Full Press Release Details
CureVac Receives U.S. FDA IND Clearance to Initiate
Phase 1 Clinical Trial for Novel
mRNA-Based Precision Immunotherapy in Squamous Non-Small Cell Lung Cancer
T BINGEN, Germany/BOSTON, USA -
April 7, 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 that the U.S. Food and Drug Administration (FDA) has
cleared its Investigational New Drug (IND) application for a Phase 1 clinical study of CVHNLC in patients with squamous non-small
cell lung cancer (sqNSCLC). CVHNLC is CureVac's investigational mRNA-based precision immunotherapy consisting of two different mRNA
constructs encoding eight tumor-associated antigens (TAAs) with prevalence across sqNSCLC patients. Encoded antigens include a novel class
of TAAs that have not been previously tested in cancer immunotherapy trials.
The phase 1, dose-finding, open-label study will
assess the safety and tolerability of CVHNLC plus pembrolizumab in patients with advanced sqNSCLC. The study comprises a dose-escalation
part (Part A) of first-line maintenance treatment after either chemotherapy combined with pembrolizumab or pembrolizumab monotherapy.
This is followed by an optional dose expansion part (Part B) in which CVHNLC is tested in combination with first-line chemotherapy and
"Immune checkpoint blockade has become a
new standard of care for patients with metastatic squamous non-small cell lung cancer; however, overall prognosis still remains poor in
advanced as well as in early settings of this disease, highlighting the urgent need for new therapeutic options," said Dr. Myriam
Mendila, CureVac's Chief Scientific Officer. "Squamous non-small cell lung cancer exhibits a high prevalence of shared tumor
antigens among patients, presenting a unique opportunity for developing targeted off-the-shelf mRNA immunotherapies. We believe by administering
CVHNLC with checkpoint inhibition, we will trigger an amplified and targeted immune response, thereby increasing the efficacy against
the cancer. Our goal is to take this combination also into earlier setting of the 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 plus pembrolizumab maintenance therapy for up to 12 months or until disease progression
or undue toxicity occurs, will be administered with dose escalation. Primary endpoints include incidence of dose-limiting toxicities and
treatment-related and emergent adverse events; secondary endpoints include overall response rate, progression-free survival, duration
of response, and disease control rate.
"CVHNLC is our second oncology program to
enter the clinical stage, highlighting the continued progress we are making with our mRNA-based precision immunotherapies. Importantly,
we have been able to design CVHNLC using both known, shared tumor antigens and novel proprietary antigens discovered using our differentiated
in-house technology platform," said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. "We are leveraging this approach
in the design of multiple novel cancer mRNA programs in our collaboration with MD Anderson Cancer Center, which we anticipate entering
the clinic in the next 18-24 months."
CVHNLC has been built on CureVac's advanced
second-generation mRNA backbone, featuring two different constructs utilizing unmodified mRNA formulated in lipid nanoparticles (LNPs).
Its multi-epitope design encodes eight shared antigens, four of which are well-known with established relevance in solid tumors. The other
four antigens are a novel class of TAAs uniquely derived from CureVac's proprietary whole-genome discovery platform.
About Squamous Non-Small Cell Lung Cancer
In the U.S., there are approximately 225,000 new
cases of lung cancer each year, 87 % of which are NSCLC, according to the American Cancer Society. Squamous non-small cell lung cancer
(sqNSCLC) represents approximately 20-30% of all NSCLC cases and is considered a more aggressive form, posing significant challenges in
disease control and treatment. Patients with sqNSCLC often face a tougher prognosis compared to other types of NSCLC. In the early sqNSCLC
setting after neoadjuvant treatment, there is a 30-40% relapse rate within two years, with median overall survival of 15-17 months in
CureVac (Nasdaq: CVAC) is a pioneering multinational
biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than
two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced
and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying
the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined
with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer immunotherapy product candidates.
It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins.
Headquartered in T bingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information
can be found at www.curevac.com.
CureVac Media and Investor Relations Contact
Fakih, Vice President Corporate Communications and Investor Relations
Forward-Looking Statements of CureVac
This press release contains statements that constitute
"forward looking statements" as that term is defined in the United States Private Securities Litigation Reform Act of 1995,
including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or
its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH,
CureVac Belgium SA and CureVac Netherlands B.V. (the "company") regarding future events or future results, in contrast with
statements that reflect historical facts. Examples include discussion of the potential efficacy of the company's vaccine and treatment
candidates and the timing of programs entering the clinic. In some cases, you can identify such forward-looking statements by terminology
such as "anticipate," "intend," "believe," "estimate," "plan," "seek,"
"project," "expect," "may," "will," "would," "could," "potential,"
"intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based
on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking
statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking
statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions
and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future
preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration
partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation,
regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects
of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel,
reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect
of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause
the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside
of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking
statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines,
any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future
events or developments, except as required by law.
For further information, please reference the
company's reports and documents filed with the U.S. Securities and Exchange Commission (the "SEC"). You may get these
documents by visiting EDGAR on the SEC website at www.sec.gov.