Much of Moderna’s focus is on nabbing FDA approval for a respiratory syncytial virus vaccine, a decision expected in a matter of weeks. But clinical investments are also pouring into a late-stage cancer treatment.
Moderna detailed plans for its individual neoantigen cancer vaccine in a first-quarter earnings update Thursday, with three new phase 2 studies underway in conjunction with Keytruda. The Flagship Pioneering success story is now testing its Merck & Co.-partnered treatment, mRNA-4157, in patients with neoadjuvant or adjuvant cutaneous squamous cell carcinoma, adjuvant high-risk muscle-invasive bladder cancer and adjuvant renal cell carcinoma.
Moderna President and R&D chief Stephen Hoge, M.D., said the company was guided by data produced from a successful phase 2 melanoma study in addition to cancer types where Keytruda has seen success.
“We have been aggressively pursuing adjuvant indications where I-O is approved and where we see an opportunity and all three of these fit squarely in that space,” he said.
At the same time, Moderna has elected not to pursue its own checkpoint inhibitor, a preclinical PD-L1 therapy, after a “strategic review.” The biopharma said in a release that it will not pursue additional treatments in this area.
Moderna’s foray into cancer is led by mRNA-4157’s use in patients with high-risk melanoma and non-small cell lung cancer on top of Keytruda. Since the start of the year, Moderna has seemingly coalesced around submitting the therapy for accelerated approval as a melanoma treatment. That’s contingent on substantially enrolling the phase 3 melanoma study, which would serve as the confirmatory trial, and building up manufacturing capacity at a Marlborough, Massachusetts site.
“We're optimistic that both [enrollment] and the facility will be available in short order,” Hoge told investors. He noted that Moderna has yet to engage regulators on using the accelerated pathway, waiting until it has “crossed [its] own threshold.”
“Our view is that if we're able to get to the point where accelerated approval is appropriate, and regulators are supportive of that, we can't imagine why ourselves and Merck wouldn't want to make the product available to help people suffering from cancer right now,” Hoge said.