Full Press Release Details
CureVac and GSK Start
Clinical Development of Second-Generation COVID-19 Vaccine Candidate, CV2CoV
T BINGEN, Germany/ BOSTON, USA -
March 30, 2022 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines
based on messenger ribonucleic acid ("mRNA"), today announced that the first participant was dosed in a Phase 1 study of COVID-19
second-generation mRNA vaccine candidate, CV2CoV, developed in collaboration with GSK. The clinical trial is expected to provide valuable
data to further evaluate the performance of CureVac's second-generation mRNA backbone, which has the potential to be applied broadly
in future vaccines against COVID-19 variants and other pathogens.
A preclinical study of CV2CoV in cynomolgus macaques,
published in Nature in November 2021, demonstrated rapid induction of higher antibody titers, better induction of immune memory
and stronger protective efficacy of CV2CoV compared to CureVac's first-generation vaccine candidate, CVnCoV. The same study demonstrated
comparable neutralizing antibody titers in animals fully vaccinated with either 12 g of CV2CoV or a 30 g standard dose of
a licensed mRNA COVID-19 vaccine.
"Continued innovation and progress in the
development of mRNA-based vaccines is a critical prerequisite to combat the evolving COVID-19 pandemic and to further extend the possibilities
of mRNA technology to a broad range of indications," said Dr. Klaus Edvardsen, Chief Development Officer of CureVac. "Our
second-generation mRNA backbone was engineered to enable faster and stronger immune responses than our first-generation vaccine. This
Phase 1 trial of CV2CoV will provide clinical data to further establish this backbone as a basis to flexibly address not only different
COVID-19 variants, but also a range of other diseases and potential combination vaccines."
The Phase 1 dose-escalation study is being conducted
at clinical sites in the U.S. and is expected to enroll up to 210 healthy adults to evaluate the safety, reactogenicity and immunogenicity
of CV2CoV in the dose range of 2 to 20 g. Data results from the Phase 1 study are expected in the second half of 2022. The program
follows the recent start of the Phase 1 clinical study for the jointly developed seasonal influenza vaccine candidate, CVSQIV, also applying
the optimized second-generation mRNA backbone.
The CureVac-GSK infectious disease collaboration
was first announced in July 2020 and focuses on the development of new products based on CureVac's mRNA technology for different
targets in the field of infectious diseases. In 2022, both companies have broadened their development strategy to test chemically modified
mRNA technologies in addition to unmodified mRNA. Clinical programs with chemically modified mRNA for COVID-19 and influenza are expected
to start later this year.
CV2CoV is CureVac's first COVID-19 vaccine
candidate based on the advanced second-generation mRNA backbone from the broad second-generation program, currently developed in collaboration
with GSK. The vaccine candidate is a non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the
SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs). CV2CoV was engineered with specifically optimized non-coding regions
to exhibit improved mRNA translation for increased and extended protein expression compared to the first-generation mRNA backbone. A clinical
study to test the use of chemically modified mRNA is expected to begin later this year.
CureVac is a global biopharmaceutical company
in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing and manufacturing this
versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of optimized mRNA
as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020,
CureVac entered into a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on
CureVac's second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19
vaccine candidates and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac 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 900 people
across its sites in T bingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.
Investor Relations Contact
Vice President Corporate Communications and Investor Relations
Bettina J dicke-Braas, Manager Communications
CureVac, T bingen, Germany
T: +49 7071 9883-1087
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