maddie meyer
Moderna will pursue the FDA’s accelerated approval pathway for its personalized cancer vaccine, Chairman Stephen Hoge said Monday at the annual Cowen healthcare conference.
In December, the company announced mid-stage data for the mRNA-4157/V940 mRNA-based candidate with from Merck (New York Stock Exchange:MRK) Keytruda checkpoint inhibitor in melanoma. The phase 2b trial indicated that the combination reduced the risk of disease recurrence or death by 44% compared to Keytruda alone as adjuvant therapy.
“At some point, this 150-person Phase IIb randomized study that we conducted could become the basis for accelerated approval,” Hoge said, adding: “It’s too early to say, but we’re hopeful that the data grow up that way.”
Earlier this year, the FDA issued a Breakthrough Therapy Designation for mRNA-4157/V940 ahead of a potential Phase 3 study for treatment expected in 2023 for adjuvant melanoma.
Meanwhile, Moderna (NASDAQ:MRNA) Chief Executive Stéphane Bancel also spoke about the company’s plans for a cancer vaccine at the WSJ Health Forum in Boston on Monday. “The first chapter is going to be: going after the places where Keytruda works,” he said, adding that the researchers are also looking at conditions in which the PD-1 inhibitor did not indicate efficacy.
“But also the scientific and clinical teams are working to discover other places where Keytruda didn’t work, that perhaps there is a scientific rationale for combining Keytruda and the Moderna vaccine to potentially overcome the hump of the immune system and achieve clinical impact.” he added.
Bancel also responded to criticism of the company’s pricing plans for its COVID-19 vaccine, noting that its mRNA platform, the foundation of its portfolio, was funded by investors, not the government.
“We didn’t get a penny,” Bancel said, adding that public funding only accelerated the development of the vaccine.
His comments come amid concerns that as COVID products transition to a commercial market, Moderna (MRNA) and rival Pfizer (PFE) plan to increase prices for COVID vaccines to ~$110 to $ 130 per dose, versus $26-$30 implied in recent government contracts.