StemEx is an expanded cord blood stem cell transplant for patients with no suitable bone marrow donor.

Gamida Cell raised $10 million through an internal Series E financing round with all its existing major shareholders. The proceeds will be used to support global commercialization of the firm’s Phase III-stage StemEx cord blood stem cell therapy for blood cancers, and continue development of additional pipeline candidates, including clinical development of its cord blood-based NiCord® cell therapy for the treatment of sickle cell disease and thalassemia.

StemEx is an expanded stem cell product in development through a joint venture with Teva as an alternative allogeneic therapy for patients with blood cancers such as leukemia and lymphoma who could be cured by bone marrow transplantation but for whom there is no matched bone marrow donor available. Results from the ongoing registrational study are expected by the end of 2012, and market launch of StemEx is projected for 2013.

StemEx comprises a graft of expanded stem/progenitor cells derived from a single umbilical cord blood unit, and transplanted by IV administration together with the remaining cells from the same cord blood unit. Gamida Cell says that in contrast with competing cord blood-derived products in development that use two units of blood, StemEx should be significantly less expensive. The firm is currently looking for a strategic partner for global commercialization of the product.

Gamida Cell’s remaining pipeline is based on its nicotinamide (NAM) stem cell expansion platform. The lead NAM-based product NiCord is in Phase I/II clinical development for the potential treatment of hematologic malignancies and hemoglobinopathies such as sickle cell disease and thalassemia. The NAM technology also forms the basis of the firm’s CordBridge™ candidate for treating neutropenia, and is being applied to natural killer cell expansion to develop products for solid and hematological cancers, and to mesenchymal stem cells for applications in regenerative medicine. 

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