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TÜBINGEN, GERMANY AND BOSTON, MA - CureVac N.V. (NASDAQ:CVAC), a biopharmaceutical company focused on mRNA-based therapies with a current market capitalization of $581 million, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CVHNLC, an mRNA-based immunotherapy targeting squamous non-small cell lung cancer (sqNSCLC). According to InvestingPro analysis, the company appears undervalued based on its Fair Value metrics, despite facing recent stock price pressure with a 24% decline year-to-date.
The Phase 1 clinical study will evaluate the safety and tolerability of CVHNLC in combination with pembrolizumab, a checkpoint inhibitor, in patients with advanced sqNSCLC. The trial will begin with a dose-escalation phase to determine the appropriate maintenance therapy dosage, followed by an optional expansion phase.
Dr. Myriam Mendila, CureVac’s Chief Scientific Officer, emphasized the urgent need for new therapeutic options for sqNSCLC, a condition with a high prevalence of shared tumor antigens among patients. The company aims to enhance the efficacy of cancer treatment by combining CVHNLC with checkpoint inhibition to stimulate a more targeted immune response. With a strong liquidity position and a current ratio of 2.29, InvestingPro data shows CureVac is well-positioned to fund its clinical development programs, though analysts note the company is quickly burning through its cash reserves.
CureVac’s CEO, Dr. Alexander Zehnder, highlighted the significance of the IND clearance as a reflection of CureVac’s progress in developing mRNA-based precision immunotherapies. CVHNLC, which uses a mix of known and proprietary tumor-associated antigens discovered through CureVac’s technology platform, is the second oncology program from the company to enter clinical trials.
CVHNLC is built on CureVac’s second-generation mRNA backbone and features two mRNA constructs encapsulated in lipid nanoparticles. The treatment is designed to encode eight shared antigens, four of which are novel and derived from the company’s whole-genome discovery platform.
SqNSCLC accounts for 20-30% of all NSCLC cases in the U.S. and is known for its aggressive nature and difficult prognosis. With approximately 225,000 new cases of lung cancer yearly in the U.S. and a high relapse rate in early sqNSCLC settings, there is a clear need for improved treatment options.
CureVac, founded in 2000, has been at the forefront of mRNA technology, contributing to mRNA vaccine development against COVID-19 and now focusing on cancer immunotherapies, prophylactic vaccines, and protein therapies. The company operates internationally with headquarters in Germany and additional sites across Europe and the U.S. Financial metrics from InvestingPro reveal strong revenue growth of 75% in the last twelve months, with analysts projecting continued sales growth of nearly 9% for the current fiscal year. Discover more insights about CureVac’s financial health and growth prospects through InvestingPro’s comprehensive research reports, available for over 1,400 US-listed companies.
Patient treatment with CVHNLC is expected to start in the second half of 2025, with further candidates planned to enter clinical trials in 2026. This announcement is based on a press release statement and reflects the company’s ongoing commitment to addressing unmet medical needs through innovative mRNA technologies.
In other recent news, CureVac has achieved a significant legal victory with the European Patent Office (EPO) upholding its amended patent EP 3 708 668 B1, despite opposition from BioNTech. This decision marks a pivotal moment in the ongoing intellectual property dispute between the two companies, with further proceedings scheduled to determine potential patent infringement and damages. CureVac’s CEO, Dr. Alexander Zehnder, emphasized the importance of this ruling, highlighting the company’s pioneering role in mRNA technology. The upheld patent involves CureVac’s split poly-A tail technology, which is designed to enhance the efficacy of mRNA-based treatments. Meanwhile, CureVac’s stock has seen positive movement amid rising flu cases in the United States, reflecting broader gains in the vaccine sector. The Centers for Disease Control and Prevention (CDC) reported an increase in flu activity, which has led to heightened investor interest in vaccine developers. CureVac, along with other companies in the sector, continues to focus on advancing mRNA-based therapies as the legal and health landscapes evolve.
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