Personalized Cancer mRNA Vaccine Seeks Acceleration

Moderna Inc. president Stephen Hoge commented at a conference on healthcare on March 6, 2023, indicating it would accelerate the approval pathway for its personalized cancer vaccine candidate mRNA-4157/V940.

"At some point, this randomized 150-person Phase IIb study that we ran might — might — be able to become the basis of accelerated approval," Hoge said, according to EndPoint News.

"It's too early to say, but we are hopeful that the data will mature that way."

On December 13, 2022, mRNA-4157/V940, combined with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with a high risk of recurrence following complete resection.

An advantage of Moderna's mRNA platform is that it allows for investigational medicines that combine several different approaches to activate the immune system to attack cancer in a single mRNA therapy.

The U.S. Food and Drug Administration has already issued breakthrough therapy designation for mRNA-4157/V940 ahead of a potential Phase 3 study for the treatment expected in 2023 for adjuvant melanoma, a type of skin cancer.

In 2019, the latest year for which incidence data are available, 88,059 new cases of melanoma of the skin were reported, and 8,092 people died of this cancer in the U.S. Cancer is the second leading cause of death in the U.S., exceeded only by heart disease, says the U.S. CDC.

The CDC's real-time cancer dashboard is available at this link.