Sernova is a biotechnology company focused on developing regenerative therapies to treat people with chronic diseases, including type 1 diabetes. 

The Sernova Cell Pouch System is a small, thin device that is filled with islet cells — the parts of the pancreas that produce beta cells and secrete insulin. The Cell Pouch, a new therapy under investigation, is surgically implanted just under the skin against the abdomen. The pouch can house and protect transplanted islet cells that could allow people with type 1 diabetes (T1D) to stop using insulin injections. It could contribute to an eventual cure for type 1 diabetes.

Sernova recently shared an update on its pursuit of a functional cure for type 1 diabetes: All six participants in Sernova’s small trial successfully achieved insulin independence for at least nine months. The company’s leadership team spoke to Diabetes Daily about their innovation.

Sernova’s Cell Pouch Technology

Surgeons have been transplanting islet cells into people with type 1 diabetes for decades, generally by implanting the cells into the portal vein, which connects the pancreas to the liver. While the portal vein method has been used for decades, it faces a high failure rate due to a variety of complications. This is why biotechnology companies like Sernova are developing superior transplant methods. 

Sernova’s pouch system aims to better support and protect the cells, ensuring that they are properly adopted by the body through vascularization.

After implantation, the pouch is gradually “vascularized” by the body: The recipient’s blood vessels can grow through the pouch. The blood vessels can then pick up the insulin and deliver it throughout the entire body, while the islet cells remain in the pouch.

Donated Islet Cells

To date, Sernova has been using human donor cells, which must come from a deceased organ donor. These cells are only available only in very limited quantities, and most experts believe that any practical widescale transplantation solution will require a different approach.

To access a larger supply of viable islet cells, Sernova has partnered with Evotec to manufacture unlimited quantities of proprietary insulin-producing cells in a laboratory. Sernova hopes future clinical trials will use these manufactured cells, eliminating the reliance on donated human pancreases. 

Additionally, Sernova and Evotec intend to genetically edit these cells to ensure they are “hypoimmune” — making them invisible to the immune system. Though years away from reality, this technological leap would allow the transplantation of islet cells without any need for immunosuppression therapy, which could make the Cell Pouch safer and more sustainable.

Cell Pouch Results

Six participants were enrolled in Sernova’s latest clinical trial. Before the trial began, they were taking an average of 45 units of insulin per day to manage type 1 diabetes. At different points within the year of observation, all six participants achieved insulin independence — a truly incredible achievement!

The very first participant to receive the implanted Cell Pouch containing human donor islet cells achieved insulin independence for 4 1/2 years. Unfortunately, they had to stop the trial due to the diagnosis of another health condition unrelated to the clinical trial. (Sernova cannot share that patient’s personal health details beyond their participation in the trial.)

Two other participants sustained insulin independence for about two years each, and another participant’s insulin independence lasted approximately nine months.

“We’ve never seen such a duration of effect from implanted islet cells,” says Frank Shannon, Sernova’s VP of clinical development and regulatory affairs.

Eventually, however, all six participants needed to have their Cell Pouches removed, mostly due to issues tolerating immunosuppressive drugs. Removing the pouch, though disappointing, also points to another of its features.

“One of the biggest benefits of our Cell Pouch technology is that it can be safely and entirely removed,” says Shannon. “It is easily retrievable.”

Competition From Vertex

Sernova is not the only company searching for a type 1 diabetes cure using islet cells. Vertex Pharmaceuticals is leading the way with its VX-880 and VX-264 clinical trials. 

VX-880 involves the implantation of lab-manufactured insulin-producing cells along with immunosuppression therapy. VX-880 has seen great success so far, with seven participants achieving insulin independence.
VX-264, like Sernova’s Cell Pouch, protects insulin-producing cells with a device. The device aims to prevent the immune system of a person with T1D from attacking and destroying the cells while eliminating the need for immunosuppression therapy. Vertex began recruiting for this trial in 2023 and has not shared any updates as of September 2024.

Vertex can manufacture as many insulin-producing cells as needed. It does not rely on human donor cells. This significantly increases its ability to recruit participants. Vertex recently partnered with another company to build a manufacturing facility in New Hampshire to mass-produce the cells — a clear signal it feels confident in moving forward with its product.

Real Life Experience With Type 1 Diabetes

Sernova’s leadership understands the reality of life with type 1 diabetes.

“When I became diabetic, I was injecting pork insulin from a reusable glass syringe with no ability to actually check my blood glucose level,” explains Jonathan Rigby, Sernova’s CEO. Rigby has lived with type 1 diabetes for nearly 40 years, since he was diagnosed at 18 years old around 1985. He knows firsthand the real-life challenges of managing insulin every day.

“My wife is petrified of me ever traveling on my own because I’ve had many severe lows and three seizures,” says Rigby.

Just this past summer, Rigby took his 10-year-old son to a Yankees baseball game. They spent the night in a hotel in Manhattan after.

“We had a great time, but he woke up to me struggling with an extremely low blood sugar. He had to help me drink soda and eat glucose tabs until I was okay. The reality is that if he wasn’t there, I might not be here today.” 

Despite how far today’s diabetes technology and medications have come, Rigby says the general public needs to understand that people with diabetes are still suffering and struggling.

“People are still dying. People are still getting legs amputated or losing their vision,” says Rigby. “We still have so far to go in fixing this damn disease. Your immune system is your best friend, and it can be your worst enemy.”

Immunosuppression: Developing a Gentler Regimen

“Sernova’s Cell Pouch technology is referred to as an ‘open device,’” explains Shannon. “It does not protect the cells from your immune system, which means it requires immunosuppression therapy.”

While immunosuppression may sound worthwhile to someone who’s been taking injections of insulin for decades, the trade-offs aren’t usually worth it unless you’re truly struggling to survive with T1D. Immunosuppression comes with a wide range of potential side effects that can affect quality of life — including skin conditions, gastrointestinal symptoms, constant fatigue, significant inflammation, and risk of infection.

Shannon agrees that the holy grail is to develop a functional cure that can protect the cells without the need for immunosuppression. But that has still never been achieved in humans — only in mice.

“We have seen it in animals, but that does not mean it will work in a human,” says Shannon. 

For now, Sernova has developed a gentler immunosuppression regimen that is already being administered in the next group of participants. 

“By the time we recognized that some patients were struggling with [our first] immunosuppression regimen, we had already embarked on a kinder, gentler immunosuppression regimen.” 

The first recipient to start the revised immunosuppression regimen was enrolled in late summer 2024. They’ll undergo the cell pouch transplant soon. So far, Sernova says the immunosuppression therapy has been very well tolerated.

Big Steps Forward and Small Steps Back

While those of us with T1D want to press fast-forward on the cure research remote, there is still a long way to go. But companies like Sernova are forging ahead full throttle. 

“We believe this first-in-world data is significant for Sernova and, more specifically, provides tangible hope for T1D patients that we are a significant step further in our mission of providing a functional cure for this terrible disease,” Rigby says.

Would Rigby sign up for Sernova’s Cell Pouch technology?

“Yes, I would,” he says. “Type 1 diabetes is like a gremlin that sits on your shoulder, drawing at your neck 24 hours a day. The fear of hypoglycemia is overwhelming for me.”

He also dismisses any skepticism that insulin manufacturers may try to block the success of a T1D cure.

“I do not buy the story that Big Pharma would attempt to stop us from curing type 1 diabetes,” says Rigby. “The FDA wants to first make sure drug products are safe and then second, that they are efficacious. They are very supportive, and they are happy with where we are going — they understand that this is a development in a bigger path to cure.”

Sernova’s team is just as eager for Vertex’s work to succeed as they are for their own. 

“I want everybody in this space to succeed,” adds Rigby. “I want Vertex to succeed because if they succeed, we succeed. There’s more than one company that sells insulin, and there can be more than one company that offers a functional cure.”

“Any progress that can be made in this space is a win for people with diabetes,” says Rigby. “We will get there one day.”