As Moderna prepares for seasonal uptake of its multi-billion-dollar COVID vaccine, the mRNA company is confident that the rest of its pipeline can make clinical and commercial in-roads in 2023. And while much of Moderna’s hype has centered on treating respiratory diseases, some of the more exciting prospects are elsewhere.
That was the aura, at least, exuded by Moderna’s executives on a third-quarter earnings call Thursday, with developments in respiratory syncytial virus, cancer and rare diseases being the source of the optimism. First up on Moderna’s plate of near-term readouts is phase 2 data of the company’s personalized cancer vaccine, mRNA-4157, being trialed in combination with Merck & Co's Keytruda. The study is testing the combination against Keytruda alone in patients with high-risk melanoma.
Merck’s decision to opt into the program in October appeared tantalizing to investors, raising suspicions that the data is positive. In response to prodding, Moderna President Stephen Hoge noted on the call that Merck was allowed access to the open-label data prior to making their decision.
“They have experience of what to expect in a control arm,” Hoge said. “You can infer whatever you'd like from their decision, to just say, that they believe it's worth opting into that program and proceeding to the primary analysis that we're conducting right now.” A readout from that primary analysis is expected before the end of the year.
It wasn’t all roses for Moderna’s cancer ambitions, however, as AstraZeneca handed back another asset, this time calling it quits on Moderna’s IL-12-targeting prospect called mRNA-6231. Hoge said the U.K.-based Big Pharma would complete work on a phase 1 trial, at which time Moderna will decide its next steps for the program. AstraZeneca had previously axed a Moderna-partnered cardiovascular disease candidate, AZD8601, back in July.
The IL-12 program dates back to 2016 when AstraZeneca first announced its collaboration with Moderna on two specific immuno-oncology assets. Moderna was responsible for discovery and preclinical development before AstraZeneca took the baton for early clinical development. Both companies were slated to split costs of late-stage studies, but as of now, none of Moderna’s pipeline-reflected programs are in partnership with AstraZeneca.
AstraZeneca’s walk-backs are in addition to Merck handing back rights to a KRAS mutation-based cancer vaccine earlier this year and Moderna’s decision to axe development of an IL-2 targeting autoimmune therapy last quarter.
But it was Hoge's comments about the company’s rare disease ambitions that seemed to be the most forward-looking, as he referenced Moderna's hope that it can more than double that pipeline “in the years ahead as we expand our investments in rare diseases.” At the company’s R&D day, Chief Commercial Officer Arpa Garay estimated that the company could have its first commercial launch in this area as early as 2024.