Full Press Release Details
CureVac's COVID-19 Vaccine Candidate, CVnCoV, Suitable
for Standard Fridge Temperature Logistics
T BINGEN, Germany/ BOSTON, USA - November 12,
2020 - CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based
on messenger ribonucleic acid (mRNA), announced today that its mRNA-based COVID-19 vaccine candidate, CVnCoV, remained stable and
within defined specifications for at least three months when stored at a standard refrigerator temperature of +5 C (+41 F)
and up to 24 hours as ready to use vaccine when stored at room temperature.
"Transport and storage of vaccines, which would require
ultra-low temperature setups to keep them stable, has been the topic of intense discussions and concerns in terms of feasibility,
added costs and wastage," said Dr. Florian von der M lbe, Chief Production Officer of CureVac. "We are very encouraged
by the emerging stability profile of our COVID-19 vaccine candidate that could be compatible with standard fridge-temperature storage
as well as a required room temperature application. This compatibility has the potential both to enable decentralized storage and
to significantly facilitate large-scale vaccination efforts during the current pandemic."
Storage of sample material, as well as analytical testing of
CVnCoV was performed under standard conditions defined by the International Council for Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use (ICH). Stability of the liquid drug product of CVnCoV was tested at the anticipated storage concentration
and stored at +5 C (+41 F) as well as below -60 C (-76 F) .
CVnCoV fulfilled all set release specifications at both temperatures
after three months. The stability study is ongoing with the goal to further evaluate the potential for a longer commercial product
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. The Phase 1 clinical study of CVnCoV began in June
2020 at clinical study centers in Germany and Belgium in collaboration with the Coalition for Epidemic Preparedness Innovation
(CEPI). At the end of September 2020, CVnCoV entered a Phase 2a clinical trial in Peru and Panama, extending clinical studies into
older adults and regions with high-incidence of COVID-19 infections. CureVac plans to initiate a pivotal Phase 2b/3 clinical study
by the end of 2020. Clinical trial material is provided by the company's substantial production capacities for mRNA vaccines
at its headquarters in T bingen. The company is currently expanding those manufacturing capacities to allow for broad-scale
manufacturing of CVnCoV for potential commercial supply preparedness.
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 500
people at its sites in T bingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.
The International Council for Harmonisation of Technical Requirements
for Pharmaceuticals for Human Use (ICH) develops guidelines and defines standards for drug development including methodologies
to ensure efficacy, safety and quality of active drug substance and dosage forms over time and to establish shelf life or expiration
period and to support label claims.
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
Forward-Looking Statements
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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
to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers
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
in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation
to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events
or developments, except as required by law.
For further information, please reference the company's
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