Vertex’s halt does not deter Sernova and Evotec

Sernova and Evotec have partnered on the development of an implanted device encapsulating stem cell-based beta cells for the treatment of type 1 diabetes, just two weeks after Vertex’s diabetes cell therapy was put on clinical hold. Evotec has invested €15m ($16m) in Sernova as part of the deal, and is to invest a further €5m. Preclinical development will be jointly funded; upon IND filing Sernova has the right to an exclusive global licence. Should the project go all the way, there will be a profit-share, with the split dependent on how much Evotec kicks in towards clinical trial costs. Sernova is already conducting mid-stage trials on a similar cell therapy using its Cell Pouch device, but the new project must be tested from scratch with the cells Evotec is supplying. The companies say human trials could begin in 2024. On a call today management of both groups expressed confidence that the new project would avoid the problems experienced by Vertex, since the cells are immobilised within a device; Vertex’s VX-880 is an infusion. Vertex is also working on a cell-device combo, but this remains preclinical two and a half years on from the acquisition of its originator, Semma

Selected cell therapies in development for type 1 diabetes
Company Partner Product Device-based?  Phase
Sernova - Cell Pouch w human donor islets and systemic immune protection Yes Phase 1/2
Evotec Cell Pouch w Evotec’s iPSC-based beta cells Yes Preclinical
Vertex - VX-880 No Phase 1/2 (on hold)
  Cell-device combo Yes Preclinical
Viacyte - Pec-Direct (VC-02) Yes Phase 1/2
WL Gore Pec-Encap (VC-01) Yes Phase 1/2
Crispr Pec-QT (VCTX210) Yes Phase 1
iPSC = induced pluripotent stem cells. Source: Evaluate Pharma, company websites.

NB: this piece has been updated to correct the status of Viacyte's Pec-QT. 

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