Axovant Gene Therapies Ltd. (NASDAQ:AXGT) has announced the signing of a strategic partnership with leading Contract Development and Manufacturing Organisation, Viralgen.
Partnership to help Axovant scale production of AAV therapies
Viralgen, which is leveraging AskBio’s tech platforms, has supported Axovant’s all manufacturing aspects of the AAV program, including large scale manufacturing, quality control, and fill-finish GMP-certified environment that has been tailored to bring therapies to the market quickly. As per the terms of the agreement, Axovant will get access to manufacturing resources of its AAV-based gene therapy programs with adequate capacity to support the development and eventual commercialization of the therapies. Axovant has is developing the AXO-AAV-GM1 for GM gangliosidosis and AXO-AAV-GM2 for GM2 gangliosidosis.
Gavin Corcoran, the Chief R & D Officer of the company, stated that they are pleased to collaborate with Viralgen, a leading manufacturer of AAV-based gene therapies. He said that the partnership will enable Axovant to produce their novel gene therapies that can improve or stabilize the course of GM1 and GM2 gangliosidoses on a commercial scale. The GM1 and GM2 gangliosidosis are two problematic pediatric diseases that do not have any approved treatment alternatives.
Data from Phase 1/2 AXO-AAV-GM1 expected in Q4 2020
Corcoran said that the partnership with Viralgen offers the company access to a huge facility and experienced team that is focused on delivering tech that will speed up the development of life-saving therapies. He explained that the approach is important as the company continues to advance the AAV programs with data from the current Phase1/2 AXO-AAV-GM1 study expected in Q4 2020. The company is also expecting to file an IND clearance for AXO-AAV-GM2 before the end of this year.
Viralgen CEO Javier Garcia stated that they were delighted to partner with Axovant, and they are looking forward to offering priority access and support to advance AAV gene therapies for the devastating podiatric diseases. He added that the company’s scalable and flexible production platform will be vital in complementing the development efforts of Axovant through commercialization from clinical trials.