Full Press Release Details
CureVac Reports Positive Preclinical
Data for its COVID-19 Vaccine Candidate, CVnCoV
BOSTON, USA - October 23, 2020 - CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing
a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced data from preclinical
studies of its investigational SARS-CoV-2 vaccine candidate, CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced
humoral and cellular immune responses, featuring high antibody titers and very good T cell activation. In addition to the positive
immune response, the vaccine candidate induced favorable Th1 cytokine levels. Furthermore, CVnCoV efficiently protected hamsters
against a live SARS-CoV-2 viral challenge without evidence of vaccine-induced disease enhancement. The full manuscript of the preclinical
data is available on the pre-print server bioRxiv and was submitted for potential publication in a peer-reviewed journal. This
vaccine candidate is currently being investigated in a Phase 1 and Phase 2a clinical trial. Interim Phase 1 data is expected to
be announced shortly.
CVnCoV demonstrated dose-dependent
activation of the humoral immune system in mice at doses of 0.25, 1 and 4 g. Strong IgG1 and IgG2a binding antibody titers
were observed at all doses and translated efficiently into neutralizing antibodies that were detected even at the lowest dose.
Neutralizing antibodies started to develop 3 weeks after the first vaccination and strongly increased after the second vaccination.
The impact of different dosing
schedules for the two-injection (prime and boost) regimen was investigated at 2 g with 1, 2, 3, or 4 weeks between the first
and second vaccination. The data showed induction of IgG1 and IgG2a binding antibodies 7 days after the first vaccination. Titers
increased after the second vaccination, showing higher response levels with longer injection intervals. Binding antibodies efficiently
translated into neutralizing antibodies, which started to develop 4 weeks after the first vaccination and significantly increased
after the second vaccination.
Efficient induction of neutralizing
antibodies was in line with favorable IgG2a/IgG1 ratios, indicating a balanced Th1/Th2 profile. There was no evidence of a Th2-biased
immune response, which is associated with a potential vaccine induced disease enhancement.
"The preclinical data
published today shows that our lead COVID-19 vaccine candidate has the potential to induce an efficacious and balanced immune response,
mimicking the natural immune defense and providing lung protection in a relevant challenge model," Dr. Mariola Fotin-Mleczek,
Chief Technology Officer of CureVac, said. "The study adds to our understanding of CVnCoV, which is currently being evaluated
in Phase 1 and 2a clinical trials."
mice showed positive induction of multifunctional IFNg+/TFN+ CD4+
and CD8+ T cells. Both of which have been detected in COVID-19 convalescent patients, with CD4+ T cells
being important for the generation of memory B cells. Mean values of CD4+ and CD8+ T cells amounted to
0.34% and 10.5%, respectively, after vaccination at Day 0 and 28, and also benefitted from longer injection intervals.
The potential protective
efficiency of CVnCoV was demonstrated in Syrian hamsters, representing an established animal model to investigate human-relevant
immunogenicity and pathogenesis. Vaccine dose of 10 g in hamsters showed very good reduction in replicating virus levels
in the upper respiratory tract and complete lung protection in treated animals. Following viral challenge, lungs of vaccinated
animals showed no evidence of disease enhancement.
CureVac first began development
of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is based on optimized, non-chemically modified mRNA,
encoding the prefusion-stabilized full spike protein of the SARS-CoV-2 virus. Formulation of CVnCoV is based on state-of-the-art
lipid nanoparticle (LNP) technology licensed from the company's partner, Acuitas. The company began a Phase 1 clinical study
of CVnCoV in June 2020 at clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness
Innovations (CEPI). At the end of September 2020 the vaccine candidate entered a Phase 2a clinical trial in Peru and Panama, further
extending clinical studies into older adults and regions with high incidence of COVID-19 infections. The company plans to initiate
a pivotal Phase 2b/3 clinical study by the end of 2020. Clinical trial material is provided by the company's substantial
production capacities for mRNA vaccines at its headquarters in T bingen. CureVac is currently expanding those manufacturing
capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
CureVac is a global clinical-stage biopharmaceutical company in the field of messenger RNA (mRNA) technology with more than 20
years of expertise in developing and optimizing this versatile biological molecule for medical purposes. The principle of CureVac's
proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own
proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical
pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies and the treatment of rare diseases. CureVac
had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in T bingen Germany, and employs
approximately 500 people at its sites in T bingen, Frankfurt and Boston, USA. Further information can be found at www.curevac.com.
CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1684
CureVac Investor Relations
Dr. Sarah Fakih, Vice President
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
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