What happened
Shares of Iovance Biotherapeutics (IOVA -4.30%) gained over 21% last month, according to data from S&P Global Market Intelligence. There wasn't any company-specific news to send the pharma stock higher. Well, not any new news, anyway.
Investors continue to rally around shares of Iovance Biotherapeutics after the company reported impressive results for a top drug candidate in late November. The end-of-year rally helped the stock notch a 212% gain in 2019, but shares have given up nearly 8% in the new year. Does that suggest investors are getting a little ahead of themselves?
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So what
Iovance Biotherapeutics is developing cellular medicines based on tumor-infiltrating lymphocytes. As the name suggests, the immune cells are well suited for treating solid tumor cancers. But they're uniquely active against several difficult-to-treat cancers, such as advanced melanoma and cervical cancer.
In late November, Iovance Biotherapeutics reported impressive results for its lead drug candidate, lifileucel, in a cohort of patients involved in a larger phase 2 trial. The cohort included 42 advanced melanoma patients who didn't respond to commonly used PD-1 or PD-L1 treatments. Lifileucel achieved an overall response rate of 41% and didn't reach the median duration of response at the 12-month data cutoff. Considering advanced melanoma is one of the deadliest cancers and one with the fewest treatment options, the results are pretty impressive.
Now what
Iovance Biotherapeutics expects to wrap up enrollment for a phase 3 trial of lifileucel in advanced melanoma in early 2020. That could allow the company to file a biologics license application (BLA) with American regulators by the end of 2020, which could be matched by a BLA for a separate drug candidate in cervical cancer around the same time. Throw in plans to initiate clinical trials for an entirely new type of cellular medicine later this year, and investors are right to be excited about this biopharma.
