A London-based biotechnology company developing a novel cure for Type 1 diabetes is on a hiring blitz as it embarks on the second phase of a clinical trial that’s already showing promising results.
Sernova Corp., located in Western University’s research park, has developed an implant that can house insulin-producing cells, effectively becoming a mini-pancreas for Type 1 diabetics.
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Three of the six Type 1 diabetes patients from the first round of its clinical trial at the University of Chicago no longer rely on insulin injections, Sernova’s president and chief executive Philip Toleikis said Monday. A second phase of the trial, involving seven adult Type 1 diabetics, got underway earlier this month.
“This is a disruptive technology. We’re looking at changing the lives of people with diabetes,” Toleikis said.
The research team began implanting its cell pouch device, larger than the one in the first round to accommodate more insulin-producing cells, in the new group of participants last week and is expecting to release results from the study in the second half of 2023.
The clinical trial is focusing on a subset of Type 1 diabetics, Toleikis said — ones that suffer from hypoglycemia unawareness. These patients don’t have symptoms associated with low blood sugar and are unable to tell when their levels are dangerously low, putting them at heightened risk of severe outcomes.
While the Sernova team can’t fix the cells in a Type 1 diabetic’s pancreas, they’re working on a functional cure for the condition by creating a small, organ-like structure inside the patient’s body that can safely house critical insulin-producing cells.
Sernova’s cell pouch, the scaffolding for the mini-organ, is surgically implanted deep near the muscle of the patient’s abdomen in an outpatient procedure.
Weeks later, when the patient’s own tissue and blood vessels have integrated with the cell pouch, doctors remove the placeholder rods in the implant and fill the little channels with healthy cells, in this case islet cells.
The insulin-producing cells used in the current clinical trial are carefully harvested from organ donors, a source of islet cells that is difficult to scale up in the global marketplace, Toleikis said.
For this reason, Sernova has partnered with German drug discovery company Evotec to find another source of islet cells, ones made from stem cells derived from blood samples in a lab.
Sernova is hoping to begin clinical trials with this new pipeline of islet cells in early 2024, Toleikis said.
The London-based company is also working with collaborators from the University of Miami to test a coating for the islet cells to protect them the patient’s immune system attacks. Participants in the current clinical trial are put on anti-rejection medication to prevent their bodies from attacking the transplanted cells.
Sernova has gone from about four staff to 25 in the last year and is still hiring for positions across the whole company, from management to business development to research and development, Toleikis said.
The company was listed on the Toronto Stock Exchange in June and is working to apply its cell pouch device to other conditions, including hypothyroidism.
The research has come a long way in the last 13 years, Toleikis said.
“In 2009, it was just an idea. Let’s do a cell therapy approach to try and cure diabetes. There was virtually no money in the bank, there were no patents, there was no device. It was me in the room with a few other people and an idea,” Toleikis said.
The first patient has been free of insulin injections for 2½ years now. “That’s a really big deal,” Toleikis said.
jbieman@postmedia.com
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