CellProthera Selects CELLforCURE by SEQENS for Phase 3 GMP Manufacturing of its stem cell-based therapy

CellProthera, a French 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 targeted to regenerate cardiac tissue and aimed at improving heart failure event-free survival following a severe heart attack. With promising results from a Phase 1/2b study of 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. CellProthera has also developed a unique GMP-compliant cell expansion process as well as a proprietary automation technology for in vitro production of a large quantity of purified, expanded CD34+ stem cells. Technology 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.  The technology transfer process to CELLforCURE by SEQENS will begin this year, with plans to produce clinical batches starting in 2026.“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.