The partnership leverages Sernova’s implantable cell therapy device, Cell Pouch System, which is said to have demonstrated Phase 1/2 clinical proof-of-concept using human donor islets, with Evotec’s ethically-derived induced pluripotent stem cell (iPSC)-based insulin-producing beta cells.
The combined technologies create the potential to provide a ‘functional cure’ for diabetes, said the collaborators.
Evotec will also make a strategic €20m (US$21.1m) equity investment in Sernova.
Sermova said Evotec’s decision to exclusively license its lucrative iPSC-based islet-like clusters to its device speaks to the promise of its technology.
Addressing cell therapy development obstacle
The Canadian company’s implantable cell therapy device sits just underneath the skin near the navel, about the shape and thickness of an index card.
Sernova said the pouch system has an ability to naturally vascularize, allowing cells to provide a continuous supply of insulin for years. It is also working on technology to cloak the implant from the immune system, to eliminate the need for immunosuppressives.
An ongoing Phase I/II study at the University of Chicago, said the developer, has seen seven patients treated with the device. The longest a patient has gone with no insulin injections required, to date, has been 25 months, but this treatment is currently dependent on post-mortem human donor islet cells, so only a limited number of people can be treated through donor programs, it added.
So the idea of the partnership is to expand Sernova’s implantable device, to treat millions of people with insulin-dependent diabetes - both type 1 and 2 - as Evotec will exclusively supply an unlimited quantity of iPSC-based islet-like clusters, addressing a major obstacle to bringing cell therapies to market.
The partners said Evotec has demonstrated the ability to reliably produce an unlimited supply of high quality, stable, human iPSC-derived beta cells using its proprietary process for producing islet-like clusters in a quality-controlled scalable bioreactor process. "These islet-like clusters have now been proven to be functionally equivalent to primary human islets in their ability to normalize blood glucose using in vivo models of type 1 diabetes (T1D)," said the German company.