This is the first large scale GMP production of CG01, and both the production itself and the subsequent testing were performed according to original plans. The data from the analyses will form a central part of future regulatory applications to support proceeding to clinical studies.
“The availability of the GMP production of CG01 is yet another important and value-creating milestone for
Viralgen’s CEO, Javier García, said “Viralgen is excited to play an important role in the continued advancement of CG01. This material’s successful and on-time testing is a key milestone in reaching patients and supporting both
About CG01
CG01 is a unique gene therapy candidate aimed at a large patient population to solve a global need in epilepsy treatment. Epilepsy is a major global medical problem with approximately 47,000 drug-resistant patients with focal epilepsy estimated to be added each year across the US, EU4,
Horizon 2020
CombiGene’s lead project CG01 has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 823282.
About
At
About Viralgen
https://viralgenvc.com
Viralgen is a CDMO born as a joint venture between
Viralgen was created in 2017 to respond to the unmet need for manufacturing of gene therapies, with the goal to help broaden access to these life-saving therapeutics and to contribute to the advancement of health and human welfare around the world. The company specializes in the production of rAAV viral vectors, and has built an optimized facility in San Sebastian,
Through a superior technology platform, the company deliver industry-leading titers and cGMP-certified quality for all AAV serotypes to our client partners, optimize the cost-of-goods, and accelerate clinical development and commercialization of life-saving genetic medicines.
Viralgen new commercial facility was taken into production by the end of 2021 in San Sebastian (
About
CombiGene’s vision is to offer patients affected by severe life-changing diseases opportunities for a better life through innovative gene therapies. CombiGene’s business concept is to develop effective gene therapies for serious diseases that today lack adequate treatment methods. Research assets are taken in from a network of external researchers and developed further up to clinical concept verification. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while
The Company has signed an exclusive collaboration and licensing agreement for CombiGene’s CG01 project with
The company is public and listed on the Nasdaq First North Growth Market and the company’s Certified Advisor is
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