Axovant Gene Therapies Ltd (NASDAQ:AXGT) has signed of a strategic partnership with Viralgen one of the top Contract Development and Manufacturing Organisations (CDMO).
The partnership offers Axovant access to resources to develop AAV-gene therapies
The partnership will secure access to Viralgen’s cGMP capacity as well as resources to support Axovant’s development and commercialization of its AAV gene therapies for GM1 and GM2 gangliosidosis. By leveraging AskBio’s tech platforms, Viralgen will support all the AAV program’s manufacturing needs that include large-scale productions, quality control, as well as fill-finish in cGMP-certified facility that is custom-designed to deliver therapies as quickly as possible to various markets. According to the collaboration agreement terms, Axovant will access manufacturing resources for its AAV gene therapies, AXO-AAV-GM1 and AXO-AAV-GM2 for GM1 and GM2 gangliosidosis giving it the adequate capacity to support development and commercialization of the therapies.
Gavin Corcoran, Axovant’s the Chief Research and Development Officer, said that they were delighted to enter a partnership with Viralgen, an emerging leader in AAV-gene therapies manufacturing. This will enable the company to commercial-scale manufacturing of the proprietary gene therapies holding huge potential to stabilize or improve GM1 and GM2 gangliosidosis courses. Gavin added that this partnership will offer Axovant access to highly skilled team and expansive facility focused on bringing technology that will accelerate the advancement of life-saving therapeutics.
Axovant expects IND clearance for AXO-AAV-GM2 this year
He asserted that the approach was vital as the company advances of the AAV-based programs in which data from its continuing Phase 1/2 clinical AXO-AAV-GM1 trial will be released in Q4 2020. Axovant is expecting to file AXO-AAV-GM2 IND clearance by the end of 2020.
Viralgen Chief Executive Javier Garcia said that they are pleased to enter a partnership with Axovant. He added that they look forward to providing Axovant with support and priority access to their platform to advance and develop the AAV gene therapy programs for the GM1 and GM2 gangliosidosis. The flexible and scalable production platform of Viralgen will be ideal in complementing the development efforts of Axovant from clinical through commercialization.