Meet T1D Jonathan Rigby, President & CEO of Sernova Corp

T1D Strong had the pleasure to speak to Jonathan and his wife Marylyn, Sernova’s Chief Communications Officer, about Sernova’s innovative Cell Pouch™, the success of its ongoing clinical trial, and how type 1 diabetes (T1D) affects the entire family.

Jonathan opens up about his ebullience for a cure, as well as his own struggles with nocturnal hypoglycemia and complications due to early years of mismanagement.

“Diabetes is a double-edged sword,” said Jonathan. “On one side, it really upsets and worries me; it worries, Marylyn, it worries our children. And the reality is there are inevitable complications despite how well-controlled you are.”

Jonathan has had eight eye surgeries for different things. “But the other side of the coin is that it motivates me, and it makes me fight. It makes me rebel against it. It motivates me to look after myself. Maybe if I didn’t have diabetes, I wouldn’t be this well,” he joked.

Today, his A1c is 5.9, but he has worked hard to achieve that average. He’s a triathlete who has completed dozens of marathons. Most recently, for Diabetes Awareness Month, in honor of Dr. Frederick Banting and Charles Best’s discovery of insulin over 101 years ago, Jonathan rowed 101 miles to raise funds and awareness for T1D children in need.

Jonathan Rigby’s Backstory

Jonathan was born and raised in the small Northern England town of Wigan, where his father was a carpenter, and his mother was a homemaker. He received his bachelor’s degree with honors from Sheffield University, UK, and an MBA in business administration from the University of Portsmouth, UK.

At 18 years old, Jonathan experienced symptoms of extreme thirst, frequent urination, weight loss and blurred vision. He ended up in the hospital with severe diabetic ketoacidosis (DKA). When Jonathan awoke from his coma, the physician told him that he had T1D. “The sad reality was that I had diabetes for much longer; it was undiagnosed, and my parents had no idea,” he said.

Jonathan’s diabetes care at the time was injecting pig insulin through a reusable glass syringe, and there was no way of testing his blood sugar. “I remember when I was about 26, I went to a new endocrinologist, who said, ‘Jonathan, have you ever had your A1c measured?’” He told the doctor no, he had never heard of it. When the results returned, and his A1c was 14, Jonathan asked, “Is that good? The doctor said, ‘No, it’s terrible!’ After that, things changed for me.”

Adrenalin Enthusiast

Jonathan’s interest in endurance contests began not long after his T1D diagnosis. He saw a sign at a pub for a sprint triathlon, so he and his buddies joined as a relay team. “I was just amazed watching these people do the whole thing, so I went to my doctor and said, ‘I’m going to do a triathlon, and he said, ‘Don’t, Jonathan, you’re going to kill yourself. You can’t do that as a diabetic.’”

He ignored the warning and began a lifelong journey running races, triathlons and Ironman challenges. “I did one, and then I did two, and then I did three. Then I did Olympic distances, and I started running marathons.”

After completing dozens of marathons, he thought he’d try a full Ironman. “I went to my doctor here in the US, and she said, ‘Don’t do it; you’re going to kill yourself.’”

So far, Jonathan has completed dozens of marathons and 11 Ironman triathlons, one of the world’s most physically demanding sporting events. It’s a 140.6-mile race with a 2.4-mile swim and a 112-mile bike ride, which ends with a full marathon (26.2-mile run). Moreover, the race is extremely challenging if you have diabetes, as it requires close blood sugar management, constant insulin intake monitoring, and a careful nutrition strategy.

An Advocacy Leader

Later, Jonathan began using his participation in these events to help those less fortunate. “Some people can’t afford pumps, CGMs (continuous glucose monitors), or to have their insulin covered, so I started doing it to raise money for children who can’t afford to buy insulin pumps; that’s given me a lot of satisfaction.”

Canadian Ironman

Jonathan received a call from the Canadian Breakthrough T1D (formerly JDRF), asking him to speak at an event prior to the Canadian Ironman. “I seized the opportunity and told the children not to let diabetes conquer you or stop you from doing anything.”

Unfortunately, during the bike ride segment, Jonathan crashed and lost consciousness, but instead of giving up, he insisted on finishing the race to show the kids along the sidelines that diabetes doesn’t define you.

“I thought I was done, but when I got to the village and saw children holding signs, ‘Mr. Rigby, keep going, this is great,’ I thought there’s no way I can stop now.” Jonathan finished the race and went to the hospital afterward.

“I think about that a lot and just think if one of those children remembers that, if I changed their life, it would be worth it.”

A Family of Caregivers

Jonathan’s wife, Marylyn, who happens to be a biotech senior executive and CCO for Sernova, along with their children, Heather, Rex and Juliette, are all trained diabetes caretakers.

Jonathan gives credit to Marylyn, who has taught their children what to watch for and how to deal with hypoglycemic episodes. Jonathan has had four diabetic seizures; in the first three, Marylyn rescued him by injecting glucagon.

The fourth time, Jonathan was with his eleven-year-old son. They had watched the New York Yankees play at Yankee Stadium, and the following morning, Jonathan woke up to his son pouring Coca-Cola down his throat. In addition to saving Jonathan’s life during the severe hypoglycemic incident, their son, Rex, also recognized his French teacher’s blood sugar dropping during class and assisted him by finding his glucose tablets and calling for the school nurse. “He’s well aware of the baggage that comes with this disease,” said Jonathan.

Nocturnal Hypoglycemia

Today, Jonathan’s insulin therapy consists of wearing the Tandem Mobi insulin pump and the Dexcom G7, an advanced hybrid closed-loop technology. “I wear my CGM and treat it as a badge of honor,” he said. His wife Marylyn concurred, “The Dexcom CGM has been revolutionary for treating diabetes.” 

Nocturnal hypoglycemia is a rare condition for T1Ds where blood glucose levels drop dangerously low while sleeping. “Unfortunately, when he gets that low, it’s almost impossible to wake him up,” said Marylyn, who follows his blood sugar on the Dexcom app. “He’s a rapidly depleting hypoglycemic, so his numbers will go from 112 to 68 over a minute and a half.” In addition to the glucagon shot, she recommends the Baqsimi glucose nasal spray for hypoglycemia episodes.

“It’s a horrible feeling,” Jonathan said. “My vision will turn on and off; literally, my eyesight goes blank. Things start to sound very loud; you can’t enunciate or talk. It’s a frightening experience. It’s why a lot of diabetics, and I’ve done it myself a number of times, deliberately keep blood sugars high, which in the long term is not a good thing.”

Before the T1D Strong interview, Jonathan had a Zoom call with over 150 shareholders and investors. “I thought, ‘If I go hypo, this will not be a good thing,’ so I took some glucose tablets and am now a little high as a result.”   

Professional Milestones

Jonathan, a biologist by trade, has worked in the pharmaceutical, biotechnology, and drug delivery industries for over 30 years. He moved to the San Francisco Bay area 20 years ago, where his first industry job was in diabetes. I worked for a company called Xeris Pharmaceuticals. “We developed the Gvoke liquid stable glucagon.” The Gvoke HypoPen is a ready-to-use room-temperature prefilled injection device.

Jonathan’s done quite a few things in the diabetes space. “I’ve set up a couple of biotech companies, taking them public and sold some of them,” he said. “I’m currently on the board of a company called IM Therapeutics that is developing a product to delay the onset of T1D.” He is also a past board member of Thermalin Inc., which engineered new forms of temperature-stable insulin. 

Additionally, in August 2024, Jonathan accepted the position of president, CEO, and chairman of the executive board of directors for Sernova Corp. I looked at the technology, and it really excited me,” he said.  

About Sernova Corp

Founded in 1998, Sernova is a clinical-stage regenerative medicine company that develops therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and hemophilia A. Headquartered in London, Canada, the company’s Cell Pouch™ bio-hybrid organ is in development to treat type 1 diabetes.

“(Sernova) is not just a job for me; it’s a passion and a mission. All the other diabetes-related things I’ve done are a passion and a mission because, we have to be honest, the need to treat diabetes and fix it has not been met. Are we better today than when I was diagnosed? A million percent, but we’ve got a long way to go.”

Jonathan is enthused with Sernova’s transplant system the Cell Pouch bio-hybrid organ T1D program. In a letter to his shareholders, he said, “I could not be more determined to drive our programs forward and ultimately onto the market.”

“We treat diabetes now with syringes, pens, pumps, CGMs, but we’re not addressing the full problem because we’re giving people insulin, which is wonderful,” he said. “But there are three hormones the pancreas creates (insulin, glucagon and somatostatin).”

• Insulin – lowers blood glucose
• Glucagon – raises blood glucose
• Somatostatin – regulates insulin and glucagon secretion

“If every day with diabetes were the same, it would be great, but it’s not,” said Rigby. “Some days, I get up and do the exact same thing, and then, for whatever reason, my blood sugar skyrockets.”

Sernova Cell Pouch™

Sernova’s Cell Pouch™ bio-hybrid organ, which has support from Breakthrough T1D (formerly JDRF), is leading the pack for a functional T1D cure. Its ongoing clinical trial shows insulin independence in T1D individuals.

How it Works

Therapeutic cells from donors and, eventually, iPSC-derived islets (induced pluripotent stem cells) are transplanted into an implanted medical-grade mesh bio-hybrid organ (the Cell Pouch); the body then forms a natural, vascularized tissue environment to promote long-term cell functioning. The bio-hybrid organ can also be retrieved, adding an extra safety layer.

The therapeutic cells implanted in Sernova’s Cell Pouch bio-hybrid organ produce abundant insulin, glucagon and somatostatin.

“It literally turns into an organ; we call it the bio-hybrid organ,” said Jonathan. The Cell Pouch is a thin, flexible, credit card-sized pouch with a porous surgical mesh. “The physician makes a little incision in the skin, and it goes underneath the abdomen. Then, blood vessels and cells grow over it. At the moment, it contains human donor islet cells.”

“This was taken out of a patient after five years. Then we did histology, and we can see that it’s still producing abundant insulin, glucagon, and somatostatin,” Jonathan said. “And this particular patient was insulin-independent for about four and a half years.”

After analyzing the removed cells, they compared human islet cells to Cell Pouch bio-hybrid organ islets, and there was little to no variation.

Cell Pouch Clinical Trial

September 12, 2024, Piotr Witkowski, M.D., Ph.D., Professor of Surgery and Director of the Pancreatic and Islet Transplant Program at the University of Chicago and Sernova’s chief principal investigator, presented new data with the Cell Pouch Transplant System using human donor islets, at the European Association for the Study of Diabetes (EASD) conference in Madrid.

The study’s Cell Pouch analysis found that pouches removed from a patient more than five years after transplant are as follows:

• Scientists retrieved abundant, richly vascularized, functioning islets throughout the Cell Pouch chambers. The healthy beta, alpha, and delta cells were actively secreting insulin, glucagon, and somatostatin.
• Sernova’s Cell Pouch provides full, safe retrievability without evidence of detrimental fibrotic tissue.

“Some people don’t last five years before needing another implant,” said Jonathan. He also compared their progress to a marathon and said they’re about halfway through. Sernova recently filed new patent applications to protect and strengthen the longevity of Sernova’s place in the market.

Cell Pouch PHASE I &II

Phase I/II trial is a multi-cohort study to evaluate the Cell Pouch’s safety and efficacy in combination with transplanted human-donor islets. The trial includes T1D patients aged 18-65 who experience hypoglycemic unawareness and severe hypoglycemic episodes.

Cohort A

The six patients enrolled in Sernova’s Phase I/II, Cohort A (with Cell Pouch and donor islets) achieved insulin independence after transplantation. “The first one is finished with six patients, and all six reached insulin independence,” said Jonathan.  

Cohort B

Cohort B is designed to evaluate what the optimal immunosuppression regime is to both protect the transplanted cells, while reducing the traditional side-effect associated with immunosuppressants.  A total of ten patients, 7 of which have already been transplanted, with an optimized 10-channel Cell Pouch with a 50% greater islet capacity than the one used in Cohort A. “We’re at the back end of the second now and have received positive data,” he said.

Cohort C

“The final cohort will combine all our learnings, and we’ll start in the first part of 2025,” said Jonathan. “In this study, we’re looking at an optimized immune suppression regimen, but believe we have a solution for that in the future, where we gene edit the cells, but they’re donor cells right now.”

EVOTEC Partnership

Sernova has partnered with Evotec, a drug/biotech company based in Hamburg, Germany, to develop an islet replacement therapy using implantable induced pluripotent stem cells (iPSC) that make insulin, glucagon and somatostatin. These scalable cell sources/ iPSC-derived islet-like clusters have shown long-term anti-diabetic efficacy and robust glycemic control in diabetic mice.

“They make the mice diabetic, insert the Cell Pouch with these cells, and over a pretty quick time, the blood sugar levels come down to the normal range with little to no variability,” said Jonathan. “Human donor cells are of inconsistent quality, and there is no abundant supply.”

The partnership provides Sernova with a potentially unlimited supply of insulin-producing cells.

“The plan is for Evotec to gene-edit these cells so that they become almost invisible to your immune system,” said Jonathan. “And you won’t have to use immune suppression. That’s the goal. These cells are all high quality, and they’re in an infinite supply, so it’s very exciting.”

Emerging Trends

“The problem for most T1Ds is that we give the insulin almost at the same time as the meal, and that’s not good because it takes about an hour before the insulin starts working,” said Jonathan. “Rapid-acting insulin will help overcome that.”

Jonathan is also entused about novel dual insulin pumps. “I know a few companies working on dual hormone pumps with two chambers: one that delivers insulin and one that delivers glucagon.” 

“And then there are the cell therapies; Sernova’s working on this, and Vertex is working on this as well, and I wish them success. Everyone working in this space, whether they’re competitors or not, I don’t really care because I want them to succeed.”

“These are all strides forward, but we have not cured this thing yet, and I’m sure there will be a day in the future when people say, ‘Remember when we had to deal with diabetes!’”

Advice for Newly Diagnosed T1Ds

“My advice is to research, listen, speak to people who know, speak to patients,” said Jonathan. “Learn as much as you can, take others’ advice and keep yourself controlled. Eat well, exercise is critical.”

“Diabetes makes me angry, and that motivates me to fight it,” he continued. “Don’t have the mindset, ‘I can’t do this, I’m just going to ignore it’ because you’ll regret it. Give it the respect it deserves which may sound a bit strange to say, but when you put your mind to it, you can tackle it.”