CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, has chosen CELLforCURE by SEQENS, as its CDMO partner for its planned Phase 3 trial for ProtheraCytes. CellProthera will tech transfer to CELLforCURE by SEQENS this year, with plans to produce clinical batches in 2026. 

ProtheraCytes is an autologous expanded CD34+ stem cell-based therapy aimed at improving heart failure event-free survival following a severe heart attack.

Last year, the company presented its Phase 3 design to the FDA and received favorable advice. Tech transfer and qualification of the bioproduction process in a specialized facility capable of releasing clinical batches of cellular products is an essential prerequisite for the start of Phase 3.

With promising results from a Phase 1/2b study of its lead ProtheraCytes, CellProthera has begun preparations for its late-stage clinical development.

“We selected CELLforCURE by SEQENS for the quality of its infrastructure, its equipment and the expertise of its team, who has already demonstrated its ability to release commercial batches of autologous therapies,” said Jean-Olivier Hirsch, Chief Operating Officer and Qualified Person of CellProthera.