Oncothyreon awaits pivotal data on Stimuvax

Oncothyreon ($ONTY) execs are expecting interim results from a late-stage study of lung cancer vaccine Stimuvax sometime this quarter. Results from the 1,514-person trial, which is being conducted by partner Merck KGaA, could have big implications for the rest of Oncothyreon's cancer treatment pipeline.

After receiving chemo and radiation, patients in the trial are dosed with Stimuvax, which is supposed to help the body's immune system target cancer cells. Oncothyreon and Merck are testing to see whether Stimuvax can extend survival by at least 6 months in patients who have inoperable tumors in the chest cavity. Interim results occur when a certain number of patients in the trial die, prompting an independent party to review the trial data.

"In some sense, the longer it takes, the better it is," said CEO Robert Kirkman in an interview with Reuters. Depending on the findings, the trial could be halted early if the vaccine is ineffective, or if Stimuvax is obviously working for patients. "We would be perfectly content if the decision is to continue the trial to its end," he added, noting that either way, top-line data is expected this year. 

If Merck is able to win FDA approval of the vaccine, it would trigger $90 million in milestone payments to Oncothyreon in addition to royalties on sales. The Seattle-based developer could funnel that cash into its pipeline, which consists of ONT-10 (which is expected to start human trials soon) and PI-3 kinase inhibitor PX-866.

- see the Reuters article

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