Moderna hopes for FDA accelerated approval of cancer vaccine
Maddie Meyer

Moderna will look for FDA's accelerated approval pathway for its personalized cancer vaccine, president Stephen Hoge said on Monday at Cowen's annual conference on healthcare.
In December, the company announced mid-stage data for the messenger-RNA-based candidate mRNA-4157/V940 with Merck's (NYSE:MRK) checkpoint inhibitor Keytruda in melanoma. The Phase 2b trial indicated that the combo cut the risk of disease recurrence or death by 44% versus Keytruda alone as an adjuvant treatment.
"At some point, this randomized 150-person Phase IIb study that we ran might â might â be able to become the basis of accelerated approval," Hoge said, adding, "It's too early to say but we are hopeful that the data will mature that way."
Early this year, the FDA issued breakthrough therapy designation for mRNA-4157/V940 ahead of a potential Phase 3 study for the treatment expected in 2023 for adjuvant melanoma.
Meanwhile, Moderna (NASDAQ:MRNA) Chief Executive StÃ©phane Bancel also spoke about the company's plans for the cancer vaccine at the WSJ Health Forum in Boston on Monday. "The first chapter is going to be: go after places where Keytruda works," he said, adding that the investigators are also looking at conditions where the PD-1 inhibitor did not indicate efficacy. 
"But also the scientific and clinical teams are working to figure out other places where Keytruda did not work, that maybe there's a scientific rationale where you combine Keytruda and the Moderna vaccine to potentially get over the hump of the immune system to get to clinical impact," he added.
Bancel also responded to criticism towards the company's pricing plans for its COVID-19 shot, noting that its mRNA platform, the basis for its pipeline, was funded by investors, not the government.
"We didn't get a penny," Bancel noted, adding that public funding only accelerated vaccine development.
His remarks come amid concerns that as COVID products transition to a commercial market Moderna (MRNA) and rival Pfizer (PFE) plan to raise COVID vaccine prices to ~$110 to $130 per dose, up from $26 â $30 implied in the latest government contracts.