What happened
Shares of Iovance Biotherapeutics (IOVA -0.68%) were up 11% Monday afternoon after the late-stage biotech company announced on Friday that it had filed a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for its therapy Lifileucel.
The drug is the company's lead pipeline candidate, and the BLA is seeking approval for the drug to treat patients with advanced unresectable or metastatic melanoma who have already had a PD-1/L1 therapy (a checkpoint inhibitor anticancer drug that blocks the activity of PD-1 and PDL1 immune checkpoint proteins present on the surface of cells).
The stock's shares are still down more than 63% over the past year and down more than 3% so far in 2023.
So what
The company, which focuses on novel T cell-based cancer immunotherapies, is using the company's phase 2 trial of the drug that dosed post-anti-PD1 melanoma patients with Lifileucel. The trial found that the company's lead tumor-infiltrating lymphocyte (TIL) therapy achieved an objective response rate of 31%. The drug is also in a phase 3 trial as a combination therapy to treat frontline advanced melanoma.
CEO Frederick Vogt said the BLA, if approved, would make Lifileucel the first individualized, one-time cell therapy for a solid tumor.
Now what
It's easy to see why the stock rose: It's a big step from a late-stage biotech to be on the cusp of becoming a commercial-stage biotech. The company, as of Feb. 24, said it had $669.8 million in cash, which should be enough to fund its 166.7 million pound (roughly $204.68 million) purchase of Proleukin from Clinigen Limited, and the rest of its operations into the second half of 2024, it said.
In 2022, the company had no revenue, and it posted a net loss of $395.9 million, an earnings per share (EPS) loss of $2.49.
