Viralgen has announced a partnership with Elaaj Bio, a biotechnology company focused on development of transformative treatments for CDKL5 De?ciency Disorder (CDD). The collaboration, to advance an investigational CDKL5 gene therapy, brings together complementary expertise across development and manufacturing services for Adeno-Associated Virus (AAV) vectors to support advancement of the program toward clinical development.

As part of the collaboration, Viralgen will leverage its expertise in AAV vector manufacturing to support key development activities, including process development and optimisation, manufacturing across multiple scales, and analytical characterisation and quality control. Initial development work has been successfully completed, demonstrating technical feasibility of the manufacturing approach, and ongoing activities are focused on process scale-up, including the preparation of larger-scale batches.

Jimmy Vanhove, Chief Executive Officer, Viralgen, said, "Collaborations like this are essential to advancing complex gene therapy programs, particularly in rare pediatric diseases where the need for new therapies and innovations remains high. By working with Elaaj Bio and the Loulou Foundation, we're uniting complementary strengths in development and manufacturing to help accelerate ELJ-101 toward clinical development."

CDKL5 De?ciency Disorder (CDD) is a rare and severe developmental and epileptic encephalopathy caused by alterations in the CDKL5 gene. The condition is characterised by early-onset seizures and signi?cant neurodevelopmental impairment, with a profound impact on affected individuals and their families. The investigational gene therapy program is being developed to target the underlying genetic cause of the disease.

Russ Addis, Chief of Pipeline Strategy and Head, Genetic Medicine, Loulou Foundation, said, "Elaaj Bio and the Loulou Foundation are mission-driven: everything we do is focused on ?nding treatments for CDD. The Viralgen team have embraced that mission; we have great hopes that this collaboration will result in an effective gene therapy that treats the underlying cause of CDKL5 De?ciency."

The teams plan to initiate the ?rst clinical trial for this program, ELJ-101, in early 2027. Current efforts are focused on scaling manufacturing processes to support future clinical development.