EpilepsyGTx, a biotechnology company developing gene therapies for refractory epilepsy, and Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (AAV) gene therapies, today announced a partnership to support production of EpilepsyGTx's lead investigational gene therapy program targeting patients with focal refractory epilepsy (FRE), EPY201, ahead of first-in-human clinical trials.
As part of the collaboration, Viralgen will use its proprietary Aava™ manufacturing platform to provide a reliable, efficient solution for production of EPY201. The platform enables high-yield, scalable manufacturing across AAV serotypes, and has already supported the production of 1,500 AAV batches.
Focal epilepsy describes a group of disorders in which seizures arise from a specific part of the brain. When seizures persist following trials of at least two tolerated and appropriately chosen antiseizure medications, epilepsy is deemed refractory, or pharmacoresistant. FRE affects approximately 10 million patients worldwide, including two million patients in the US, UK, and EU.
EPY201 is designed to be delivered directly into the seizure focus, with the aim of reducing neuronal hyperexcitability locally while limiting exposure beyond the target region in the brain. If successful, this approach will offer patients a single, minimally invasive option that does not require resection or ablation of brain tissue, offering patients with FRE the prospect of seizure freedom.
Viralgen's AAV manufacturing expertise and platform designed to support programs from early development through to commercial scale will be critical as we prepare to advance EPY201 into clinical development. Viralgen's infrastructure, know-how, and regulatory track record make it an excellent manufacturing partner as we work to bring our novel gene therapy approach closer to the clinic."
Nicolas Koebel, Chief Executive Officer, EpilepsyGTx
Jimmy Vanhove, Chief Executive Officer of Viralgen said: "We are proud to partner with EpilepsyGTx on this important program. Our Aava platform is purpose-built to scale AAV programs efficiently, and our manufacturing expertise positions us to help EpilepsyGTx advance EPY201 toward patients with focal refractory epilepsy as rapidly as possible."