mRNA
When used alongside Merck’s Keytruda, Moderna’s personalized cancer vaccine halved the risk of death or disease recurrence in a mid-stage trial of advanced melanoma—a result analysts said could help “instill confidence” in the regimen.
Riding a newfound surge of interest on infectious disease concerns, Moderna is linking up with a global vaccine foundation in hopes of developing a vaccine to slow the new surge in Ebola underway in the Congo and Uganda.
While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
CEO Stéphane Bancel expressed confidence in Moderna’s first quarter, touting the revenue numbers as a sign of the company’s return to prosperity.
After divorcing Denali Therapeutics earlier this month, Takeda is now splitting up with Veritas In Silico, pulling back from a partnership that advanced novel small-molecule drugs targeting mRNA.
BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other modalities while mRNA technology continues to face headwinds in the U.S.
COVID-19 partners Pfizer and BioNTech have been unable to recruit healthy adults aged 50 to 64 fast enough to deliver relevant post-marketing data. Moderna is apparently also facing enrollment challenges.
The move comes as BioNTech shifts to being a multiproduct commercial biotech, allowing Ugur Sahin and Özlem Türeci to transition back into research on next-generation mRNA therapeutics.
In August last year, the Health Department cut around $500 million in mRNA research funding, with Health Secretary Robert F. Kennedy Jr. saying the agency would instead divert the money “toward safer, broader vaccine platforms.”
The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age.
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