Orphan Therapeutics Accelerator, a non-profit biotech dedicated to advancing therapies for ultra-rare conditions, announced that Viralgen has become a Contract Development and Manufacturing Organization partner within OTXL's Orphan ClinDevNet network. As a network partner, Viralgen will have the opportunity to provide manufacturing strategy and execution for adeno-associated virus (AAV) gene therapy programs that are being developed under OTXL's distinct model from clinical development through commercialization.
OTXL's Orphan ClinDevNet brings together specialized partners with a commitment to overcoming key barriers to successful development and commercial access to ultra-rare disease treatments, including the cost and pace of late-stage clinical trials and difficulties in continuity and scaling of manufacturing for commercial access. Viralgen's expertise in AAV manufacturing and critical related strengths in chemistry, manufacturing and controls (CMC) can help to ensure that more AAV gene therapies reach patients.
"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," said Craig Martin, CEO of Orphan Therapeutics Accelerator. "Viralgen brings unique AAV gene therapy manufacturing capabilities to our network, as well as a long history of working with non-profits and biotechs in support of rare disease innovation."
Based in San Sebastián, Spain, Viralgen is a Contract Development and Manufacturing Organization dedicated to AAV gene therapy production across clinical and commercial stages. As part of ClinDevNet, Viralgen will collaborate closely with OTXL and other members of ClinDevNet to support gene therapies from investigational new drug (IND) applications through commercial readiness.
"We're proud to support OTXL's mission and contribute to AAV gene therapy manufacturing efforts across the network," said Jimmy Vanhove, CEO of Viralgen. "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".
About Orphan Therapeutics Accelerator (OTXL)
The Orphan Therapeutics Accelerator (OTXL) is a patient-centered non-profit biotech focused on obtaining and reinitiating development of promising "shelved" clinical-stage treatments for ultra-rare conditions and providing a scalable and sustainable commercialization path to get these treatments to patients. OTXL leverages its non-profit status, success-based agreements and incentives to obtain rights to shelved programs and complete development at deferred or lower cost via a network of affiliated CDMOs, CROs and other partners. When a program is approved and generates revenue, net proceeds are used to repay and reward contributing partners, companies, and institutions, with a portion returned to the Orphan Therapeutics Accelerator to fund additional programs.