Thermalin Announces:

Thermalin Engages Lilly’s Chorus Group for Early Development of Insulin Analog T-1123

Indianapolis, Indiana, November 10, 2020.  Thermalin Inc. has entered into a Development Services Agreement with Eli Lilly and Company under which Lilly’s Chorus organization will take responsibility for managing the pre-clinical and early clinical development of Thermalin’s stabilized insulin analog, T-1123. Chorus will utilize Lilly’s existing drug development project management processes, policies, guidelines and quality requirements and will leverage the Chorus network of Third Party providers.  Under the agreement, Chorus will provide guidance, regulatory consulting, and CDMO/CRO selection and oversight services over a multi-year period.  Thermalin will contract directly for services provided by CDMOs and CROs that Chorus recommends.

Dod Michael, Ph.D., Chief Scientific Officer at Thermalin, said “We look forward to working with the Chorus organization at Lilly to advance the development of our insulin analog, T-1123. Chorus-managed projects are known throughout the industry for their scientific expertise and quality of results.  This collaboration will ensure Thermalin produces the highest quality, ‘pharmaceutical grade’ data for its future regulatory filings related to T-1123.”

About T-1123.  T-1123 is a new chemical entity, stabilized insulin analog that can be formulated to be ultra-rapid at both U‑100 (100 units per ml) and U-500 (500 units per ml) concentrations.  In pre-clinical studies, T-1123 demonstrated (a) ultra-rapid insulin action for both U-100 and U-500 formulations of T-1123 in swine euglycemic clamp studies—results that are comparable with Novo Nordisk’s U-100 Fiasp®, (b) glucose-lowering potency in animal models that is comparable to human insulin and the prandial insulin analogs, (c) enhanced chemical and physical stability, and (d) potency to stimulate proliferation of human MCF-7 breast cancer cells that is six-fold less than human insulin.

About Thermalin.  Thermalin, a privately held biotechnology company with its main laboratories in Cleveland, Ohio, is developing next-generation insulin solutions for people with T1D and T2D.  Thermalin’s programs include (1) clinical candidate T-1123; (2) StampPump—a miniaturized glucose management system that will deliver the concentrated, ultra-rapid-acting formulation of T-1123; (3) basal and mix insulins that never need refrigeration; and (4) a glucose-responsive insulin that protects against hypoglycemia by losing potency when glucose levels are below normal. Thermalin insulin innovations derive from the scientific research of Prof. Michael Weiss, M.D., Ph.D., Chair of Biochemistry and Molecular Biology at Indiana University School of Medicine.  For more information, please visit www.thermalin.com.  For background on insulin therapy for diabetes, please visit www.thermalin.com/background.