Full Press Release Details
CureVac Announces Financial
Results for the Fourth Quarter and Full-Year 2021 and Provides Business Update
BOSTON, USA - April 28, 2022 - 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 fourth
quarter and full-year 2021 and provided a business update.
"Going into 2022, we are strengthening our
competitive position as a central mRNA player by leveraging our three core competencies: broad technology platform, solid product development
pipeline, and large GMP manufacturing capacities," said Franz-Werner Haas, Chief Executive Officer of CureVac. "We are extending
our technology platform into multivalent as well as modified mRNA approaches to further advance our vaccines pipeline. Together with GSK,
we initiated the clinical evaluation of COVID-19 and multivalent influenza vaccine candidates. Leveraging our broad learnings, we are
getting prepared to also drive broad innovation in oncology. Our fully owned subsidiary to advance The RNA Printer is now established
and the system is expected to support our oncology pipeline by enabling personalized therapy approaches. Overall, the progress made
with our technology as well as our manufacturing capabilities will enable us and GSK to execute on our contract for pandemic preparedness
with the German government, validating our ability to help safeguard public health today and into the future."
"While we have resolved most of the
commitments associated with the withdrawal of our first-generation COVID-19 candidate, CVnCoV, we have been working to close the
final associated negotiations," said Pierre Kemula, Chief Financial Officer of CureVac. "Importantly, we have received
confirmation from the European Union that the upfront payment of 450 million associated with the now terminated Advanced
Purchase Agreement for CVnCoV is not to be repaid. For 2022, our priorities lie in the execution of our second-generation
development program. Programs for COVID-19 and influenza have advanced into the clinic, and the latter is on track to
generating development and regulatory milestone payments. We believe our solid cash position at the end of 2021 of 811.5
million sets us up well to execute on our priorities in 2022."
Prophylactic Vaccines
Second-Generation mRNA Vaccine Program, Jointly Developed with GSK
CureVac aims to be at the forefront
of delivering second-generation mRNA-based vaccines against a range of relevant infectious diseases and is executing on a broad mRNA
vaccine program in collaboration with GSK. The optimized second-generation mRNA backbone targets improved intracellular mRNA translation
for increased and extended protein expression, resulting in earlier and stronger immune responses compared to CureVac's first-generation
candidate, CVnCoV. Second-generation mRNA-based vaccines are expected to allow for flexible protection against one or more emerging COVID-19
variants and to offer new mRNA approaches to other infectious disease vaccines, such as influenza, and potential combination vaccines
against different viruses.
CV2CoV -Second-Generation
COVID-19 Vaccine Candidate
representative of the COVID-19 vaccine program, jointly developed with GSK, based on CureVac's second-generation mRNA
backbone. Following a successful preclinical study of the non-chemically modified candidate in non-human
primates, published in Nature in November 2021, CV2CoV entered a clinical Phase 1 dose-escalation trial in March 2022. The
Phase 1 study is being conducted at clinical sites in the U.S. and is expected to enroll up to 210 participants to evaluate the
safety, reactogenicity and immunogenicity of CV2CoV at six different dose levels ranging from 2 to 20 g per dose. Data from
the Phase 1 study are expected in the second half of 2022.
In 2022, CureVac and GSK broadened their
development strategy to test chemically modified mRNA technologies in addition to unmodified mRNA. This approach will ensure a
data-driven selection of the best performing candidate. A clinical program to evaluate a variant-specific COVID-19 vaccine candidate
with chemically modified mRNA is expected to start later this year.
- Bivalent Second-Generation COVID-19 Candidate
On April 21, 2022, CureVac strengthened its
COVID-19 vaccine program based on a technology expansion into multivalent approaches combining different mRNAs in one vaccine. A
bivalent second-generation COVID-19 vaccine candidate encoding for the Beta and the Delta variants is jointly being developed with
A recently completed preclinical study,
conducted in collaboration with the Friedrich-Loeffler-Institut, Germany, assessed a 0.5 g dose of the bivalent Beta/Delta
candidate, composed of 0.25 g of each mRNA, in comparison to 0.5 g doses of the corresponding monovalent vaccine
controls in a mouse model. Despite containing only half the dose per variant mRNA, the combined Beta/Delta candidate performed
comparably to the monovalent vaccine controls to either Beta or Delta. Notably, the bivalent Beta/Delta vaccine candidate induced
two-fold higher virus neutralizing antibody titers against the Omicron variant than against the Delta variant in a rat model. This
finding provides evidence for a potentially increased breadth of immune responses resulting from the bivalent approach. The full
manuscript of the preclinical data is available on the preprint server bioRxiv.
Second-Generation Influenza Vaccine Candidate
The first candidate from
the broad infectious disease program developed in collaboration with GSK is CVSQIV, a multivalent seasonal influenza vaccine candidate
also based on the advanced second-generation mRNA backbone. This differentiated vaccine candidate features multiple, separate non-chemically
modified mRNA constructs to induce immune responses against four different influenza strains. Rapid manufacturing and the ability to feature
even short-notice strain updates for the approaching influenza season are expected to enable mRNA technology to deliver improved influenza
candidates that better meet the challenge of providing highly effective seasonally updated vaccines.
dose-escalation study was initiated in February 2022 to evaluate the safety, reactogenicity and immunogenicity of CVSQIV at five
dose levels ranging from 3 to 28 g per dose. The study is fully recruited with 240 participants. Dose-escalation was
monitored for each dose and approved without safety concerns following review by the Integrated Scientific Review Committee (iSRC).
Preliminary data on the safety and tolerability confirm CVSQIV to be well tolerated. No serious adverse events or other
dose-limiting effects were observed at any dose level.
As in the joint COVID-19 vaccine program, chemically
modified mRNA will also be tested in the influenza program to ensure data-driven selection of the best performing candidate. A clinical
program with chemically modified mRNA for influenza is expected to start later this year.
Strategic Pillars to Increase
Momentum in Oncology Pipeline
CureVac plans to build a meaningful
portfolio and create long-term value in oncology to accelerate growth beyond the recent progress in prophylactic vaccines. Developing
new oncology candidates is characterized by similar medical challenges as in infectious diseases, including selection and accessibility
of disease-relevant antigens, enhancing antigen-induced immune activation, and triggering immune responses led by a strong induction of
tumor-killing T cells.
Taking advantage of recent technology
platform advances, particularly its second-generation mRNA backbone in infectious diseases, CureVac is evaluating targeted expansions
of its unique mRNA approaches for the development of cancer vaccines based on three strategic pillars:
| 1. | Validation and optimization of its broad mRNA technology approach for T cell mediated tumor control against different classes of cancer antigens | |
| 2. | Build-up of a pipeline of cancer vaccine candidates targeting antigens predicted to be immunogenic and presented on tumors in cancer patients | |
| 3. | Addition of complementary platform technologies for improved antigen discovery, validation and optimization of vaccine design focusing on T cell activation |
In this context, CureVac
is committed to drive innovation in oncology by leveraging The RNA Printer , CureVac's automated end-to-end manufacturing
solution for GMP-grade mRNA vaccines and therapeutics. The highly standardized system is expected to allow for rapid and highly
flexible availability of mRNA to screen new targets and transition promising mRNA product candidates more efficiently into the
clinic. Designed for small-scale quantities, the automated GMP-grade output of The RNA Printer is designed to open avenues for
personalized mRNA-based cancer therapies.
Corporate Development
and Business Transformation
CureVac announced the establishment of CureVac RNA Printer GmbH, a fully owned CureVac company to advance The RNA Printer . The
RNA Printer is CureVac's solution for integrated and automated manufacturing of GMP-grade RNA vaccines and therapeutics.
The new entity is designed as a platform and services company, providing a dedicated operational environment to further develop and
establish The RNA Printer as a manufacturing end-to-end solution. The system is powered by a proprietary and advanced
manufacturing technology designed to cover all steps for rapid and standardized manufacturing of smaller scale mRNA medicines.
Engineered in collaboration with Tesla Automation, The RNA Printer aims to facilitate broad access to mRNA technology and accelerate
the transition of innovative product concepts into the clinic across different therapeutic areas e.g., for rapid supply of new
mRNA-based vaccines in pandemic situations or patient access to advanced and personalized mRNA-based therapies in oncology.
The company is led by
Dr. Markus Bergmann, who joined CureVac RNA Printer GmbH as General Manager on March 1, 2022. Prior to this position, Dr. Bergmann held
various management positions at ZF Group, Germany, and Rolls Royce plc, UK, building up a strong background in developing targeted product