CureVac said it is on track to launch the final stage of testing, after its COVID-19 vaccine triggered an immune response in the Phase 1 trial.
Shares in CureVac jumped higher on Monday, after the German biotech company said its experimental COVID-19 vaccine triggered a good immune response in humans in a Phase 1 clinical study, placing it on track to launch the final stage of testing before the end of 2020.
Tübingen-based CureVac CVAC, -2.00% said in a statement that the strongest dose of the vaccine, known as CVnCoV, produced an immune response in volunteers comparable with patients who had recovered from being hospitalized with a case of COVID-19.
The clinical data haven’t yet been published in peer-review format.
“We are very encouraged by the interim Phase 1 data,” said Franz-Werner Haas, chief executive of CureVac. “Following further data readouts and discussion with regulatory authorities, we remain fully committed and on track to initiate a pivotal Phase 2b/3 trial before the end of 2020.”
CureVac’s U.S.-listed shares, which trade on Nasdaq, rose 2.93% higher on Monday.
CureVac is using the so-called messenger RNA (mRNA) approach to develop a vaccine for COVID-19, which instruct cells to create proteins to generate an immune response protecting against a virus.
No RNA vaccine has yet been approved by regulators.
Several other companies are also using this approach to develop a vaccine, including U.S. companies Moderna as well as BioNTech BNTX, -1.28% and its partner Pfizer PFE, +1.36%, which started mass testing on humans in late July.
Together, Pfizer and BioNTech say that they have the capacity to manufacture 100 million doses of their vaccine this year, and at least 1.3 billion doses in 2021.
CureVac said the Phase 1 trial data was generally well tolerated across all five tested doses — from 2 to 12 microgrammes — and induced increases in virus-neutralizing antibodies as well as the first signs of T-cell activation. T cells are a type of white blood cell that help destroy infection.
Analysts and medical experts are paying close attention to these two metrics.
The Phase 1 study has, to date, enrolled more than 250 healthy individuals aged 18 to 60 years in Germany and Belgium. CureVac intends to provide a detailed Phase 1 data overview and publication in a scientific journal in the coming weeks.
Some participants experienced side effects of headache, chills and muscle pain, with a smaller number of people reporting fever. “All reported events were transient and resolved rapidly, usually within 24 to 48 hours,” CureVac said.
CureVac went public on Nasdaq in August to accelerate the development of its vaccine. The company’s stock more than tripled in its first day of trading and is now valued at almost $9 billion.
The company is backed by Microsoft MSFT, -0.37% founder and billionaire Bill Gates and German biotech investor Dietmar Hopp. In July, GlaxoSmithKline GSK, +2.87% bought a stake in the company, marking the latest move by a major drugmaker to boost capabilities to fight pandemics.
In August, CureVac said it was in advanced talks for the supply of at least 225 million doses of a potential COVID-19 vaccine to European Union member states.