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Best Abstracts Session

Monday April 24, 2023 - 14:45 to 16:25

Room: Riverfront

S4

.13 Manufacturing of optimized human islet-like clusters (ILCs) from iPSCs and functional testing of an ILC + Cell PouchTM combination in vivo

Matthias Austen, Germany

SVP Cell Therapy
Cell Therapy
Evotec International GmbH

Abstract

Manufacturing of optimized human islet-like clusters (ILCs) from iPSCs and functional testing of an ILC + Cell PouchTM combination in vivo

Audrey Holtzinger1, Simone Strauch1, Thomas Reinbothe1, Claudia Wrzos1, Andreas Scheel1, Cord Dohrmann1, Arash Memarnejadian2, Pardis Pakshir2, Philip M. Toleikis2, Matthias Austen1.

1Evotec International GmbH, Goettingen, Germany; 2Sernova Corp., London, ON, Canada

We have developed a scalable and comprehensive process for GMP manufacturing of ILCs from a human GMP-grade iPSC line for cell therapy in human insulin-dependent diabetes. The product candidate is characterized by a high beta cell and endocrine cell fraction and has been optimized for low-to-absent unwanted cell content. Functional studies in diabetic rodents show robust normalization of key diabetes disease parameters upon implantation of ILCs under the kidney capsule or in Theracyte encapsulation devices, such as glucose tolerance, random fed glucose levels and circulating human C-peptide. Long-term studies demonstrate no loss of function over extended periods of time, with glucose-lowering activity on a per-beta-cell basis within the same range as observed with human donor islets. Recently, Evotec entered a collaboration with Sernova Corp., which has developed the proprietary Cell PouchTM device. Following implantation, the Cell PouchTM develops a vascularized environment to support engraftment and function of therapeutic cells. The device is currently in clinical trials with human donor islets (ClinicalTrials.gov Identifier: NCT03513939). When tested in combination with the Sernova Cell PouchTM pre-implanted in diabetic NSG mice, our ILCs showed excellent function, indicating that the Cell PouchTM provides a beneficial environment not only for human donor islets but also for iPSC-derived ILCs. iPSC-derived ILC manufacturing scale-up and tech transfer activities to Evotec’s GMP cell manufacturing team are well underway in preparation for human clinical trial evaluation.


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