Full Press Release Details
CureVac Announces Financial Results for
the Second Quarter and First Half of 2021 and Provides Business Update
Germany/ BOSTON, USA - August 16, 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 financial results for
the second quarter and first half of 2021 and provided business update.
parts of the world are still under-vaccinated against SARS-CoV-2, making effective vaccines necessary to prevent further evolution of
the virus and to avoid renewed restrictions on public life," said Franz-Werner Haas, Chief Executive Officer of CureVac. "While
the recently reported final data from our pivotal Phase 2b/3 study have fallen short of expectations in older adults, our first-generation
COVID-19 vaccine candidate, CVnCoV, has shown a solid efficacy profile in the age group of 18 to 60. We are reaffirming our intention
to seek regulatory approval with the European Medicines agency and are currently submitting extensive clinical data to the agency to allow
for the assessment of CVnCoV's public health benefit. Insights from our COVID-19 development program are feeding into all areas
of our pipeline, where we are pursuing a broader technology approach and multivalent as well as combination vaccine formats, as part of
the large infectious diseases program jointly developed with GSK. This includes our second-generation COVID-19 vaccine candidate, CV2CoV,
which is advancing on track to enter clinical development in Q4 2021. In parallel, we are accelerating the development of the organization
and the expansion of our manufacturing capacity, including the capacity for more clinical trials, while creating a strong development
focus for The RNA Printer via a separate operational infrastructure for this strategic key project."
financing activities, as well as the extension of our GSK partnership in the first half of 2021, provide an important financial foundation
for accelerating our business expansion, while hedging the associated scale-up costs," said Pierre Kemula, Chief Financial Officer
of CureVac. "We closed the first half of 2021 with approximately 1.36 billion in cash, which allows us to further grow our
infrastructure for commercial product development in all areas and manufacturing supported by new members to the CureVac management team.
While we are working toward regulatory approval of CVnCoV, we are expanding our clinical pipeline through the broad infectious disease
portfolio we are developing together with GSK, including our second-generation COVID-19 vaccine program."
Executing on Corporate Development and Business
CureVac is rapidly advancing
the corporate transformation from a research-oriented biotech to a commercial-ready biopharma company. Continued build-up of a commercial
infrastructure was recently supported by the appointment of two new CureVac management team members that bring deep international expertise
and experienced leadership.
Dr. Malte Greune was appointed
to the CureVac Management Team as Chief Operating Officer on July 1, 2021. He will be focused on further enabling CureVac's comprehensive
strategy for expansion of all commercial manufacturing activities and operations for mRNA vaccines and therapeutics. On August 1, 2021,
Dr. Klaus Edvardsen joined CureVac as Chief Development Officer to advance the technology platform and grow the CureVac clinical development
pipeline in all therapeutic areas.
Prophylactic Vaccines
CVnCoV - First-Generation COVID-19 Vaccine
CVnCoV is CureVac's first-generation
vaccine candidate in its clinical COVID-19 vaccine program. Based on optimized, non-chemically modified mRNA, CVnCoV was shown to be well
tolerated at a 12 g dose and to induce robust immune responses comparable to those observed in recovered COVID-19 patients.
Phase 2b/3 (HERALD) in Europe and Latin America
pivotal Phase 2b/3 study (HERALD), initiated in December 2020, enrolled approximately 40,000 participants in ten countries in Europe
and Latin America in the predefined age groups of 18 to 60 and above the age of 60. Of those participants, approximately 75% were
enrolled in sites in Latin America and 25% were enrolled in sites in Europe.
2021, data of the final analysis was reported based on 228 adjudicated COVID-19 cases, occurring at least two weeks after administration
of the second dose. In the unprecedented context of 15 different virus variants circulating within the study population at the time of
final analysis, CVnCoV demonstrated an overall vaccine efficacy of 48% against COVID-19 disease of any severity across all age groups.
CVnCoV demonstrated significant protection among participants in the age group of 18 to 60, with an efficacy of 53% against disease of
any severity, including single non-respiratory mild symptoms. Protection against moderate to severe disease was calculated to be 77% in
the age group of 18 to 60. In the same age group, CVnCoV provided 100% protection against hospitalization or death. In participants above
60 years, the available data did not enable a statistically significant determination of efficacy. The data further confirmed the favorable
safety profile of CVnCoV in all age groups.
228 adjudicated cases, 204 were sequenced to identify the variant causing the infection. Approximately 86% of these cases were caused
by Variants of Concern (51%) and Variants of Interest (35%),
the latter including the Lambda strain first identified in Peru (21%)
and B.1.621, first identified in Colombia (14%). Approximately 3%
of cases were attributable to the original SARS-CoV-2 virus. The remaining 11% were caused by less-explored strains. In the age group
of 18 to 60, across strains of higher prevalence, strain-dependent vaccine efficacy ranged from approximately 42% (B.1.621 variant, first
identified in Colombia) up to 67% (Gamma variant) against any severity of disease. The Delta variant was not represented in the pool of
adjudicated cases and could therefore not be separately assessed.
CureVac intends to apply for regulatory approval
of CVnCoV with the European Medicines Agency (EMA), to leverage the vaccine's strengths in the age segment of the population where
it provides demonstrated protection. Within the rolling submission initiated with the EMA in February 2021, submission of comprehensive
clinical data packages is ongoing and is expected to be finalized toward the end of the third quarter. The potential subsequent application
for conditional approval will be informed by continuing interactions with EMA.
Recent Amendments to the Clinical CVnCoV Development
The protocol amendment for the ongoing Phase 2a
study in Peru and Panama, filed in March 2021 for the enrollment 40 adolescent participants between the ages of 12 and 17, has been withdrawn.
A separate study to test CVnCoV in this highly important age-group is currently being prepared.
The Phase 3 trial, started in April 2021 to evaluate
the safety, reactogenicity and immunogenicity of CVnCoV in adults with an elevated risk of severe COVID-19 infection due to comorbidities,
is ongoing. Due to the advancement of the vaccination program in Belgium where the study is conducted, including this particularly vulnerable
population, the study will continue with a reduced number of 131 recruited participants.
The flu-co-administration study, planned to be
initiated together with Bayer to assess compatibility with established seasonal vaccines in case of seasonal COVID-19 vaccinations, is
currently being redesigned based on inconclusive efficacy of CVnCoV in adults above the age of 60 in the HERALD study.
A Phase 2 study, focusing on immunogenicity and
a deep characterization of immune responses in older adults above the age of 65 compared to younger adults was cancelled based on inconclusive
efficacy of CVnCoV in adults above the age of 60 in the HERALD study.
- Second-Generation COVID-19 Vaccine Candidate
CureVac's second-generation vaccine candidate in its COVID-19 vaccine program, featuring a new mRNA backbone, jointly advanced with
GSK. The optimized mRNA backbone targets improved intracellular mRNA translation for increased and extended protein expression, resulting
in earlier and stronger immune responses compared to CVnCoV.
Study of CV2CoV on Immune Responses and Protection against Virus Challenge
On August 16, CureVac published preclinical data,
characterizing immune responses as well as the protective efficacy of CV2CoV and CureVac's first-generation vaccine candidate, CVnCoV,
against SARS-CoV-2 challenge in non-human primates. The study assessed cynomolgus macaques vaccinated with 12 g of either the first-
or second-generation vaccine candidate. Better activation of innate and adaptive immune responses was achieved with CV2CoV compared to
CVnCoV, resulting in faster response onset, higher titers of antibodies and stronger memory B and T cell activation. Higher antibody neutralizing
capacity was observed with CV2CoV across all selected variants, including the Beta, Delta and Lambda variants. During challenge with the
original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the
virus in the lungs and nasal passages. The full manuscript of the preclinical data is available on the pre-print server bioRxiv.
Following the current preclinical development of CV2CoV, a Phase 1
clinical trial is expected to start in Q4 2021.
- Cancer immuno-modulator in solid tumors
lead oncology candidate, CV8102, is being assessed in a Phase 1 dose-escalation study, evaluating tolerability and activity as a single
agent and in combination with systemic anti-PD-1 antibodies. An expansion part of the Phase 1 trial, announced in February 2021, aims
to confirm the safety, tolerability and efficacy of CV8102 at a preferred 600 g dose in 40 patients with a focus on PD-1 refractory
melanoma. As of July 6, 12 out of 30 patients had been successfully recruited to receive intra-tumoral injections of CV8102 in combination
with PD-1 antibodies. In the group assigned for CV8102 single-agent treatment, recruitment has been completed with 10 out of 10 patients.
Updates on the progress of the trial are expected at the European Society for Medical Oncology (ESMO) congress and the Society for Immunotherapy
of Cancer (SITC) annual meeting later this year.
- Boehringer Ingelheim Collaboration