Viralgen accelerates clinical development process: scaling manufacturing and completing GMP production of Trogenix’s AAV gene therapy in under 12 months.
San Sebastián, Spain, 6 May 2025 – Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (rAAV) gene therapies, has established a strategic collaboration with Trogenix, a pioneering biotech company dedicated to developing innovative cancer therapies. As part of this partnership, Viralgen successfully scaled-up and completed a good manufacturing practice (GMP) clinical trial material batch of Trogenix’s rAAV gene therapy, TGX-007, in under 12 months, 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.
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.
About Viralgen
Viralgen, founded in 2017 as a subsidiary of AskBio Inc. within the Bayer AG group, is a contract development and manufacturing organization specializing in the large-scale production of current good manufacturing practice (cGMP) adeno-associated virus (AAV) for cell and gene therapies. Utilizing the Pro10™ suspension manufacturing platform, Viralgen achieves high titers for all AAV serotypes, enhancing clinical development and commercialization efficiency. Located in San Sebastian, Spain, its state-of-the-art facility features three cGMP suites with 2,000 liter capacities each, certified by the AEMPS/EMA. The company also offers advanced services for transitioning from clinical to commercial manufacturing and has recently expanded its development services to include construct and process optimization.
For more information, visit viralgen.com.
For Viralgen media enquiries:
Marta Caldero
Corporate communications & Public Affairs Manager
+34 671 32 63 45
mcaldero@viralgenvc.com
