Cobra Biomanufacturing has entered into a manufacturing development agreement with GenVec for TNFerade, GenVec's lead product candidate
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, United Kingdom.
"GenVec selected Cobra based upon their expertise in viral manufacturing and the experience of key staff members with commercial biopharmaceutical products.
"Activities under this agreement will establish a clear path for the submission of the chemistry, manufacturing, and controls (CMC) portion of a biological license application for TNFerade as GenVec works towards the completion of our current phase III clinical trial," said Bryan Butman, GenVec's senior vice president of vector operations.
"We are delighted to work with GenVec on this exciting project.
"TNFerade has demonstrated great potential for the treatment of pancreatic cancer," added Simon Saxby, Cobra Biomanufacturing's chief operating officer.
"This agreement will leverage Cobra's significant experience manufacturing recombinant adenovirus under cGMP conditions".
GenVec is a biopharmaceutical company developing novel therapeutic drugs and vaccines.
GenVec's lead product, TNFeradea 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 also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and influenza.
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumour necrosis factor-alpha (TNFa), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumours.
After administration, TNFerade stimulates the production of TNFa in the tumour.
GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
