Firm will undertake tech transfer, scale-up, and process validation to enable GenVec’s BLA.
GenVec entered into a manufacturing development agreement with Cobra Biomanufacturing related to its anticancer agent, TNFerade™. The therapy is being evaluated as a treatment for pancreatic, head and neck, and rectal cancers as well as metastatic melanoma. The most advanced program is a Phase II/III trial in in the pancreatic indication.
The agreement will cover technology transfer, scale-up, and validation of the manufacturing process for TNFerade through cGMP consistency lots. These will be produced at Cobra’s facility in Oxford, U.K.
“Activities under this agreement will establish a clear path for the submission of the chemistry, manufacturing, and controls portion of a biological license application for TNFerade as GenVec works towards the completion of our current Phase III clinical trial,” says Bryan Butman, Ph.D., svp of vector operations at GenVec.
The firm is developing TNFerade for use in combination with radiation and/or chemotherapy. The treatment is an adenovector, which contains the gene for tumor necrosis factor-alpha. After administration, TNFerade reportedly stimulates the production of TNFá in the tumor.