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Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel oncology therapeutics that target both cancer stem cells (CSCs) as well as the tumor bulk. Among Stemline's drug candidates are SL-401 and SL-701, both of which have demonstrated single agent clinical activity in Phase 1/2 studies of advanced cancer patients.
In a multicenter Phase 1/2 trial in patients with advanced hematologic cancer, SL-401 demonstrated single agent activity in multiple indications, including durable complete responses (CRs) in relapsed or refractory acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN), and an overall survival (OS) improvement relative to historical data in the most heavily pre-treated patients. In addition, SL-401 was well-tolerated and was not toxic to the bone marrow. SL-401 is being advanced into a pivotal Phase 2b trial in patients with BPDCN and a registration-directed Phase 2b study in patients with advanced AML. In Phase 1/2 trials, Stemline's second clinical stage therapeutic, SL-701, has demonstrated single agent activity including durable CRs and partial responses (PRs) in adult patients with refractory or recurrent glioblastoma and pediatric patients with malignant glioma, as well as an OS benefit in adult patients with refractory or recurrent glioblastoma compared with historical data. SL-701 is now poised for later stage trials in pediatric and adult patients with advanced brain cancer.
Stemline is also developing a broad portfolio of preclinical small molecules and antibodies for a variety of solid and hematological cancer types. Many of these compounds have derived from the Company's proprietary discovery platform, StemScreen®. Stemline also possesses a landmark portfolio of intellectual property that includes the earliest filings in the CSC field covering CSC-directed therapeutics, diagnostics, and drug discovery.