CureVac N.V. (NASDAQ: CVAC) advanced in the fight against COVID-19 by beginning enrollment in its midstage vaccine candidate study. Investors cheered on this news and sent shares higher.
The firm enrolled its first participant in its pivotal Phase 2b/3 study of its mRNA vaccine candidate (CVnCoV). The midstage trial goes by the name HERALD, and it will assess the safety and efficacy of CVnCoV in adults at a dose of 12 micrograms. This study is expected to include more than 35,000 participants at sites in Europe and Latin America.
The HERALD trial begins with an initial Phase 2b part, which is expected to merge into a Phase 3 efficacy trial. Subjects 18 and older will be enrolled at multiple sites and will receive a two-dose schedule of either CVnCoV or a placebo.
Apart from the primary safety objective, the study design includes two primary efficacy objectives: the demonstration of the efficacy of CVnCoV in preventing first episodes of confirmed cases of COVID-19 of any severity, as well as preventing moderate to severe confirmed cases of COVID-19 in participants who have never been infected.
After the conclusion of the trial, subjects will continue to be monitored in a one-year extension study. The extension study will collect additional data to evaluate long-term safety, persistence of antibodies and the occurrence of COVID-19 cases in an effort to assess the duration of vaccine efficacy.
Management noted that with the start of the pivotal Phase 2b/3 study, the company has reached another important milestone in the development of its vaccine candidate. The clinical safety and immunogenicity data achieved to date look promising, and management is hopeful that this trial will continue to demonstrate the impact of mRNA technology and its vaccine to prevent COVID-19.
Excluding Monday’s move, CureVac stock had outperformed the broad markets with a gain of about 111% year to date. In the past quarter alone, the share price was up over 122%.
CureVac stock traded up about 8% Monday morning to $127.89, in a 52-week range of $36.15 to $151.80. The consensus price target is $73.20.