COVID-19: CureVac Announces Promising Phase 1 Results with Lower Vaccine Dosage Than Competitors
By T. Chakraborty, Ph.D.
On November 2nd, CureVac announced positive interim data from their ongoing Phase 1 trial of its experimental SARS-CoV-2 vaccine, CVnCoV. The German biotech company added that their mRNA vaccine dose in development helped escalate the production of virus-neutralizing antibodies and showed nascent indications of T-cell activation. The news comes in at a time when its competitors, Moderna and BioNTech/Pfizer are racing to get their mRNA vaccines to the marketplace.
Dr. Mariola Fotin-Mleczek, Chief Technology Officer of CureVac said, “These initial data show a robust and highly efficient immune response to our natural mRNA-based CVnCoV vaccine candidate, including antibody and initial T cell responses at the level of a relevant panel of symptomatic convalescent patients. We are grateful to all study volunteers who are helping to enable the development of a vaccine that will provide the best possible protection for people.”
The Phase 1 clinical trial consisted of 250 healthy individuals who were injected with the mRNA vaccine, with doses ranging from 2-12 µg twice in a span of 29 days. According to the data, the company mostly concentrated on the 12µg dose group. Individuals receiving the 12 µg dosage developed neutralizing antibodies similar to 67 patients who were seriously ill with COVID-19.
The proportion of neutralizing to binding antibodies was also similar between the treatment and control group suggesting that the vaccine generated a normal immune response. The major adverse events reported at 12 µg dose of the vaccine were fatigue, headache, and fever. Though no data with other doses of the vaccine were released, it is to be noted that the vaccine was well tolerated across all the doses. The company plans to publish the complete data in a leading scientific journal soon. Currently, the vaccine is being used in a Phase 2a clinical trial comprising older adults in Peru and Panama.
Dr. Franz-Werner Haas, Chief Executive Officer of CureVac said, “We are very encouraged by the interim Phase 1 data. It represents a critical milestone in our COVID-19 vaccine program and strongly supports the advancement of our vaccine candidate. 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.”
Recently, CureVac closed a $640 million private financing round with the German federal government and GSK contributing $343 million for a 23% stake and $171 million for a 10% stake, respectively. The raising of this round is substantially larger than all of CureVac’s previously disclosed rounds combined, as the company looks laser focussed on bringing an mRNA COVID-19 vaccine to market.
However, its rivals might already have the final stage clinical trial data which would be used to seek emergency approval. Moderna has chosen 100 µg as its probable Phase 3 dose while CureVac is leaning towards their 12-µg dose. If this works out, CureVac would be manufacturing less material per vial, thus scaling up production rapidly and will be interesting to see how it navigates the market in this closely watched vaccine race. Not succumbing to the pressure, the company has gone ahead and lined up a deal to sell 225 million doses of the vaccine to the EU.
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