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The Islet Product, Planning for Trials, and Manufacturing

Tuesday April 25, 2023 - 10:15 to 11:30

Room: Riverfront

S7

.2 Stem cell-derived islets for treating diabetes: The Seraxis approach

William Rust, United States

CEO
Seraxis Inc

Biography

Will Rust, PhD CEO and President Seraxis Inc Will Rust, PhD, spent most of his scientific career developing research tools and therapies from embryonic and iPS cells. As an early mover with pluripotent stem cell technology, he was uniquely aware of the potency and limitations of these cells. He had a strong conviction that a modified or variant form of this cell type could be the basis for a superior cell therapy. Based on this conviction, Will Rust raised the funds to launch Seraxis Inc, where he developed an alternative stem cell line with enhanced pancreatic differentiation potential to be a basis for anti-diabetes islet replacement therapy. Under his leadership, Seraxis completed three rounds of funding, developed cGMP manufacturing of highly pure and potent replacement pancreatic islets and is preparing for clinical testing this year. In parallel, Seraxis has developed two proprietary methods of immune evasion to enable implant of its lab-grown islets in non-immune-suppressed patients.

Abstract

Stem cell-derived islets for treating diabetes: The Seraxis approach

William Rust1.

1Seraxis Inc, Germantown, MD, United States

Seraxis has developed a novel human multipotent immortal stem cell line, SR1423, and manufacturing process that generates cell clusters with hallmarks of functional, endocrine pancreatic phenotypes. These cell clusters, termed Synthetic Replacement Endocrine (SRE) clusters, contain cell types that recapitulate native islet function in vitro and potently control blood glucose in different animal models of insulin-dependent diabetes. Detailed characterization reveals significant distinctions between SRE, native islets and SC-beta cells. SRE clusters are manufactured following GMP requirements in closed vessels with large-scale formats and are being developed for near-term clinical studies. The Seraxis path to the clinic includes in-house development of quality systems, achievement of consistency and purity milestones and demonstration of stability adequate for lot release, distribution and patient care.


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