ExCellThera’s Cell Therapy for Blood Cancer Gets European Approval

MONTREAL, Canada, August 28, 2025 – ExCellThera announced today that the European Commission (EC) has granted conditional marketing authorization for its cell therapy, Zemcelpro, to treat blood cancer patients who lack access to a suitable donor. The approval, granted to its subsidiary Cordex Biologics, makes Zemcelpro available for distribution across the European Union (EU), as well as in Iceland, Norway, and Liechtenstein.

Zemcelpro, also known as UM171 Cell Therapy, is intended for adults with hematological malignancies who require an allogeneic hematopoietic stem cell transplant. It combines both UM171-expanded CD34+ cells and unexpanded CD34- cells and from the same cord blood unit, offering a new transplant option for a critical unmet need.

According to ExCellThera and Cordex Biologics CEO David Millette, this marks a pivotal milestone as Zemcelpro is the “first and only cell therapy approved for patients without access to suitable donor cells.” The authorization follows a positive recommendation from the European Medicines Agency (EMA) in June 2025.

The treatment has been tested on 120 patients in trials across the U.S., Europe, and Canada and has received multiple regulatory designations, including Orphan Drug status from the U.S. FDA and PRIority MEdicines (PRIME) designation from the EMA. ExCellThera plans to pursue additional regulatory submissions in the U.S., the UK, Canada, and Switzerland.