DiscGenics, a clinical stage regenerative medicine company focusing on developing cell therapies for degenerative diseases of the spine, has announced its partnership with CCRM and GE Healthcare to advance the manufacturing capability of its off-the-shelf cell therapy.
DiscGenics’ first product candidate, IDCT, is a homologous, allogeneic, injectable cell therapy developed for the treatment of patients with degenerative disc disease (DDD). IDCT is currently being tested in a prospective, randomized, double blinded Phase 1/2 study to evaluate its safety and preliminary efficacy in subjects with Intervertebral Disc Degeneration. The trial initiated earlier this year is expected to complete by mid-2021.
Through the collaboration with CCRM and GE Healthcare, DiscGenics intends to optimize its manufacturing steps including process, assay, and media development, for the production and commercialization of IDCT. CCRM and GE Healthcare together with the Federal Economic Development Agency for Southern Ontario are conducting the work at Toronto’s Centre for Advanced Therapeutic Cell Technologies (CATCT).
CCRM, hosted by the University of Toronto, is a Canadian government-funded organization that supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy.
Flagg Flanagan, DiscGenics’ CEO commented: “We recently initiated a Phase 1/2 trial of IDCT in patients with DDD, and in preparation for commercialization, we are committed to optimizing our in-house manufacturing capabilities and ensuring our processes comply with cGMP regulations. The CCRM and GE Healthcare team is playing an integral role in these manufacturing initiatives by providing invaluable scale-up know-how and process development expertise, as well as allowing us to evaluate manufacturing equipment options.”
Source: New Cell Therapy Could Help Millions Suffering from Back Pain; Press Release