Late-Breaking Results of a Preclinical Efficacy Study Presented at ENDO 2023 Show Seraxis SRE Sustainably Reverses Type-1-Diabetes Hyperglycemia

GERMANTOWN, Md., June 16, 2023 (Newswire.com) - Seraxis today announced late-breaking results of an ongoing study evaluating the efficacy of SRE pancreatic clusters in a type 1 diabetes model at the Endocrine Society Annual Scientific Meeting ENDO held in Chicago, IL. The poster (#10117) is available at www.seraxis.com.

Results from an ongoing type 1 diabetes efficacy study with Seraxis SRE (Synthetic Replacement Endocrine) clusters (SR1423) implanted into the kidney capsule or gonadal fat pad in a diabetic mouse model showed that implantation resulted in sustained euglycemia. Control mice that did not receive an implant remained hyperglycemic. SRE transplantation resulted in euglycemia 3-4 weeks post-implant; 72 mg/dL +/- 12 SEM when implanted to the kidney capsule (n=13), and 79 mg/dL +/- 15 SEM when implanted to the gonadal fat pad (n=10). Control mice (without SRE implant) in this model of type 1 diabetes (n=2) remained hyperglycemic; 570 mg/dL +/- 20 SEM. Both of the doses evaluated in the study demonstrated a similar efficacy. The two sites of implants showed equivalent performance.

The non-iPSC and non-ESC derived SRE clusters demonstrate a distinct and unique single-cell sequencing profile, which does not overlap with other stem cell-derived beta cells. They secrete a similar level of insulin as native islets, show a low tumorigenic potential and are composed of each pancreatic endocrine cell type in physiologic proportions.

"Despite advances in diabetes management, the need for a long-term cure remains unmet. These preclinical results continue to support the promise of our stem cell-derived replacement therapy for type 1 diabetes, which I believe could be transformative for patients in need," said Paul S. Strumph, MD, and Chief Medical Officer of Seraxis. "I am encouraged by the data thus far and confident in our progress towards developing a safe and effective clinical candidate."

ABOUT Seraxis, Inc.

Seraxis' proprietary human stem cell line SR1423 and manufacturing process efficiently generates SRE clusters that mimic native islets in purity and potency and have shown the potential to reverse diabetes in animal models. Seraxis has also developed the SeraGraft device and other tools to enable survival and function of the islet replacement therapy in immunocompetent hosts. Seraxis is a privately held biotechnology company with operations located in the BioHealth Capital Region, Maryland. Further information can be found at www.seraxis.com