After an interim analysis, NewLink Genetics ($NLNK) is planning to keep on keeping on with a Phase III study of its cancer vaccine. But that news came as an apparent disappointment to investors, who hoped the drug's promise would result in an early trial termination, and the biotech's shares fell more than 12% on Friday morning.
NewLink's treatment, algenpantucel-L, is a pancreatic cancer immunotherapy in the midst of a 722-patient Phase III study. This week, under standard procedure for clinical trials, the company's independent data monitoring committee convened to look over the results so far, and, finding neither alarming safety issues nor exhilarating efficacy numbers, the group recommended NewLink stick to the script until the next planned interim analysis.
That, says NewLink, is business as usual, and, as the company has "previously emphasized, continuation of this study was an anticipated outcome considering the high statistical threshold assigned to this first interim analysis under the special protocol assessment," CEO Charles Link said in a statement.
But investors weren't quite so understanding, and NewLink's shares dropped to as low as $33 in premarket trading Friday. The company has had a brisk 2014 on Wall Street, more than doubling its stock value to peak at $50.33 last week before dipping back down.
NewLink's latest interim analysis was tied to the achievement of 222 "patient events," which generally means deaths. Many expected algenpantucel-L to hit the 222 mark last year, and, when it didn't, that stoked investor hopes that patients in the treatment arm were living longer than expected and thus made Friday's revelation so disappointing.
|NewLink Genetics Chief Medical Officer Nicholas Vahanian|
The interim analysis by no mean spells doom for the Phase III trial, but, as TheStreet's Adam Feuerstein pointed out last week, late-stage cancer vaccine trials helmed by biotechs have a less than thrilling success rate. Oncothyreon ($ONTY), Ziopharm ($ZIOP) and Keryx ($KERX) all had promising treatments with analyses delayed by slow death rates, and all eventually failed in the clinic.
But that doesn't change anything for NewLink in the short term, Chief Medical Officer Nicholas Vahanian said.
"In any case, it is reassuring that no unexpected safety issues or other concerns were raised by the independent data safety monitoring committee," Vahanian said in a statement. "Now, with the first interim analysis behind us, we look forward to continuing the study and to gathering additional, more mature data in support of our mission to provide improved treatment options for patients with pancreatic cancer."
- read the announcement