After mastering mass-market mRNA production during the pandemic, the industry now needs to achieve the timely delivery of individualized vaccines to thousands of patients.
The recent clinical success of Merck and Moderna’s intismeran autogene raised expectations for personalized mRNA cancer vaccines across the industry. Yet getting the products to patients presents new challenges.
In the past, the industry was focused on scaling up, Roberta Duncan, founder and principal of strategic consulting firm The Modeste Duncan Group, told BioSpace. Now, the conversation is about “scaling out and scaling down,” added Duncan, who also serves on the board of the Alliance for mRNA Medicines.
To make intismeran, Moderna sequences an individual’s cancer and healthy cells and analyzes the data using an automated bioinformatics system to identify up to 34 patient-specific neoantigens. Formulated in a lipid nanoparticle delivery system, mRNA encoding the neoantigens triggers protein production in the body to drive an immune response against the tumor.
By 2025, Moderna had reduced the time from sample collection to vaccine administration to around six weeks, down from roughly seven to eight weeks in 2019. The turnaround time “can probably be brought under one month,” Guggenheim Securities analysts said in an Aug. 21 note to investors, citing Memorial Sloan Kettering Cancer Center computational oncologist Benjamin Greenbaum.
Moderna has set up a dedicated facility in Massachusetts to support intismeran’s planned launch. The company calculates that the facility can support the vaccine “for several years,” Moderna President Stephen Hoge said on an earnings call in July. The plant should “satisfy the initial indication” of melanoma, Hoge added, and Moderna will add more capacity to meet demand beyond an initial launch.
Hoge was speaking before the INTerpath-001 trial readout raised expectations for intismeran. Last month, an earlier-than-expected trial readout showed the personalized vaccine combined with Keytruda improved outcomes in patients with melanoma, nearly doubling Moderna’s share price while Merck’s stock jumped 12%.
Moderna, which is primarily responsible for manufacturing intismeran under the terms of its deal with Merck, did not respond to BioSpace’s questions about how the clinical success has affected the company’s thinking about demand and capacity.
Moderna’s ability to make intismeran for the thousands of patients in active trials of the vaccine is built on years of investment in in-house capabilities. Biotechs without such capabilities can supply the market by working with CDMOs, Duncan said, provided they can find partners “willing to invest in miniaturizing scale, because they’re all built for large-scale manufacturing.”
As personalized mRNA vaccines come to market, Duncan warned, “we’re going to have to have a really hard conversation about cost of goods and the cost of manufacturing.” Believing that clinical data show the novel modality works, Duncan now sees the speed and cost of production as the keys to commercial success.
“It’s not going to be on the biology,” she said. “It’s going to be on the logistics and the cost.”
Editor’s note: Heather McKenzie contributed reporting to this story.
