Cobra signs manufacturing agreement with GenVec
UK-based biopharma company Cobra Biomanufacturing has entered into a manufacturing development agreement with GenVec, of the US, for GenVec's lead product candidate TNFerade.
UK-based biopharma company Cobra Biomanufacturing has entered into a manufacturing development agreement with GenVec, of the US, for GenVec's lead product candidate TNFerade.
The agreement will cover technology transfer, scale-up, and validation of the manufacturing process for TNFerade through cGMP consistency lots that will be produced at Cobra's facility in Oxford, UK.
TNFerade is an adenovector that contains the gene for tumor necrosis factor-alpha (TNFÃŽ±) for direct injection into tumours. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers. It is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. Additional clinical trials are in progress in rectal cancer, head and neck cancer and melanoma.
"GenVec selected Cobra for its expertise in viral manufacturing and the experience of key staff members with commercial biopharmaceutical products," said Dr Bryan Butman, GenVec's senior vice president of vector operations. "Activities under this agreement will establish a clear path for the submission of the chemistry, manufacturing, and controls (CMC) portion of a biological licence application for TNFerade as GenVec works towards the completion of our current Phase III clinical trial."