CellProthera Selects CELLforCURE by SEQENS as CDMO Partner for Phase 3 ProtheraCytes Trial

• CellProthera has chosen CELLforCURE by SEQENS as its CDMO partner for Phase 3 production of its autologous cell therapy, ProtheraCytes.

• Tech transfer is scheduled for this year, with clinical batches expected in 2026.

CellProthera, a developer of regenerative therapies for ischaemic diseases, has named CELLforCURE by SEQENS as its contract development and manufacturing organisation (CDMO) partner for the planned Phase 3 trial of ProtheraCytes. The cell-based therapy is designed to improve heart failure event-free survival following severe myocardial infarction.

Under the agreement, CellProthera will transfer technology to CELLforCURE by SEQENS by this year, with the goal of initiating clinical batch production in 2026. The partnership marks a key step in advancing ProtheraCytes into late-stage development.

The decision follows positive outcomes from a Phase 1/2b study and recent feedback from the US Food and Drug Administration on the proposed Phase 3 design. Qualification of the bioproduction process at a facility capable of releasing clinical batches is essential to begin the next phase of trials.

“Having a partner with expertise in advanced stage of clinical development and commercialization of cell and gene therapies adds substantial value for CellProthera,” said Matthieu De Kalbermatten, CEO of CellProthera.

“We chose CELLforCURE by SEQENS because of the strength of its infrastructure, the quality of its equipment, and the proven expertise of its team, which has already shown it can deliver commercial batches of autologous therapies,” said Jean-Olivier Hirsch, Chief Operating Officer and Qualified Person of CellProthera.

CELLforCURE by SEQENS will support production in its specialised facility, equipped for autologous therapies. The collaboration is expected to facilitate the path toward market authorisation of ProtheraCytes.