Galena moves NeuVax-Herceptin combo studies forward, but DOJ investigation lingers

breast cancer
Galena Biopharma has moved two NeuVax-Herceptin combo trials forward.

Amid a marketing investigation and an executive shakeup, Galena Biopharma is finally hearing some good news. The company says it can proceed with clinical trials combining its lead breast cancer vaccine NeuVax with Roche's Herceptin after a team of independent inspectors ruled out safety and futility concerns.

Investigators are testing the combo, plus an adjuvant, in two ongoing phase 2 trials in patients with low-to-intermediate HER2 expression and patients with high HER2 expression.

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The company took a serious hit last June when a trial committee stopped a phase 3 study of NeuVax in early stage breast cancer, triggering an early look into the combo trials. That failure made investors question the vaccine’s future, and the company's stock fell by 80%.

A combo therapy seems to represent a remaining glimmer of hope. After the new report that there aren't safety or futility concerns in the combo trials, investors sent shares up by 80%, but much of the gains were lost and Galena shares closed up by 18% on Monday.

After evaluating 242 patients in the low-to-intermediate HER2 expression phase 2b trial, the committee now recommends that its interim efficacy analysis be moved up from 12 months after the last enrollment to just 6 months. That readout is now planned by the end of this year.

For the trial in high-risk patients, the estimated primary completion date is slated for October 2018, according to

Aside from last year's NeuVax setback, Galena is also facing a Department of Justice probe into its promotional practices for Abstral, an opioid-based painkiller.

The company sacked CEO Mark Schwartz just a few days ago, less than three years after it kicked out Mark Ahn for his part in a stock promotion scandal. Schwartz played a key role in acquiring Abstral in 2013 and also its marketing afterward, as reported by TheStreet. The company offloaded the drug in 2015.

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