Full Press Release Details
CureVac Announces Financial Results for the
Third Quarter and First Nine Months of 2023
and Provides Business Update
Germany/BOSTON, USA - November 14, 2023 - CureVac N.V. (Nasdaq: CVAC) ("CureVac"), 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 2023 and provided a business update.
"We began 2023 with promising data out of
our seasonal flu and COVID-19 programs and have maintained strong forward momentum in the clinical advancement of those vaccines as well
as in oncology, where we recently opened the third cohort of our Phase 1 trial in glioblastoma. With both of our infectious disease programs
now in Phase 2 and set to produce topline data in early 2024, we are delivering across our strategic priorities," said Dr. Alexander
Zehnder, Chief Executive Officer of CureVac. "At the same time, we have made progress toward the recognition of our intellectual
property rights with recent favorable developments in German courts."
"The focused execution on our clinical development
programs in 2023 has been accompanied by important financial milestones, including our successful follow-on offering in February 2023.
We also triggered a second developmental milestone payment of 15 million from GSK when our joint seasonal flu vaccine program advanced
to Phase 2," said Pierre Kemula, Chief Financial Officer of CureVac. "These milestones enable us to reaffirm our cash runway
until mid-2025, supported by an even more disciplined focus on cost management going into 2024."
Prophylactic Vaccines
Second-Generation mRNA Vaccine Program, Jointly Developed with GSK
CureVac continues to advance its broad clinical
development program in prophylactic vaccines in collaboration with GSK. Positive preliminary data reported in early 2023 in COVID-19 and
flu provided strong validation of CureVac's mRNA technology platform. All jointly tested candidates are based on CureVac's
proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses.
Seasonal Influenza Program
In the ongoing Phase
1/2 study in seasonal influenza, CureVac announced dosing of the first participant in the Phase 2 part of the study on November 1,
following the selection of a promising vaccine candidate based on positive Phase 1 interim data announced September 12. The potentially
differentiated, multivalent candidate encodes antigens matched to all WHO-recommended flu strains. It was selected from the Phase 1 part
of the study that compared a comprehensive series of multivalent, modified mRNA seasonal flu vaccine candidates with up to eight separate
mRNA constructs per candidate at different dose levels in 270 healthy younger adults (age 18-50). Interim Phase 1 safety data showed no
safety concerns across all dose levels for the multivalent candidates. Humoral responses supported the selection of the preferred vaccine
candidate for further evaluation in Phase 2. In Phase 2, the selected candidate will be tested in younger and older adults at different
dose levels and compared to age-appropriate licensed seasonal flu comparator vaccines. Data are expected in 2024.
Recruitment for the ongoing Phase 2 study in COVID-19
was completed at 427 randomized participants after dosing of the first participant was announced in August 2023. The study assesses
the safety and immunogenicity of different single booster doses of two modified mRNA COVID-19 vaccine candidates: the monovalent candidate,
CV0601, encoding the spike protein of the omicron BA.4-5 variant and the bivalent candidate, CV0701, encoding the spike protein of the
omicron BA.4-5 variant as well as the original SARS-CoV-2 strain. Vaccine candidates are compared to a licensed or authorized bivalent
mRNA COVID-19 comparator vaccine. Interim Phase 2 data are expected in early 2024 and will inform the design of a pivotal Phase 3 study
planned to start in 2024. The Phase 3 study is expected to feature an updated vaccine candidate and comparator vaccine according to the
latest COVID-19 standard-of-care.
Broadening of Oncology
Footprint with mRNA Cancer Vaccines
CureVac continues to
execute on its strategy to develop the next generation of targeted mRNA-based cancer vaccines based on cutting-edge technologies for antigen
discovery combined with CureVac's second-generation mRNA backbone.
The strategy focuses
on two approaches: 1) the development of off-the-shelf cancer vaccines based on tumor antigens shared across different cancer indications
and 2) the development of fully personalized cancer vaccines based on a patient's individual tumor genomic profile.
Clinical off-the-shelf
program in glioblastoma
Phase 1 study of patients with resected glioblastoma is on track without any dose limiting toxicities and has escalated to the
third dose level after dosing the first patient with its multiepitope cancer vaccine candidate, CVGBM, in June 2023.
The open-label study
evaluates the safety and tolerability of CVGBM in up to 54 patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma
or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from
known tumor-associated antigens with demonstrated immunogenicity in glioblastoma. A first data readout is expected in the second half
More information can
be found at clinicaltrials.gov (NCT05938387).
Preclinical Research
CureVac recently presented
preclinical studies supporting the potency of a multiepitope mRNA cancer vaccine construct targeting tumors in a murine melanoma model.
The data support the evaluation of CVGBM, CureVac's multiepitope cancer vaccine candidate currently being tested in a Phase 1 study
in patients with resected glioblastoma. The preclinical data were presented at the 11th International mRNA Health Conference,
hosted by CureVac on October 31 - November 2, 2023, in Berlin, Germany.
A multiepitope mRNA construct
encoding ten epitopes derived from the murine B.16.F10 melanoma cell line was tested in mice. The study applied three 5 g doses
of LNP-formulated B.16 mRNA, administered intramuscularly at weekly intervals. Data obtained on day 21 confirmed prominent induction of
CD8+ and CD4+ T cell responses recognizing epitopes across the full multiepitope construct. Median survival of the animals increased to
30.9 days for treated mice compared to 23.2 days for a group vaccinated with formulated control mRNA.
Strong T cell activation
is particularly encouraging and relevant, as the B16-F10 tumor model is characterized as a cytokine deficient "cold" tumor
model that exhibits only very little immune cell infiltration and resistance to check-point inhibitors. The data suggest that single-agent
application of the multiepitope B.16 mRNA construct generated robust T cell activation in the tumor microenvironment, thereby inhibiting
tumor growth and extending survival in the applied preclinical model.
CureVac's end-to-end solution for integrated and automated manufacturing of GMP-grade mRNA vaccines and therapeutics, successfully
achieved the first milestone in an ongoing regulatory review process by obtaining a manufacturing license for an mRNA in the cancer vaccine
development program to support CureVac's oncology strategy.
small-scale quantities through an automated process, The RNA Printer is expected to support rapid and flexible provision
of clinical trial material to screen and advance new antigens into clinical studies. Regulatory review is ongoing for an advanced approval
to cover fully formulated vaccine candidates. Extension of manufacturing licenses to include a so-called framework license will ultimately
allow for greater regulatory freedom and flexibility to manufacture different mRNA cancer vaccine candidates.
Protection of Intellectual
Over the last 23 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 is asserting
its intellectual property rights in litigation against Pfizer/BioNTech in Germany, the U.S. and the UK. In Germany, where eight intellectual
property rights are at issue, the Regional Court D sseldorf chose to postpone a ruling on infringement on September 28, for
four out of the eight rights until challenges made by BioNTech to their validity have been decided by the relevant patent offices.
CureVac considers the
postponement a favorable outcome as German courts typically delay infringement proceedings to wait for a decision on validity only if
the challenged intellectual property right is in fact considered infringed. The postponement of the infringement ruling has no effect
on the expected validity ruling. It does not reflect a preliminary assessment of validity, which can be determined only by the responsible
and technically qualified patent authorities.
the U.S., a trial date has been confirmed for October 1, 2024. The U.S. District Court for the Eastern District of Virginia will
adjudicate infringement, validity, and damages in a single jury trial. In the U.S., CureVac's counterclaim to a Declarative Judgment
Action by Pfizer/BioNTech in July 2022 proceeds under ten of its U.S. patents.
CureVac, as the earliest pioneer in mRNA technology,
continues to be at the forefront of innovation in the mRNA field. Accordingly, CureVac's intellectual property rights need to be