TÜBINGEN, GERMANY and BOSTON, MA - CureVac N.V. (NASDAQ:CVAC), a biopharmaceutical company specializing in messenger RNA (mRNA) therapeutics, has reported encouraging preliminary results from the first part of its Phase 1 study of the CVGBM cancer vaccine for patients with glioblastoma. The data, presented at the European Society for Medical Oncology (ESMO) Congress, showed that the vaccine was generally well tolerated and induced specific T-cell responses in a majority of patients.
The study evaluated the safety, tolerability, and immunogenicity of the CVGBM vaccine across various doses in patients who had undergone surgery and chemo-radiation therapy. The results indicated that 77% of evaluable patients developed cancer antigen-specific T-cell responses. Notably, 84% of these immune responses were de novo, meaning they were new responses in patients who previously had no T-cell activity against the targeted cancer antigens.
Prof. Dr. Dr. Ghazaleh Tabatabai, who is leading the study, highlighted the significance of the vaccine's ability to generate new immune responses against the tumor. CureVac's Chief Scientific Officer, Dr. Myriam Mendila, also noted the potential of the company's second-generation mRNA backbone in cancer immunotherapy, as evidenced by the elicitation of both CD8+ and CD4+ T-cell responses.
Regarding safety, the vaccine did not cause any dose-limiting toxicities, even at the highest tested dose of 100 µg. The most common adverse events were mild to moderate systemic reactions such as headache, fever, and chills, which resolved within a couple of days post-injection. A 100 µg dose was selected for the ongoing dose-expansion phase of the study.
CVGBM is an mRNA-based vaccine encoding a fusion protein comprising epitopes from tumor-associated antigens relevant to glioblastoma. The Phase 1 study is being conducted in Germany, Belgium, and the Netherlands and is registered with clinicaltrials.gov (NCT05938387).
CureVac, founded in 2000, has been a pioneer in the mRNA technology field, contributing to mRNA vaccine developments against COVID-19. The company is now exploring mRNA's potential in other therapeutic areas, including cancer vaccines. This press release is based on a statement from CureVac and does not include independent verification of the data. CureVac has cautioned that the results are preliminary and further research is required to confirm the vaccine's efficacy and safety.
InvestingPro Insights
CureVac N.V. (NASDAQ:CVAC) has recently shared promising data from its ongoing study, which has garnered attention in the biopharmaceutical sector. As investors consider the potential impact of these developments on the company's financial health and stock performance, it's important to look at key metrics and insights.
InvestingPro data indicates that CureVac holds a market capitalization of $693.13 million. Despite the company's significant revenue growth of 75.11% over the last twelve months as of Q2 2024, it is important to note that CureVac has reported a gross profit margin of -131.0% in the same period, reflecting challenges in converting revenues into actual profit. This is underscored by the company's operating income margin, which stands at -433.71%, pointing to operational costs outpacing gross profits.
One of the InvestingPro Tips highlights that CureVac has more cash than debt on its balance sheet, which could provide some financial flexibility for the company as it continues its research and development efforts. However, another tip suggests that the company is quickly burning through cash, which could be a concern for investors given the company's current lack of profitability. CureVac does not pay dividends, which may affect the investment considerations for income-focused shareholders.
Investors should also be aware of the stock's volatility, as indicated by a significant return over the last week of 12.77%, yet a year-to-date price total return of -26.6%. This could suggest short-term opportunities for gains, but also a higher risk profile that should be carefully considered.
For those interested in a deeper analysis, there are additional InvestingPro Tips available at InvestingPro, which could provide further insights into CureVac's financial health and stock performance. These tips may help investors make more informed decisions in light of the company's recent clinical study results and future prospects in the mRNA technology field.
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