Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (rAAV) gene therapies, has formed a strategic collaboration with Trogenix to accelerate the development of a novel gene therapy for glioblastoma. The partnership has already yielded significant progress, with Viralgen successfully scaling up and completing good manufacturing practice (GMP) production of Trogenix's AAV gene therapy candidate, TGX-007, in less than 12 months.
This manufacturing milestone represents a critical step toward first-in-human clinical trials for a therapy targeting glioblastoma, one of the most aggressive and treatment-resistant forms of brain cancer. Glioblastoma patients currently face limited treatment options and poor prognosis, with median survival typically ranging from 12 to 15 months after diagnosis.
Manufacturing Expertise Accelerates Clinical Timeline
Viralgen's contribution extends beyond standard manufacturing services. The company has developed a gene-specific titration method and a custom formulation buffer that will serve as a diluent for the drug product's administration, providing comprehensive support for Trogenix's therapeutic program.
"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."
The rapid timeline—completing GMP manufacturing in under 12 months—demonstrates the efficiency of Viralgen's Pro10™ suspension manufacturing platform, which achieves high titers for all AAV serotypes and enhances clinical development efficiency.
Innovative Approach to Glioblastoma Treatment
Trogenix's TGX-007 is developed using the company's proprietary Synthetic Super-Enhancers (SSEs) platform, called Odysseus™. This technology is designed to develop precision genetic medicines that specifically target the disease cell state, potentially offering a more effective approach to treating glioblastoma.
"Glioblastoma, the most common form of brain cancer, is a devastating disease with very poor prognosis and few treatment options for patients," explained Ken Macnamara, PhD, CEO of Trogenix. "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."
AAV Vectors in Oncology: An Emerging Frontier
While AAV vectors have been primarily utilized in rare genetic disorders, their application in oncology represents an emerging frontier in gene therapy. AAV vectors offer several advantages for cancer treatment, including their ability to deliver therapeutic genes with high efficiency and minimal immunogenicity.
For glioblastoma specifically, the blood-brain barrier presents a significant challenge for conventional therapeutics. AAV vectors can be engineered to cross this barrier and deliver therapeutic payloads directly to tumor cells, potentially improving treatment efficacy.
Manufacturing Capabilities Support Clinical Development
Viralgen's state-of-the-art facility in San Sebastian, Spain, features three cGMP suites with 2,000-liter capacities each, certified by the AEMPS/EMA. This infrastructure enables the company to support both clinical and commercial manufacturing needs.
Following the successful manufacturing of the first GMP batch of Trogenix's rAAV vector, TGX-007 is now advancing toward clinical evaluation. The collaboration underscores Viralgen's commitment to accelerating the development of innovative AAV-based therapies by providing scalable, high-quality manufacturing solutions.
As the field of gene therapy continues to evolve, partnerships like this between specialized manufacturing organizations and innovative biotech companies will be crucial for bringing novel treatments to patients with high unmet medical needs.
