October 15, 2024, Germantown, MD. Seraxis Inc., a clinical stage regenerative medicine company invested by Viva BioInnovator (VBI), has received FDA's allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first reprogrammed stem cell-derived pancreatic product candidate allowed by FDA for testing in humans as a potential functional cure for insulin-requiring diabetes.
“It is established that replacement islets can free a patient of diabetes from insulindependency. Our goal is to make a highly allocompatible and oN-the-shelf productavailable to the millions of patients in need,” said Will Rust, PhD, Seraxis President and CEO.
The SR-02 therapeutic candidate is comprised of allogeneic pancreatic endocrine cellclusters that, when implanted to the omentum, form a functional endocrine pancreasoutside of the native pancreas. SR-02 is manufactured at clinical scale in the company’scGMP manufacturing facility from a proprietary stem cell line reprogrammed from healthydonor pancreas tissue.
“Seraxis is making an important contribution in the eNort to relieve patients with diabetesfrom insulin injections and long-term health complications. This route of administrationmay oNer a safer option for the development of these treatments,” said James Markmann, MD PhD, Vice President of Transplant Services, Penn Transplant Institute.
About Seraxis
Seraxis is bringing transformative therapies to the millions of people worldwide strugglingwith the management of insulin-requiring diabetes and the associated life-threateningcomplications. Seraxis’ lead program, SR-02, is a novel islet replacement therapy forpatients of insulin-requiring diabetes with concurrent immunosuppression therapy. Thistherapy is the foundation of Seraxis follow-on therapies for patients without immunesuppression. Frazier Life Sciences, Polaris Partners, Eli Lilly and Company, the T1D Fundand others are investors in Seraxis. Visit www.seraxis.com.
