Degenerative disc disease (DDD) is one of the most common causes of chronic low back pain a condition that affects approximately 25 million adults in the U.S. alone. Current treatments range from exercise, non-invasive physical therapy and pain medication, through to spinal surgery in severe cases. DiscGenics, a regenerative medicine company that develops therapies to alleviate pain and restore function in patients with degenerative diseases of the spine, has engaged with CCRM and GE Healthcare, leaders in developing and commercializing cell and gene therapy technologies, to support the Company’s efforts to scale and optimize manufacturing of its homologous, allogeneic (off-the-shelf), injectable cell therapy, which is referred to as IDCT.
Through the partnership, the CCRM and GE Healthcare team, working out of CCRM’s Toronto headquarters, are conducting process, assay, and media development for DiscGenics’ manufacturing process, which begins with isolating cells from donated intervertebral disc tissue and results in highly-specialized “Discogenic Cells” to address the complex environment of the degenerated disc. This approach enables DiscGenics to introduce restorative progenitor cells to the damaged disc and offers a therapeutic option for millions suffering from the debilitating effects of back pain.
“We recently initiated a Phase I/II 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,” says Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. “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.”
CCRM and GE Healthcare are conducting the work through their partnership with the Federal Economic Development Agency for Southern Ontario (FedDev Ontario) in the Centre for Advanced Therapeutic Cell Technologies (CATCT). The centre was established to accelerate the development and adoption of cell manufacturing technologies that improve patient access to novel regenerative medicine-based therapies. The projects are executed at CCRM, in CATCT’s 10,000 ft² (~930 m²) development facility in the MaRS Discovery District, next to Toronto’s world-leading hospitals and the University of Toronto.
“The DiscGenics project is an excellent case study of CATCT’s ability to successfully accelerate scale-up and process development,” says Michael May, President and CEO, CCRM. “This is yet another example of how CCRM and GE Healthcare are fulfilling their mission of supporting cell and gene therapy by industrializing cell manufacturing and delivering results that help customers develop better treatments for patients.”
“Manufacturers need to be able to duplicate product attributes at larger scale as they progress through clinical trials and into commercial phases, so it’s critical to develop scaled up manufacturing processes early on,” says Phil Vanek, GM of Cell and Gene Therapy Strategy at GE Healthcare Life Sciences. “DiscGenics was an early adopter of the process development capabilities we’ve built together with CCRM, and we look forward to continued collaborations.“
DiscGenics is a privately held, clinical stage regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics is harnessing the restorative potential of cells native to the intervertebral disc to develop what we hope will be a profound therapeutic option for millions suffering from the debilitating effects of back pain. Our first product candidate, IDCT, is a homologous, allogeneic, injectable cell therapy for the treatment of patients with degenerative disc disease (DDD).
CCRM (ccrm.ca), a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, strategic investors and entrepreneurs, CCRM aims to accelerate the translation of scientific discovery into new companies and marketable products for patients, with specialized teams, funding, and infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Toronto’s Medicine by Design. CCRM is hosted by the University of Toronto.
About GE Healthcare
Harnessing data and analytics across hardware, software and biotech, GE Healthcare (gehealthcare.com) is the $19 billion healthcare business of GE (NYSE: GE). As a leading provider of medical imaging equipment, with a track record of more than 100 years in the industry and more than 50,000 employees across 100 countries, we transform healthcare by delivering better outcomes for providers and patients.
 Nahin R, et al. “Estimates of Pain Prevalence and Severity in Adults: United States, 2012.” J of Pain. Aug 2015;16(8):769-780.