Galena Biopharma Inc., a biotechnology company focused on developing innovative, targeted oncology treatments, has signed an agreement with a subsidiary of Teva Pharmaceutical Industries Limited for the commercialisation of NeuVax (nelipepimut-S or E75) in Israel.
"This agreement is the first piece of our global commercialisation strategy," said Mark Ahn, president and chief executive officer, Galena Biopharma. "Teva is a world-class pharmaceutical company and a major pharmaceutical company in Israel. We look forward to their valuable financial support towards our development goals in Israel, as well as market leadership for NeuVax commercialization in the region."
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. Specific financial terms were not disclosed, but the agreement allows for significant royalty payments to Galena Biopharma on future sales.
Israel will be the location of at least four clinical trial sites for the NeuVax phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment) study.
"We are embarking on a very exciting and innovative venue for the adjuvant treatment of early breast cancer. In this study we are boosting the body's natural immune system to deal with possible residual cancer cells still present. The biological reasoning behind this treatment is sound. We hope that the results of this large randomised study will confirm the encouraging results seen in earlier studies using this agent," commented Dr Noa Efrat (Ben-Baruch), MD, Head Department of Oncology at Kaplan Medical Centre, and an investigator for the trial in Israel.
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 recognise, 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 Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its phase III PRESENT (P revention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.
According to the National Cancer Institute, over 230,000 women in the US are diagnosed with breast cancer annually. Of these women, only about 25 per cent are HER2 positive (IHC 3+). NeuVax targets approximately 50-60 per cent of HER2-negative patients (IHC 1+/2+ or FISH < 2.2) who achieve remission with current standard of care, but have no available HER2-targeted adjuvant treatment options to maintain their disease-free status.
Galena Biopharma, Inc. develops innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care.