Moderna

Intismeran autogene (mRNA-4157)

In Development

An individualized neoantigen cancer therapy, co-developed with Merck, that is custom-manufactured for each patient's tumor mutations and given with KEYTRUDA to train the immune system against the cancer. It is Moderna's highest-value pipeline asset.

Latest update Sep 8, 2026

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Current status

Investigational. Phase 3 INTerpath-001 (adjuvant melanoma) met both its primary endpoint (recurrence-free survival) and key secondary endpoint (distant metastasis-free survival) in August 2026, the first positive Phase 3 result ever for an individualized mRNA neoantigen cancer therapy. As of September 8, 2026 no regulatory filing has been submitted; Moderna and Merck say they will present data at a medical meeting and engage with regulators. Phase 3 lung-cancer trials remain enrolling, across nine Phase 2/3 oncology studies.

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Specifications2

Melanoma Phase 3 (INTerpath-001)
Met primary

(RFS) and key secondary (DMFS) endpoints, Aug 2026

Regulatory Filing
Not yet filed as of Sept 8, 2026

companies engaging regulators after an upcoming data presentation

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