Cobra Biologics delivers final plasmids for production of CG01 in CombiGene’s epilepsy project

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

Keele, UK and Lund, UK, 13th 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 DNAplasmids 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 GGO1 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.”

About CombiGene AB
CombiGene’s vision is to provide patients affected by severe life-altering diseases with the prospect of a better life through novel gene therapies. CombiGene’s business concept is to develop effective gene therapies for severe life-altering diseases where adequate treatment is currently lacking. Development assets are sourced from an external research network and developed to achieve clinical proof of concept. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while the company may manage this process on its own for drugs targeting niched patient populations.

CG01 is CombiGene’s lead project, targeting pharmacoresistent focal epilepsy. Epilepsy is the fourth most common neurological disorder, affecting around 65 million people worldwide, and is characterised by seizures, which are caused by the abnormal firing of neurons in the brain. CG01 uses AAV to deliver neuropeptide Y (NPY) and the Y2-receptor into brain cells, which has been able to prevent epileptic seizures in preclinical studies.

The company is public and listed on the Swedish marketplace Nasdaq First North Growth Market and the company’s Certified Advisor is FNCA Sweden AB, +46 (0)852 80 03 99

About Cobra Biologics
Cobra Biologics is a leading international contract development and manufacturing organisation(CDMO) providing biologics and pharmaceuticals for pre-clinical, clinical and commercial supply to an international customer base.
Each of Cobra’s GMP approved facilities are tailored to serving our customers around the world. We offer a broad range of integrated and stand-alone contract development and manufacturing services for clinical trials and the commercial market.

As a trusted provider and a key partner in the drug development and commercialisation process, we take pride in our manufacturing excellence and comprehensive range of services to the pharmaceutical and biotech industries.