Full Press Release Details
CureVac Announces Financial Results for
the Third Quarter and First Nine Months of 2021 and Provides Business Update
BOSTON, USA - November 18, 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 third
quarter and first nine months of 2021 and provided a business update.
"As the global fight against SARS-CoV-2
continues, we are focused on creating a new generation of vaccines while building CureVac's position as a leading player in the
mRNA space," said Franz-Werner Haas, Chief Executive Officer of CureVac. "The strategic decision to withdraw our first-generation
COVID-19 candidate, CVnCoV, enables us to accelerate our second-generation program in partnership with GSK. Together, we are advancing
our technology platform to deliver a suite of innovative mRNA vaccines in infectious diseases, including an endemic COVID-19 vaccine with
the goal to address evolving market demands as the world transitions from the current pandemic to an endemic COVID-19 environment. Learnings
from the first-generation program are not only expected to support the second-generation program but will also be leveraged for our programs
in oncology and protein therapies."
"Following the withdrawal of CVnCoV, we now aim to refocus our
existing contractual commitments on our second-generation vaccine program," said Pierre Kemula, Chief Financial Officer of CureVac.
"Over the last 18 months, we aimed to balance our significant COVID-19 financial exposure with upfront payments such as in the European
APA as well as revenues from collaborations and grants. Looking forward, we will continue to run our operations with financial discipline."
Prophylactic Vaccines
Focus to Second-Generation mRNA Program, Jointly Developed with GSK
On October 12, 2021, CureVac
announced the strategic decision to focus its COVID-19 vaccine program on the development of second-generation mRNA vaccine candidates
in collaboration with GSK and to withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the approval process with the
European Medicines Agency (EMA).
communication from the EMA in October 2021, CureVac estimated that the earliest possible approval of CVnCoV would come in the second
quarter of 2022. By this time, CureVac and GSK expect candidates from the second-generation vaccine program to be progressing
through clinical development. The decision is aligned with the evolving dynamics of the pandemic response toward greater need for
differentiated vaccines with the gradual transition from an acute pandemic to an endemic SARS-CoV2 environment.
Current clinical studies
with CVnCoV, including a Phase 1 study in Germany, a Phase 2a study in Peru and Panama, a Phase 2b/3 (HERALD) study in Europe and Latin
America, and a Phase 3 study in participants with comorbidities in Belgium, continue with the scheduled safety follow-up times for all
trial participants as per the respective trial protocols.
As a direct consequence of the
withdrawal of CVnCoV, the existing Advanced Purchase Agreement with the European Commission, which was predicated on employing CVnCoV
to address the acute pandemic need, will cease. CureVac remains in contact with the European Commission and is supportive of its public
CureVac remains committed to
the long-term fight against COVID-19 and aims to leverage CVnCoV learnings and infrastructure to be at the forefront of delivering advanced
second-generation vaccines together with GSK. These are expected to provide more flexible protection against emerging COVID-19 variants
and to offer new mRNA approaches to other infectious disease vaccines such as flu, as well as potential combination vaccines against different
viruses. Second-generation clinical development is expected to start within the next few months.
First Representative of Second-Generation COVID-19 Vaccine Program
CV2CoV is the first representative
of the second-generation COVID-19 vaccine program, featuring a new mRNA backbone, jointly developed 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 the first-generation candidate, CVnCoV.
of Extended Data from Preclinical Study of CV2CoV in Non-Human Primates
On November 18, 2021, CureVac published data
in the journal Nature of a preclinical study conducted in collaboration with Dan Barouch, MD, PhD, of Beth Israel Deaconess
Medical Center, investigating immune responses as well as the protective efficacy of CV2CoV and the first-generation candidate, CVnCoV,
against SARS-CoV-2 challenge in cynomolgus macaques. The study was made available via the bioRxiv preprint server in August 2021.
The newly published data features a direct comparison
of CV2CoV with the licensed mRNA vaccine, Comirnaty (Pfizer/BioNTech). Neutralizing antibody levels measured following full vaccination
of animals with either 12 g of CV2CoV or a 30 g standard dose of Comirnaty were shown to be highly comparable.
The data confirm how targeted optimizations of
a non-chemically modified mRNA can significantly improve immune responses in a preclinical model, providing substantiated support for
the unmodified mRNA technology approach. This applies not only to the development of advanced COVID-19 vaccines but to the mRNA technology
Cancer Immuno-Modulator in Solid Tumors
oncology candidate, CV8102, is being assessed in a fully recruited Phase 1 dose-escalation study evaluating its tolerability and activity
as a single agent and in combination with systemic anti-PD-1 antibodies. An expansion part of the Phase 1 study, announced in February
2021, aims to confirm the safety, tolerability and efficacy of CV8102 at a preferred 600 g dose in patients with advanced melanoma.
In October 2021, the expansion part of the study was fully recruited with 10 patients in the single-agent cohort and 30 patients in the
On September 16, 2021,
at the European Society for Medical Oncology (ESMO) conference, CureVac presented preliminary results from the completed dose escalation
part of the study in 33 patients in the single-agent cohort and 25 in the combination cohort. As of June 21, 2021, in the single-agent
dose-escalation cohort, one patient with a complete response and two patients with a partial response were observed. In addition, 12 patients
experienced stabilization of disease. In the PD-1 combination dose-escalation cohort, one PD-1 refractory melanoma patient experienced
a partial response while three patients experienced stabilization of disease.
On November 10, 2021,
at the Society for Immunotherapy of Cancer (SITC) conference, CureVac further extended the ESMO update with an extensive analysis of immune
cell activation to better understand the mobilization of the immune system against CV8102-injected as well as non-injected tumors. The
data showed efficient stimulation of the immune system characterized by the induction of interferon alpha and interferon gamma signaling
pathways. Serial tumor biopsies from individual patients demonstrated increased infiltration of tumor-fighting T cells in the microenvironment
of injected as well as non-injected tumors. Both observations support the hypothesis that local injection of the RNA immuno-modulator
into a single tumor lesion is able to induce a systemic response leading to immune attack against both injected and non-injected tumors.
A data update for the expansion part of the study is expected in the second half of 2022.
in Liver Fibrosis and Cirrhosis
A publication in the
peer-reviewed Journal of Hepatology announced by CureVac on August 30, 2021, provides the first preclinical data demonstrating
the therapeutic applicability of mRNA-encoded HNF4A (hepatocyte nuclear factor 4 alpha) transcription factor in the treatment of liver
fibrosis and cirrhosis. The study was conducted in collaboration with experts of the renowned REBIRTH-Research Center for Translational
Regenerative Medicine and Department of Gastroenterology, Hepatology and Endocrinology at the Hannover Medical School, Hannover (Germany)
and applied well-established preclinical liver disease models.
HNF4A is an important
regulator and key factor in liver metabolism, which has been shown to gradually decrease with disease progression. In this study, mouse
models of the disease were treated with mRNA encoding HNF4A. The treatment was able to restore HNF4A levels and thereby significantly
reduce liver injury in treated animals.
Liver fibrosis and cirrhosis
contribute to millions of deaths annually and represent a major health care burden worldwide. However, there are currently no approved
drugs that robustly inhibit liver fibrosis. The results of the study provide the first direct preclinical evidence that mRNA therapeutics
have the potential to serve as treatment options for fibrosis.
In the context of a reduced
short-term peak demand for vaccines following the first wave of pandemic vaccination efforts, CureVac announced on September 14, 2021
its strategic decision to streamline the footprint of the European manufacturing network for its mRNA product pipeline, first announced
in November 2020. As a result, contracts with two manufacturing partners were terminated.
To prepare for the more
differentiated demand of second-generation vaccines in line with the gradual transition from an acute pandemic to an endemic COVID-19
environment going into 2022, CureVac has initiated the switch of manufacturing processes from its discontinued first-generation vaccine
candidate, CVnCoV, to manufacturing processes for clinical material of second-generation constructs at the European network facilities
as well as its in-house manufacturing plant GMPIII.
This includes the implementation
of processes for flexible adaption to new variant-specific constructs as well as processes for the production of modified mRNA constructs,