Full Press Release Details
CureVac Initiates Phase
2a Clinical Trial of COVID-19 Vaccine Candidate
BOSTON, USA - September 29, 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 the first
participant has been dosed in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study,
entitled CV-NCOV-002, is being conducted in Peru and Panama and will enroll a total of 690 healthy participants in two distinct
groups: older adults ages 61 and above, and younger participants 18 to 60 years old.
The participants will receive
two vaccinations at intervals of 28 days. Different dose levels will be investigated, starting at 6 g, with the aims to
confirm safety and evaluate reactogenicity of the vaccine in older adults. In addition, in a geographical environment with a high
incidence of COVID-19 infection, the humoral immune response after administration of CVnCoV will be assessed and the safety database
will be expanded to prepare for the start of a phase 2b/3 study. First comprehensive data of Phase 2a in older adults are expected
later in the fourth quarter 2020.
The study design was coordinated
with and approved by the health authorities and ethics committees of Peru and Panama and is based on preliminary safety and immunogenicity
data from CureVac's ongoing Phase 1 CV-NCOV-001 study in healthy adult volunteers in Germany and Belgium. Pending further data
from the ongoing Phase 1 and the Phase 2a study, CureVac plans to initiate the global Phase 2b/3 clinical trial enrolling approximately
30,000 participants in the fourth quarter of 2020.
"The start of the clinical
Phase 2a trial in Peru and Panama represents an important step forward in our COVID-19 clinical study program," Dr. Mariola
Fotin-Mleczek, Chief Technology Officer of CureVac, said. "This trial is designed to further confirm the selection of the
dose of our vaccine candidate and to confirm that we can provide a safe and tolerable vaccine, also to older adults, who are at
a higher risk of experiencing serious impacts from COVID-19."
CureVac first began development
of its mRNA-based COVID-19 vaccine candidate in January 2020. After extensive preclinical development, the company began its Phase
1 clinical study of CVnCoV in June 2020 at clinical study centers in Germany and Belgium. The company has substantial production
capacities for mRNA vaccines at its headquarters in T bingen and is currently expanding those manufacturing capacities to
allow for broad-scale manufacturing of CVnCoV and other mRNA-based vaccines.
CureVac is a global clinical-stage biopharmaceutical company in the field of messenger RNA (mRNA) technology with expertise in
developing and optimizing this versatile molecule for medical purposes. The principle of CureVac's proprietary technology is the
use of mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a wide range of diseases.
The company applies its technologies for the development of prophylactic vaccines, cancer therapies, antibody therapies and the
treatment of rare diseases. CureVac is headquartered in T bingen, Germany with sites in Frankfurt and Boston, USA.
CureVac Media Contact
Thorsten Sch ller, Vice
President Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1577
CureVac Investor Relations
Dr. Sarah Fakih, Vice President
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
Contact for Latin American
Gloria Ni o de Rivera
Face-to-Face Proyecci n y Cuidado de Asuntos Corporativos,
01330 Ciudad de M xico
Dir: +52 55 5292 3568 | Mobile: +521 55 5076 1524
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uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility
in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical
trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability
to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects
of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel,
reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due
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are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and
could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included
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to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events
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For further information, please reference the company's
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