Northwest Bio, NewLink proceed with cancer vax trials to mixed reviews

A pair of biotechs will proceed with cancer vaccine studies thanks to recent recommendations from data-monitoring committees. Their announcements drew mixed results from investors, with Northwest Biotherapeutics' ($NWBO) shares soaring and NewLink Genetics' ($NLNK) sinking. But as they forge ahead, both companies will have to shake off the looming specters of failed cancer vaccine trials past.

Shareholders late last week cheered an interim analysis of the study of Northwest Biotherapeutics' personalized cancer vaccine, and news that all was going according to plan pushed shares up as much as 10% despite the omission of still-pending efficacy data. Shares rocketed even higher--almost 30%--a few days later on news that German health regulators had cleared a special hospital exemption allowing sale of the drug for all glioma brain cancers.

NewLink's shareholders, on the other hand, weren't quite so supportive upon learning that the company would roll on with a Phase III study of its pancreatic cancer immunotherapy. Investors had hoped the drug's promise would trigger an early end to the trial, and when that didn't come, shares declined by more than 12%.

As CEO Charles Link said in a statement, continuation of the study "was an anticipated outcome considering the high statistical threshold assigned to this first interim analysis under the special protocol assessment." And plenty of other wannabe cancer vaccines have fared much worse in the clinic. Oncothyreon ($ONTY), Ziopharm ($ZIOP) and Keryx ($KERX) all at one time boasted promising candidates with analyses delayed by slow death rates, and their treatments all eventually bit the dust before reaching the market.

Even those cancer vaccines that have reached the promised land of regulatory approval don't have such a stellar track record with investors. Dendreon ($DNDN), maker of Provenge, provides a cautionary tale: The company struggled to control costs, and with increased competition and disappointing sales taking their toll, one analyst last summer went so far as to predict bankruptcy in the company's future. As Argos ($ARGS) CEO Jeff Abbey told FierceBiotech in August, "there remains, if not a bias, a skepticism against personalized cell therapy for cancer because of Dendreon."

- get more from FierceBiotech on Northwest Bio
- and read its take on NewLink

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