Canada-based biotech company ExCellThera has received conditional authorisation from the European Commission (EC) for Zemcelpro to treat blood cancers.
Zemcelpro is a personalised stem cell therapy product derived from a single cord blood unit. It was developed by Cordex Biologics, a subsidiary of ExCellThera.
The cell therapy mitigates the need for life-saving transplants in patients with conditions such as leukaemias and myelodysplastic syndromes.
Zemcelpro is approved for adults with haematological malignancies who require allogeneic stem cell transplantation but lack suitable donor cells.
The EC approval allows ExCellThera to commercialise the drug in all EU member states, along with Iceland, Norway, and Liechtenstein.
The rollout of Zemcelpro is contingent on national reimbursement procedures, and Cordex Biologics is working with health authorities to expedite this process.
Besides, ExCellThera is seeking partnerships to speed up commercialisation in European and other international markets.
ExCellThera and Cordex Biologics CEO David Millette said: “This authorisation marks a pivotal milestone in delivering on the therapeutic promise of Zemcelpro for adults battling life-threatening haematological malignancies.
“As the first and only cell therapy approved for patients without access to suitable donor cells, Zemcelpro offers a vital new stem cell transplant option, and renewed hope, for those who have been left without one.”
Zemcelpro was evaluated in the clinical trials in the US, Europe and Canada.
It underwent Phase 2 trials in patients with acute leukaemias and myelodysplasias, with a Phase 3 trial set to commence soon.
The drug received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the US Food and Drug Administration (FDA).
In addition, Zemcelpro received orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the European Medicines Agency (EMA).
