Full Press Release Details
CureVac Announces Financial Results for the
Fourth Quarter and Full-Year 2024
and Provides Business Update
Strategic Milestone Achievement and Increased Financial Discipline
Underscore Year of Corporate Transformation
Germany/BOSTON, USA - April 10, 2025 - CureVac N.V. (Nasdaq: CVAC) ("CureVac"),
a global biotech 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 2024 and provided a business update.
Commenting on the quarter Dr. Alexander Zehnder,
Chief Executive Officer of CureVac said:
"The fourth quarter of 2024
marked a strong finish to a year of significant transformation for CureVac. We strategically repositioned the company around impactful
R&D and technology innovation, which enabled us to advance several novel development programs, leveraging our unique mRNA platform.
The successful restructuring and improved financial discipline position the company for stronger performance, supported by recent validation
of our intellectual property in Europe."
Selected Business Updates
Protection of Intellectual Property Rights
Litigation in Europe was successfully advanced
with a positive ruling by the Opposition Division of the European Patent Office (EPO), announced on March 27, 2025, confirming the
validity of CureVac's European patent EP 3 708 668 B1, subject to amendments to specify the scope of protection. The decision is
appealable. The patent describes a foundational invention of CureVac, called split poly-A tail technology, which aims to enhance medical
efficacy by improving expression of the protein encoded on an mRNA construct.
In its decision, the Opposition Division largely
dismissed the opposition originally filed by BioNTech SE in April 2023 challenging the patent's validity and maintained the
patent in amended form. The ruling represents a major milestone in the ongoing patent dispute between CureVac and BioNTech in Germany,
which involves a total of six intellectual property rights. CureVac believes that this patent is infringed in its amended form. An infringement
hearing is scheduled for July 1, 2025, before the Regional Court D sseldorf. A positive infringement decision would trigger
proceedings to assess damages in the same court.
"The positive litigation
development in Europe sends a strong message that reinforces the strength and impact of our patent portfolio, which is one of the broadest
and most diverse portfolios in the entire mRNA space," said Dr. Zehnder. "Our breakthrough and pioneering inventions
have contributed significantly to innovation in mRNA medicine and most assuredly deserve formal recognition where due."
in the European litigation will be a hearing to rule on the validity of European patent EP 4 023 755 B1 scheduled for May 13-15,
2025, before the same EPO board.
CureVac aims to create breakthrough treatment
options for earlier settings of multiple solid tumor types and is strengthening its clinical development pipeline with two complementary
approaches: off-the-shelf precision immunotherapies targeting tumor antigens shared across different patient populations and/or tumor
types and fully personalized precision immunotherapies based on a patient's individual tumor genomic profile.
New off-the-shelf program in squamous non-small
CureVac's new program for a shared-antigen
precision immunotherapy targeting squamous non-small cell lung cancer (sqNSCLC) is on track with recent Investigational New Drug (IND)
and Clinical Trial Application (CTA) submissions to regulatory authorities in the U.S. and Europe, respectively. With the FDA clearance
received, as reported on April 7, 2025, to proceed with the Phase 1 study of CureVac's investigational precision immunotherapy,
CVHNLC, in patients with sqNSCLC, dosing of the first patient is expected in the second half of 2025.
CVHNLC is a multiepitope mRNA-based precision
immunotherapy consisting of two different mRNA constructs encoding a total of eight tumor-associated antigens with prevalence across sqNSCLC
patients. Four of the encoded antigens represent established antigens, while the other four are novel antigens lying outside of the exome
space identified under the CureVac myNEO Therapeutics collaboration, applying myNEO Therapeutic's advanced AI-powered technology
platform. These novel antigens have not been previously tested in cancer immunotherapy trials. CVHNLC will be tested in combination with
the check point inhibitor pembrolizumab.
The Phase 1, dose-finding, open-label study will
assess the safety and tolerability of CVHNLC as a first line treatment for metastatic disease. In Part A, patients with metastatic
Stage IV sqNSCLC, who have received at least three cycles of pembrolizumab, either as monotherapy or in combination with chemotherapy,
will be enrolled. CVHNLC doses between 100 g and 400 g will be administered in escalating fashion in combination with
pembrolizumab maintenance therapy for up to 12 months or until disease progression or undue toxicity occurs.
"Our approach to precision
immunotherapy aims to induce a potent immune response that translates into clinical benefit for patients by applying the ability of mRNA
to precisely and safely guide the immune system to one or more tumor antigens," said Dr. Myriam Mendila, Chief Scientific Officer
at CureVac. "With this approach, we aim to target earlier stages of cancer in patients, who have not previously undergone multiple
lines of treatment, where there is a higher chance to increase cure rates."
Further discovery work in CureVac's oncology
therapeutic area aims to deliver additional off-the-shelf precision immunotherapies, with the selection of a second clinical candidate
anticipated in 2026.
In parallel, the program for fully personalized
precision immunotherapies is on track with the Phase 1 study expected to begin in the second half of 2026.
Clinical off-the-shelf program in glioblastoma
Phase 1 study with shared antigen precision immunotherapy candidate CVGBM is ongoing in patients with resected glioblastoma. Part B
successfully completed patient enrollment, adding 20 patients to be treated with CVGBM monotherapy at the recommended dose of 100 g.
Data from Part B and a decision on advancing the program to Phase 2 are expected in the second half of 2025.
CureVac presented preliminary clinical data from
Part A of the CVGBM Phase 1 study 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
demonstrated cancer antigen-specific T-cell responses in 77 % of 13 evaluable patients; 84 % of immune responses were being generated
de novo. At the 100 g dose, the majority of 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
generally well tolerated, with no dose-limiting toxicities. 91 % of treatment-related adverse events (TRAEs) were mild to moderate systemic
reactions, resolving within 1-2 days post-injection. Seven patients reported nine severe TRAEs, including four serious adverse events.
information can be found at clinicaltrials.gov (NCT05938387).
Prophylactic Vaccines
Urinary Tract Infections Program
In November 2024, CureVac announced the initiation
of a new program to address urinary tract infections (UTIs), supported by promising preclinical data. UTIs are among the most frequent
bacterial infections, most commonly caused by uropathogenic Escherichia coli (UPEC) bacteria. UPEC 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.
The program is progressing, and it is expected
to file an IND submission in the second half of 2025 for a Phase 1 study to commence in the first half of 2026.
Seasonal Influenza/COVID-19 Combination
Vaccine - Program Licensed to GSK
In November 2024, GSK initiated the Phase
1 of a combined Phase 1/2 study to assess reactogenicity, safety and immune responses of a multivalent seasonal influenza/COVID-19 combination
vaccine candidate. The start of the Phase 1 was accompanied by a 10 million milestone payment to CureVac, which was invoiced in
the fourth quarter of 2024.
information can be found at clinicaltrials.gov (NCT06680375 ).
previously announced in July 2024, CureVac and GSK restructured their collaboration into a new licensing agreement. Under the new
agreement, GSK has assumed full control of the development, manufacturing and global commercialization of mRNA vaccine candidates against
influenza and COVID-19, including combinations. All vaccine candidates currently in clinical development are based on CureVac's
proprietary second-generation mRNA backbone.
Update for the Fourth Quarter and Full-Year 2024
on the financial results, Axel Sven Malkomes, CureVac's Chief Financial Officer, said: