Full Press Release Details
CureVac Expands CVnCoV Covid-19
Vaccine Candidate Clinical Trial Analyses to Include
Phase 3 Variant Specification and Efficacy Secondary Endpoint to Phase 2a
| Impact of new SARS-CoV-2 variants supports specification of select strains for anticipated case-driven interim analysis in pivotal Phase 2b/3 study | ||
| Progress in Phase 2a trial in older adults in Peru and Panama enables addition of secondary vaccine efficacy endpoint | ||
| CureVac reaffirms intention to apply for formal market authorization in Q2 2021 |
T BINGEN, Germany/ BOSTON,
USA - March 22, 2021 - CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class
of transformative medicines based on messenger ribonucleic acid (mRNA), today announced plans to expand and further specify the
protocols of its ongoing late-stage clinical trials with CVnCoV, its COVID-19 vaccine candidate.
CVnCoV efficacy is currently
being evaluated in the pivotal HERALD Phase 2b/3 trial in Europe and Latin America. Rapid distribution of new virus variants in
the countries where the study is conducted supports the need for further analysis specification for the anticipated case-driven
interim analysis. This will allow to determine efficacy of the vaccine candidate for select variants. The company has ongoing
discussions with the European Medicines Agency (EMA) to potentially include an amendment related to select virus strains in the
For its Phase 2a dose-confirmation
trial in older adults in Peru and Panama, CureVac has submitted a protocol amendment to include a secondary objective for vaccine
efficacy. The study initially aimed to evaluate safety, reactogenicity and immunogenicity of CVnCoV in adults. Expanded trial
analysis is expected to allow for collection of relevant efficacy data which includes the important group of approximately 270
participants above the age of 60, treated with 12 g of CVnCoV.
"Our goal is to offer the
public and especially the vulnerable older age groups the best possible protection against the virus and its variants with our
vaccine candidate", said Ulrike Gnad-Vogt, Interim Chief Development Officer of CureVac. "The additional efficacy
analysis in Phase 2a is intended to leverage the data we can collect from older adults, and will represent important complementary
data to the statistically relevant efficacy data from our HERALD trial. At the same time we need to make sure that our efficacy
data are meaningful in view of the emergence of new virus variants. We are therefore aiming to specify what type of virus we are
dealing with in the HERALD trial."
expects data readouts from both clinical trials in the second quarter 2021. It also reaffirms its intention to file for formal
marketing authorization within the second quarter 2021.
began development of its mRNA-based COVID-19 vaccine candidates in January 2020. The vaccine candidate chosen first for clinical
development, CVnCoV, is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein
of the SARS-CoV-2 virus, and formulated within Lipid Nanoparticles (LNPs). 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. In December 2020 CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12 g dose of CVnCoV. In February
2021 CureVac initiated a rolling submission with the European Medicines Agency (EMA) for CVnCoV.
has entered into several strategic partnerships for the further development, production and commercialization of CVnCoV. The company
signed a collaboration agreement with Bayer in January 2021 with regards to CureVac s current vaccine candidate CVnCoV.
In February 2021 CureVac and the British pharmaceutical company GlaxoSmithKline (GSK) agreed to jointly develop next-generation
multi-valent mRNA vaccines against COVID-19. The development of new vaccine candidates is strengthened by a partnership with the
UK Government and its Vaccines Taskforce, which CureVac also entered in February 2021. GSK will also potentially contribute to
this collaboration. Clinical trial and commercial 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,
allowing broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.
the Phase 2a Clinical Trial
started its Phase 2a Clinical Trial with CVnCoV at the end of September 2020. The dose-confirmation study has been conducted in
Peru and Panama and enrolled a total of 670 participants in two distinct groups: older adults ages 61 and above, and younger participants
18 to 60 years old. The participants received two vaccinations at intervals of 28 days with the aim to evaluate safety, reactogenicity
and immunogenicity in healthy adults.
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 600 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
Dr. Sarah Fakih, Vice President
CureVac, T bingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
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