Full Press Release Details
CureVac's CVnCoV Phase 2b/3 Study
Data Published in Preprints with The Lancet
Germany/ BOSTON, USA - August 31, 2021 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a
new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced the publication of its
pivotal Phase 2b/3 (HERALD study) primary data of CVnCoV, its first-generation COVID-19 vaccine candidate, in Preprints with The Lancet.
The HERALD study enrolled approximately 40,000 participants in ten countries across Latin America and Europe, in the predefined age groups
18 to 60 and above 60. For the final analysis, COVID-19 cases were caused by 15 different virus variants.
announced, the data were based on 228 adjudicated COVID-19 cases, occurring at least two weeks after administration of the second dose.
CVnCoV demonstrated overall vaccine efficacy of 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms.
Significant protection was demonstrated among participants in the age group of 18 to 60, with an efficacy of 53% against disease of any
severity and across all 15 identified strains; protection against moderate to severe disease for this age group was calculated to be 77%.
In the same age group, CVnCoV provided 100% protection against hospitalization or death.
in close interaction with the European Medicines Agency (EMA) and will continue to seek regulatory approval for CVnCoV to leverage the
vaccine's strengths in the large segment of the population where it provides demonstrated protection. Submission of comprehensive
clinical data packages to the EMA is ongoing as part of the rolling submission initiated in February 2021 and is expected to be finalized
toward the end of the third quarter of 2021. As the lack of effective vaccines is still a challenge in many parts of the world, CVnCoV
has the potential to contribute to the fight against COVID-19 and the increasingly complex variant context, which warrants a vaccine that
has been clinically tested in a variant-dominated environment.
CureVac began development of mRNA-based COVID-19
vaccine candidates in January 2020. The vaccine candidate chosen for first clinical development, CVnCoV, is an optimized, non-chemically
modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles
(LNPs). Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November
2020 showed that CVnCoV was generally well tolerated across all tested doses and induced robust antibody responses in addition to T cell
activation. The quality of the immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after
natural COVID-19 infection. A pivotal Phase 2b/3, the HERALD study, with a 12 g dose of CVnCoV was initiated in December 2020. In
February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing
and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the
use of optimized 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, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies,
antibody therapies, and the treatment of rare diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop
new products in prophylactic vaccines for infectious diseases based on CureVac's second-generation mRNA technology. In February
2021, this collaboration was extended to the development of second-generation COVID-19 vaccine candidates. CureVac had its initial public
offering on the New York Nasdaq in August 2020. It is headquartered in T bingen, Germany, and employs more than 700 people at its
sites in T bingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.
CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President
Corporate Communications and Investor Relations
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
CureVac Media Contact
Anna Kamilli, Manager Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1684
Bettina J dicke-Braas, Manager Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1087
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its wholly owned subsidiaries CureVac AG, CureVac Real Estate GmbH, CureVac Inc., CureVac Swiss AG and CureVac Corporate Services GmbH
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