Type 1 Cure Research Update: The Sernova Cell Pouch

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 filled with islet cells. This is the part of the pancreas that produces beta cells and secretes insulin. The new treatment under investigation, the cell pouch, is surgically implanted against the abdomen just below the skin. The pouch can accommodate and protect implanted islet cells that may allow people with type 1 diabetes (T1D) to stop using insulin injections. It may contribute to the ultimate treatment of type 1 diabetes.

Sernova recently shared an update on the pursuit of functional treatment for type 1 diabetes. All six participants in the Sernova small trial successfully achieved insulin independence for at least nine months. The company’s leadership team spoke about innovation in diabetes every day.

Sernova’s cell pouch technology

Surgeons have implanted pancreatic cells into type 1 diabetes patients for decades, and they connect the pancreas to the liver, typically by trapping the cells in the portal vein. meanwhile Portal venous technique It has been used for decades, but has faced high failure rates due to various complications. This is why biotech companies like Sernova are developing great porting methods.

Sernova’s pouch system aims to better support and protect cells, ensuring that it is properly adopted by the body through angiogenesis.

After implantation, the pouch gradually becomes “angiogenesis” depending on the body. The recipient’s blood vessels may grow through the pouch. The blood vessels then pick up insulin and supply it all over the body, but the islet cells remain in the pouch.

Donated pancreatic islet cells

Until now, Sernova has used human donor cells that must come from the deceased organ donor. These cells are only available in very limited quantities, and most experts believe that practical wide-scale implant solutions require a different approach.

To access more viable islet cells, Sernova partners with Evotec to produce unlimited amounts of insulin-producing cells in the laboratory. Sernova hopes that future clinical trials will use these manufactured cells and eliminate dependence on donated human pancreas.

Additionally, Sernova and Evotec intend to genetically edit these cells to make sure they are “immune deficiency” and make them invisible to the immune system. Though years away from reality, this leap in technology allows for the transplant of islet cells without the need for immunosuppressive therapy, making 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. All six participants at various points within the year of observation achieved insulin independence. This is truly an incredible achievement!

The first participants to receive an embedded cell pouch containing human donor islet cells achieved insulin independence over four and a half years. Unfortunately, they had to suspend the trial to diagnose another health condition that was not related to the clinical trial. (Sernova cannot share details of the patient’s personal health beyond participating in the trial.)

The other two participants each maintained insulin independence for about two years;Insulin independence in other participants lasted approximately 9 months.

“I have never seen a period of such an effect from an implanted islet cell,” says Frank Shannon, Vice President of Clinical Development and Regulation Affairs at Cernova.

However, in the end, all six participants had to remove the cell pouch, primarily due to resistance to immunosuppressive drugs. It’s a shame to remove the pouch, but it also points out another aspect of its functionality.

“One of the greatest benefits of cell pouch technology is that it can be safely and completely removed,” says Shannon.. “It’s easy to recover.”

Competition from the top

Sernova isn’t the only one using islet cells to search for type 1 diabetes treatment. Vertex Pharmaceuticals is leading the way in that way VX-880 and VX-264 clinical trials.

• VX-880 It includes transplantation of laboratory-producing insulin-producing cells, along with immunosuppressive therapy. VX-880 So far, seven participants have achieved insulin independence, resulting in great success.
• VX-264like a Cernova cell pouch, Protect insulin-producing cells with the device. The device aims to prevent the immune system of people with T1D from attacking and destroying cells, while eliminating the need for immunosuppressive therapy. Vertex began recruiting for this trial in 2023 and has not shared any updates as of September 2024.

Apex can produce as many insulin-producing cells as necessary. that’s right do not have It depends on human donor cells. This greatly improves our ability to recruit participants. Vertex recently partnered with another company Construction of manufacturing facilities in New Hampshire To mass-produce cells – a clear signal that is confident in moving forward with that product.

Real-life experiences of type 1 diabetes

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

“When I got diabetes, I had no ability to actually check my blood sugar levels and injected pork insulin from a reusable glass syringe,” he explains. Jonathan RigbyCEO of Sernova. Rigby has lived with type 1 diabetes for almost 40 years since being diagnosed at the age of 18 in 1985. He knows firsthand the real challenges of managing insulin every day.

“My wife has had a lot of severe lowness and three seizures, so I’m petrifying my own trip,” Rigby says.

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

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

Despite how far away the technology and medicines of diabetes today are, Rigby says the general public needs to understand that people with diabetes are still struggling and struggling.

“People are still dying. People are still amputated or have lost their eyesight,” Rigby says. “We still need to go to fix this damn illness. Your immune system is your best friend and it could become your worst enemy.”

Immunosuppression: Development of mild regimens

“Sernova’s cell pouch technology is known as an “open device,” explains Shannon. “It doesn’t protect cells from the immune system. That means immunosuppressive therapy is necessary.”

Immunosuppression may be valuable to those who have been injected with insulin for decades, but unless you really struggle to survive with T1D, the trade-offs are usually not worth it. It comes with immunosuppression A wide range of potential side effects It can affect quality of life, including skin condition, gastrointestinal symptoms, constant fatigue, serious inflammation, and the risk of infection.

Shannon agrees that the Holy Grail is to develop functional therapy that can protect cells None The need for immunosuppression. But that has never been achieved in humans yet. Only with the mouse.

“We’ve seen it in animals, but that doesn’t mean working in humans,” says Shannon.

For now, Sernova is developing a mild immunosuppressive regimen that has already been administered in the next group of participants.

“By the time we realized that some patients were struggling with their (our first) immunosuppressive regimen, we had already embarked on a kind and gentle immunosuppressive regimen.”

The first recipients to launch the revised immunosuppressive regimen were registered at the end of summer 2024. They will undergo cell pouch implantation immediately. So far, Sernova says immunosuppressive therapy is highly tolerated.

A big step forward and a small step backward

We who use T1Ds want to fast-forward Cure Research Remote, but we still have a long way to go. But companies like Sernova are moving forward with full throttle.

“This first-dimensional data is important to Sernova and, more specifically, provides specific hope for T1D patients that it is an even more important step in our mission to provide functional treatment for this horrifying disease,” says Rigby.

Will Rigby sign up for Sernova’s cell pouch technology?

“Yes, I will,” he says. “Type 1 diabetes is like a gremlin sitting on my shoulder, I draw my neck 24 hours a day. The fear of hypoglycemia is overwhelming for me.”

He also dismisses skepticism that insulin makers could try to block successful T1D treatments.

“I won’t buy Big Pharma about trying to stop us from curing Type 1 diabetes,” Rigby says. “The FDA wants to first make sure the medicines are safe and then they are effective. They are very supportive and they are happy where we go – they understand that this is a development of a bigger path to treatment.”

The Sernova team is keen to make Vertex work as successful as theirs.

“I hope everyone in this field will succeed,” Rigby adds. “If the vertex is successful, we’re successful, so we want to make the vertex a success. There are multiple companies that sell insulin and several companies that offer functional treatments.”

“The advances that can be made in this area are a victory for people with diabetes,” Rigby says. “I’ll get there someday.”