On May 6, 2025 Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (rAAV) gene therapies, reported to have established a strategic collaboration with Trogenix, a pioneering biotech company dedicated to developing innovative cancer therapies (Press release, Trogenix, MAY 6, 2025, View Source [SID1234652608]). As part of this partnership, Viralgen successfully scaled-up and completed in under 12 months a good manufacturing practice (GMP) clinical trial material batch of Trogenix’s rAAV gene therapy, TGX-007, accelerating the program’s progression toward first-in-human (FIH) clinical trials for glioblastoma, one of the most aggressive and treatment-resistant forms of brain cancer.
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Beyond manufacturing, Viralgen has developed a gene-specific titration method and a custom specific formulation buffer to serve as a diluent for the drug product’s administration. These efforts will support the advancement of Trogenix’s gene therapy.
"Our expertise in rAAV vector manufacturing and ability to scale allows us to support and accelerate critical clinical therapeutic programs" said Jimmy Vanhove, CEO of Viralgen. "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," stated Vanhove.
Trogenix’s proprietary Synthetic Super-Enhancers (SSEs) platform, Odysseus, is designed to develop precision genetic medicines targeting the disease cell state. Following the successful manufacturing of the first GMP batch of Trogenix’s rAAV vector at Viralgen’s state-of-the-art facility, TGX-007 is now advancing toward clinical evaluation, and, ultimately, to patients in need.
"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," said Ken Macnamara, PhD, CEO of Trogenix. "By collaborating with Viralgen, we can rapidly scale product supply and bring the therapy to patients as quickly as possible."
This collaboration underscores Viralgen’s commitment to accelerating the development of innovative AAV-based therapies by providing scalable, high-quality manufacturing solutions that help bring treatments to patients faster.