Moderna and Merck aim to file personalized cancer vaccine for FDA approval after Phase 3 success

Moderna CEO Stéphane Bancel said the company’s personalized cancer vaccine, intismeran, met its primary goals in a pivotal Phase 3 trial. The success was disclosed during an interview at the ESMO meeting in Madrid.

He added that Moderna and partner Merck are accelerating plans to submit the vaccine to the U.S. Food and Drug Administration, with an approval target set for 2027. The firms also intend to evaluate the product in additional cancer types.

The positive readout underscores Moderna’s broader strategy to apply mRNA technology beyond infectious‑disease vaccines, extending into oncology, rare diseases and autoimmune disorders. Bancel highlighted an ambitious concept of using mRNA to program T cells to eliminate B cells that drive autoimmune disease.