Viralgen, a contract development and manufacturing organisation (CDMO) focused on recombinant adeno-associated virus (rAAV) gene therapies, has entered into a manufacturing partnership with biotechnology firm Trogenix.
The collaboration centres on the clinical advancement of TGX-007, an investigational gene therapy developed to target glioblastoma, a form of brain cancer noted for its resistance to existing treatments.
Trogenix CEO Ken Macnamara said: “Glioblastoma, the most common form of brain cancer, is a devastating disease with very poor prognosis and few treatment options for patients. At Trogenix, our aim is to transform cancer treatment from chronic disease management to a potentially curative one-time treatment.
“By collaborating with Viralgen, we can rapidly scale product supply and bring the therapy to patients as quickly as possible.”
Under the terms of the partnership, Viralgen scaled up and completed good manufacturing practice (GMP) clinical trial material for TGX-007 within a 12-month timeframe. The production is expected to support the therapy’s progression towards first-in-human clinical trials.
Viralgen CEO Jimmy Vanhove said: “Our expertise in rAAV vector manufacturing and ability to scale allows us to support and accelerate critical clinical therapeutic programmes.
“We are thrilled to contribute to Trogenix’s pioneering approach in oncology gene therapy, which has potential for curative responses in glioblastoma and other cancers.”
TGX-007 remains under development and is expected to enter first-in-human trials pending necessary regulatory approvals and safety validations.
In addition to manufacturing capabilities, Viralgen has developed a gene-specific titration method and created a formulation buffer designed to act as the diluent for TGX-007 administration. These developments aim to facilitate the controlled delivery of the therapy during upcoming clinical studies.
TGX-007 is based on Trogenix’s Odysseus platform, which uses synthetic super-enhancers (SSEs) to engineer genetic medicines that target disease-specific cellular states. The successful production of TGX-007’s GMP batch at Viralgen’s facility paves the way for clinical evaluation of the therapy.
In addition to its work with Trogenix, Viralgen also announced a separate initiative in February 2025 involving the CTNNB1 Foundation. The two parties are jointly producing an investigational gene therapy for CTNNB1 Syndrome, a rare condition affecting cognitive and motor functions in children.
That partnership is intended to enable access to clinical-grade material that could support the development of a targeted treatment for the disorder.
