiated the HERALD study with a 12µg dose of CVnCoV. In February 2021, it initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
Last month, CureVac along with partner GlaxoSmithKline GSK announced the first preclinical data in a rat model, which showed that its second-generation COVID-19 vaccine candidate, CV2CoV, induces high levels of antigen production as well as strong and dose-dependent immune responses in vaccinated animals.
CureVac’s stock has surged 37.4% in the year so far against the industry’s decline of 4.1%.
There is a significant need for different vaccines across the globe to respond effectively to the emerging variants of COVID-19. Currently, players like Pfizer PFE/ BioNTech and Moderna MRNA are leading the vaccine race with their approved vaccines.
CureVac currently carries a Zacks Rank #3 (Hold. You can see the complete list of today’s Zacks #1 Rank (Strong Buy stocks here.
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