TÜBINGEN, GERMANY and BOSTON, MA - CureVac N.V. (NASDAQ:CVAC), a biopharmaceutical company specializing in messenger RNA (mRNA) therapeutics, has announced the initiation of Part B in the Phase 1 study of its mRNA-based cancer vaccine candidate, CVGBM, for the treatment of glioblastoma. This follows the successful completion of Part A, which involved dose escalation in 16 patients and did not reveal any dose-limiting toxicities.
The current open-label study is focused on the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. The vaccine is administered post-surgery and after radiotherapy, with or without chemotherapy. Part B of the study is expected to enroll up to 20 patients to further assess safety, tolerability, and immunogenicity at a 100 µg dose, as recommended by the Data Safety Monitoring Board.
Dr. Myriam Mendila, Chief Scientific Officer of CureVac, stated that the dose expansion is critical to confirm the appropriate dose for future studies based on safety and immunogenicity data. The vaccine candidate utilizes CureVac's proprietary second-generation mRNA backbone and encodes a single fusion protein with eight epitopes known to induce immune responses in glioblastoma patients.
The Phase 1 proof-of-principle study is being conducted across Germany, Belgium, and the Netherlands. Initial data from Part A will be presented at the European Society for Medical Oncology Congress on September 13, 2024.
CureVac, founded in 2000, has been a pioneer in mRNA technology, contributing to the development of mRNA vaccines against COVID-19. The company continues to leverage its expertise to explore mRNA applications in cancer vaccines, prophylactic vaccines, and treatments that enable the production of therapeutic proteins.
The information in this article is based on a press release statement. Further details on the study can be found on the clinical trials registry with identifier NCT05938387.
In other recent news, CureVac N.V. has announced key developments in its operations and strategic partnerships. The company reported a decrease in full-year revenues due to lower collaboration income, despite making significant strides in clinical trials, particularly in infectious diseases and oncology. CureVac is also teaming up with MD Anderson to develop mRNA cancer vaccines.
In its bid to enhance innovation and research, CureVac has appointed Dr. Mehdi Shahidi, a seasoned clinical oncologist, as an independent director to its Supervisory Board. Dr. Shahidi, who is currently the CEO of Petalion Therapeutics, is expected to contribute significantly to CureVac's advancement of mRNA-based cancer vaccines.
In a significant partnership evolution, GSK has acquired mRNA vaccine rights from CureVac in a deal valued at €1.05 billion. The agreement allows GSK to develop and manufacture vaccine candidates for influenza and COVID-19 using mRNA technology.
CureVac has also disclosed crucial dates for its impending patent disputes with Pfizer/BioNTech in various jurisdictions, including the United States, the United Kingdom, and Germany. The resolution of these disputes is anticipated to shape the company's operations and strategic direction in the coming years. These recent developments underscore the potential of mRNA technology in vaccine development and highlight CureVac's strategic direction.
InvestingPro Insights
As CureVac N.V. (NASDAQ:CVAC) advances its mRNA-based cancer vaccine candidate, CVGBM, into Part B of the Phase 1 study, investors and stakeholders are closely monitoring the company's financial health and market performance. Here are some key insights from InvestingPro that may provide additional context to CureVac's current situation and future prospects:
InvestingPro data indicates that CureVac holds a market capitalization of approximately $734.56 million. Despite the challenges faced in the biopharmaceutical sector, CureVac has managed to maintain a price/book ratio of 1.51, suggesting that the company's assets are valued reasonably in relation to its share price. Additionally, CureVac experienced a notable quarterly revenue growth of 73.56% in the last twelve months as of Q1 2024, reflecting the company's ability to generate increased sales over a short period.
Two InvestingPro Tips that are particularly relevant to CureVac at this stage are:
- The company holds more cash than debt on its balance sheet, which is a positive sign of financial stability and may provide the flexibility needed to fund ongoing research and development efforts without excessive reliance on external financing.
- Analysts anticipate sales growth in the current year, which could be a positive indicator for the company's revenue trajectory and may reflect optimism about the market's reception of CureVac's mRNA technology and vaccine candidates.
These InvestingPro Tips, along with 9 additional tips available on the platform, offer a more nuanced view of CureVac's financial position and market expectations. With the next earnings date set for August 15, 2024, stakeholders will be keen to see how these factors play out in the company's financial results and strategic direction.
For a more comprehensive analysis and additional insights, readers can explore further InvestingPro Tips for CureVac at https://www.investing.com/pro/CVAC.
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