Full Press Release Details
CureVac Commences Global Pivotal Phase 2b/3 Trial for COVID-19
Vaccine Candidate, CVnCoV
T BINGEN, Germany/ BOSTON, USA - December
14, 2020 - CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of
transformative medicines based on messenger ribonucleic acid (mRNA), announced today that it has enrolled the first
participant in the pivotal Phase 2b/3 study of its mRNA vaccine candidate, CVnCoV, against COVID-19. The randomized, observer
blind, placebo-controlled Phase 2b/3 trial called HERALD will assess the safety and efficacy of CVnCoV in adults at a dose of
12 g. The study is expected to include more than 35,000 participants at sites in Europe and Latin America.
"With the start of the pivotal Phase 2b/3 study, we have
reached another important milestone in the development of our vaccine candidate, CVnCoV," said Dr. Franz-Werner Haas, CEO
of CureVac. "The clinical safety and immunogenicity data achieved to date look promising and we are hopeful that this trial
will continue to demonstrate the impact of mRNA technology and our vaccine to prevent COVID-19, and to help defeat this pandemic."
The HERALD trial will start with an initial Phase 2b part, which
is expected to seamlessly merge into a Phase 3 efficacy trial. Subjects 18 years of age or older will be enrolled at multiple sites
and will receive a two-dose schedule of either SARS-CoV-2 or placebo.
Besides the primary safety objective, the study design includes
two primary efficacy objectives: the demonstration of the efficacy of CVnCoV in preventing first episodes of confirmed cases of
COVID-19 of any severity, as well as preventing moderate to severe confirmed cases of COVID-19 in participants who have never been
infected with SARS-CoV-2.
Efficacy of CVnCoV will be assessed by an event-driven
analysis based on a certain number of participants who present with laboratory confirmed symptomatic COVID-19 disease during the study. To ensure
continued and close safety monitoring of the participants in the trial, data will be reviewed by an independent Data Safety
Monitoring Board on a regular basis.
Following completion of the trial, subjects will continue to
be monitored in a 1-year extension study. The extension study will collect additional data to evaluate long-term safety, persistence
of antibodies to SARS-CoV-2 and the occurrence of COVID-19 cases to assess the duration of vaccine efficacy.
The study will be conducted in compliance with the requirements
of the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonisation
of Technical Requirements for Pharmaceuticals for Human Use (ICH). A detailed outline of the study is available at clinicaltrials.gov
(Identifier: NCT04652102) and the full study protocol can be viewed on the CureVac website.
CureVac began development
of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding
the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. 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 immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19
infection. The data supported CureVac's decision to advance a 12 g dose in its pivotal Phase 2b/3 study. Clinical trial
material is provided by the company's substantial production capacities for mRNA vaccines at its headquarters in T bingen,
supported by the current expansion of manufacturing capacities in Europe 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 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 500 people at its sites in T bingen, Frankfurt, and
Boston, USA. Further information can be found at www.curevac.com.
CureVac Media Contact
Thorsten Sch ller, Vice President Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1577
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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