Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 Diabetes

Sernova and Evotec on Track to Initiate Clinical Testing of the First iPSC-Derived Islets in Cell Pouch as a Potential Functional Cure for Type 1 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 Sernova’s Cell Pouch has now demonstrated consistent long-term insulin independence de-risking the combined technologies for both companies

LONDON, Ontario – January 10, 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 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

Dr. Philip Toleikis, President and Chief Executive Officer of Sernova, commented, “Together Sernova and Evotec maintain a shared, singular focus on developing the first combination product involving ethically sourced iPSC-derived islet-like clusters within Sernova’s Cell Pouch for a type 1 diabetes functional cure that could, conceivably, eliminate the need for daily insulin injections in patients with diabetes and significantly reduce the burden on healthcare systems worldwide. Furthermore, we believe that Evotec’s strategic design of its islet-like clusters to closely match human islets and the cost-efficient manufacturing process combined with our collective approach to efficiently deliver the islet-like clusters to patients for transplant into our Cell Pouch represents a disruptive and commercially attractive treatment, that could one day treat people with insulin-dependent diabetes worldwide.”

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec, commented, “Evotec’s iPSC-derived human beta cells in combination with Sernova’s implantable Cell Pouch device represent a unique cell therapy product opportunity aiming to provide a potential functional cure to insulin-dependent diabetic patients. The combination product is highly differentiated through the quality of the cells and the device but also the scalability of the manufacturing process of the iPSC-derived cells and therefore clearly positioned to become the best-in-class cell therapy in the field.”

ABOUT SERNOVA AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells.

On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago.

Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression.

In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral Factor VIII gene therapy for hemophilia A. 

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FORWARD-LOOKING INFORMATION

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