Full Press Release Details
CureVac Announces Financial Results for the Third Quarter and First
and Provides Business Update
Strengthened Cash, Strategic Refocus and Pipeline Progress Define
Transformative Quarter
T BINGEN, Germany/BOSTON, USA -
November 12, 2024 - 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 2024 and provided a business update.
Commenting on the quarter Dr. Alexander Zehnder,
Chief Executive Officer of CureVac said:
"The third quarter was truly
transformative for CureVac. By restructuring our collaboration with GSK, we have embarked on a new chapter of growth and innovation, unveiling
new programs that leverage our advanced mRNA technology to tackle critical health challenges. The strategic decisions we've made, combined
with encouraging initial clinical results, have laid a solid foundation for our future success. We are now strategically aligned, more
operationally efficient, and financially empowered to create shareholder value by advancing our portfolio of novel mRNA-based medicines."
Selected Business Updates
CureVac made meaningful
progress in restructuring its operations during the third quarter by implementing significant cost-cutting measures. These include the
previously announced 30% workforce reduction, which is on track to be completed by the end of 2024. The goal of the restructuring is to
reorganize the company for flexibility in executing immediate priorities while maintaining a strong innovation focus and ensuring long-term
value creation. Right-sizing CureVac for future growth allows for continued focused development of a prioritized portfolio, including
high-value mRNA projects in oncology, infectious diseases and other areas.
"With funding secured into
2028, and our operational expenses increasingly streamlined by our ongoing redesign, we are in a strong position to expand our R&D
efforts across several promising areas," said Dr. Zehnder. "We will be launching new development programs in the
coming quarters and will continue to execute our business and pipeline strategy well into the future."
2024, CureVac welcomed a new Chief Financial Officer, Axel Sven Malkomes. Mr. Malkomes brings over three decades of senior corporate
and investment banking experience within the biotech and pharmaceutical industries. Most recently, he served as CFO at Cardior Pharmaceuticals,
a private clinical-stage company developing non-coding RNA-based therapeutics for heart disease. During his tenure, he played a crucial
role in strategically and financially preparing the company for capital markets, co-leading financing rounds, and supporting potential
M&A and partnering transactions, culminating in the successful acquisition of Cardior by Novo Nordisk in 2024.
Before Cardior, Mr. Malkomes
was CFO and Chief Business Officer at Medigene AG, a publicly listed cell therapy company. His extensive experience also includes senior
healthcare investment banking roles at Barclays and Soci t G n rale, as well as co-heading European healthcare
investments at 3i Group plc, a UK-listed private equity firm with over $20 billion in assets under management. Earlier in his career,
he held senior leadership positions at Merck KGaA.
development pipeline
CureVac sees significant opportunities to apply
precision immunotherapy using mRNA vaccines in large patient populations. The company aims to create earlier treatment options for multiple
solid tumor types and is strengthening its clinical development pipeline following two complementary approaches: off-the-shelf cancer
vaccines targeting tumor antigens shared across different patient populations and/or tumor types and fully personalized cancer vaccines
based on a patient's individual tumor genomic profile.
CureVac is extending its off-the-shelf cancer vaccine pipeline and
has selected an additional clinical candidate for a shared-antigen cancer vaccine targeting squamous non-small cell lung cancer (sqNSCLC).
Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions are being prepared for filing in the first half of 2025.
Additional discovery work aims to deliver further off-the-shelf cancer vaccines and selection of a second clinical candidate is anticipated
In parallel, the program for fully personalized
cancer vaccines is progressing and on track with the planned start of a Phase 1 study expected in the second half of 2026.
Clinical off-the-shelf program in glioblastoma
CureVac presented the first clinical data from
the Phase 1 study of CVGBM, its off-the-shelf mRNA cancer vaccine candidate, in patients with resected glioblastoma in September 2024
at the European Society for Medical Oncology (ESMO) Congress and in November at the Society for Immunotherapy of Cancer (SITC) and
the Society for Neuro-Oncology (SNO) Congresses. Preliminary immunogenicity results in this highly aggressive and challenging cancer indication
demonstrate the potential of CureVac's proprietary second-generation mRNA backbone to enhance the immune system's capacity
for a coordinated defense against the disease.
"As our lead oncology program,
CVGBM has demonstrated encouraging initial clinical results in patients with resected glioblastoma," said Dr. Myriam Mendila,
Chief Scientific Officer of CureVac. "Data presented recently at the ESMO, SITC and SNO congresses showed that 77% of evaluable
patients exhibited sustained immune response induction over a 99-day monitoring period. Importantly, we believe these data are very promising
because the response was led by de novo T-cell generation, which likely plays a crucial role in the success of a cancer vaccine."
In the fully enrolled
dose-escalation Part A, CVGBM monotherapy induced cancer antigen-specific T-cell responses in 77% of 13 evaluable patients. Notably,
84% of these immune responses were generated de novo, inducing T-cell activity in patients without prior immunity to the encoded
antigens. Among responding patients, 69% showed CD8+ responses, 31% had CD4+ responses, and 23% had both. 67% of
responding patients showed immune responses against multiple antigens. At the recommended 100 g dose for the expansion part of
the study, responses were sustainable over a 99-day monitoring period. Induction of cellular responses was accompanied by systemic cytokine
and chemokine activation, indicating innate immune response activation.
The treatment was well
tolerated, with no dose-limiting toxicities up to the highest dose of 100 g. 91% of treatment-related adverse events (TRAEs)
were mild to moderate systemic reactions characteristic of mRNA-based therapeutics, resolving within 1-2 days post-injection. Seven patients
reported nine severe TRAEs, including four serious adverse events; no grade 4 or 5 adverse events occurred.
The dose-expansion Part B
of the study is ongoing at the recommended 100 g dose. Initial data and a decision on advancing the program to Phase 2 are expected
in the second half of 2025.
More information can
be found at clinicaltrials.gov (NCT05938387).
Prophylactic Vaccines
Initiation of Urinary Tract Infections
CureVac has initiated a new program to address
urinary tract infections (UTIs), which are among the most common bacterial infections. UTIs are most commonly caused by uropathogenic
Escherichia coli (UPEC) bacteria, which can enter the urinary tract, invade and colonize bladder and kidney tissues. These infections
can lead to complications such as kidney damage and urosepsis. UTIs lead to approximately 8-10 million doctor office visits and 1-3
million emergency department visits per year in the U.S. alone.
"Urinary tract infections are
extremely common, affecting millions of people each year-often repeatedly-and are increasingly prone to antibiotic resistance,"
said Dr. Mendila. "Our encouraging preclinical data show that our investigational vaccine candidates targeting uropathogenic
Escherichia coli elicit strong antibody titers and robust T-cell responses, comparing very favorably to recombinant protein-based vaccines.
Based on these promising results, we believe there is a significant commercial opportunity for an mRNA solution that offers meaningful
benefits to individuals suffering from these infections."
mRNA technology is ideally
suited for developing prophylactic vaccines against bacterial targets like UPEC due to its ability to target specific disease antigens
and flexibly combine multiple antigens.
CureVac has conducted
preclinical studies with several UPEC vaccine candidates and selected a lead candidate for further preclinical testing. The promising
data, which compares favorably to recombinant protein-based vaccines, is being presented at the 12th International mRNA Health Conference
in Boston from November 11-14, 2024.
The studies assessed
two mRNA vaccine candidates encoding FimH, an antigen facilitating UPEC adhesion to bladder epithelial cells, in mouse and rat models.
Both candidates induced high levels of binding antibodies in serum and urine, correlating with high serum functional antibodies, and showed
strong induction of antigen-specific CD8+ and CD4+ T-cells. Additionally, both vaccine candidates demonstrated superior