Axovant and Viralgen Sign Strategic Gene Therapy Development and Manufacturing Partnership

• Partnership secures access to cGMP capacity and resources at Viralgen to support the development and commercialization of Axovant’s AAV gene therapy programs for GM1 and GM2 gangliosidosis
• Partnership bolsters the Company’s clinical and commercial capacity and expands access to process development, analytical development, and manufacturing expertise

NEW YORK and BASEL, Switzerland, Sept. 15, 2020 (GLOBE NEWSWIRE) — Axovant Gene Therapies Ltd (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies for neurological diseases, today announced that it has signed a strategic partnership with Viralgen, a leading Contract Development and Manufacturing Organization (CDMO). Leveraging the technology platforms of AskBio, Viralgen is able to support all aspects of manufacturing for Axovant’s AAV programs, including large-scale manufacturing, fill-finish, and quality control in a GMP-certified environment custom-designed to bring therapies to market as quickly as possible. Under the terms of the partnership, Axovant will have access to manufacturing resources for Axovant’s AAV-based gene therapy programs, AXO-AAV-GM1 for GM1 gangliosidosis and AXO-AAV-GM2 for GM2 gangliosidosis (also known as Tay-Sachs/Sandhoff disease) with sufficient capacity to support ongoing development and eventual commercialization.

“We are pleased to partner with Viralgen, an emerging leader in the manufacturing of AAV-based gene therapies, to enable commercial-scale production of our novel gene therapies that we believe hold potential to stabilize or improve the course of GM1 and GM2 gangliosidoses, two devastating pediatric diseases with no approved treatment options,” said Gavin Corcoran, M.D., Chief R&D Officer of Axovant. “Our partnership with Viralgen provides us access to an expansive facility and a highly skilled team focused on delivering technology that can accelerate the development of life-saving therapeutics. This approach is crucial as we continue to advance our AAV programs where data from the ongoing Phase 1/2 clinical study of AXO-AAV-GM1 is expected in Q4 2020 and we anticipate IND clearance of the AXO-AAV-GM2 IND application before year end.”

Javiér Garcia, Chief Executive Officer of Viralgen, said, “We are thrilled to partner with Axovant and look forward to providing support and priority access to our platform as they advance their AAV gene therapies for the rare fatal pediatric diseases GM1 and GM2 gangliosidosis. Viralgen’s flexible and scalable production platform will be an ideal complement to Axovant’s development efforts from clinical trials through to commercialization to advance potential cures for patients in need.”