Sernova Corp. announced that significant progress has been achieved in its collaboration with Evotec SE. This progress includes advancement of Evotec's iPSC derived islet-like clusters in combination with Sernova's implantable Cell Pouch™ device toward a first-in-human Phase 1/2 clinical trial for the treatment of patients with T1D and severe hypoglycemia slated for regulatory filing in 2024.

The objective of the collaboration is to produce an off-the-shelf, commercially viable, ethically derived cell therapy treatment for people suffering from T1D. The treatment would include Sernova's Cell Pouch System™ incorporating Evotec's iPSC-derived islet-like clusters. The combination product is anticipated to be the first treatment of its kind to reach clinical testing for T1D.

The Evotec and Sernova collaboration has to date resulted in the following significant achievements: Development of a robust, cost-efficient, scalable, highly controlled iPSC differentiation protocol with the ability to cryopreserve and store batches of differentiated islet-cell clusters; Demonstration of excellent islet-like cluster survival under standard shipping conditions and following transplantation; Demonstration of consistent long-term insulin independence with no hypoglycemic events and consistent safety profiles in a gold standard T1D preclinical model with Evotec's iPSC-derived islet-like clusters transplanted in Sernova's Cell Pouch; iPSC islet-like cluster manufacturing scale-up and technology transfer activities to Evotec's iPSC GMP facility are well under way in preparation for manufacture of clinical and commercial iPSC islet-like clusters supply; Interactions with experts in support of design of the first Phase 1/2 clinical trial. Based on these achievements the following activities will be continuing throughout 2023 in preparation for regulatory filings anticipated in 2024: Completion of standard formal safety/toxicology studies and other required preclinical studies; Identification and securing of potential clinical study sites to enable efficient patient enrollment following initiation of the Phase 1/2 clinical study; Preparation of regulatory submissions for planned trial geographies, combining both the established library of regulatory documentation for Sernova's Cell Pouch and that developed by Evotec for their iPSC islet-like clusters.