Evotec-partner Sernova provides update on development of iPSC-derived cell therapy for diabetes
First iPSC-derived commercially viable off-the-shelf islet combination product is advancing towards regulatory filing in 2024 for anticipated clinical trial authorization to treat patients with Type 1 Diabetes (T1D) and severe hypoglycemia
iPSC islet-like cluster manufacturing scale-up and tech transfer activities are well under way in preparation for first human clinical evaluation
T1D preclinical models with iPSC derived islet clusters transplanted in Sernovas Cell Pouch has now demonstrated consistent long-term insulin independence de-risking the combined technologies for both companies
London, ON, Canada, 10 January, 2023:
Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that significant progress has been achieved in its collaboration with Evotec SE (FSE: EVT; NASDAQ: EVO). This progress includes advancement of Evotecs iPSC derived islet-like clusters in combination with Sernovas 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 Sernovas Cell Pouch System incorporating Evotecs 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 Evotecs iPSC-derived islet-like clusters transplanted in Sernovas Cell Pouch
iPSC islet-like cluster manufacturing scale-up and technology transfer activities to Evotecs 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 Sernovas Cell Pouch and that developed by Evotec for their iPSC islet-like clusters |
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