Moderna Presents Phase 1/2 Data on Cancer Antigen Therapy

Investigational mRNA-4359 therapy shows promise in combination with pembrolizumab for advanced melanoma.

Apr. 17, 2026 at 9:19pm

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A highly detailed, translucent X-ray image showing the complex internal structure of a human melanoma tumor, with ghostly glowing lines and shapes revealing its intricate biological makeup.Cutting-edge cancer research aims to harness the power of mRNA technology to target advanced melanoma tumors.Cambridge Today

Moderna, Inc. announced that it will present Phase 1/2 data on its investigational cancer antigen therapy mRNA-4359 at the 2026 AACR Annual Meeting. The data will focus on the use of mRNA-4359 in combination with the immunotherapy drug pembrolizumab as a first-line treatment for locally advanced or metastatic melanoma. The U.S. FDA has granted Fast Track designation for this combination therapy.

Why it matters

Melanoma is an aggressive form of skin cancer, and new treatment options are needed, especially for patients whose cancer has become resistant to checkpoint inhibitor immunotherapies. The combination of mRNA-4359 and pembrolizumab represents a potential new approach that could improve outcomes for these patients.

The details

mRNA-4359 is Moderna's investigational cancer antigen therapy that is designed to stimulate the immune system to recognize and attack tumor cells. The Phase 1/2 data will evaluate the safety and efficacy of using mRNA-4359 in combination with pembrolizumab, a PD-1 checkpoint inhibitor, as a first-line treatment for locally advanced or metastatic melanoma patients whose tumors express PD-L1.

  • The data will be presented at the 2026 AACR Annual Meeting.

The players

Moderna, Inc.

A biotechnology company focused on developing messenger RNA (mRNA) therapeutics and vaccines.

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The takeaway

This investigational combination therapy represents a promising new approach for treating advanced melanoma, a disease with significant unmet medical needs. The Fast Track designation from the FDA underscores the potential of this therapy to improve outcomes for patients.