Shares of Germany’s CureVac jumped more than 7% in US pre-market trading after the biopharma company announced the enrollment of the first participant in the large-scale study of its mRNA vaccine candidate, CVnCoV, against COVID-19.
CureVac (CVAC) stated that the randomized, placebo-controlled pivotal Phase 2b/3 study will test the safety and efficacy of CVnCoV in adults at a dose of 12 µg. The study is expected to include more than 35,000 participants at sites in Europe and Latin America.
“With the start of the pivotal Phase 2b/3 study, we have reached another important milestone in the development of our vaccine candidate, CVnCoV,” said CureVac CEO Franz-Werner Haas. “The clinical safety and immunogenicity data achieved to date look promising and we are hopeful that this trial will continue to demonstrate the impact of mRNA technology and our vaccine to prevent COVID-19, and to help defeat this pandemic.”
As part of the trial, which will start with an initial Phase 2b part, and is expected to seamlessly merge into a Phase 3 efficacy trial, patients 18 years of age and older will be enrolled at multiple sites and will receive a two-dose schedule of either CVnCoV or placebo.
In addition to the primary safety objective, the study includes two primary efficacy objectives: the testing of the efficacy of CVnCoV in preventing first episodes of COVID-19 infections of any severity, as well as preventing moderate to severe cases of the illness in participants who have never been infected with SARS-CoV-2.
Upon completion of the trial, participants will continue to be monitored in a 1-year extension study. The study will collect additional data to evaluate long-term safety, persistence of antibodies to SARS-CoV-2 and the occurrence of COVID-19 cases to determine the vaccine’s efficacy duration.
CureVac shares have surged a stellar 57% over the past month. Berenberg Bank analyst Zhiqiang Shu last month raised the stock’s price target to $72 (39% downside potential) from $68 and reiterated a Buy rating.
“We think Phase 1 results of its COVID-19 vaccine are encouraging and suggest a differentiated profile,” Shu commented in a note to investors. “The positive Phase 3 outcome from another mRNA-based COVID-19 vaccine [Pfizer-BioNTech candidate] increases our confidence of the mRNA approach.” (See CVAC stock analysis on TipRanks)
Following a meeting with CureVac’s Haas, the company expects to be on track to present vaccine data from its Phase 2b/3 trial in the first quarter of 2021, with a regulatory decision set to come in early Q2, the analyst added.
Meanwhile, Credit Suisse’s Martin Auster, the other analyst covering the stock in the past three months, lowered his price target to $47 from $52, while maintaining a Hold rating. That provides the stock with an average price target of $59.50, which implies downside potential of 50% over the coming 12 months.
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