Intismeran autogene (mRNA-4157)
In Development
Moderna
Overview
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.
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; Moderna and Merck plan to file for regulatory approval within months. Phase 3 lung-cancer trials remain enrolling, across nine Phase 2/3 oncology studies.