First clinical batches of ProtheraCytes® planned for 2026

CellProthera, a regenerative cell therapy developer specializing in ischemic diseases, has chosen CELLforCURE by SEQENS, as its contract development and manufacturing organization (CDMO) partner for its planned Phase 3 trial for ProtheraCytes®, its autologous expanded CD34+ stem cell-based therapy aimed at improving heart failure event-free survival following a severe heart attack. CellProthera will tech transfer to CELLforCURE by SEQENS this year, with plans to produce clinical batches starting in 2026.

With promising results from a Phase 1/2b study of its lead ProtheraCytes®, CellProthera has begun preparations for its late stage of clinical development. Last year, the company presented its Phase 3 design to 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.

“Having a partner with expertise in advanced stage of clinical development and commercialization of cell and gene therapies adds substantial value for CellProthera as we enter the final phase of development for ProtheraCytes, looking at Phase 3 and through to market authorization,” said Matthieu De Kalbermatten, CEO of CellProthera.

“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. “We look forward to supporting CellProthera at this critical juncture for ProtheraCytes’ development,” said Marc-Olivier Mignon, President of CELLforCURE by SEQENS. “Our ability to embrace innovative technologies and scale up production for late-stage clinical trials will help accelerate the investigation of potential new therapies.”