Blood stem cell therapies company ExCellThera Inc, the parent company of Cordex Biologics, announced on Monday that Cordex has entered into exclusive licensing and supply agreements granting Netherlands-based Avanzanite Bioscience B.V. commercialisation rights for Zemcelpro (dorocubicel), also known as UM171 Cell Therapy, across 32 countries covering the European Economic Area, the United Kingdom and Switzerland.

Zemcelpro is a novel personalised cryopreserved haematopoietic stem cell transplantation product containing two cellular components: UM171-expanded CD34+ cells (dorocubicel); and unexpanded CD34- cells, each derived from the same cord blood unit. The product is used to treat haematological malignancies (blood cancers), such as leukaemia and myelodysplasias. It is indicated in the European Union for the treatment of adult patients with haematological malignancies requiring allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no suitable donor is available.

The transaction includes development fees, commercial milestone payments and royalties, supporting the funding of the planned Phase 3 trial evaluating Zemcelpro in patients with high- and very high-risk acute leukaemia and myelodysplastic syndromes. The trial is intended to generate confirmatory evidence of efficacy and safety and support a potential indication expansion.

Avanzanite will lead regulatory activities, market access, pricing and reimbursement, medical affairs, commercial operations and distribution across the licensed territories. Following completion of the regulatory transfer, Avanzanite will become the holder of the existing EU marketing authorisation for Zemcelpro. Avanzanite also plans to submit marketing authorisation applications in the United Kingdom and Switzerland.

Cordex will continue to lead global development of Zemcelpro and will be responsible for the manufacturing and supply of Zemcelpro to Avanzanite.

Cordex also continues to pursue additional strategic partnerships to support and accelerate the commercialisation of Zemcelpro in the USA and other international markets.