Stemline Therapeutics, Inc. is a clinical stage biopharmaceutical company developing novel oncology therapeutics. Stemline is developing three clinical stage product candidates, SL-401, SL-801, and SL-701.
SL-401 is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a wide range of malignancies. A Phase 2 potentially pivotal trial with SL-401 is enrolling patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). The U.S. Food and Drug Administration (FDA) granted SL-401 Breakthrough Therapy Designation (BTD) based on data from this ongoing trial, which is demonstrating high overall response rates (ORR), with multiple complete responses (CRs). Patients are also being followed for response duration and outcomes. In addition, ongoing Phase 2 trials with SL-401 are currently enrolling patients with additional malignancies including acute myeloid leukemia (AML) in remission with minimal residual disease (MRD) and advanced, high risk myeloproliferative neoplasms (MPN) of unmet medical need. A Phase 1/2 trial in relapsed/refractory multiple myeloma with SL-401 in combination with standard therapies is also enrolling patients.
SL-801 is a novel oral small molecule reversible inhibitor of XPO1, that has demonstrated broad in vivo and in vitro preclinical activity in a wide array of solid and hematologic malignancies. A Phase 1 trial is open and enrolling patients with advanced solid tumors, and a Phase 1 trial in hematologic malignancies is planned.
SL-701 is an immunotherapy designed to activate the immune system to attack tumors. A Phase 2 trial with SL-701 is currently ongoing in adult patients with second-line glioblastoma multiforme (GBM).