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\u00ae, 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\u00ae, 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.
\u201cHaving 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,\u201d said
Matthieu De Kalbermatten, CEO of CellProthera.
\u201cWe 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,\u201d said Jean-Olivier Hirsch, Chief Operating Officer and Qualified Person of
CellProthera.
\u201cWe look forward to supporting CellProthera at this critical juncture for ProtheraCytes\u2019 development,\u201d
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.\u201d<\/p>\n\n\n\n