JDRF Enters Partnership with Thermalin Diabetes for Ultra‐Rapid Insulin

CLEVELAND - April 24, 2014 - PRLog -- JDRF Enters Partnership with Thermalin Diabetes for Ultra‐Rapid Insulin

Cleveland, OH and Boston, MA - April 24, 2014 ‐ JDRF has entered into a partnership with Thermalin Diabetes, LLC to accelerate  the translation of ultra‐rapid‐insulin engineering advances made by Dr. Michael Weiss, Chairman of Biochemistry at Case Western Reserve Medical School and Chief Scientific Officer of Thermalin.  Dr. Weiss’s approach is substantiated by new insights into the binding interfaces between insulin and its receptor, work first  published in the January 10, 2013 Nature by an international team of protein crystallographers co‐led by Dr.Weiss.

“Mike’s insights have uncovered ways to shorten the duration of insulin signaling by manipulating how the insulin ‘key’ fits into the insulin receptor ‘keyhole.’  We plan to use this support to explore more broadly the space of possible modifications which might exhibit the same effect in order to identify a clinical candidate insulin analog with optimized characteristics,” said Bruce Frank, Ph.D., co‐inventor of Humalog and now Vice President of Insulin Development at Thermalin.

Specifically, the partnership with the JDRF will provide up to $1M to achieve specific milestones in identifying a clinical candidate insulin analog with shortened duration of activity.  In a closed loop artificial pancreas system, such an “ultra‐rapid‐off” insulin analogue would enable algorithms to safely maintain tighter control over blood sugar levels and is considered a critical enabling technology for next generation systems.  For diabetes patients who inject insulin before meals, this new insulin analog could reduce the risk of delayed post‐meal hypoglycemia.

Artificial pancreas systems will be external devices which people with T1D could use to do what their bodies cannot:  control both high and low blood sugar around the clock and maintain blood sugar levels within a range close to normal. These systems will work by combining a continuous glucose monitor (CGM), an insulin pump, and sophisticated computer software to provide automatically the right amount of insulin at the right time. One of JDRF’s top priorities is the development of Artificial Pancreas Systems. JDRF‐funded studies have shown improved clinical outcomes from early clinical trials of prototype systems. While Thermalin’s novel insulin will need to be further developed, tested in outpatient trials, and approved for people with T1D, the availability of an ultra-rapid and safe insulin analogue will address one of the key rate‐limiting factors in realizing advanced closed loop systems.

“JDRF has identified a number of areas where new technologies will move us closer to delivering optimal glucose control from artificial pancreas systems. One of these areas is the need for even faster acting insulins ‐ ones that can start and stop working very fast, more like naturally acting insulin.  We are excited to be partnering with Thermalin on their ultra‐rapid insulin technology, which has the potential to accelerate the development of advanced, next generation artificial pancreas systems for T1D patients,” said Aaron J. Kowalski, Ph.D., Vice President of Artificial Pancreas Research at JDRF.

“Thermalin is honored by the support it is receiving today from JDRF.  JDRF staff and the senior scientists it consulted exhibited extraordinary effort and expertise in evaluating Thermalin and its proposal.  We view this partnership as recognition of the quality of our science and the potential of our work to greatly improve the quality of life for patients with T1D.” said Thermalin CEO Rick Berenson.
Thermalin has committed matching funds to the project, which is expected to last 15 months.

About Thermalin
Thermalin’s insulin engineering platform has led to a pipeline of new insulins. Our first will be entering IND enabling studies shortly in preparation for 2015 human studies. To date, Thermalin has raised $9.4M in equity and been awarded $7.8 in grants from the NIH. Our Clinical Advisory Board includes some of the leading endocrinologists in the nation.

About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. JDRF’s goal is to progressively remove the impact of T1D from people’s lives until we achieve a world without T1D.  JDRF collaborates with a wide spectrum of partners and is the only organization with the scientific resources, regulatory influence, and a working plan to better treat, prevent, and eventually cure T1D. As the largest charitable supporter of T1D research, JDRF is currently sponsoring $568 million in scientific research in 17 countries.

About Insulin
T1D is a condition where an individual’s pancreas no longer produces insulin. Insulin is the hormone that lowers blood glucose levels by fitting into the insulin receptor on liver, muscle, and fat cells, thereby instructing those cells to take‐in and store glucose.  When blood glucose runs high, for example after a meal, a healthy pancreas releases insulin to bring blood sugar levels back down to normal.  T1D patients must administer insulin to themselves before meals because their pancreas cannot.  Insulin cannot be taken orally because it is a protein and would be digested.

An insulin analogue is a modified form of the insulin molecule which is designed to work better than regular human insulin when injected subcutaneously (into the skin). For example, some insulin analogues absorb or act faster than others. The market for rapid‐acting insulin analogues (such as Humalog®, Novolog®, and Apidra®) today exceeds $5B and is expected to double over the next ten years.