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news.Fate Therapeutics, a California-based developer of stem cell modulators (SCMs) to guide cell fate for therapeutic purposes, has presented preliminary data from an ongoing Phase 1b clinical trial of FT1050.
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FT1050 is a small, SCM-designed molecule which enhances hematopoietic stem cell support during the normal course of a stem cell transplant in patients suffering from hematologic malignancies, such as leukemia and lymphoma.
The study, which is being conducted at the Dana-Farber Cancer Institute and Massachusetts General Hospital, aims to determine the safety and tolerability of introducing FT1050 during the standard course of dual umbilical cord blood transplant in adults with hematologic malignancies who have undergone non-myeloablative conditioning therapy.
Fate is developing FT1050 with the aim of improving the overall efficiency of hematopoietic stem cell (HSC) support by enhancing HSC homing to and proliferation in the bone marrow.
The company has also received orphan drug designation (ODD) for FT1050 from the US Food and Drug Administration (FDA) for the ex vivo treatment of human allogeneic hematopoietic stem cells to enhance stem cell engraftment by treating neutropenia, thrombocytopenia, lymphopenia and anemia.
It has also received a positive recommendation from the Committee for Orphan Medicinal Products for orphan designation in the European Union.
Fate Therapeutics vice president of Clinical Development Pratik Multani said the orphan drug status, combined with encouraging preliminary Phase 1b clinical trial results and a strong intellectual property portfolio, gives the company the confidence to continue developing FT1050 for patients who have life threatening blood cancers and disorders.