CombiGene AB, a gene therapy company, has signed an agreement with the CDMO Cobra Biologics for the production of drug candidate CG01 for early clinical trials. The agreement with Cobra consists of three separate contracts that will be undertaken, specifically quality, production of plasmids and production of CG01. 
 
The Master Service Agreement includes manufacturing of CG01 for clinical studies as well as commercial production upon approval. CombiGene will pay Cobra approximately SEK 1.5 million in conjunction with the signing of the agreement.
 
CombiGene has conducted a thorough assessment of a large number of potential CDMOs. Selection criteria included, Adeno Associated Virus (AAV) experience, technical expertise, capacity, price and ability to collaborate.
 
“I am very pleased that we have selected Cobra, as our manufacturing partner,” said Karin Agerman, chief R&D officer at CombiGene. “The choice of a CDMO marks a significant milestone in the CG01 project and an important step towards clinical studies. Cobra meets all of our selection criteria and has shown itself to be a company that responds quickly and is easy to collaborate with. Cobra’s roots can be traced back as far as 1963 and the company is very highly reputed, with operations in both the UK and Sweden. Our collaboration will now begin in earnest and we see potential for it to continue for many years to come.”
 
Peter Coleman, chief executive officer at Cobra Biologics, said, “For almost 20 years Cobra has been manufacturing DNA and viral vectors for its gene therapy customers and we are pleased to be involved in bringing CG01 closer to market. CombiGene has recognised our expertise and track record, and this project fits perfectly into our newly expanded viral vector manufacturing facility which will soon be capable of commercial scale supply.”
 
Initially, Cobra will work with production of the plasmids required for production of CG01 and, concurrently, with the broad transfer of technology and methodology from the Cell and Gene Therapy Catapult. Then, an Engineering Run will be initiated, whereby the entire production process will be tested. Material from this Engineering Run will be used in the toxicity and biodistribution tests that are planned to start in 2020.