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. Stemline Therapeutics has developed a Discovery Platform called StemScreen® to identify novel compounds that target and kill CSCs.
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.
StemScreen®-1 is a 3-step platform which involves:
1. CSC isolation and target identification.
2. Proprietary in silico screen which identifies compound classes that interact with CSC targets.
3. Battery of anti-CSC functional assays that test compounds for activity against CSCs both in vitro and in vivo. In some cases the Company has employed medicinal chemistry to optimize lead compounds. Stemline currently has 6 active oncology programs — three of which have yielded lead compounds to date.
StemScreen®-2 is a proprietary high throughput screen currently in development. StemScreen®-2 takes advantage of a landmark discovery that cancer cell lines harbor CSCs. This technology enables the development of high throughput screens for compounds that target CSCs.