Entos is manufacturing GMP-grade Covigenix VAX-001 in Alberta Cell Therapy Manufacturing (ACTM) in the Li Ka Shing Centre for Health Research Innovation at the University of Alberta.
Entos announces partnership with The Ottawa Hospital's Biotherapeutics Manufacturing Centre (BMC) to fill Covigenix VAX-001 in vials.
BMC and ACTM will collaborate to boost Canada's biotherapeutics manufacturing capacity.
EDMONTON, AB, Feb. 25, 2021 /CNW/ - Entos Pharmaceuticals (Entos), a biotechnology company developing genetic medicines with its Fusogenix nucleic acid delivery platform, is excited to work with Alberta Cell Therapy Manufacturing and The Ottawa Hospital's Biotherapeutics Manufacturing Centre to manufacture and ready doses of Entos' made-in-Canada Covigenix VAX-001 vaccine for upcoming clinical trials at the Canadian Centre for Vaccinology.
Covigenix VAX-001 is a single-dose COVID-19 DNA vaccine that is similar to the recently approved mRNA vaccines but with the important advantages of stability at room temperature for 30 days or in the fridge for a year, and prepared in-vials at a ready-to-use concentration. In preclinical studies, Covigenix VAX-001 induced strong neutralizing antibody and durable T cell immune responses against SARS-CoV-2. Covigenix VAX-001 can be easily transported, stored, and administered for the benefit of Canadians and potentially the world. Entos received CIHR and NRC-IRAP funding for Phase 1 trial manufacturing and is actively seeking funding to advance through Phase 2 and 3 clinical trials.
Rollout of the first generation COVID-19 mRNA vaccines are underway. However, vaccine production needs to continue so enough doses are made to end the pandemic. Investing now in Canada's biotherapeutic manufacturing capacity could still produce a made-in-Canada COVID-19 vaccine. Canada could also rapidly respond to new SARS-CoV-2 variants and future pandemics and position Canada as a leader in genetic medicine.
"Finding a facility in Canada that could ready our DNA vaccine in vials time for the Phase 1 trials was extremely challenging because the few that we have here are all in high demand right now," said John Lewis, CEO of Entos Pharmaceuticals. "We were thrilled to partner with The Ottawa Hospital's Biotherapeutics Manufacturing Centre and benefit from their world-class expertise."
BMC has manufactured and readied cell, gene, and viral therapies for clinical trials for over ten years and is now instrumental in doing this for COVID-19 therapies and vaccines, including Entos' DNA vaccine. BMC also shares its world-class manufacturing and clinical trial expertise with industrial partners and will help ACTM increase its capacity by spring 2021.
"I'm delighted that The Ottawa Hospital's Biotherapeutics Manufacturing Centre is helping to fill Canada's critical needs in COVID-19 vaccine manufacturing," said Dr. Duncan Stewart, Executive Vice-President of Research at The Ottawa Hospital and professor of medicine at the University of Ottawa. "In addition to the Entos vaccine, we will be manufacturing two other COVID-19 vaccines for clinical trials and we are already manufacturing a cell-based therapy for a COVID-19 trial. With our sustained track record of success, we are well positioned to play a key role in strengthening Canada's biotherapeutics manufacturing capacity now and into the future."
About The Ottawa Hospital's Biotherapeutics Manufacturing Centre
Over the last 10 years, The Ottawa Hospital's Biotherapeutics Manufacturing Centre has successfully manufactured more than a dozen different biotherapeutics for human clinical trials in Canada and around the world, making it the most experienced facility of its kind in Canada. The Centre also leads the only hands-on training program in Canada in biotherapeutics manufacturing, in partnership with Algonquin College, the University of Ottawa and Mitacs. The Centre has been supported by the Canada Foundation for Innovation, the Ontario Research Fund, BioCanRx (a Canadian Network of Centres of Excellence) and generous donors to The Ottawa Hospital Foundation. www.ohri.ca/bmc.
About Alberta Cell Therapy Manufacturing
Located at the University of Alberta, ACTM offers a range of integrated services from technology transfer, process and assay development through to GMP manufacturing of products for clinical trials. The ACTM's Scientific Director Dr. Greg Korbutt and ACTM Manager Gayle Piat are excited to support the production of Ento's vaccine. With state-of-the-art equipment, a 10,000 square foot cleanroom facility and expert GMP staff, ACTM is ideally positioned to deliver biotherapeutic manufacturing services in Canada. The addition of a fill-finish suite is currently underway and will be operational in 2021. Visit www.ualberta.ca/actm.
About Entos Pharmaceuticals, Inc.
Entos develops next generation genetic therapies using their breakthrough Fusogenix nucleic acid delivery system. Fusogenix is a proteolipid vehicle (PLV) formulation that uses a novel mechanism of action to deliver molecules, intact and unmodified, directly into the cytosol of target cells. The technology is applicable to a wide range of therapeutic types including gene therapy, mRNA, miRNA, RNAi, CRISPR and small molecule drugs. Visit www.entospharma.com.
SOURCE Entos Pharmaceuticals