Biological materials CDMO Cobra Biologics and gene therapy specialist CombiGene AB have signed agreements covering GMP production of two essential plasmids needed for the manufacture of CG01, a gene therapy designed for the treatment of drug-resistant focal epilepsy. GMP production of the two plasmids, derived from master cell banks, represents a highly signficant development in the production of CG01 for the first clinical study. The agreement follows the recent announcement that Cobra had successfully completed production of the GMP master cell banks to produce three plasmids used as starting material for CombinGene’s gene therapy vector, CG01.

Every year, about 47,000 patients with drug-resistant focal epilepsy are estimated to be added in the US, EU5, Japan and China. CombiGene believes that it is realistic that 10-20 per cent of these patients could be treated with the company’s gene therapy and the global market for drug candidate CG01 is estimated at $750 million to $1 5 billion annually.