Company: RXi Pharmaceuticals
Target: Breast cancer
In September, RXi Pharmaceuticals received FDA permission to go ahead with a Phase III clinical trial of an experimental therapeutic vaccine called NeuVax, which the company obtained by acquiring its erstwhile developer Apthera in March.
The vaccine candidate is based on a single immunostimulatory peptide called E75, derived from the HER2/neu receptor, and administered in combination with granulocyte macrophage colony stimulating factor (GM-CSF) as an adjuvant.
If positive Phase II data bear out, NeuVax could delay disease recurrence and progression in breast cancer patients whose tumors express only low to intermediate levels of the HER2 receptor, and who thus are ineligible to receive Genentech's blockbuster drug Herceptin, which blocks that receptor. It appears that NeuVax can spur cell-killing T-cells to attack cells expressing any level of HER2-good news for the more than 50% of breast cancer patients denied Herceptin. NeuVax is given by intradermal injection monthly for half a year, followed by a booster shot for another 6 months.
Because Herceptin is so widely desired-and patients take the news of being rejected for treatment with it so hard-RXi would be in a nice spot if NeuVax data allow it to be positioned as the "go-to" alternative. Better yet: the cost of the rejection that in effect becomes the referral is linked to Herceptin and the companion diagnostic for it.
RXi plans to begin the Phase III trial of NeuVax named PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) in the first half of 2012. About 100 trial sites in the U.S., Europe and Canada are expected to participate.
Apthera earlier conducted studies of NeuVax in combination with Herceptin, and reported positive data from a trial of it as a standalone treatment for HER2 positive prostate cancer patients.