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Stemline Therapeutics is a publicly traded, New York City based clinical stage biopharmaceutical company which develops novel oncology therapeutics that was founded in 2003 by Eric Rowinsky and Ivan Bergstein. As of December 2018, the company is developing three clinical stage products candidates, SL-401, SL-801, and SL-701.
SL-401, also known as ELZONRIS, is a targeted therapy directed to the interleukin-3 receptor (CD123) present on a wide range of malignancies. A Phase 2 Trial with SL-401 is enrolling patients with BPDCN (Blastic Plasmacytoid Dendritic Cell Neoplasm).
Stemline has submitted a rolling Biologics License Application (BLA) to the FDA for ELZONRIS, which has been granted breakthrough therapy designation (BTD) for the treatment of BPDCN. If successful, the company anticipates the acceptance of the BLA within 60 days of submission and potential U.S. marketing approval by the first quarter of 2019.
SL-801 is a novel oral small molecule reversible inhibitor of nuclear transport protein. It is in Phase 1 clinical trial for the treatment of solid and hematological cancers.
SL-701 is an immunotherapy designed to activate the immune system to attack tumors. Phase 2 trials in adult patients with second-line glioblastoma mutiforme (GBM) has been completed. The data and next steps for the program are being evaluated.
Two other product candidates are also in Stemline's pipeline, SL-501 and SL-101, two next generation IL-3R-targeted compounds. The company has also constructed an innovative drug discovery platform (StemScreen).
On April 9, 2008 Stemline Therapeutics completed their series A funding round with $12.5 million in funding from Prequot Capital.
On March 29, 2010 Stemline Therapeutics completed a venture capital funding round with $1.3 million in funding from undisclosed investors.