Contract development and manufacturing organisation (CDMO) Viralgen has partnered biotech company Trogenix to accelerate the development of a recombinant adeno-associated virus (rAAV) gene therapy for glioblastoma, an aggressive brain cancer.
The partnership has enabled Viralgen to scale up and complete a good manufacturing practice (GMP) trial material batch of Trogenix’s TGX-007 in under twelve months, expediting it to the first-in-human (FIH) glioblastoma trial.
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Viralgen has focused on manufacturing and also on the development of a gene-specific titration method and a custom-specific formulation buffer to act as a diluent for the administration of the drug product – crucial in progressing Trogenix’s gene therapy.
Trogenix CEO Ken Macnamara stated: “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.”
Odysseus, the synthetic super-enhancers platform of Trogenix, is designed to develop precision genetic medicines targeting disease cell states.
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By GlobalDataWith the first GMP batch of Trogenix’s rAAV vector manufactured at Viralgen’s facility, the gene therapy is now set to move into clinical assessment.
Viralgen CEO Jimmy Vanhove stated: “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.”
Founded in 2017 as a subsidiary of AskBio within the Bayer group, Viralgen is focused to expediting the AAV-based therapy development.
The company leverages the Pro10 suspension manufacturing platform, which can achieve high titers [strength or concentration of a substance, often antibodies, in a solution] across all AAV serotypes.
Viralgen also provides services to assist in the transition from clinical to commercial manufacturing.
In January 2025, Viralgen announced that it was set to form a partnership with Axovia Therapeutics to progress the development and manufacturing of an AAV9-based gene therapy for retinal dystrophy in individuals with Bardet-Biedl syndrome due to BBS1 gene mutations.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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