Full Press Release Details
CureVac Reports Positive Interim
Phase 1 Data for its COVID-19 Vaccine Candidate, CVnCoV
Germany/ BOSTON, USA - November 2, 2020 - CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical
company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today
announced positive interim data from its ongoing Phase 1 dose-escalation study evaluating the safety, reactogenicity and
immunogenicity of CVnCoV, its investigational SARS-CoV-2 vaccine candidate. The vaccine candidate was generally well
tolerated across all tested doses (2-12 g) and induced strong binding and neutralizing antibody responses in addition
to first indication of T cell activation. CureVac intends to provide a detailed Phase 1 data overview and publication in
a scientific journal in the coming weeks. CVnCoV is currently also being investigated in a Phase 2a clinical trial in older
adults in Peru and Panama.
"We are very encouraged
by the interim Phase 1 data. It represents a critical milestone in our COVID-19 vaccine program and strongly supports the advancement
of our vaccine candidate," said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac. "Following further
data readouts and discussion with regulatory authorities, we remain fully committed and on track to initiate a pivotal Phase 2b/3
trial before the end of 2020."
The Phase 1 study has enrolled
to date more than 250 healthy individuals aged 18 to 60 years. Individuals were vaccinated intramuscularly with CVnCoV at escalating
dose levels of 2, 4, 6, 8 and 12 g on days 1 and 29. Per dose level, the trial included up to 10 participants who had previously
tested positive for a COVID-19 infection (seropositives) to further evaluate the safety and immunogenicity of CVnCoV in this sub-population.
The data support the decision
to advance the 12 g dose in the upcoming pivotal Phase 2b/3 study.
Immunogenicity data showed
induction of binding antibody titers, translating into titers of virus neutralizing antibodies
at all tested dose levels. Geometric Mean Titers (GMTs) of binding and neutralizing antibodies of study participants were compared
to peak serum titers of 67 symptomatic convalescent COVID-19 patients (human convalescent sera, or HCS). The applied HCS panel
was composed to provide a medically relevant comparator to validate CVnCoV potency. The panel was highly representative of the
immune activation of seriously ill patients with multiple symptoms of whom approximately 24% were hospitalized.
At 12 g, GMTs of binding
antibodies increased to the level measured in the HCS panel. Virus neutralizing antibodies increased to HCS levels at 12 g
and were measured in a live-virus micro-neutralization assay. Analysis of T cell mediated immunity is ongoing. Early data show
indications of functional T cells confirming activation of cellular immune response.
show a robust and highly efficient immune response to our natural mRNA-based CVnCoV vaccine candidate, including antibody and initial
T cell responses at the level of a relevant panel of symptomatic convalescent patients," said Dr. Mariola Fotin-Mleczek,
Chief Technology Officer of CureVac. "We are grateful to all study volunteers who are helping to enable the development
of a vaccine that will provide the best possible protection for people."
CVnCoV's unique mode
of action mimics the natural immune response to the infection observed in recovered COVID-19 patients. This is reflected in the
relative proportion of neutralizing to binding antibody levels, which are similar in vaccinated individuals and convalescent patients.
"The data are highly encouraging," said Prof.
Dr. Peter Kremsner, Director of the Institute of Tropical Medicine of the University of T bingen and lead investigator of
the Phase 1 trial. "In this accelerated development program, it is paramount to ensure safety while generating a favorable
level of immunogenicity. With this study, we had a strong focus on identifying the optimal dose for CVnCoV and we have succeeded
Reactogenicity of CVnCoV was continuously monitored by a Data
and Safety Monitoring Board, and the vaccine was generally well tolerated across all tested doses. No related serious adverse events
were observed. At 12 g, grade 3 adverse events occurred mostly after administration of the second dose and included fatigue,
headache, chills, muscle pain, and to a lesser extent, fever. All reported events were transient and resolved rapidly, usually
within 24 to 48 hours.
Formulation of CVnCoV is based on state-of-the-art lipid nanoparticle
(LNP) technology licensed from CureVac's long-standing partner Acuitas Therapeutics.
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 clinical-stage
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 approximately 500 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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