Viralgen partners with Trogenix for glioblastoma AAV gene therapy

Viralgen has announced a strategic partnership with Trogenix, aiming to expedite the development of innovative cancer therapies through the use of recombinant adeno-associated virus (rAAV) gene therapies. This collaboration has already achieved a significant milestone: Viralgen successfully scaled up and completed a batch of good manufacturing practice (GMP) clinical trial material for Trogenix’s gene therapy, TGX-007, in less than a year. This rapid production is poised to hasten the commencement of first-in-human (FIH) clinical trials targeting glioblastoma, a particularly aggressive type of brain cancer known for its resistance to existing treatments.

Beyond its manufacturing capabilities, Viralgen has devised a gene-specific titration method and a custom formulation buffer designed for the drug's administration. These innovations are pivotal in advancing Trogenix's therapeutic solutions. Jimmy Vanhove, CEO of Viralgen, expressed enthusiasm about supporting Trogenix’s groundbreaking work in oncology gene therapy, highlighting the potential for transformative responses in treating glioblastoma and other forms of cancer.

Trogenix’s unique approach utilizes its proprietary platform, Odysseus™, which is based on Synthetic Super-Enhancers (SSEs). This platform is crafted to create precise genetic medicines that target specific disease states within cells. With the successful production of the initial GMP batch of Trogenix's rAAV vector at Viralgen’s advanced facility, TGX-007 is advancing towards clinical trials, with the ultimate goal of reaching patients who are in dire need of new treatment options.

Glioblastoma is noted as one of the most common and devastating types of brain cancer, marked by a bleak prognosis and limited treatment pathways. Ken Macnamara, PhD, CEO of Trogenix, emphasized the company’s mission to revolutionize cancer treatment from managing a chronic condition to potentially delivering a curative one-time therapy. He noted that the collaboration with Viralgen enables a rapid scale-up of product supply, crucial for delivering the therapy to patients swiftly.

This partnership highlights Viralgen’s commitment to accelerating the development of innovative AAV-based therapies by providing scalable and high-quality manufacturing solutions, effectively bringing advanced treatments to patients more quickly.

Viralgen was established in 2017 as a subsidiary of AskBio Inc., which operates under the Bayer AG umbrella. The company is a prominent contract development and manufacturing organization focused on the large-scale production of current good manufacturing practice (cGMP) adeno-associated virus (AAV) for cell and gene therapies. Viralgen utilizes the Pro10™ suspension manufacturing platform, which allows for high titers across all AAV serotypes, significantly enhancing the efficiency of clinical development and commercialization processes. Situated in San Sebastian, Spain, Viralgen boasts a cutting-edge facility equipped with three cGMP suites, each with a capacity of 2,000 liters, certified by the AEMPS/EMA. The company also provides advanced services to aid the transition from clinical to commercial manufacturing and has recently expanded its development services to include construct and process optimization.

This collaboration with Trogenix marks a significant step forward in the field of gene therapy, particularly for conditions like glioblastoma that currently have limited treatment options. Through their combined expertise, Viralgen and Trogenix are setting the stage for potentially life-changing advancements in cancer treatment.