Key insights
- Moderna's mRNA-4359 melanoma therapy combined with pembrolizumab showed an 83% response rate in a Phase 1/2 trial. The treatment also received FDA Fast Track designation. This positive news could boost investor confidence in Moderna and the broader biotech sector, potentially leading to a short-term positive impact on US equity markets, particularly for companies involved in cancer research and mRNA technology.
CAMBRIDGE, Mass. - Moderna Inc. (NASDAQ:MRNA) reported data from a Phase 1/2 study of mRNA-4359, an investigational cancer therapy, presented at the American Association for Cancer Research Annual Meeting on Monday. The announcement comes as shares trade near their 52-week high of $59.55, with the stock surging 85% year-to-date to $55.63.
The Phase 2 dose-expansion cohort evaluated mRNA-4359 combined with pembrolizumab as a first-line therapy in 12 patients with locally advanced or metastatic melanoma. The combination achieved an overall response rate of 83%, with two patients achieving complete response and eight achieving partial response, according to the press release statement. The disease control rate reached 92%.
The median time to response was six weeks. Among patients with PD-L1+ tumors, the response rate was 88%, while patients with PD-L1- tumors showed a 67% response rate.
Antigen-specific T-cell responses and novel expanded T-cell receptor clonality was observed in all seven patients with evaluable samples. The treatment demonstrated a manageable safety profile with no new immune-related adverse events.
"This study evaluating mRNA-4359 + pembrolizumab as a first-line treatment option reflects our ambition to demonstrate the potential of mRNA technology throughout a cancer patient’s journey," said David Berman, Moderna’s Chief Development Officer.
The company previously presented data at the 2025 European Society for Medical Oncology Congress showing a 24% response rate among 29 patients with checkpoint inhibitor-resistant melanoma. Among patients with PD-L1+ tumors in that cohort, the response rate was 67%.
The U.S. FDA granted Fast Track designation for mRNA-4359 combined with pembrolizumab for treating checkpoint inhibitor refractory unresectable or metastatic melanoma with PD-L1+ tumors. Fast Track designation facilitates development and expedites review of therapies for serious conditions with unmet medical needs.
mRNA-4359 is designed to encode epitopes of PD-L1 and IDO1, targeting tumor cells and immunosuppressive cells.
In other recent news, Moderna has reached a settlement agreement with Arbutus Biopharma Corporation and Genevant Sciences GmbH to resolve ongoing patent litigation concerning its infectious disease vaccines. The agreement involves a noncontingent lump sum payment of $950 million to be made by Moderna by July 2026, effectively covering litigation related to its COVID-19 vaccine Spikevax, RSV vaccine mRESVIA, and other pipeline products. Additionally, Moderna has agreed to a potential payment of up to $1.3 billion depending on future legal decisions, bringing the total possible settlement amount to $2.25 billion. This settlement resolves all U.S. and international legal actions accusing Moderna of using lipid nanoparticle delivery technology without permission.
Jefferies has reiterated a Hold rating on Moderna stock following the resolution of this global patent litigation. The analyst firm maintains a price target of $37.00 for the company. In separate news, OpenAI has launched GPT-Rosalind, an AI model aimed at advancing research in biology and drug discovery. This model is optimized for scientific workflows, including chemistry and genomics, potentially impacting the lengthy process of drug development.
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