Moderna Inc (NASDAQ:MRNA, XETRA:0QF)'s melanoma trial success is prompting Wall Street to assign new platform value to the company's oncology pipeline, Jefferies said, as investors look beyond its COVID-dependent revenue base.
The Jefferies note said intismeran vipatamotide (mRNA-4157), an individualized neoantigen therapy (INT) combined with Merck's Keytruda, succeeded in the Phase III INTerpath-001 study evaluating patients with Stage IIB-IV melanoma following complete surgical resection.
The trial randomized 1,137 patients 2:1 to receive the combination versus Keytruda alone for about one year, hitting statistical significance on the primary endpoint of recurrence-free survival at the first prespecified interim analysis. A key secondary endpoint, distant metastasis-free survival, was also met.
Jefferies said it now expects a hazard ratio below 0.80 on recurrence-free survival, with a reading below 0.70 at an upcoming medical meeting, potentially ESMO in late October, needed to reinforce the market's confidence in the therapy's benefit relative to Keytruda alone. That would compare with a hazard ratio of 0.561 seen in the Phase IIb trial after two years.
The firm raised its price objective to $170 from a prior level and upgraded the stock to Neutral, citing improved visibility into Moderna's diversification beyond infectious disease.
Jefferies now models $54 billion in unadjusted global peak sales for intismeran, after raising assumptions including a 60% peak share and 85% probability of success in adjuvant melanoma, a $260,000 price point, and higher peak share estimates in adjuvant renal cell carcinoma and non-small cell lung cancer. Moderna splits economics on the therapy 50/50 with Merck under their existing collaboration, with Merck fully reimbursing cost of goods sold.
Downside risks flagged by Jefferies include gaps in the upcoming data presentation or slower-than-expected commercial uptake.
Shares of Moderna pulled back around 17% on Thursday morning, according to the note, after rallying 135% following the initial melanoma data release.