• Evotec’s scalable GMP manufacturing process has been designed to produce induced pluripotent stem cell (iPSC)-derived islet-like clusters (ILCs) with high insulin-producing beta cell content as well as glucagon and somatostatin (produced by alpha cells and delta cells, respectively), similar to human islets
• The ILCs are cryopreserved during manufacturing, enabling storage of mass volumes and cost efficient on-demand worldwide delivery as required
• Results from a type 1 diabetes (T1D) preclinical model with Evotec’s ILCs implanted into Sernova’s Cell Pouch™ demonstrated robust and durable insulin independence with blood C-peptide levels and glucose tolerance test results equivalent to a test group with human islets
• An additional T1D study with Evotec’s ILCs demonstrated sustained normalization of blood sugar levels in diabetic mice throughout the 320 day term of the study
• IND filing and Phase 1/2 clinical program with Sernova’s Cell Pouch and Evotec’s iPSC ILCs on track for 2024

LONDON, Ontario, April 24, 2023 (GLOBE NEWSWIRE) -- April 24, 2023 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced the presentation of preclinical data supporting the anticipated 2024 IND submission and planned Phase 1/2 clinical trial of Evotec SE’s (FSE: EVT; NASDAQ: EVO) iPSC-derived ILCs in combination with Sernova’s implantable Cell Pouch device for the treatment of patients with T1D. The objective of the partnership is to produce an off-the-shelf, commercially scalable cell therapy treatment, with human testing anticipated to begin in 2024.

The data were presented by Matthias Austen, PhD, SVP Cell Therapy at Evotec SE (Evotec), as an oral podium presentation at the 4^th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, held from April 24-25, 2023 in Cambridge, Massachusetts. The presentation included an introduction to Evotec’s proprietary GMP process for manufacturing iPSC-derived ILCs for use in Sernova’s Cell Pouch, as well as encouraging results from multiple studies using a standard mouse model of T1D.

Key findings:

• Evotec has developed a scalable GMP manufacturing workflow, starting from GMP-grade iPSCs to the final product of ILCs, yielding a high beta cell fraction with no post-implantation variability of cell composition.
• Evotec ILCs are cryopreserved at a late-intermediate stage of differentiation allowing for a cost-effective large-scale manufacturing process to optimize both pre- and post-implantation durability, offering a major advantage over competing cell therapies in development.
• ILCs implanted to mouse kidney capsule demonstrated complete and durable normalization of glucose levels in a standard diabetic mouse model out to the pre-planned termination date at 320 days.
• ILCs implanted into Sernova’s Cell Pouch demonstrated rapid normalization of glycemic control in the streptozotocin (STZ)-induced diabetic NSG (NOD.SCID.IL-2Rgamma^null) mouse model.
  • Circulating C-peptide levels (a biomarker for insulin production) in mice implanted with the Cell Pouch and ILCs were equivalent after 6 weeks to those in mice that received 4000 IEQ human islets under the kidney capsule.
  • Efficient glucose clearance and no hypoglycemia was demonstrated in an oral glucose tolerance test administered at 8 weeks post-implantation. Animals implanted with Cell Pouch and ILCs showed an identical glucose clearance time course compared to animals transplanted with 4000 IEQ human islets.
• Upon explantation of the Cell Pouch with ILCs after the 32-week survival period, histological graft analyses showed the presence of all relevant islet cell types including insulin-producing beta cells, glucagon-producing alpha cells, and somatostatin-producing delta cells, indicating a favorable cell composition of the implanted ILCs.
• Histological graft analyses also revealed extensive intra-graft vascularization, likely contributing to the excellent endocrine cell survival with a high beta cell fraction, and consistent with the observed functional outcomes.

“Our ongoing productive partnership with Evotec continues to progress towards human clinical trials in 2024 with an impressive cell therapy paired with our Cell Pouch to create a potential ‘functional cure’ for T1D,” said Dr. Philip Toleikis, President and Chief Executive Officer of Sernova. “These results demonstrate that Evotec’s ILCs in the Cell Pouch can become fully functional endocrine islets following implantation, with potency equivalent to human islets. Our goal is to advance beyond decades-old insulin injections to provide a potential one-time treatment to restore normal pancreatic glycemic control for individuals with T1D. We look forward to providing an update at the American Diabetes Association conference in June on our ongoing Phase 1/2 study in T1D patients with our Cell Pouch containing human donor islet cells and to progressing our next generation product utilizing Evotec cells into the clinic in 2024.”

Dr. Cord Dohrmann, Chief Scientific Officer of Evotec commented, “We are thrilled to show these results with Evotec’s ILCs that we have spent years perfecting with a scalable cost-effective GMP workflow to create a cryopreserved product with excellent survival under standard shipping conditions and optimized for implantation into Sernova’s Cell Pouch. These new data demonstrating rapid, complete, and durable normalization of glucose control that is equi-potent comparable in potency to human islets is one of the final steps prior to our anticipated human testing in 2024.”

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing 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 (induced pluripotent stem cells) based 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 has secured an exclusive option for an exclusive global license for Evotec’s ethically derived iPSC insulin producing islet clusters for use with Sernova’s Cell Pouch System or alone with other technologies. Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

FORWARD-LOOKING INFORMATION

This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.