Further milestone paves the way for production of novel gene therapy drug candidate designed to treat drug-resistant focal epilepsy

Keele, UK and Lund, Sweden, 13 July 2020: Cobra Biologics (Cobra), part of the Cognate BioServices family, an international Contract Development and Manufacturing Organisation (CDMO) for biologics and pharmaceuticals, and CombiGene AB (publ) (CombiGene), the leading gene therapy company in the Nordic region, today announced that Cobra has successfully produced and supplied two further DNA plasmids for the production of CombiGene’s gene therapy drug candidate CG01, which is being developed for the treatment of drug-resistant focal epilepsy. This successfully completes delivery of all plasmids required to progress to the next phase of the project.

The production of CG01, is dependent on manufactured and specifically modified plasmids. All three plasmids delivered by Cobra are key components of the gene therapy vector tasked with “transporting” CG01’s active substances NPY and Y2 into the patient’s brain tissue. To produce CG01 the plasmids are introduced into specific cells that act as “the factory” to produce the CG01 compound which will then be purified through a series of advanced techniques. The development of the manufacturing process for CG01, is thereby significantly more complex and time consuming than is the case for traditional small molecule medicines.

The first plasmid was delivered in April and with Cobra now delivering the two remaining plasmids, CombiGene is ready to begin production of CG01 as soon as the final manufacturing process is defined.

Karin Agerman, Chief Research and Development Officer, CombiGene: “The successful production and delivery of the last two of the three vital plasmids is another milestone in our collaboration with Cobra in the CG01 project. Since the start of our collaboration, Cobra has consistently delivered according to plan, which makes us feel great confidence in our continued collaboration in the CG01 project.”

Peter Coleman, Chief Executive, Cobra Biologics: “This is a further milestone in the progression of the CGO1 project and it gives me great pride in Cobra playing such a key role, drawing on our many years’ of experience and expertise in gene therapy production. We are looking forward to continuing to work with the CombiGene team on the next stages of manufacture.”