BioCentury
ARTICLE | Company News

Galena Biopharma, Leica Microsystems deal

December 17, 2012 8:00 AM UTC

Leica's histopathology division Leica Biosystems will develop a companion diagnostic using its Bond Oracle HER2 IHC System to aid in selecting breast cancer patients to enroll in the ongoing Phase III PRESENT trial of Galena's NeuVax nelipepimut-S ( E75). The partners will use the companion test to select patients with low to intermediate epidermal growth factor receptor 2 ( EGFR2; HER2; ErbB2; neu) expression for the trial, which has an SPA from FDA. The partners declined to disclose details.

Leica's Bond Oracle HER2 IHC assay is approved in the U.S. as an aid in assessing patients for whom Herceptin trastuzumab treatment is being considered. The immunohistochemical (IHC) assay determines HER2 oncoprotein status in formalin-fixed, paraffin-embedded breast cancer tissue. NeuVax is a vaccine consisting of an immunogenic peptide derived from EGFR2 and sargramostim. Galena (formerly RXi Pharmaceuticals Corp.) gained NeuVax through its acquisition of Apthera Inc. in 2011 (see BioCentury, April 18, 2011). ...