Riding its European approval, ExCellThera's Montreal-based subsidiary Cordex Biologics has signed exclusive licensing and supply agreements granting Medexus Pharmaceuticals (TSX: MDP) Canadian commercialization rights for Zemcelpro (dorocubicel) — the first and only cell therapy authorized in the EU for blood cancer patients who lack access to suitable donor cells. The Zemcelpro Canada licensing deal positions the UM171 cell therapy for a potential Health Canada submission, with commercialization not expected before 2028.
Financial terms were not disclosed beyond confirmation that the transaction includes royalties on Canadian net sales and milestone payments. Cordex retains manufacturing, supply, and clinical program responsibilities globally.
Deal context
Zemcelpro (dorocubicel) is a cryopreserved, cord blood-derived hematopoietic stem cell transplant product manufactured using ExCellThera's proprietary UM171 small molecule. The molecule works by activating the CRL3-KBTBD4 E3 ubiquitin ligase complex, which degrades the CoREST1/LSD1 transcriptional repressor and simultaneously limits chromatin-bound MYC levels — a dual mechanism that preserves primitive stem cell identity while permitting ex vivo expansion. The result is a cryopreserved, off-the-shelf hematopoietic stem cell therapy product that can be manufactured from smaller cord blood units previously considered clinically unusable, broadening donor availability for patients who lack matched donors.
The product received conditional marketing authorization from the European Commission in August 2025 following a positive CHMP opinion in June 2025. Phase II data reported at the EBMT 2026 Annual Meeting in 60 adults with high- and very high-risk acute leukemias and myelodysplastic syndromes demonstrated 63.7% overall survival and 57% progression-free survival at 24 months — compared with a historical benchmark of 25–40% overall survival with conventional allogeneic grafts in similar-risk patients. Grade III–IV acute graft-versus-host disease occurred in 20% of patients; moderate-to-severe chronic GVHD was reported in 7% at two years. A pivotal Phase III trial is planned. The product carries FDA orphan drug and RMAT designations, as well as EMA orphan, ATMP, and PRIME designations.