Collaboration with AAV-specialist CDMO will support scalable production of EPY201 for focal refractory epilepsy affecting 10 million people
LONDON and SAN SEBASTIÁN, Spain, Sept. 9, 2026 /PRNewswire/ -- EpilepsyGTx, a biotechnology company developing gene therapies for refractory epilepsy, and Viralgen, a leading contract development and manufacturing organization (CDMO) specialising in recombinant adeno-associated virus (AAV) gene therapies, today announced a partnership to support production of EpilepsyGTx's lead investigational gene therapy programme 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 worldwide1, 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.
Nicolas Koebel, Chief Executive Officer of EpilepsyGTx, commented: "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, 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."
Jimmy Vanhove, Chief Executive Officer of Viralgen said: "We are proud to partner with EpilepsyGTx on this important programme. Our Aava platform is purpose-built to scale AAV programmes efficiently, and our manufacturing expertise positions us to help EpilepsyGTx advance EPY201 toward patients with focal refractory epilepsy as rapidly as possible."
- Vaughan et al (2019): https://thejns.org/doi/abs/10.3171/2018.3.JNS171722
About EpilepsyGTx
EpilepsyGTx is a biotech company developing cutting-edge gene therapies for epilepsy. Its technology offers patients with focal refractory epilepsy (FRE), the prospect of seizure freedom in a single procedure, delivered directly to the seizure focus with minimal damage to surrounding brain tissue.
The Company has generated substantial evidence of potential anti-seizure activity and tolerability in translatable preclinical models of FRE for a variety of seizure focus locations. The Company's lead programme, EPY201, is administered to the seizure focal point via intraparenchymal delivery, reducing neuronal activity, and preventing seizures. EPY201 is entering first-in-human clinical trials for FRE in the first half of 2027.
EpilepsyGTx was founded in 2021 based on pioneering research from University College London Institute of Neurology, with its founders bringing many years of unique experience in synaptic research. For more information, please visit: www.epilepsygtx.com.
About EPY201
EPY201 is an investigational gene therapy targeting focal refractory epilepsy. EPY201, also known as AAV9-CAMK2A-EKC, utilizes an AAV9 capsid, a CAMK2A promoter, and an engineered naturally occurring form of the Kv1.1 potassium channel (referred to as "EKC"). The therapy is administered directly to the target seizure focus, the specific region of the brain responsible for seizures, via intraparenchymal delivery.
About Viralgen
Viralgen is a leading Contract Development and Manufacturing Organization (CDMO) specializing exclusively in adeno-associated virus (AAV)-based cell and gene therapies. Founded in 2017 as a subsidiary of AskBio Inc. within the Bayer AG group, Viralgen delivers end-to-end support from early development to large-scale commercial manufacturing. Leveraging their proprietary Pro10 suspension cell line and Aava manufacturing platform, Viralgen achieves industry-leading, high-yield, scalable manufacturing across all AAV serotypes.
Located in San Sebastian, Spain, its state-of-the-art facility features three cGMP suites with 2,000-liter capacities each, certified by the AEMPS/EMA, and integrates services including plasmid production, process optimization, fill-finish, and in-house QC testing. With over 1,500 AAV batches produced, Viralgen provides reliable, efficient solutions to bringing life-changing gene therapies to patients with greater speed and consistency. Learn more at viralgen.com and follow us on LinkedIn.
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