NGen has approved Supercluster funding for a transformative C$4.2 million project led by iVexSol Canada to develop an advanced manufacturing process for lentiviral vectors. These gene-editing reagents are critical components in the manufacturing processes of cell and gene therapies (CGTs), which have been successfully employed to fight cancer and repair a variety of rare and inherited genetic disorders in both children and adults.
In the last two years, Canadian and US regulators have approved the first CGTs for market release that, along with approved clinical trials being conducted in Canada and the US, are showing positive results in treating a variety of conditions, including leukaemia.
Expectations of further breakthroughs have attracted billions of dollars of investment into advanced clinical research for CGTs for other diseases, leading to an unprecedented leap in demand for viral vectors, the molecular tools used to package and deliver genetic material into patients.
Bains-Supercluster-announcement-2iVexSol (intelligent Vector Solutions) Canada is a newly formed vector manufacturing company founded on an advanced technology that transforms the way lentiviral vectors (LVVs) are produced. In collaboration with other partners, the project will enable the development of an advanced LVV manufacturing platform in Canada - a first of its kind - and aims to establish the country as a world leader in gene-editing tools and technology.
Expectations of further breakthroughs have attracted major investment in CGTs leading to an unprecedented leap in demand for viral vectors
The future of CGTs are heavily dependent on resolving the manufacturing challenges facing the production of viral vectors, from rising demand from clinicians to reducing costs and ensuring a high level of quality and safety.
"Our project will lower costs and increase access for patients waiting to receive these life-changing treatments," says Dr Rodney Rietze, iVexSol Canada's CEO.
NGen, which runs Canada's Advanced Manufacturing Supercluster, will provide C$1.89m in Supercluster funding to the project, an investment expected to lead to the creation of approximately 470 jobs.
Over the past 30 years, LVVs have delivered an outstanding safety and therapeutic record. But they are produced using legacy methods that are costly, inefficient and hard-to-scale. These limitations have caused global shortages of this critical reagent and slowed the progress of clinical trials leading to the development of lifesaving CGTs.
iVexSol's clinically proven, LVV manufacturing process promises to address these shortages by producing nearly 10 times the quantity of potent, high-quality vectors at a fraction of the cost and duration of legacy processes.
Using the catalyst of NGen funding, iVexSol intends to form a core team of partners:
CCRM Enterprises, a wholly-owned subsidiary of the Centre for Commercialization of Regenerative Medicine (CCRM), to provide the supporting manufacturing infrastructure and downstream processing capabilities;
GE Healthcare to provide the required knowledge and expertise of manufacturing processes, along with access and use of specialized tools and technology
STEMCELL Technologies to provide advanced reagents.
This collaborative project will attract and retain highly educated talent in Canada. Access to a steady supply of high-quality LVVs will also drive growth in the Canadian CGT ecosystem of about 40 Canadian companies, while attracting others to Canada.
"Advanced technologies are not just leading to the development of new life-saving therapeutics; they’re opening up new ways to manufacture biomedical products," says Jayson Myers, NGen's CEO. "This project shows how advanced manufacturing leads to more investment and high-value jobs in Canada."
iVexSol believes the transformative nature of its manufacturing platform will position the consortium as a global leader in supplying this critical therapeutic agent to meet rapidly expanding global demand. Based on an expected 200 clinical trial applications each year, the US Food and Drug Administration anticipates approving 10 to 20 new CGTs per year by 2025.
Supplying the global market of vectors will spur innovation in medical, engineering and environmental fields, as well as other supportive industries, leaving an enduring legacy of benefits to Canadian advanced manufacturing and, equally important, those receiving life-changing treatments as a result of these advances.
"The establishment of this large-scale LVV manufacturing platform is critical for the development of the next generation of regenerative medicines in Canada," said Catarina Flyborg, General Manager, Cell and Gene Therapy, GE Healthcare.
