The agreement is part of preparations for GMP production of material for the first clinical study of CG01
Lund, Sweden and Keele, UK, 10 September 2020. Cobra Biologics (Cobra), part of the Cognate BioServices family, an international CDMO manufacturer of biological materials and pharmaceuticals, and CombiGene AB (publ) (CombiGene), the leading gene therapy company in the Nordic region, today announced that they have signed agreements covering Good Manufacturing Practice (GMP) production of two essential plasmids needed for the manufacture of CG01, a gene therapy designed for the treatment of drug resistant focal epilepsy.
The GMP production of two essential plasmids, derived from master cell banks, represents a crucial development in the production of CG01 for the first clinical study. Increasing production of plasmids to large scale and according to GMP requires management of the scale-up process to ensure plasmids are of therapeutic-grade quality. Cobra’s long-established plasmid production platform along with in-house expertise will ensure high quality plasmids are produced for CG01.
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.
Jan Nilsson, CEO, CombiGene: “The fact that CombiGene has now signed an agreement with Cobra regarding the production of two plasmids is very positive as we thus secure access to crucial components for the production of CG01. Cobra has consistently delivered in terms of both time and quality and it is therefore very satisfactory that they will now be responsible for the production of this important part in the production of CG01. Through this agreement with Cobra, we are taking another step closer to clinical studies.”
Peter Coleman, Chief Executive, Cobra Biologics: “We are excited to continue the journey with CombiGene and this agreement is the next big step in the production of CG01. We have a well-established plasmid production platform and in-house expertise in quality control that will ensure the delivery of GMP quality plasmid.”
CG01 is a gene therapy developed to treat drug-resistant focal epilepsy. Every year, approximately 47,000 drug-resistant patients with this type of epilepsy are estimated to be added in the United States, EU5, Japan and China. CombiGene believes that it is realistic that 10-20 percent of these patients could be treated with the company’s gene therapy. The global market for drug candidate CG01 is estimated at USD 750 –1 500 million annually.