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Conceptual image courtesy of Thermalin

Imagine having an insulin pump that’s so small, it’s equivalent to the size of a postage stamp and is prefilled with an ultra-concentrated form of insulin that doesn’t require refrigeration — and with a glucose sensor attached, the system automates insulin delivery to help keep blood sugars in range.

That is the dream of Ohio-based biotech company Thermalin, which is developing not only a novel type of ultra-fast insulin that won’t need cooling like existing insulins, but also a miniaturized closed loop device (aka artificial pancreas system) known as the StampPump.

We’re at least a few years away from both, but Thermalin has been actively presenting its recent progress at diabetes conferences for at least a year now.

DiabetesMine spoke recently with Thermalin’s CEO Rick Berenson and Chief Scientific Officer Dr. Dod Michael, who formerly headed insulin biology research and development (R&D) at Eli Lilly, to learn about the company’s exciting vision and what it hopes to accomplish in the coming years.

Thermalin first came on the diabetes scene in 2010, pledging to revolutionize how we all think about insulin by re-engineering some of the fundamentals.

Thermalin has a number of game-changing concepts in the works, all revolving around the new insulin analog they’re developing, known in prototype research form as T‑1123:

  • First, a new ultra-rapid insulin analogue will be launched, a first-generation T-1123 that will rival the onset speed of Fiasp insulin from Novo Nordisk. (Fiasp starts lowering glucose in 15 to 20 minutes, versus Humalog/Novolog that can take as long as a half-hour to start lowering glucose levels.) New T-1123 will also be more stable in order to last longer than those currently on the market; it will be resistant to fibrillation, the process by which insulin corrodes over time, becoming less effective and causing occlusions in pump tubing.
  • Next, an even faster, hyper-rapid acting insulin would be developed from there. Thermalin hopes this version would be “meaningfully faster” than Fiasp or even Lilly’s ultra-rapid Lyumjev insulin.
  • Then, a concentrated U-500 version of T-1123 would be introduced, allowing people with greater insulin needs to take more insulin in smaller liquid amounts.
  • No refrigeration. A next-generation of T-1123 would be new stable basal (background) insulin that wouldn’t need refrigeration, making it ideal for mail order shipping and prefilled insulin devices. Thermalin is developing a basal form as well as a bolus-basal (background-mealtime) mixed version that would ideally be usable for a year or more without any refrigeration.
  • Glucose-responsive insulin. Finally, a long-discussed dream often referred to as the “holy grail of insulins” could actually respond to glucose fluctuations and effectively turn itself on and off automatically, based on the body’s needs.

Several years have passed since Thermalin initially forecasted the debut of its novel insulin, leading to some public skepticism. But now, company leadership says they are working to finish preclinical prep on the initial T-1123 versions in 2021, with hopes to start clinical trials in 2022.

The Cleveland-based start-up has long touted that their team includes the co-inventor of Eli Lilly’s Humalog insulin, Dr. Bruce Frank, and he’s helping forge the path forward. Other notable names on their team include prestigious scientist Dr. Michael Weiss, Thermalin’s co-founder and chief invention officer, and John L. Brooks, who led the respected Joslin Diabetes Center for years before eventually joining Thermalin as the board chair.

Note that as a clinical-stage biotech company largely focused on R&D, Thermalin would most likely not market the new insulin itself. Instead, they’d likely partner with a larger Pharma player. It seems Eli Lilly already has its eyes on them, given the November 2020 agreement that Lilly’s Chorus clinical R&D group signed with Thermalin.

As anyone who uses insulin will recognize, a new insulin that could remain potent for a year (or more) without needing any cold storage would be a game changer.

Today’s insulins need to be kept in the refrigerator until use, and most are labeled for use within a month after opening. This makes travel, and even daily storage, complicated for many people with diabetes.

Thermalin’s T-1123 would address important cold storage supply chain issues, meaning people with diabetes (PWDs) who rely on mail order companies and retail pharmacies wouldn’t need to worry about the insulin going bad in case it got too warm.

“Being able to store prefilled insulin vials or cartridges, or do direct-to-consumer shipping without needing Styrofoam coolers and cold packs… that could be a huge advantage,” said Dr. Michael. “Maybe it’d allow for more of a one-stop shop for patients in getting their insulin and supplies.”

One of the things holding back today’s insulin delivery devices from optimizing efficiency and convenience is the need to change out insulin cartridges/reservoirs every few days. The fact that today’s insulins can’t hold up too long also leads to clogged cannulas (occlusion errors), causing gaps in delivery, and the need to fill the devices by hand rather than having them prefilled.

Thermalin hopes to address all those issues, largely by focusing first on the concentrated stable insulin as the foundation for improved new systems.

“We think that’s a big step forward because it enables new devices and distribution (channels) that have a lot of benefits for the folks involved in the diabetes ecosystem,” Berenson said. “This has the potential to really change the treatment and disease management paradigms for insulin therapy.”

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Conceptual image courtesy of Thermalin

Thermalin notes that its T-1123 insulin could lead to slimmer insulin pens or even compatibility with a future implantable insulin pump. But mainly, the Ohio company plans to develop its own new diabetes device — a prefilled, patch pump that it refers to as the StampPump. It will literally be the size of a U.S. postage stamp.

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Conceptual image courtesy of Thermalin

Specifics of the StampPump are:

  • It’s a patch pump that sticks onto the body and doesn’t use traditional tubing — ultra-thin at only 6.5 millimeters (mm), and a 36 by 33 mm total footprint. Thermalin boasts that it’s 75 percent smaller than an Omnipod, by comparison.
  • Factory filled with up to 600 units of insulin (concentrated, so the amount of liquid would be roughly the same size of a current 300mL cartridge on existing technology). With no need for refrigeration, the StampPump would come in prefilled cartridges.
  • Using Thermalin’s T-1123 insulin, they believe the StampPump could be worn for 7 days (rather than the current 2 to 3 of existing pumps using today’s insulins).
  • Each unit would be fully disposable, meaning you’d swap the entire StampPump out each week.
  • It sports an easy applicator, which in conceptual images looks similar to the current Dexcom G6 applicator, where the user just pushes a single button to stick the unit on the body.
  • It would deliver both basal and bolus insulins, and would be designed to be a full closed loop system with mobile app connectivity.
  • The first-generation device would include other biosensors to monitor heart rate, activity, and stress.

Note that Thermalin is not creating its own continuous glucose monitor (CGM), but instead would use Bluetooth to connect with CGMs currently available.

Future generations would resemble a U.S. silver dollar, with a built-in CGM sensor from any one of the many different companies developing future CGM technology. Berenson says Thermalin is at least a couple years out from selecting an initial CGM company to work with on integration.

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Conceptual image courtesy of Thermalin

Because it’s so small, there wouldn’t be any user interface on the device itself except for maybe a flashing light. Instead, Berenson said it would be operated through a mobile app. It also wouldn’t need to have the mobile device nearby to function, because the device would have a microprocessor inside to work and store data if you forget your phone at home.

“Existing pump hardware is obtrusive,” Berenson said. “It’s just very hard not to ‘advertise’ that you have diabetes if you’re wearing one of these current devices. Getting rid of the tube has worked for Insulet with the Omnipod being so popular from just that innovation, but it’s still pretty big like you’re wearing an egg.”

“What the StampPump will do is create a tiny, ultra low-profile device that will literally disappear under even tight clothing. That is a significant innovation,” Berenson said.