CombiGene Signs Agreement for Production of Gene Therapy Drug Candidate
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CombiGene, a gene therapy company, has signed an agreement with the Contract Development and Manufacturing Organisation (CDMO) Cobra, for production of candidate drug CG01. The production of CG01 will be of a quality required for early clinical trials. The agreement with Cobra consists of a Master Service Agreement which specifies the terms under which the two companies will collaborate. Initially, three separate contracts will be undertaken, specifically quality, production of plasmids and production of CG01.
The Master Service Agreement that CombiGene has signed with Cobra includes manufacturing of CG01 for clinical studies as well as commercial production of a future, authority approved CG01 drug. This means that the agreement is very long-term in character and that CombiGene over time will make continuous investment within the scope of the agreement with Cobra. CombiGene will pay Cobra approximately SEK 1.5 million in conjunction with the signing of the agreement, a payment that is partly financed through the funds that CombiGene receives from Horizon 2020, EU’s Research and Innovation programme.
"I am very pleased that we have selected Cobra, as our manufacturing partner” says Karin Agerman, Chief Research and Development Officer at CombiGene. "The choice of a CDMO marks a significant milestone in the CG01 project and an important step towards clinical studies.”
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. Thereafter, 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.