RAHWAY, N.J. & CAMBRIDGE, Mass. - Merck (NYSE: MRK) and Moderna , Inc. (Nasdaq: NASDAQ:MRNA) have announced the commencement of a Phase 3 clinical trial, INTerpath-009, to evaluate the efficacy of V940 (mRNA-4157) in conjunction with KEYTRUDA® (pembrolizumab) as an adjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). This trial targets patients who have not achieved a pathological complete response after initial treatment with neoadjuvant KEYTRUDA plus platinum-based chemotherapy. The first patients have been enrolled in Canada, marking a significant step in the ongoing INTerpath clinical program's expansion.
V940, also known as mRNA-4157, is an investigational individualized neoantigen therapy (INT) that leverages a patient's unique tumor DNA sequence to stimulate a tailored antitumor immune response. KEYTRUDA is an immunotherapy that enhances the immune system's ability to detect and combat tumor cells. Previous studies have suggested that the combination of mRNA-4157 with KEYTRUDA may offer a meaningful benefit over KEYTRUDA alone.
The INTerpath-009 trial will involve 680 patients who have undergone surgical resection of Stage II, IIIA, or IIIB (N2) NSCLC but did not achieve a pathological complete response following neoadjuvant therapy. Participants will be randomly assigned to receive either V940 and KEYTRUDA or a placebo and KEYTRUDA, with the primary endpoint being disease-free survival.
Lung cancer remains the leading cause of cancer death globally, with non-small cell lung cancer accounting for approximately 80% of all lung cancer cases. In the United States, the five-year survival rate for lung cancer patients stands at 25% as of 2024, underscoring the critical need for improved treatment options.
This press release is based on a press release statement and contains forward-looking statements regarding the potential of the V940 and KEYTRUDA combination therapy. These statements are subject to risks and uncertainties, and actual results may differ. The information provided here does not include promotional content or endorsements of the therapy's effectiveness, as its success will depend on the outcomes of the ongoing trial.
Merck and Moderna continue to evaluate and expand the V940 INTerpath clinical development program for additional tumor types and treatment settings, reflecting their commitment to advancing cancer treatment through innovative research. For more information on the clinical trial, please refer to the clinicaltrials.gov page for INTerpath-009.
In other recent news, Moderna has seen significant developments in its financial and operational landscape. Piper Sandler has maintained its Overweight rating on Moderna shares, citing the potential for increased sales following the Advisory Committee on Immunization Practices' recommendation for more frequent COVID-19 vaccinations for older and immunocompromised individuals. Moderna's sales guidance for this year ranges from $3 billion to $3.5 billion, potentially boosted by this updated guidance. In contrast, TD Cowen has kept a Hold rating on Moderna shares, adjusting the company's financial model, including a reduction in projected expenses and a revised sales forecast for Moderna's Respiratory Syncytial Virus (RSV) vaccine.
Moderna is also facing a lawsuit from GlaxoSmithKline (NYSE:GSK) over alleged patent infringement related to its COVID-19 vaccine, Spikevax. On the brighter side, the FDA approved Moderna's updated monovalent SpikeVax vaccine, which targets the KP.2 variant, and the company is preparing to file Biologics License Applications for its next-generation COVID vaccine mRNA-1283, a combination flu and COVID vaccine mRNA-1083, and mRESVIA, aimed at high-risk adults.
The company's financial position remains robust, with $10.8 billion in cash as of the second quarter of 2024. This strong cash reserve is expected to enable the company to reach cash flow breakeven. These are the recent developments for investors to consider.
InvestingPro Insights
As Moderna embarks on this significant Phase 3 clinical trial with Merck, investors should consider some key financial metrics and insights from InvestingPro. Moderna's market capitalization stands at $20.41 billion, reflecting its position as a major player in the biotech industry. However, the company's financial health presents a mixed picture.
InvestingPro data shows that Moderna's revenue for the last twelve months as of Q2 2024 was $5.05 billion, but with a concerning revenue growth decline of -52.6% over the same period. This aligns with an InvestingPro Tip indicating that analysts anticipate a sales decline in the current year. The company's gross profit margin is also under pressure, standing at -62.99%, which corresponds to another InvestingPro Tip highlighting weak gross profit margins.
On a more positive note, an InvestingPro Tip reveals that Moderna holds more cash than debt on its balance sheet, suggesting financial flexibility to fund important research and development initiatives like the INTerpath-009 trial. Additionally, the company's liquid assets exceed short-term obligations, providing some financial stability.
The stock's recent performance has been challenging, with InvestingPro data showing a -56.52% price return over the last three months. This is reflected in an InvestingPro Tip noting that the stock is trading near its 52-week low. However, for long-term investors, it's worth noting that Moderna has shown a strong return over the last five years, according to another InvestingPro Tip.
These insights offer a snapshot of Moderna's financial position as it pursues this potentially groundbreaking lung cancer treatment. Investors interested in a more comprehensive analysis can access 14 additional InvestingPro Tips for Moderna, providing a deeper understanding of the company's financial health and market position.
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