#Spain #San Sebastián #Viralgen #AAV Gene Therapy #Trogenix

Viralgen and Trogenix Join Forces to Advance Gene Therapy

In a groundbreaking collaboration, Viralgen, a prominent contract development and manufacturing organization focusing on recombinant adeno-associated virus (rAAV) gene therapies, has aligned with Trogenix, a biotech innovator dedicated to creating novel cancer treatments. This partnership aims to expedite the clinical development of Trogenix's AAV gene therapy, known as TGX-007, targeted at glioblastoma, a particularly aggressive type of brain cancer known for its difficult treatment landscape.

Accelerating Clinical Trials

Viralgen's initiative has successfully scaled up the manufacturing process and completed a good manufacturing practice (GMP) batch of TGX-007 in less than a year. This rapid progression positions the therapy closer to its first-in-human (FIH) clinical trials. According to Jimmy Vanhove, CEO of Viralgen, "Our expertise in rAAV vector manufacturing and ability to scale ensures we support and accelerate critical clinical therapeutic programs. We are excited to play a role in Trogenix's pioneering approach to oncology gene therapy, which holds promise for curative outcomes in glioblastoma and other cancers."

Innovative Technology at Work

Beyond just manufacturing, Viralgen has also created a gene-specific titration method alongside a tailored formulation buffer to assist in drug administration. These advancements are designed to enhance the potential success of Trogenix's gene therapy.

Trogenix utilizes a proprietary platform called Synthetic Super-Enhancers (SSEs), Odysseus™, aimed at developing precision genetic medicine that targets specific disease conditions. Following the successful GMP batch production of the rAAV vector at Viralgen's cutting-edge facilities, TGX-007 is nearing the clinical evaluation phase, aligning the therapy to meet the urgent needs of patients suffering from this debilitating illness.

The Future of Glioblastoma Treatment

Ken Macnamara, PhD, CEO of Trogenix, emphasized the urgency of transforming glioblastoma treatment. He points out that this form of cancer has a notoriously poor prognosis and limited treatment options: "At Trogenix, we aspire to change the landscape of cancer care from managing a chronic disease to offering a potentially curative one-time treatment. Collaborating with Viralgen allows us to quickly scale our product's availability, ultimately facilitating faster access for patients in need."

The partnership exemplifies Viralgen's commitment to enhancing the development of innovative AAV-based therapies, providing scalable and quality manufacturing solutions that aid in accelerating treatments to those who require them most.

About Viralgen

Founded in 2017 as a subsidiary of AskBio Inc. within the Bayer AG group, Viralgen specializes in the large-scale production of adeno-associated virus (AAV) suitable for cell and gene therapies while maintaining current good manufacturing practice (cGMP). Utilizing its Pro10™ suspension manufacturing platform, Viralgen yields high titers for various AAV serotypes, facilitating efficient advancement in both clinical development and subsequent commercialization efforts. The company's state-of-the-art facility located in San Sebastián, Spain, is equipped with three cGMP suites, each capable of 2,000-liter capacities and certified by regulatory bodies such as AEMPS/EMA. Viralgen also offers advanced services for transitioning from clinical to commercial production and has recently broadened its development services to include construct and process optimization,

For additional information, please visit viralgen.com.

Conclusion

The collaborative efforts between Viralgen and Trogenix signify a monumental step toward bringing novel glioblastoma treatments to fruition. As this partnership progresses, the hope is to deliver transformative therapies to patients who desperately need better options in their fight against this relentless form of cancer.