- EpilepsyGTx has partnered with Viralgen to support manufacturing of EPY201, its lead investigational gene therapy for patients with focal refractory epilepsy, ahead of first-in-human clinical trials.
- Viralgen will use its Aava manufacturing platform to produce EPY201, with the platform designed for high-yield and scalable manufacturing across AAV serotypes.
EpilepsyGTx has entered into a partnership with Viralgen, a CDMO specializing in recombinant adeno-associated virus (AAV) gene therapies, to support production of EPY201 ahead of first-in-human clinical trials. EPY201 is being developed for patients with focal refractory epilepsy (FRE).
Under the collaboration, Viralgen will use its proprietary Aava manufacturing platform to produce EPY201. According to the announcement, the platform enables high-yield and scalable manufacturing across AAV serotypes and has supported the production of 1,500 AAV batches.
Focal epilepsy involves seizures that arise from a specific part of the brain. Epilepsy is considered refractory, or pharmacoresistant, when seizures persist following trials of at least two tolerated and appropriately chosen antiseizure medications. The release states that FRE affects approximately 10 million patients worldwide, including two million patients in the US, UK and EU.
EPY201 is designed for direct delivery into the seizure focus. The approach aims to reduce neuronal hyperexcitability locally while limiting exposure beyond the target region of the brain. If successful, the therapy is intended to provide a single, minimally invasive option that does not require resection or ablation of brain tissue.
“Viralgen’s AAV manufacturing expertise and platform designed to support programmes from early development through to commercial scale will be critical as we prepare to advance EPY201 into clinical development. Viralgen’s infrastructure, expertise and regulatory track record supported its selection as a manufacturing partner for the program.”
Nicolas Koebel, chief executive officer of EpilepsyGTx
