LONDON & ONTARIO—Clinical-stage company Sernova Corp. is getting some traction for advancing its potential diabetes treatment with the launch of a research funding agreement with JDRF. Per the terms of the agreement, JDRF will provide up to $2.45 million to Sernova to support a clinical trial at a major U.S. transplantation site of Sernova’s CPS (Cell Pouch System) technologies for the treatment of hypoglycemia unawareness patients with severe type 1 diabetes (T1D).
“JDRF has previously provided funding to advance the development of Sernova’s technologies through a preclinical collaboration with Massachusetts General Hospital, and we are proud to continue our support as Sernova’s technologies progress into new safety and efficacy clinical trials,” said Derek Rapp, JDRF president and CEO. “JDRF is excited about this collaboration, which advances research in encapsulated cell therapies, and will continue to drive progress toward our mission to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications.”
T1D occurs when the immune system attacks and destroys the pancreatic cells that produce insulin, thereby throwing off the body’s ability to properly process glucose and maintain healthy blood sugar levels. JDRF reports that 1.25 million Americans have T1D, with 40,000 individuals diagnosed each year in the United States alone. It’s expected that by 2050, five million Americans will have T1D.
At present, there’s no cure for this disease; T1D patients rely on insulin therapy to maintain proper blood sugar levels. The current approach of multiple doses of insulin each day requires constant monitoring, however, and miscalculating doses can lead to episodes of high or low blood sugar. When blood sugar levels get dangerously low, or hypoglycemic, individuals can pass out or lapse into a diabetic coma. Dr. Phillip Toleikis, president and CEO of Sernova, says that some 30 percent of T1D patients experience hypoglycemia unawareness, or very low levels of blood sugar without any of the warning signs such as dizziness, nausea or tremors.
“Their sugar levels can drop to precipitously low levels, and they can go into a coma and not even realize it,” he explains. “So this is a subgroup of patients that have hypoglycemic events that we’re working on treating, and these people can benefit from an islet transplant.”
Sernova’s CPS, “when transplanted with insulin-producing islets, has demonstrated efficacy in three different small and large animal transplantation models (isograft, autograft and allograft) of diabetes, where animals achieved sustained glucose control,” the company notes on its website.
“Our device is an implantable, small medical device, just a few millimeters thick, and when the device is placed into the body, natural tissue is encouraged to incorporate or fill in around the device, and that natural tissue forms highly vascularized tissue chambers, into which we can put the therapeutic cells,” Toleikis tells DDNews. “Islets in particular have a very high metabolic rate, and they require a lot of blood vessel incorporation, and we have shown with our device in particular that the islets become infiltrated with the blood vessels, very similar to what occurs in the pancreas. So the device is designed specifically to create an ideal tissue environment to house therapeutic cells, including islets.”
This could offer a long-term solution for patients with diabetes, according to Toleikis. While they don’t know exactly how long they can last—he says Sernova “will find out how long the cells operate in the clinical studies that we’re working on”—they do know that if healthy islets are used in the device, they have a long lifespan. Another bonus, he adds, is that Sernova’s device can be implanted for a long period of time without forming any fibrotic tissue.
“One of the issues with a lot of medical devices when they’re placed in the body is that, rather than incorporate the tissue, the body tends to wall the device off like a splinter and cut off the blood supply to the device. Our device is specifically designed to form these highly vascularized tissue chambers which help the islets to survive, so it forms a much more natural tissue environment and the device becomes a part of the body, essentially,” remarks Toleikis.
He says they expect the future of diabetes treatment to be a cell therapy approach for a number of reasons. For one, “the best glucose control you can get is with natural islets or even stem cell-derived technologies, whereby these cells can read blood sugar levels and release insulin accordingly.” In addition, he notes, “with tighter control of blood sugar levels, you can reduce the microvascular side effects of the disease.”
The company’s technology is also being explored in hemophilia A and hypothyroidism.