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.

The HERALD 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 12μg of CVnCoV in preventing COVID-19 infection of any severity in participants without prior exposure to SARS-CoV-2.

About CVnCoV

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 12μg dose of CVnCoV. In February 2021, CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.

About CureVac

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 Tübingen, Germany, and employs more than 700 people at its sites in Tübingen, Frankfurt, and Boston, USA.