#Spain #San Sebastián #Viralgen #AAV Gene Therapy #Orphan Therapeutics Accelerator

Viralgen Joins Orphan Therapeutics Accelerator's Clinical Development Network

In a significant move to bolster the development of therapies for ultra-rare conditions, Viralgen has announced its partnership with the Orphan Therapeutics Accelerator (OTXL) as a Contract Development and Manufacturing Organization (CDMO). This collaboration is poised to strengthen the efforts towards delivering life-saving treatments for patients suffering from rare diseases.

Background of the Partnership

The OTXL is recognized for its commitment to advancing treatments for ultra-rare diseases, which often encounter obstacles such as high costs and extended timelines in late-stage clinical trials. Viralgen’s robust capabilities in manufacturing adeno-associated virus (AAV) gene therapies will play a critical role in overcoming these challenges. As part of the Orphan ClinDevNet network, Viralgen will provide strategic manufacturing support throughout the lifecycle of the drug development process, from initial investigations to commercialization.

Craig Martin, CEO of Orphan Therapeutics Accelerator, highlighted the potential impact of this partnership, stating, "Dozens of promising gene therapy programs for ultra-rare diseases have been shelved in recent years – often because of the investment and time required to complete their development." The inclusion of Viralgen’s AAV manufacturing expertise is expected to significantly influence the pace at which these therapies can reach the market.

Viralgen's Manufacturing Excellence

Founded in 2017 and based in San Sebastián, Spain, Viralgen specializes in the large-scale production of AAV for gene therapies. Utilizing advanced technologies, including the Pro10™ manufacturing platform, the organization is equipped to produce high titers for various AAV serotypes, facilitating both clinical and commercial applications.

With their state-of-the-art facilities that include multiple cGMP suites, Viralgen is strategically positioned to deliver substantial AAV manufacturing solutions. Their cooperation within the ClinDevNet will involve close collaboration with OTXL and the network participants to propel gene therapies from the investigational new drug (IND) applications phase through to readiness for market launch.

"Each therapy we can manufacture is a chance to change the life of someone living with a rare disease - inspiring us to push forward with urgency and care," commented Jimmy Vanhove, CEO of Viralgen, underscoring the urgency of these developments.

About Orphan Therapeutics Accelerator

The OTXL is a non-profit organization focused on reviving shelved clinical-stage treatments for rare diseases, facilitating a sustainable path for their commercialization. By navigating partnerships and leveraging a community of affiliated CDMOs and CROs, OTXL addresses critical roadblocks in the development of these therapies, ensuring that when programs are successful, the profits are reinvested back into funding additional initiatives.

Through this model, OTXL aims to foster an environment of innovation and accessibility, making a positive impact on the lives of patients facing ultra-rare diseases.

Looking Ahead

As Viralgen joins the OTXL in its mission, the collaboration represents a breakthrough in the field of rare disease therapies. By applying their resources and expertise, the partnership aims to not only enhance the manufacturing processes but also to expedite access to innovative treatments for patients who have been waiting too long for viable options.

For more information about their commitments and future projects, visit orphanxl.com and viralgen.com.