Seraxis Announces Publication of Preclinical Data for a Novel Islet Replacement Therapy and Clinical Candidate SR-02 for Insulin-Requiring Diabetes; Oral Presentation at IPITA

Manuscript describes the unique character of a pancreatic endocrine cell population derived from a non-pluripotent stem cell that closely resembles native islets in composition and in vivo function. Dr. William Rust, CEO of Seraxis, will deliver a lecture at the IPITA-IXA-CTRMS Joint Congress on October 29 at 10:00 a.m. in San Diego entitled “Novel stem cell-derived islet-like clusters potently control rodent blood glycemia”. Seraxis will be taking meetings at BIO-Europe, November 6-8, in Munich.


Seraxis, Inc., a regenerative medicine company developing pancreatic islet replacement therapies to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, today announced the publication in bioRxiv of “Pancreatic Endocrine cell clusters derived from a non-pluripotent stem cell capable of regulating blood glucose in animal models of diabetes.” The manuscript describes a novel population of stem cell-derived pancreatic endocrine cell clusters (SR-02) that form functional pancreatic grafts and potently regulate blood glucose levels in animal models. The SR-02 program is the subject of an upcoming IND filing for the treatment of severe recurrent hypoglycemia in patients with T1D. The unique nature of the SR-02 program and the company’s clinical goals will be discussed by Dr. William Rust, CEO of Seraxis, at the International Pancreas & Islet Transplantation Association Congress on October 29 in San Diego, and further discussed by Ted Hibben, Chief Corporate Development Officer, at BIO-Europe, November 6-8, in Munich.

“This manuscript is the first description of a novel population of pancreatic endocrine cell clusters with the potential to be best-in-class as a practical cure for children and adults with insulin-requiring diabetes,” said William Rust. 


Seraxis is bringing transformative cures to the millions of people worldwide struggling with the management and life-threatening complications of T1D and insulin-requiring T2D. 

Seraxis’ lead program, SR-02, is a novel, off-the-shelf islet replacement therapy slated to enter clinical testing with immunosuppressive therapy in 2024 in patients with severe recurrent hypoglycemia. A follow-on diabetes program, SR-03, is a version of the Seraxis pancreatic clusters altered to be unrecognized by the immune system for use by the broader population of T1D and insulin-requiring T2D without chronic immune suppression.

Seraxis’ underlying proprietary technology enables the creation of a pipeline of novel stem cell-derived therapies originating from single donated organs for other indications. The company’s lead therapeutic program, SR-02, is manufactured from a stem cell line derived from a human donor pancreas. These cells preferentially re-differentiate into pancreatic clusters containing all the endocrine cells of the native pancreatic islet, and with safety, potency, and manufacturing advantages over embryonic and induced pluripotent stem cells.

Seraxis is backed by Frazier Life Sciences, Polaris Partners, Eli Lilly, the JDRF T1D Fund and independent investors. Seraxis manufactures its best-in-class therapeutic pancreatic clusters using scalable, clinically compliant processes in its cGMP facility located in Maryland’s I-270 Biotech Corridor. 

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Source: Seraxis Inc.

About Seraxis, Inc.

Seraxis is a private biotechnology company launched in 2013 and located in Germantown, Maryland. Its mission is to bring to the market a practical and potent cell replacement therapy for insulin-dependent diabetes. The Seraxis team has developed a novel cell replacement therapy that reverses diabetes. The company is currently working to advance this therapy to the clinic.

Seraxis, Inc.
20400 Century Boulevard , #Suite 150
Germantown, MD


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