Moderna Eyes Regulatory Approval for Cancer Vaccine, Expands Beyond COVID-19

Moderna's mRNA platform has been at the center of its evolution beyond COVID-19 vaccines, according to CEO Stéphane Bancel. The company currently has a vaccine business with five approved products and two product launches planned this year, alongside oncology, rare disease, and autoimmune programs.

Bancel emphasized that Moderna is now the only remaining broad mRNA platform company following changes among competitors, including CureVac's failed late-stage COVID vaccine and Sanofi's decision to stop mRNA vaccine programs. The company believes its individualized mRNA cancer vaccine, intismeran, provides a strong case for regulatory approval.

Moderna is developing intismeran with Merck, and the Phase 3 melanoma study met both its primary endpoint and a secondary endpoint of distant metastasis-free survival at the first interim analysis. The company plans to file a biologics license application and is studying intismeran in other cancer settings.

Bancel pointed out that manufacturing for intismeran is a synthetic, cell-free liquid process that can be scaled through smaller equipment footprints and faster cycle times. The principal bottleneck may be hospital operations rather than manufacturing, particularly the ability to rapidly obtain biopsies and related patient information.