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German biotech CureVac has enrolled the first participant for a final-stage clinical study of its COVID-19 vaccine candidate, the company said on Monday.
Tübingen-based CureVac CVAC, +3.39% said the Phase 2b/3 trial will include more than 35,000 volunteers aged 18 years or older, who will be enrolled at multiple sites in Europe and Latin America.
Shares in CureVac rose 7.91% to $126 in pre-market trading.
“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,” said CureVac Chief Executive Franz-Werner Haas.
CureVac is using the so-called messenger RNA approach, the same as rivals BioNTech BNTX, -8.14% and drug company Pfizer PFE, -3.34%, as well as biotech Moderna MRNA, -0.10%. The approach instructs cells to create proteins to generate an immune response protecting against a virus.
Read: Medical experts vote in favor of FDA authorization of Pfizer-BioNTech COVID-19 vaccine candidate
Unlike BioNTech 0A3M, +4.99% and Pfizer’s 0Q1N, -2.79% vaccine, which needs to be stored at -70° C (-94°F), CureVac’s experimental shot remains stable for at least three months at standard refrigerator temperatures, and up to 24 hours as a ready-to-use vaccine when stored at room temperature.
The vaccine candidate being developed by drug company AstraZeneca AZN, -6.74% and the University of Oxford can also be stored in normal refrigerator-like temperatures, making it easier to store and transport.
The start of CureVac’s Phase 3 trial comes after the company in November disclosed additional clinical data about how its vaccine candidate is performing in a Phase 1 clinical trial. The study tested different doses of the two-dose vaccine in adults between the ages of 18 and 60 years old; all doses generated an immune response. At the time, CureVac said it had selected the 12 microgram dose to move forward with in Phase 2 and 3 studies.
Read: CureVac’s COVID-19 vaccine shows immune response in Phase 1 trial
The European Commission, the European Union’s executive arm, announced a new supply agreement with CureVac for 405 million doses of its vaccine candidate.
CureVac listed on the Nasdaq stock market on Aug. 14, raising $213 million, after the German government paid €300 million to take a 23% stake in the company.
The company is also backed by Microsoft MSFT, +0.59% founder and billionaire Bill Gates, and German biotech investor Dietmar Hopp. In July, pharmaceutical company GlaxoSmithKline GSK, -1.00% acquired a 10% stake in CureVac in a deal worth up to £866 million ($1.16 billion) to develop up to five mRNA-based vaccines and monoclonal antibodies for infectious diseases.
Last month, CureVac said it is setting up a European network to ramp up manufacturing of its vaccine candidate, allowing it to produce up to 300 million doses in 2021 and up to 600 million in 2022.
