Overview

• The European Commission authorized Zemcelpro for adults needing allogeneic HSCT after myeloablative conditioning when no suitable donor cells are available, covering the EU plus Iceland, Norway and Liechtenstein, and making it the first therapy of its kind in Europe.
• Zemcelpro is a personalized, cryopreserved graft that pairs UM171‑expanded CD34+ cells with unexpanded cells from the same cord blood unit to boost usable cell dose for adult transplants.
• Across two early‑phase trials (n=50), investigators reported an estimated 2‑year overall survival of 67% and progression‑free survival of 63% at a median follow‑up of 24 months.
• Safety findings included acute graft‑versus‑host disease rates of 69% for grade 2–4 and 16% for grade 3–4, with moderate‑to‑severe chronic GVHD occurring in 7% of patients.
• ExCellThera’s subsidiary Cordex Biologics is engaging national authorities on early access while preparing additional filings in the United States, United Kingdom, Canada and Switzerland and advancing a U.S. phase 3 program.