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The Gene therapy company CombiGene announced yesterday that an agreement has been signed with CDMO manufacturer Cobra Biologics, regarding GMP production of two of the essential plasmids needed for the production of the company’s drug candidate CG01. In doing so, the company is taking a step closer to clinical studies with CG01 and a future treatment for drug-resistant focal epilepsy.

Cobra Biologics, a part of Cognate BioServices, is an international contract manufacturer (CDMO) that produces DNA viral vectors and microbiota products for preclinical, clinical and commercial use.

Cobra, with Blackrock as one of the major and well-known shareholders, has two GMP-approved facilities and offers integrated and independent development and manufacturing services for both clinical studies and the commercial market.

New agreement with CombiGene

CombiGene and Cobra Biologics entered into an agreement in October last year. Yesterday, an agreement was signed regarding GMP production of two of the essential plasmids needed for the production of CG01, CombiGene’s gene therapy intended for the treatment of drug-resistant focal epilepsy.

The GMP production of the two essential plasmids from master cell banks is a crucial step in the development of CG01 production for the first clinical study. Increasing the production of plasmids on a larger scale and in accordance with GMP requires a safe upscaling of the process to ensure that the plasmids are of therapeutic quality.

»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« – Jan Nilsson, CEO CombiGene.

According to CombiGene, Cobra’s well-established plasmid production platform, together with their in-house expertise, will ensure that high quality plasmids are produced for CG01.

The agreement follows the recent announcement that Cobra has successfully completed the production of GMP master cell banks for the production of the plasmids used as starting material for CombinGene’s gene therapy vector CG01.

»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« – Peter Coleman, CEO of Cobra Biologics

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