First clinical batches of ProtheraCytes expected in 2026

CellProthera has selected CELLforCURE by SEQENS to manufacture clinical batches of its lead therapy, ProtheraCytes, for an upcoming phase 3 trial.

The French biotech specializes in regenerative therapies for ischemic conditions and will begin tech transfer to the CDMO later this year. Production of the Good Manufacturing Practice (GMP) material is expected to start in 2026.

ProtheraCytes is an autologous expanded CD34+ stem cell product designed to improve event-free survival in patients with heart failure following a severe myocardial infarction.

CellProthera reported encouraging results from its earlier phase 1/2b study and has received favorable feedback from the FDA on its phase 3 development plan.

“Having a partner with expertise in advanced clinical development and commercialization of cell and gene therapies adds substantial value as we prepare for phase 3 and market authorization,” said Matthieu de Kalbermatten, CEO of CellProthera.

The company highlighted CELLforCURE by SEQENS for its GMP infrastructure and ability to handle complex autologous therapies.

“We selected CELLforCURE for the quality of its equipment and the expertise of its team, which has already demonstrated its ability to release commercial batches of autologous therapies,” added Jean-Olivier Hirsch, CellProthera’s COO.

Marc-Olivier Mignon, president of CELLforCURE by SEQENS, said the project reflects the company’s strategic focus on advanced therapy manufacturing.

“We look forward to supporting CellProthera at this critical juncture. Our ability to scale up production for late-stage clinical trials will help accelerate the development of innovative therapies like ProtheraCytes.”

CellProthera’s phase 3 preparations include the tech transfer and qualification of the manufacturing process in a facility equipped to produce and release clinical-grade cellular products, a key milestone before initiating pivotal studies.