NGen Funding to Transform Manufacturing of Critical Materials in Gene Therapies

08/21/2019
NGen Funding to Transform Manufacturing of Critical Materials in Gene Therapies
August 21, 2019 - NGen has approved Supercluster funding for a transformative $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 U.S. regulators have approved the first CGTs for market release which, along with approved clinical trials being conducted in Canada and the U.S., are showing positive results in treating a variety of conditions, including leukemia.

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.

iVexSol (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.

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 $1.89 million 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 Inc., 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; and,
  • 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 U.S. 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," says Catarina Flyborg, General Manager, Cell and Gene Therapy, GE Healthcare. "GE Healthcare will share our expertise and knowledge to help this project reach its full potential."

About iVexSol Canada

iVexSol Canada is a newly formed vector manufacturing company founded on a proprietary, next-generation, stable lentiviral vector production process that transforms the way these essential gene-delivery vehicles are made. Its technology will greatly reduce the complexity, cost and development time of these critical reagents, thereby accelerating the development and enabling greater access to life-changing cell and gene therapies. For more information visit www.ivexsol.com.

About CCRM Enterprises Inc.

CCRM Enterprises Inc. is the for-profit venture investment arm of the Centre for Commercialization of Regenerative Medicine (CCRM). CCRM is a Canadian not-for-profit organization funded by the Government of Canada and leading academic and industry partners, supporting the development of advanced therapies, regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. CCRM Enterprises invests in early stage ventures and projects developing therapeutic technologies and manufacturing capacity. Through an extensive network of investors, it catalyzes risk capital to support these early-stage ventures as they scale up along the development pathway. Visit www.ccrm.ca.

About GE Healthcare Life Sciences

GE Healthcare Life Sciences helps therapy innovators, researchers and healthcare providers accelerate how precision diagnostics and therapies are invented, made and used. Our products enable biological analysis, research, development and the manufacture of advanced therapies and vaccines. Life Sciences is part of the $19.8 billion healthcare business of GE (NYSE: GE). With over 100 years of experience in the healthcare industry and more than 50,000 employees globally, GE Healthcare helps efficiently improve outcomes for patients, healthcare providers, researchers, and life sciences companies around the world. Visit our website www.gehealthcare.com/about/life-sciences for more information.

About STEMCELL Technologies Canada Inc.

STEMCELL Technologies is a Canadian biotechnology company based out of Vancouver that supports life sciences research with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, and educational resources that are used by scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research globally. More information at www.stemcell.com.