#gene therapy #Viralgen #EpilepsyGTx

EpilepsyGTx and Viralgen Collaborate to Advance Gene Therapy

EpilepsyGTx, a forefront player in biotechnology specializing in innovative gene therapies for refractory epilepsy, has announced a strategic partnership with Viralgen, a notable Contract Development and Manufacturing Organization (CDMO) proficient in adeno-associated viruses (AAV). This collaboration is set to propel the production of EPY201, EpilepsyGTx's lead gene therapy candidate tailored for the treatment of focal refractory epilepsy (FRE) as they prepare for the initial human clinical trials.

Understanding Focal Refractory Epilepsy

Focal refractory epilepsy is characterized by seizures that originate from a specific area within the brain. If a patient continues to experience seizures despite attempting at least two well-tolerated and appropriately selected antiepileptic medications, their condition is classified as refractory or pharmacoresistant. Approximately 10 million individuals globally suffer from FRE, with around 2 million affected in the USA, UK, and EU.

The Role of EPY201

EPY201 is designed for direct delivery into the seizure focus, aiming to reduce local neuronal hyperexcitability while minimizing the exposure of surrounding areas in the brain. Should this therapeutic approach be successful, it may provide patients with a singular, minimally invasive treatment option, eliminating the need for brain tissue resection or ablation, thus offering the hope of seizure freedom.

Nicolas Koebel, CEO of EpilepsyGTx, commented on the collaboration, stating, "Viralgen's expertise in AAV production and their streamlined platform designed to support programs from early development to commercial manufacturing are crucial as we prepare to advance EPY201 to clinical development. Their infrastructure, know-how, and impressive track record in regulatory processes make them an exceptional production partner as we work towards bringing our novel gene therapy approach to clinical application."

Jimmy Vanhove, CEO of Viralgen, expressed his enthusiasm regarding the partnership, saying, "We are honored to collaborate with EpilepsyGTx on this significant program. Our Aava™ platform has been specifically developed to scale AAV programs efficiently. Through our manufacturing expertise, we aim to accelerate the development of EPY201 for patients with focal refractory epilepsy as swiftly as possible."

Research and Development Progress

EpilepsyGTx was founded on pioneering research at the University College London Institute of Neurology in 2021. The company's founders possess extensive expertise in synaptic research, contributing to the development of effective gene therapies aimed at addressing epilepsy. In preclinical models of FRE, substantial evidence points to the potential anticonvulsant effects and tolerance of EPY201, paving the way for its anticipated clinical applications.

The innovative nature of EPY201, also recognized as AAV9-CAMK2A-EKC, utilizes an AAV9 capsid, a CAMK2A promoter, and a genetically modified version of the naturally occurring Kv1.1 potassium channel referred to as