According to an article in Biospace, CureVac of Boston, MA, with headquarters in Tübingen, Germany, just announced interim results from its Phase 1 study evaluating CVnCoV, a vaccine candidate against SARS-CoV-2.
Note that the virus causing COVID-19 is somehow related to the virus that also causes SARS. Therefore, scientists have called this new virus SARS-CoV-2.
Can We Begin to Flatten the Curve?
After gaining confidence earlier this year that countries worldwide were beginning to “flatten the curve” the opposite now seems to be true.
To flatten the curve of COVID-19, the number of new cases must be reduced each day. Instead, we are seeing new spikes. Healthcare systems are overwhelmed.
The continuing controversy over whether to wear masks or whether state and local governments should mandate masks may be one of the primary factors causing these new spikes.
Drug Makers and Startups
At this juncture, twenty-three companies, consisting of major drug companies as well as small startups, are in a race to develop treatments or vaccines to target the coronavirus infection. CureVac is now one of these companies.
The companies are chasing a virus that to date has affected over eleven million people and killed almost 250,000 throughout the US.
We have all seen results from drug companies that have cycled from “exciting news” to putting a hold on the drug due to serious adverse events.
Where is CureVac’s CVnCoV in the mix?
CureVac reports that the results of their Phase 1 study, enrolling 250 healthy individuals, showed an immune response that is comparable to that of patients who have recovered from COVID-19. The participants were ages eighteen to sixty years old.
The participants were vaccinated with CVnCoV at doses ranging from 2 to 12µg in twenty-nine-day cycles. Ten COVID-infected individuals (a sub-population) were also included in each dose level to test its safety and resistance of CVnCoV to the virus.
The drug was continuously monitored by a Safety Monitoring Board. It was found to be well tolerated in the range of 2 to 12µg. CVnCoV is therefore on track for a clinical trial, Phase 2b/3, during the latter part of 2020.
Grade 3 adverse events (AEs) occurred at 12µg generally after the second dose. AEs included headache, fatigue, muscle pain, chills, and occasional fever. The AEs generally were resolved within forty-eight hours.
A Brief View of CVnCoV
CureVac began the development of CVnCoV in January 2020. The basis for CVnCoV’s formulation is lipid nanoparticle (LVP) technology. It is licensed through Acuitas Therapeutics, a partner of CureVac.
Dr. Fotin-Mleczek, CureVac’s CTO, added that CVnCoV showed T cell and antibody responses similar to those of recovering COVID-19 patients.
Dr. Kremsner, lead Phase 1 trial investigator, pointed out that the study met one of its endpoints and successfully determined CVnCoV’s optimal dose.
About CureVac’s Technology
CureVac has over twenty years’ expertise as a developer in the area of messenger RNA (mRNA) technology.
The company’s technology is based on the use of modified mRNA that results in the production of the body’s own proteins to fight a wide range of diseases.
As a result, CureVac has a product line consisting of cancer therapies, vaccines, and antibody therapies, as well as therapies for rare diseases.
According to CureVac, the trial results support its plan to administer a 12µg dose in its forthcoming Phase 2b/3 trial.
A detailed Phase 1 overview will be published in a scientific journal within the next few weeks.