Date: 2012-12-04
Type of information: Commercialisation agreement
Compound: NeuVax™ (nelipepimut-S or E75)
Company: Galena Biopharma (USA) Teva Pharmaceutical (Israel)
Therapeutic area: Cancer - Oncology
Type agreement: commercialisation
Action mechanism: NeuVax™ (nelipepimut-S) is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase II trial, which achieved its primary endpoint of disease free survival (DFS), the FDA granted NeuVax™ a Special Protocol Assessment (SPA) for a Phase III clinical trial in adjuvant therapy of women with low-to-intermediate (also known as HER2-Negative, not eligible for Herceptin) status.
Disease: breast cancer
Details: Galena Biopharma, a biotechnology company focused on developing targeted oncology treatments, has signed an agreement with a subsidiary of Teva Pharmaceutical Industries Limited for the commercialization of NeuVax™ (nelipepimut-S or E75) in Israel. Under the agreement, Teva Israel will assume responsibility for regulatory registration in Israel, provide financial support for local development, and will commercialize the product in the region. Israel will be the location of at least four clinical trial sites for the NeuVax Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study.
Financial terms: Specific financial terms were not disclosed.
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