Full Press Release Details
CureVac Announces Start
of Combined Phase 1/2 Study in Avian Influenza (H5N1); Development in Collaboration with GSK
Germany/BOSTON, USA - April 24, 2024 - CureVac N.V. (Nasdaq: CVAC) ("CureVac"), a global
biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"),
today announced the start of the Phase 1 part of a combined Phase 1/2 study of an investigational influenza A (H5N1) pre-pandemic vaccine
candidate developed in collaboration with GSK. The H5N1 avian influenza virus is considered a potential future pandemic threat, known
to sporadically cross species from its original bird host to other animal hosts and humans. The monovalent vaccine candidate is based
on CureVac's proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen.
"The highly pathogenic avian influenza virus
is frequently cited as one of the viruses with high pandemic potential, with cases of animal-to-human transmission of the H5N1 strain
already documented. Leveraging our clinically validated mRNA-technology platform and second-generation mRNA backbone, we aim to provide
an effective countermeasure to the pandemic threat of potential human-to-human transmission", said Dr. Myriam Mendila, Chief
Development Officer of CureVac. "This clinical milestone, in collaboration with GSK, expands the application of our mRNA technology
into an additional indication in infectious diseases and addresses the need to be prepared for potential future pandemics."
The combined Phase 1/2 study will evaluate the
safety, reactogenicity and immunogenicity of an investigational influenza A (H5N1) pre-pandemic vaccine candidate in healthy younger adults
aged 18 to 64 and healthy older adults aged 65 to 85. In the initial Phase 1 dose-escalation part of the study, up to five dose levels
will be assessed compared to a placebo control. The study will be conducted in the United States.
The broad CureVac-GSK infectious disease collaboration
was first announced in July 2020. It focuses on applying CureVac's mRNA-technology to the development of new products for infectious
(Nasdaq: CVAC) 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 in 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 N.V. has its headquarters in T bingen, Germany, and has more than 1,100 employees across
its sites in Germany, the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.
CureVac Media Contact
Patrick Perez, Junior
Manager Public Relations
T: +49 7071 9883-1831
M: +49 151 14 115247
CureVac Investor Relations Contact
Vice President Corporate Communications and Investor Relations
T: +49 7071 9883-1298
M: +49 160 90 496949
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AG, CureVac Corporate Services GmbH, CureVac RNA Printer GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the "company")
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