Full Press Release Details
CureVac Announces Financial
Results for the Second Quarter and First Half of 2022 and
Provides Business Update
BOSTON, USA - August 18, 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 second
quarter and first half of 2022 and provided a business update.
"CureVac has pioneered a technology that
is changing today's medicine. As a central mRNA player, we are executing on our 2022 goals in our three core competencies: broad
technology platform, solid product development pipeline, and large GMP manufacturing capacities. By extending our clinical development
into modified mRNA, we are further broadening the potential of our mRNA technology platform for several product development programs. In
addition, our integrated manufacturing capabilities are instrumental in enabling ongoing supply of clinical material and in delivering
on our pandemic preparedness contract with the German government," said Franz-Werner Haas, Chief Executive Officer of CureVac. "At
the same time, we continue to accelerate our core oncology strategy through the acquisition of Frame Cancer Therapeutics. This synergistic
acquisition brings a complementary bioinformatics platform in-house that translates genetic tumor information into tailored therapies.
We are committed to driving innovation in our three therapeutic areas to fight disease by enabling the body to make its own drugs."
"In the second quarter of 2022, the wind-down
costs related to our first-generation vaccine candidate, CVnCoV, still impacted our financial position but continue to decrease as we
conclude our remaining commitments," said Pierre Kemula, Chief Financial Officer of CureVac. "At the same time, we are driving
forward our corporate transformation from a biotech to a fully integrated biopharma company and advancing our three core competencies
with now over 1,000 employees. Moving into the second half of 2022, we are further broadening our mRNA technology platform and advancing
our programs in prophylactic vaccines as well as executing on our core strategy in oncology."
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 COVID-19
Second-generation mRNA-based
vaccines are expected to allow for flexible protection against one or more emerging COVID-19 variants and to enable new mRNA vaccines
against other infectious diseases, such as influenza, as well as potential combination vaccines against different viruses.
Expanding Clinical Development into Modified
Modified, Omicron-Targeting COVID-19 Vaccine
CureVac is delivering on its previously announced
2022 clinical development program in prophylactic vaccines by initiating a Phase 1 study with the modified COVID-19 mRNA vaccine candidate
CV0501. The candidate is being administered as a booster dose to previous COVID-19 vaccination. Developed in collaboration with GSK, CV0501
is based on CureVac's second-generation mRNA backbone and uses a modified mRNA technology. It is designed to specifically protect
against the Omicron variant.
As clinical studies of the second-generation backbone
expand into modified mRNA, targeting the Omicron variant will further explore the potential of the improved backbone design as a booster
vaccine for any relevant COVID-19 variant.
The Phase 1 CV0501 dose-escalation study will
be conducted at clinical sites in the U.S., the UK, Australia and the Philippines and is expected to enroll up to 180 healthy, COVID-19
vaccinated adults to evaluate the safety and reactogenicity of a single booster dose of CV0501 in the dose range of 12 g to 50 g.
Additional dose levels below 12 g and above 50 g may be evaluated if supported by safety and immunogenicity data at these
dose levels. The study follows the start of a Phase 1 study in March 2022 that evaluates the unmodified second-generation COVID-19 vaccine
candidate CV2CoV in the U.S. Data from both studies are expected to be reported as a combined data set.
COVID-19 studies are being conducted alongside
CureVac and GSK's jointly developed influenza vaccine program, in which clinical evaluation of the unmodified seasonal influenza
candidate CVSQIV and the modified candidate FLU SV mRNA have similarly been initiated.
Modified Influenza Vaccine Candidate
CureVac has dosed the first participant in a Phase
1 study of the modified influenza vaccine candidate FLU SV mRNA, developed in collaboration with GSK, completing initiation of all studies
in the previously announced 2022 clinical development program in prophylactic vaccines. FLU SV mRNA is a monovalent vaccine candidate
based on CureVac's second-generation mRNA backbone.
By leveraging the semi-parallel conduct of clinical
studies in modified vaccine candidates across influenza and COVID-19, the Phase 1 study is designed to rapidly evaluate the safety and
reactogenicity of the modified second-generation backbone with increased accuracy and efficiency.
The Phase 1 FLU SV mRNA dose-escalation study
will be conducted in Canada, Spain and Belgium, and is expected to enroll up to 198 healthy adult participants to evaluate the safety,
reactogenicity and immunogenicity of FLU SV mRNA in up to five dose levels ranging from 2 g to 54 g. Later-stage clinical
development is expected to evaluate a multivalent form of the candidate, which would range in dose up to 200 g - the upper
limit of the dose range in the complementary study of the modified COVID-19 candidate CV0501.
The study follows the start of a Phase 1 study
in February 2022 to evaluate an unmodified, multivalent influenza vaccine candidate, CVSQIV, at clinical sites in Panama. Data from both
studies are expected to be reported as a combined data set.
Protection of Intellectual
Over the last 22 years,
CureVac has developed proprietary foundational technology related to mRNA design, delivery and manufacturing that has materially contributed
to the development of safe and efficacious COVID-19 vaccines.
CureVac moved to assert its intellectual property rights by filing a lawsuit in the German Regional Court in D sseldorf against
BioNTech SE and two of its subsidiaries. CureVac is seeking fair compensation for infringement of a portfolio of CureVac's
intellectual property rights, EP 1 857 122 B1, EP 3 708 668 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1 and DE 20 2015 009 974
U1, utilized in the manufacture and sale of Comirnaty , BioNTech and Pfizer's mRNA COVID-19 vaccine.
The company does not
seek an injunction nor intend to take legal action that impedes the production, sale or distribution of Comirnaty by BioNTech and
In the US on July 25, 2022, BioNTech and Pfizer jointly brought an action seeking a declaration that they do not infringe
three CureVac US patents.
Acquisition of Frame Cancer
Therapeutics Accelerates Oncology Strategy
Based on its recent progress in prophylactic
vaccines, most notably the second-generation mRNA backbone, CureVac is broadening its foundation in oncology and preparing to build up
a meaningful portfolio of cancer vaccine candidates based on promising new tumor antigens predicted to elicit strong immune responses.
Within this strategy, CureVac is following two
approaches. The first approach assesses tumor antigens shared by different cancer patients for the development of off-the-shelf cancer
vaccines. The second approach is tailored to a patient's individual tumor profile.
To advance both approaches, in June 2022 CureVac
acquired Frame Cancer Therapeutics, a private company focused on using advanced genomics and bioinformatics to identify both shared and
unique neoantigens across different cancer types. The acquisition complements existing in-house expertise to identify and validate promising
neoantigens for mRNA cancer vaccine candidates.
The former Frame Cancer Therapeutics site was
inaugurated as CureVac Netherlands B.V. and is located at one of the largest science hubs in Europe. The new oncology hub will further develop
the proprietary FramePro platform, which has the potential to identify a broad panel of neoantigens that go beyond conventional neoantigens.
FramePro strongly increases the likelihood of developing cancer vaccines, both personalized and off-the-shelf, that are highly effective
in activating the human immune system against cancer.
The total consideration for the Frame Cancer Therapeutics
acquisition is 34 million, to be paid mostly in CureVac shares. Following a 50% upfront payment, the residual amount will
be split across two project milestone-driven steps.
The acquisition of Frame
Cancer Therapeutics follows a strategic oncology partnership with Belgium-based company myNEO in May 2022. The highly synergistic technologies
are expected to accelerate CureVac's oncology strategy by accessing novel classes of tumor antigens and identifying those with the