"Stemline's approach to cancer treatment, targeting the cancer stem cells that support tumor growth and recurrence, is innovative and may provide patients with longer lasting remission from cancer," said
SL-401 is a novel targeted therapy that attacks both tumor bulk cells and CSCs of multiple hematologic cancers including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). SL-401 targets the interleukin-3 receptor (IL-3R), which is over-expressed on tumor cells and CSCs, but is only minimally expressed on healthy cells. As trials conducted to date have shown, this specific activity leads to an improved safety profile with minimal off-target effects. IL-3R is strongly over-expressed on BPDCN, an uncommon but very aggressive cancer that has no good treatment options. In the Phase 1/2 trial of single agent SL-401, 5 of 6 BPDCN patients achieved tumor shrinkage (83% overall response rate), and there were 3 complete responses (CR). In addition to BPDCN, SL-401 has shown very promising single agent activity in patients suffering from relapsed/refractory AML.
The company is also developing SL-701 which is an off-the-shelf, subcutaneously injected peptide vaccine for advanced brain cancer. Highly malignant gliomas have high fatality rates because they grow rapidly, regenerate and have tendrils extended into surrounding brain areas that often cannot be accessed surgically or adequately respond to chemotherapy and/or radiation. SL-701, is comprised of several synthetic peptides, is designed to stimulate the immune system in a very targeted manner to cross the blood-brain barrier and attack tumor cells located anywhere in the brain. In Phase 1/2 clinical trials, SL-701 was shown to be safe and well tolerated, with injection site reactions and fever the only notable adverse events. These trials also showed single agent efficacy, with an overall response and disease stabilization rate of 59% (13/22) in adult patients with recurrent/refractory high-grade gliomas, including recurrent/refractory glioblastoma multiforme (GBM). The overall response and disease stabilization rate in pediatric patients with gliomas, including brainstem and non-brainstem gliomas, was 86% (19/22).
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