Full Press Release Details
CureVac's First-Generation COVID-19 Vaccine Candidate, CVnCoV,
Continues Toward Phase 2b/3 Efficacy Readout in Variant-rich Environment Following DSMB Recommendation
T BINGEN, Germany/ BOSTON, USA - May 28, 2021 -
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 that the independent Data Safety Monitoring Board (DSMB) has confirmed that the
pivotal Phase 2b/3 study (HERALD) for CureVac's first-generation COVID-19 vaccine candidate, CVnCoV, has passed a first interim
analysis at 59 adjudicated COVID-19 cases. The DSMB confirmed that there were no safety concerns for CVnCoV. As a standard procedure within
a blinded trial, CureVac has no access to trial data. The trial will continue to collect
sufficient data in order to conduct statistically significant efficacy analysis.
The HERALD trial is conducted in an environment characterized by the
spread of multiple virus strains. COVID-19 cases within the trial are currently being sequenced to provide critical complementary data
to the efficacy readout.
study has enrolled approximately 40,000 participants in ten countries in Latin America and Europe. Of those participants, approximately
75% were enrolled in Latin America and 25% in Europe. The primary objective
of the HERALD study is to demonstrate the efficacy of a two-dose administration of 12 g of CVnCoV in preventing COVID-19 infection
of any severity in participants without prior exposure to SARS-CoV-2.
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 strong antibody responses in addition to first indication
of 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. In December 2020, CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12 g dose of
CVnCoV. In February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
CureVac is 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 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 more than 700 people at its sites in T bingen, Frankfurt, and Boston, USA. Further information can be found
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
CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Investor Relations
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
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