Accelerated approval incoming? Moderna ‘hopeful’ for personalized cancer vaccine

Moderna will look to use the FDA’s accelerated approval pathway for its personalized cancer vaccine, president Stephen Hoge said at Cowen’s annual conference on healthcare.

The company read out Phase IIb results in December suggesting the mRNA-based therapy reduced melanoma patients’ risk of cancer recurrence or death by 44% in combination with Keytruda, with a p-value of 0.0266 and a hazard ratio of 0.56. However, Hoge said on Monday that investigators are curious whether that hazard ratio may improve over time.

They’re also analyzing translational biomarker data that could show “not only is the picture robust and strong, but there may be populations that are already really strong,” Hoge said.

“At some point, this randomized 150-person Phase IIb study that we ran might — might — be able to become the basis of accelerated approval,” he added. “It’s too early to say but we are hopeful that the data will mature that way.”

Last month, Moderna announced plans to launch a Phase III study in adjuvant melanoma this year and “rapidly expand” into other tumor types such as non-small cell lung cancer.

“The first chapter is going to be: go after places where Keytruda works,” CEO Stéphane Bancel said on Monday at the WSJ Health Forum in Boston. “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.”

Stephen Hoge

As for respiratory disease, Moderna plans to file for approval of its experimental RSV vaccine in older adults in the first half of this year. Pfizer received priority review for its own candidate last month, and expects a decision by May. Moderna’s flu program, dubbed mRNA-1010, is currently in Phase III and headed for an interim analysis by the end of this quarter. Once the company lands those individual approvals, Hoge expects to roll out combination doses relatively quickly.

“We are focused on getting those first-generation models approved, working our way through the big three very quickly here, and then we will go very fast — think of what we did with the Covid updates — on the combos and then roll those out shortly thereafter,” Hoge said.

Bancel added during the WSJ presentation that Moderna’s “true goal” is combination vaccines for respiratory viruses, including flu and Covid vaccines adapted to seasonal strains and RSV.

“I don’t know about you, but I don’t like to get two, three, or four shots a winter,” Bancel said. “I think for most people, it is going to be hard to remember: Which one did I already get, when?”

Moderna has considered pricing its Covid shots between $110 and $130 per dose in the US, the same price suggested by Pfizer last fall. On Friday, Bancel added that the price will reflect a “wide range” depending on circumstances such as discounts. He also specified that the company is moving toward single-dose prefilled syringes, which “increased the cost tremendously.”

“I think a lot of people don’t realize that the price that was offered to the government during the pandemic was actually a massive discount to value,” the CEO said.

Regardless of their insurance status, all Americans will be able to receive the Moderna vaccine at no out-of-pocket cost, he reaffirmed on Friday.

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