- 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
The data were presented by
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-2Rgammanull) 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.
Dr.
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VP, Investor Relations christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.com | cdavis@lifesciadvisors.com Tel: 212-915-2577 | emiller@lifescicomms.com Tel: 646-791-9705 |
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