NASDAQ : STML
|Aug 24, 2016
||4:00 PM ET
|Delayed at least 20min., by eSignal.|
Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel therapeutics that target cancer stem cells (CSCs) and tumor bulk. Stemline is developing two clinical stage product candidates, SL-401 and SL-701, and a pipeline of preclinical candidates that includes SL-801.
SL-401 is a targeted therapy directed to the interleukin-3 receptor (IL-3R) present on CSCs and tumor bulk of a wide range of hematologic cancers. Three multicenter clinical trials with SL-401 are currently open in seven indications. SL-401 is currently completing the lead-in stage of the pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN). Clinical studies with SL-401 are also open in additional hematologic indications including acute myeloid leukemia (AML) in first complete remission (CR) with minimal residual disease (MRD), relapsed/refractory AML, and four types of advanced high-risk myeloproliferative neoplasms (MPN), including systemic mastocytosis, advanced symptomatic hypereosinophilic disorder, myelofibrosis, and chronic myelomonocytic leukemia. Previously, SL-401 demonstrated single-agent activity, including multiple durable CRs, in a Phase 1/2 trial in BPDCN and relapsed/refractory AML.
SL-701 is an immunotherapy designed to activate the immune system to attack tumors, and is being developed in adult patients with glioblastoma multiforme (GBM) in first recurrence. Previously an earlier version of the therapy demonstrated clinical activity, including tumor shrinkages, disease stabilizations, and an overall survival signal compared to historical data, in investigator sponsored Phase 1/2 trials in advanced adult and pediatric brain cancers.
SL-801 is a novel oral small molecule reversible inhibitor of Exportin-1 (XPO1). SL-801 has demonstrated broad in vivo and in vitro preclinical activity in a wide array of solid and hematologic malignancies. SL-801 is currently being advanced toward investigational new drug (IND) filing for clinical development in solid and hematologic cancers.
Stemline’s preclinical pipeline also includes SL-501 and SL-101, two next generation IL-3R-targeted compounds. Stemline has also constructed an innovative drug discovery platform (StemScreen™), and built an extensive intellectual property portfolio that includes some of the earliest patents in the CSC field.
Aug 23, 2016
Stemline Therapeutics Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for SL-401
Aug 11, 2016
Stemline Therapeutics to Present at the 2016 Wedbush PacGrow Healthcare Conference
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