Policy

Thermalin Diabetes wins $250,000 to develop new insulins

Thermalin Diabetes Inc., the Cleveland start-up that is developing new forms of insulin, has received a $250,000 investment commitment from JumpStart Ventures on the way to a Series A fundraising likely to be completed by the end of May. “It’s the first piece of what I think will be close to $2 million-worth of financing […]

Thermalin Diabetes Inc., the Cleveland start-up that is developing new forms of insulin, has received a $250,000 investment commitment from JumpStart Ventures on the way to a Series A fundraising likely to be completed by the end of May.

“It’s the first piece of what I think will be close to $2 million-worth of financing we’re going to close within the next two months,” said Rick Berenson, executive chairman of Thermalin and managing director of Venzyme Venture Catalyst in Newton, Mass.

“We were very pleased about it. JumpStart was very constructive throughout the process and we ended up with a great outcome,” Berenson said. JumpStart Ventures is the investment arm of JumpStart Inc., the nonprofit venture developer in Northeast Ohio.

Thermalin is commercializing the discoveries of Dr. Michael Weiss, chairman of the Biochemistry Department at Case Western Reserve University School of Medicine. Weiss started studying insulin in 1985 when he was a clinical fellow in medicine at Brigham & Women’s Hospital in Boston.

Since then, he has developed several “insulin analogs“–new proteins engineered to act like insulin in the body. Insulin enables the body to convert fuels like sugar to energy. Diabetes patients make too little insulin–or none at all–so they often must inject themselves with the hormone to survive.

Weiss is founder and chief scientific officer for Thermalin. The company purchased an option to license the Weiss discoveries last fall, notably an ultra-fast-acting insulin taken with meals. Since then, Weiss has finished development of a long-acting insulin. Berenson said he is in “detailed license negotiations” with Case Western Reserve for these insulins.

The insulin analogs are heat resistant, unlike the natural hormone, which must be refrigerated. Resistance to heat makes the analogs especially useful in insulin pumps worn outside the body or in locations, like disaster sites, where there is no refrigeration.

“Over the next 20 years, worldwide insulin sales are expected to grow from $12 billion to $54 billion,” said Ted Frank, JumpStart Venture Partner who will be helping Thermalin, in a written statement. “That growth, combined with the medical community’s interest in insulin with higher performance, fewer side effects and storage flexibility, position Thermalin’s pipeline to be in high demand.”

Since October, Thermalin has opened a lab in Cleveland and hired its first employee “who’s working in the lab, helping us to synthesize new insulins,” Berenson said.

The fast-acting insulin–developed through one of two Small Business Innovation Research grants to Thermalin–is exciting because it acts the same way as Lantus, the long-acting insulin by drug company Sanofi-Aventis, Berenson said.

“Lantus has taken the market by storm because it has a very favorable property where you inject it and it gives you a steady, base-level of insulin that’s pretty flat for 24 hours,” he said. “We may be able to get significantly longer kinetics” with reduced long-term side effects.

Thermalin will use the JumpStart and other Series A investments to validate its insulin analogs, sign a manufacturer and move toward Food and Drug Administration market approvals. “We have a pretty good pipeline of insulins,” Berenson said. “There are several key milestones we’re going to be achieving with this financing.

“One is, we’re going to complete our proof-of-concept studies in large animals,”  he said. Once this study is completed, Thermalin will have a significant product.

“We’re also going to be having our pre-Investigational New Drug meeting with the FDA. That’s not scheduled yet,” Berenson said. “And we’ll be getting all the pieces in order to be able to start our preclinical studies,” likely early next year.