Galena starts registration for breast cancer vaccine trial

Galena Biopharma has started a phase III trial of its breast cancer vaccine NeuVax with the aim of preventing recurrence in women who are not eligible for treatment with Roche's Herceptin.

The 700-patient study will enrol women with low or intermediate expression of the HER2 breast cancer biomarker, a group which accounts for around half of all breast cancer patients.

“These patients are successfully rendered disease-free following treatment with current standards of care, and are then sent home to watch and wait with the hope their cancer never returns,” said Beth Mittendorf of MD Anderson Cancer Center in the US, the principal investigator in the new trial.

Prior results from a phase I/II trial have suggested that NeuVax can “maintain disease-free survival in these patients who have no other [adjuvant treatment] options”, she added.

If successful, the new study – called PRESENT – could be sufficient in its own right to support marketing approval for NeuVax, according to Galena.

That could mean impressive returns for investors in the Oregon-based biotech, which currently has a market capitalisation of just $30m, according to analysts at Zacks Investment Research.

NeuVax could “easily” top $1bn in sales if it is approved for use in the 20,000 or so eligible breast cancer patients who are diagnosed each year in the US, the analysts added.

The company has also forged an alliance with Roche subsidiary Genentech to conduct a phase II study looking at the combination of NeuVax with Herceptin (trastuzumab) in 300 patients intermediate HER2 status patients who are currently not eligible for Herceptin treatment.

NeuVax consists of the E-75 peptide from the HER2/neu protein as an antigen, delivered alongside an immune stimulator (granulocyte macrophage colony-stimulating factor/GM-CSF). Galena acquired rights to the vaccine from the US military in July 2011.