An experimental cancer vaccine developed by NewLink Genetics (NLNK - Get Report) failed to prolong survival in patients with pancreatic cancer compared to a standard therapy, according to results from a phase III study disclosed Monday.
NewLink shares were halted at $16.50 ahead of the trial results being announced. When trading re-opened, NewLink shares fell 36% to $10.60.
The NewLink vaccine, known as algenpantucel-L, was designed to stimulate a patient's immune system to recognize and kill cancer cells. It did no such thing.
Pancreatic cancer patients treated with algenpantucel-L lived for a median of 27.3 months in NewLink's phase III trial compared to median survival of 30.4 months for patients treated with standard therapy.
The three-month median survival difference went in the wrong direction -- suggesting patients might have been harmed by treatment with algenpantucel-L.
NewLink's statistical plan prohibited independent data monitors from performing an interim futility analysis on algenpantucel-L. Had one been conducted last May during a pre-scheduled safety check, the study might have been terminated early.
Newlink has never explained why it didn't allow independent data monitors to conduct a futility analysis of the algenpantucel-L phase III study, but the absence of one has been profitable for NewLink CEO Charles Link Jr. He sold approximately $9.5 million in company stock since last May, according to SEC filings.
Now that NewLink's therapeutic cancer vaccine platform looks to be a zero, the company's dwindling valuation relies even more heavily on its so-called IDO inhibitors -- another form of cancer immunotherapy -- in early stages of clinical development. The field of companies developing cancer immunotherapies is competitive and crowded.NewLink shares have lost 70% of their value since hitting an all-time high of $57 last April.