Galena Biopharma and Dr. Reddy’s Laboratories have entered into a strategic development and commercialization partnership on NeuVax (nelipepimut-S) in India.
NeuVax (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein for therapeutic intervention in breast carcinoma.
According to Galena, the nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) after binding to HLA-A2/A3 molecules on antigen presenting cells (APC) and the 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 via inter- and intra-antigenic epitope spreading.
The US Food and Drug Administration (FDA) has also granted NeuVax a special protocol assessment (SPA) for its Phase III PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) trial, based on successful Phase II trial.
Galena Biopharma president and CEO Mark Ahn said the deal with Dr. Reddy’s is consistent with the company’s strategy to expand the clinical utility of NeuVax in unmet medical needs while simultaneously increasing the commercial footprint of this innovative cancer immunotherapy.
“Dr. Reddy’s is a leading pharmaceutical company in India with significant commercialization and development expertise,” Ahn added.
“The gastric cancer trial will add a significant indication to our pipeline for NeuVax, while doubling our potential patient population if approved.”
Galena is focused on commercializing and developing new targeted oncology treatments that address major unmet medical needs to advance cancer care, while Dr. Reddy’s provides affordable and new medicines for healthier lives.
Dr. Reddy chairman and CEO G V Prasad said the partnership accelerates the company’s commitment to innovation and efforts to bring newer options for cancer patients.
“We are delighted with our partnership with Galena Biopharma and we believe NeuVax can be a good potential treatment option to prevent the recurrence of breast and gastric cancer,” Prasad added.