Moderna, Inc. (NASDAQ:MRNA) will present data from a Phase 1/2 study of mRNA-4359, an investigational cancer antigen therapy, at the American Association for Cancer Research (AACR) Annual Meeting, the company announced on April 17, 2026. The therapy is being evaluated in combination with pembrolizumab as a first-line treatment for patients with locally advanced or metastatic melanoma.
"The presentation will report safety, efficacy and translational data from a Phase 2 dose-expansion cohort of the Phase 1/2 study," the company said in a statement. The study, identified as NCT05533697, focuses on a specific patient population with PD-L1+ (TPS> 1%) melanoma that is refractory to checkpoint inhibitors.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for mRNA-4359 in combination with pembrolizumab for this indication. This designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.
The upcoming data presentation is a significant step for Moderna as it seeks to expand its pipeline beyond COVID-19 vaccines. A positive outcome from the mRNA-4359 trial could strengthen the company's position in the competitive oncology market and provide a new treatment option for patients with advanced melanoma. Investors will be closely watching the full data set presented at the AACR meeting between April 17-22, 2026, for details on the therapy's efficacy and safety profile.
This article is for informational purposes only and does not constitute investment advice.